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Background Urinary fistula (UF) is a global health problem but less common in well-resourced countries. Over the past decade there has been a trend toward managing UF in dedicated centres. Most of the evidence for surgical treatment is from individual case series, with few publications that involve high numbers. We describe the repair of recurrent and complex UF cases and outcomes in a tertiary referral setting. Objective To describe UF aetiology, repair techniques, and outcomes. Design, setting, and participants This is a retrospective study of a series of patients undergoing UF repair at a specialist unit. Outcome measurements and statistical analysis We describe the aetiology, cure rate, complications, and postoperative urinary incontinence rates for the series of UF cases. Results and limitations A consecutive series of 98 patients was identified, all of whom were tertiary referrals. Of these, 31 (31.6%) had at least one prior attempt at repair at another centre. The median age was 48 yr (interquartile range [IQR] 40–60.25). The median time from occurrence to repair was 12 mo (IQR 6–12). UF occurred most commonly following hysterectomy (48.0%), Caesarean section (9.2%), other gynaecological surgery (7.1%), and anti-incontinence surgery (7.1%). Complex fistulae (eg, repeat cases, radiation, ureteric involvement) comprised 41 of the cases (41.8%). Most patients with vesicovaginal fistula underwent repair via a transabdominal approach (70.4%). Tissue interposition was used in 96 cases (98%). There were no Clavien-Dindo grade >3 complications. Two patients (2%) had a persistent UF postoperatively. Two patients (2%) developed recurrence more than 2 yr after their initial repair, and both were successfully repaired at our centre. Twelve patients (12.3%) developed de novo overactive bladder, 22 (22.5%) developed stress urinary incontinence (13 had subsequent incontinence surgery), and two (2%) developed bladder pain (both had a subsequent cystectomy). Conclusions Despite a high rate of recurrent and complex UF, successful lasting closure was achieved in 96% of our cases. A minority of patients developed other problems such as de novo overactive bladder and stress urinary incontinence that may require further treatment. Patient summary Urinary fistula is an abnormal opening or connection in the urinary tract and is less common in well-resourced countries. As a consequence, management of this condition is more frequently undertaken at specialist units. Even patients with a complex fistula and those who have had multiple attempts at repair can experience a cure. Urinary leakage is a common complication after the operation but can be successfully managed with surgery., Take Home Message Despite a high number of complex and recurrent cases, we achieved a success rate in excess of 95% in the surgical management of genitourinary fistula. It is important that such cases are managed by teams of surgeons who are comfortable in undertaking both vaginal and abdominal approaches to repair.

Objective:Transvaginal excision of urethral diverticulum (UD) is the gold standard treatment for symptomatic women with UD. Complete UD excision can be challenging due to poor access to the surgical field, especially with proximal, circumferential and recurrent UD. Prone patient positioning has been suggested as an effective way of improving surgical access and vision compared to the traditional supine positioning. However, direct comparison of the two positions is yet to be performed. This study aimed to compare patients who underwent UD excision in prone and supine positions.Materials and Methods:Prospectively recorded data of 79 women undergoing urethral diverticulectomy between 2004 and 2017 in a single referral centre were reviewed. Patients were operated either in supine or prone positions based on the surgeon’s preference. Data collected included patient demographics, UD characteristics on magnetic resonance imaging, intraoperative details and postoperative outcomes. Operative time was calculated from the electronic theatre records starting from the entry of the patient into the operating room to their exit.Results:The mean patient age was 42.38 (±15.24) years. More than half of the patients had a recurrent UD at presentation (51.89%). The mean size of the diverticulum was 25.06 (±1.2) mm, and the mean operative time was 146.18 (±6.0) min. UD excision was undertaken in prone position in 50 (63.3%) and supine position in 29 (36.7%) patients. Patients in the prone position group were older and had relatively larger and proximal UD. In the multivariable analysis, it was found that a proximally located UD was the main indicator for undergoing surgery in the prone position.Conclusion:Despite longer operative times, prone patient positioning appears to be the preferred option for patients with larger and proximal UD, presumably because it offers better access to the surgical field.

Background Female urethral diverticula (UD) are an uncommon and often overlooked aetiology in women presenting with lower urinary tract symptoms, urethral pain, and recurrent urinary tract infection. With increasing awareness, appropriate imaging is more commonly undertaken with consideration given to surgical management. Objective The video presented demonstrates the technique for excising large and/or complex UD using a modified prone jack-knife position—a position that offers excellent surgical access and allows the surgeon to operate in a more ergonomic position. Design, setting, and participants A retrospective review of the data on patients undergoing excision of UD at a tertiary referral unit was performed. Surgical procedure Urethral and suprapubic catheters (±insertion of ureteric stents) were placed in supine position. UD excised in the modified prone jack-knife position (±placement of a Martius flap). Measurements Subjective cure rate, recurrence rate, rates of postoperative urinary incontinence, need for secondary incontinence procedure, and postoperative complications were measured. Results and limitations A total of 121 patients were operated on in the study period. The mean follow-up time was 10 mo (range 3–40). The most frequent presenting symptoms included a vaginal mass (n = 76, 63%), followed by dysuria (n = 72, 60%) and pelvic pain (n = 71, 59%). An identifiable aetiological factor was present in 45 patients, including traumatic vaginal delivery (18, 15%), prior periurethral surgery (17, 14%), and urethral dilatation (10, 8%). All patients underwent postvoiding magnetic resonance imaging (MRI) to confirm the diagnosis and plan surgery. UD ranged in maximum diameter from 8 to 48 mm, with a mean of 43 mm (standard deviation 9.24). The most common anatomical location was midurethral (55, 46%), followed by distal (36, 30%), proximal (25, 21%), and full length (5, 4%). Most UDs were single in configuration (74%), followed by multiloculated (15%), saddle shaped (7%), and circumferential (5%). On preoperative videourodynamics, 17 (14%) had stress urinary incontinence. UD excision was undertaken in the modified prone jack-knife position in all cases. A Martius flap was utilised in 36 (30%). The median postoperative postvoiding residual was 26 ml (interquartile range 0–40). In total, 88 (73%) patients were continent postoperatively and 16 (13%) experienced de novo stress urinary incontinence. Of the 37 with pre-existing stress incontinence symptoms, 20 (54%) were continent after operation. A total of 14 patients had subsequent autologous fascial sling at 6 mo. In total, five symptomatic recurrences occurred (4%); of these patients, three elected to undergo surgical excision, all of whom had symptom resolution and were continent after operation. A total of 11 patients (9%) experienced a Clavien-Dindo grade I–II complication within 90 d after operation. Five patients complained of dyspareunia, which resolved by 6 mo. Conclusions The modified prone jack-knife position facilitates excellent access for excision of both simple and complex UDs. This positioning of the patient is not widely recognised amongst urologists. Using this approach, there were low rates of symptomatic recurrence and de novo stress incontinence at medium-term follow-up. Associated urinary incontinence resolves in over half of patients following UD excision; hence, we advocate deferring any incontinence procedure until after the results of surgery are established. Patient summary Surgical removal of urethral outpouching (diverticula) in women is challenging due to its potential to damage the nearby sphincter muscle, which controls continence, or the urethra tube. Placement of patients on their front, rather than on their back, provides excellent access for the surgical removal of urethral diverticula. With this approach, we achieved excellent rates of cure and low rates of urinary incontinence at an average follow-up of 10 mo.

Purpose of review Urethrotomy remains the first-line therapy in the treatment of a urethral stricture despite data showing no real chance of a cure after repeated urethrotomies. An anastomotic or an augmentation urethroplasty using oral mucosa can be offered to patients following failed urethrotomy. The potential for a tissue engineered solution as an alternative to native tissue has been explored in recent years and is reviewed in this article. Recent findings More than 80 preclinical studies have investigated a tissue-engineered approach for urethral reconstruction mostly using decellularized natural scaffolds derived from natural extracellular matrix with or without cell seeding. The animal models used in preclinical testing are not representative of disease processes seen with strictures in man. The available clinical studies are based on small noncontrolled series. Summary There is a potential role for tissue engineering to provide a material for substitution urethroplasty and work has demonstrated this. Further work will require a rigorous basic science programme and adequate evaluation of the material prior to its introduction into clinical practice. The research with tissue engineering applied to the urethra has not yet been resulted in a widely available material for clinical use that approaches the efficacy seen with the use of autologous grafts.

Urethrotomy remains the first-line therapy in the treatment of a urethral stricture despite data showing no real chance of a cure after repeated urethroplasties. An anastomotic or an augmentation urethroplasty with oral mucosa should be offered to patients with a failed urethrotomy. The availability of grafts can be a concern for both patients and surgeons. The potential for a tissue-engineered solution has been explored in recent years and is explored in this article.More than 80 preclinical studies have investigated a tissue-engineered approach for urethral reconstruction mostly using decellularized natural scaffolds with or without cell seeding. The animal models used in preclinical testing are not representative of disease processes seen with strictures in man. The available clinical studies were of small sample size and lacked control groups. The choice of biomaterial were mostly acellular matrices derived from natural extracellular matrix. The reported success rates in the pilot clinical studies were highly variable.The research with tissue engineering of the urethra has not yet been translated into a clinically available material. This is an area where much more research is needed and we would conclude that it is an area of unmet clinical need where users of tissue-engineered urethra in the future need to carry out a rigorous basic science programme and need to be cautious in drawing conclusions based on initial experience and report on long-term clinical results.

PURPOSE OF REVIEW To review the current clinical management of stress urinary incontinence and pelvic organ prolapse following the adverse complications seen in the use of polypropylene mesh to treat both. RECENT FINDINGS Materials developed for use in abdominal hernia repair have not proven risk-free when used to support pelvic organs particularly when inserted via the vagina. Following unacceptably high levels of severe complications when high-density polypropylene mesh is inserted via the vagina to treat pelvic organ prolapse, reported over the last decade, there is now an agreed consensus between surgeons about surgical approaches and materials, which should be recommended for use in stress urinary incontinence and pelvic organ prolapse. SUMMARY There is a need for new biomaterials and tissue engineered/regenerative medicine approaches to treat stress urinary incontinence and pelvic organ prolapse. New materials need to be evaluated critically in both preclinical and clinical studies before being adopted into routine clinical use.

Background Polypropylene meshes cause severe complications in some patients. Materials that are biomechanically compatible and can better integrate into host tissues are urgently needed. Objective To design an oestradiol-releasing electrospun poly- l -lactic acid (PLA) mesh and evaluate its ability to stimulate new extracellular matrix and new blood vessel formation. Design, setting, and participants Human adipose derived mesenchymal cells (ADMSC) were isolated from fat. PLA meshes with micro- to nano-sized fibres containing 1%, 5%, and 10% oestradiol were constructed and used for in vitro and in vivo experiments. Intervention The angiogenic potential of the fibrous meshes was evaluated using an in vivo chorioallantoic membrane and an in vitro chick aortic arch assays. Outcome measurements and statistical analysis Oestradiol release was measured fluorometrically. The effect of fibrous meshes on proliferation and extracellular matrix (ECM) production of ADMSC was assessed using immunohistology. Mechanical properties were tested using a tensiometer. Results and limitations The ultrastructure of the mesh was not affected by the inclusion of oestradiol and mechanical properties were only slightly modified. Oestradiol was released from PLA meshes over a 5-mo period. ADMSCs cultured on oestradiol-releasing PLA meshes produced more ECM involving collagen I, collagen III, and elastin. Oestradiol-releasing meshes doubled new blood vessel formation in the chorioallantoic membrane assay ( p = 0.001) and outgrowth of pro-angiogenic cells in the aortic arch assay ( p = 0.001). Further studies in longer-term animal models are required to confirm these results. Conclusions Oestradiol-releasing PLA meshes increase ECM production and stimulate angiogenesis. As such, they are promising candidate materials to be used in pelvic floor repair and to improve the initial healing phase of a repair material following implantation. Patient summary In this study, we designed a tissue engineered material to be used to support weakened pelvic floor tissues in women to avoid the complications associated with current surgical mesh. Our results showed that this material can stimulate new blood vessel formation in simple chick assays and tissue production in vitro. Both properties should help with the integration of this material into patients’ tissues and merit further study in physiologically relevant animal models.

The surgical mesh material used in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women is associated with significant complications in some women. This has recently become a public health issue with involvement of national parliaments and regulatory bodies. The occurrence of mesh complications is thought to be a result of multifactorial processes involving problems related to the material design, the surgical techniques used and disease, and patient-related factors. However, the infectious complications and mesh-tissue interactions are least studied. The aim of this article is to review any previous clinical and basic scientific evidence about the contribution of infectious and inflammatory processes to the occurrence of mesh-related complications in SUI and POP. A literature search for the relevant publications without any time limits was performed on the Medline database. There is evidence to show that vaginal meshes are associated with an unfavourable host response at the site of implantation. The underlying mechanisms leading to this type of host response is not completely clear. Mesh contamination with vaginal flora during surgical implantation can be a factor modifying the host response if there is a subclinical infection that can trigger a sustained inflammation. More basic science research is required to identify the biological mechanisms causing a sustained inflammation at the mesh-tissue interface that can then lead to contraction, mesh erosion, and pain.

Urethral stricture disease (USD) is initially managed with minimally invasive techniques such as urethrotomy and urethral dilatation. Minimally invasive techniques are associated with a high recurrence rate, especially in recurrent USD. Adjunctive measures, such as local drug injection, have been used in an attempt to reduce recurrence rates.To systematically review evidence for the efficacy and safety of adjuncts used alongside minimally invasive treatment of USD.A systematic review of the literature published between 1990 and 2020 was conducted in accordance with the PRISMA checklist.A total of 26 studies were included in the systematic review, from which 13 different adjuncts were identified, including intralesional injection (triamcinolone, n = 135; prednisolone, n = 58; mitomycin C, n = 142; steroid-mitomycin C-hyaluronidase, n = 103, triamcinolone-mitomycin C-N-acetyl cysteine, n = 50; platelet-rich plasma, n = 44), intraluminal instillation (mitomycin C, n = 20; hyaluronic acid and carboxymethylcellulose, n = 70; captopril, n = 37; 192-iridium brachytherapy, n = 10), application via a lubricated catheter (triamcinolone, n = 124), application via a coated balloon (paclitaxel, n = 106), and enteral application (tamoxifen, n = 30; deflazacort, n = 36). Overall, 13 randomised controlled trials were included in the meta-analysis. Use of any adjunct was associated with a lower rate of USD recurrence (odds ratio [OR] 0.37, 95% confidence interval [CI] 0.27-0.50; p 0.001) compared to no adjunct use. Of all the adjuncts, mitomycin C was associated with the lowest rate of USD recurrence (intralesional injection: OR 0.23, 95% CI 0.11-0.48; p 0.001; intraluminal injection: OR 0.11, 95% CI 0.02-0.61; p = 0.01). Urinary tract infection (2.9-14%), bleeding (8.8%), and extravasation (5.8%) were associated with steroid injection; pruritis of the urethra (61%) occurred after instillation of captopril; mild gynaecomastia (6.7%) and gastrointestinal side effects (6.7%) were associated with oral tamoxifen.Adjuncts to minimally invasive treatment of USD appear to lower the recurrence rate and are associated with a low adjunct-specific complication rate. However, the studies included were at high risk of bias. Mitomycin C is the adjunct supported by the highest level of evidence.We reviewed studies on additional therapies (called adjuncts) to minimally invasive treatments for narrowing of the urethra in men. Adjuncts such as mitomycin C injection result in a lower recurrence rate compared to no adjunct use. The use of adjuncts appeared to be safe and complications are uncommon; however, the studies were small and of low quality.

Background Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery. Objectives The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome. Design This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research. Setting Urology departments of 26 NHS hospitals in England. Participants Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised. Interventions Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm). Main outcome measures The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness. Results A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (–0.33, 95% CI –1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43–44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS. Limitations The trial met its predefined recruitment target, but surgery rates were lower than anticipated. Conclusions Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS. Future work Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy. Trial registration Current Controlled Trials ISRCTN56164274. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 42. See the NIHR Journals Library website for further project information.

Background There is an urgent need to develop better materials to provide anatomical support to the pelvic floor without compromising its function. Objective Our aim was to assess outcomes after simulated vaginal prolapse repair in a sheep model using three different materials: (1) ultra-lightweight polypropylene (PP) non-degradable textile (Restorelle) mesh, (2) electrospun biodegradable ureidopyrimidinone-polycarbonate (UPy-PC), and (3) electrospun non-degradable polyurethane (PU) mesh in comparison with simulated native tissue repair (NTR). These implants may reduce implant-related complications and avoid vaginal function loss. Design, setting, and participants A controlled trial was performed involving 48 ewes that underwent NTR or mesh repair with PP, UPy-PC, or PU meshes (n = 12/group). Explants were examined 60 and 180 d (six per group) post-implantation. Intervention Posterior rectovaginal dissection, NTR, or mesh repair. Outcome measurements and statistical analysis Implant-related complications, vaginal contractility, compliance, and host response were assessed. Power calculation and analysis of variance testing were used to enable comparison between the four groups. Results There were no visible implant-related complications. None of the implants compromised vaginal wall contractility, and passive biomechanical properties were similar to those after NTR. Shrinkage over the surgery area was around 35% for NTR and all mesh-augmented repairs. All materials were integrated well with similar connective tissue composition, vascularization, and innervation. The inflammatory response was mild with electrospun implants, inducing both more macrophages yet with relatively more type 2 macrophages present at an early stage than the PP mesh. Conclusions Three very different materials were all well tolerated in the sheep vagina. Biomechanical findings were similar for all mesh-augmented repair and NTR. Constructs induced slightly different mid-term inflammatory profiles. Patient summary Product innovation is needed to reduce implant-related complications. We tested two novel implants, electrospun and an ultra-lightweight polypropylene textile mesh, in a physiologically relevant model for vaginal surgery. All gave encouraging outcomes., European Urology Focus, 6 (1), ISSN:2405-4569

Objective To describe the surgical approach and outcomes in the treatment of adult patients with complications of childhood hypospadias surgery, as such patients present a significant reconstructive challenge due to the combination of anatomical and cosmetic deformity, which often results in major functional and psychosexual sequelae. Patients and methods We analysed prospectively collected data on 79 adults with complications of childhood hypospadias surgery, who were operated on between 2004 and 2016. Of the 79 patients, 48 underwent a two-stage urethroplasty using a buccal mucosa graft, and 31 underwent a one-stage distal urethroplasty. Results Patients were followed up using flexible cystoscopy (every 6-9 months). The mean (range) follow-up was 48 (12-96) months. Of the 48 patients who underwent a two-stage repair, eight (16%) needed a revision of the first-stage graft. In total, nine of the 48 patients (16%) developed fistula requiring closure after the second stage; all but one was closed successfully on the first attempt, whilst one required two attempts before closure. Only two of the 48 patients that underwent a two-stage procedure required a re-do urethroplasty within 3 years. Of the 31 patients who underwent a one-stage repair, six (19%) needed fistula closure, all of which were successful. No patient required a further urethroplasty during follow-up. Conclusions Despite the significant surgical challenges found in this patient group, excellent long-term functional outcomes can be achieved. As expected there is a need for additional intervention, either for revision of the first stage or to close fistulae and less commonly for further reconstruction for stricture recurrence.

Underactive bladder (UAB) is a voiding disorder which generates disabling lower urinary tract symptoms (LUTS) due to the inability to produce an effective voiding contraction sufficient to empty the bladder. The underlying abnormality, that is usually appreciated when performing urodynamic studies, has been defined by the International Continence Society (ICS) as detrusor underactivity (DUA). DUA is a common yet under-researched bladder dysfunction. The prevalence of DUA in different patient groups suggests that multiple aetiologies are implicated. Currently there is no effective therapeutic approach to treat this condition. An improved understanding of the underlying mechanisms is needed to facilitate the development of new advances in treatment. The purpose of this review is to discuss the epidemiology, pathophysiology, common causes and risk factors potentially leading to DUA; to aid in the appropriate diagnosis of DUA to potentially improve treatment outcomes.

Context Lower urinary tract symptoms (LUTS) are one of the most common and troublesome nonmalignant conditions affecting quality of life in aging men. A spectrum of established medical and surgical options is available to provide relief of bothersome LUTS. Both the adverse events of medication and the morbidity with surgical treatment modalities have to be counterbalanced against efficacy. Novel minimally invasive treatment options aim to be effective, ideally to be performed in an ambulatory setting under local anaesthesia and to offer a more favourable safety profile than existing reference techniques. Objective A comprehensive, narrative review of novel minimally invasive treatment modalities for the management of male LUTS due to benign prostatic enlargement is presented. Evidence acquisition Medline, PubMed, Cochrane database, and Embase were screened for randomised controlled trials (RCTs), clinical trials, and reviews on novel minimally invasive treatment options for male LUTS due to benign prostatic enlargement. Evidence synthesis With regard to newly devised intraprostatic injectables (botulinum neurotoxin A, NX1207, PRX302), PRX302 is currently the only substance that was superior to placebo in a phase 3 RCT providing proof of efficacy and safety. The prostatic urethral lift technique has been evaluated in several phase 3 trials showing rapid and durable relief of LUTS without compromising sexual function in carefully selected patients without a prominent median lobe. The first clinical experience of the temporary implantable nitinol device demonstrated that implantation of this novel device is a safe procedure, easy, and fast to perform. Further studies are required to evaluate efficacy, durability, and to define appropriate patient selection. New ablative approaches like the image guided robotic waterjet ablation (AquaBeam) or procedures based on convective water vapour energy (Rezūm) are in the early stages of development. Prostatic artery embolization performed by interventional radiologists at specialised centres shows a high technical success rate in the treatment of bothersome LUTS. However, a substantial clinical failure rate and a particular spectrum of complications not commonly seen after urologic interventions do occur and need to be critically evaluated. Conclusions Initial promising clinical results on novel minimally invasive treatment options indicate efficacy comparable to standard techniques, often associated with a more favourable safety profile, in particular with preservation of sexual function. Many of these techniques are in their infancy and based on experience of new developments in the past. Further RCTs are required to evaluate efficacy, safety, and durability of novel techniques with long-term follow-up and careful evaluation of the selection criteria, which have been applied in clinical trials. The prostatic urethral lift is the only procedure with Level 1 evidence data and that can therefore be recommended for treatment of male LUTS in clinical practice for selected patients. Patient summary Minimally invasive treatment options have been developed to provide relief of lower urinary tract symptoms comparable to standard surgical techniques with a more favourable safety profile. However, long-term clinical evaluation is still needed for most of these innovations before they can be recommended to be an effective replacement for standard surgical treatment.

Objective\ud \ud To assess the hypothesis that patients receiving placebo in overactive bladder (OAB) trials who experience less benefit from “treatment” continue with behavioral modifications such as fluid restriction, whereas those on active treatment adopt more normal drinking patterns. This may manifest itself as a reduction in micturition frequency (MF).\ud \ud Materials and Methods\ud \ud We interrogated a large integrated database containing pooled patient data from 4 randomized, placebo-controlled phase III OAB solifenacin studies. A statistical correction was applied to MF to remove the influence of fluid intake.\ud \ud Results\ud \ud Pooled analysis using patient-level data from 3011 patients and accounting for the studies within the models showed that all patients voided progressively less total urine per 24 hours during treatment than at baseline. However, reduction in total urine volume voided per 24 hours was larger in patients receiving placebo vs those on solifenacin; with a substantial decrease in 24-hour urine output in the placebo group from baseline to week 4, which was not the case in active groups. After correcting MF for volume voided for each patient using the statistical correction and averaging the corrected MF per treatment arm, the placebo effect almost disappeared. Patients on solifenacin voided less often, with a statistically significant increase in volume voided each time they voided, vs placebo.\ud \ud Conclusion\ud \ud Assuming volume voided is a good surrogate measure for fluid intake, this analysis shows that fluid restriction almost completely explains the reduction in MF in the placebo group. In contrast, patients receiving active treatment adopt more normal drinking patterns once they start to perceive improvement in their OAB symptoms.

Context Bladder pain syndrome/interstitial cystitis (BPS/IC) is a poorly understood chronic debilitating condition. Surgery is reserved for severe refractory cases; however, there is no consensus on patient selection or optimal approach. Objective To evaluate the evidence relating to the safety and efficacy of surgical interventions for treating BPS/IC. Evidence acquisition PubMed and Scopus databases were searched for original studies, using keywords “cystectomy”, “interstitial cystitis”, and “bladder pain syndrome”. Articles were reviewed and screened by three independent reviewers. Evidence synthesis A total of 450 patients were identified from 20 eligible studies: mean age was 54.5 yr and 90.2% were female. The median duration of symptoms preoperatively was 60 mo (range 9–84), with a mean follow-up of 45.5 mo. A total of 448 patients underwent surgery: subtotal cystectomy with cystoplasty (48.6%), cystectomy and orthotopic neobladder (21.9%), cystectomy and ileal conduit (11.2%), and urinary diversion only (18.3%). Symptomatic improvement occurred in 77.2%, with higher rates in the total cystectomy and orthotopic neobladder group. Thirty-one patients (6.9%) required secondary total cystectomy and/or ileal conduit diversion; 48.4% subsequently improved. Seventeen studies reported 102 complications overall (26.5%). Overall mortality was 1.3%. Conclusions Overall surgical intervention is associated with a 23% risk of failure to improve symptoms. Higher rates of improvement were reported in patients with total cystectomy. Interpretation should be guarded given the small patient number, multiple centres, and variable outcome measurements. There is a need for prospective randomised studies to answer questions regarding patient selection and optimal surgical approach. Patient summary In this review, we looked at the outcomes of surgery for treatment-refractory bladder pain syndrome/interstitial cystitis. We found overall symptom improvement in 77.2% of patients with a complication rate of 26.5%. However, there remains a need for further studies of higher quality to identify patients who will have symptom improvement and the best surgical option.

Vaginal meshes used in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) have produced highly variable outcomes, causing life-changing complications in some patients while providing others with effective, minimally invasive treatments. The risk:benefit ratio when using vaginal meshes is a complex issue in which a combination of several factors, including the inherent incompatibility of the mesh material with some applications in pelvic reconstructive surgeries and the lack of appropriate regulatory approval processes at the time of the premarket clearance of these products, have contributed to the occurrence of complications caused by vaginal mesh. Surgical mesh used in hernia repair has evolved over many years, from metal implants to knitted polymer meshes that were adopted for use in the pelvic floor for treatment of POP and SUI. The evolution of the material and textile properties of the surgical mesh was guided by clinical feedback from hernia repair procedures, which were also being modified to obtain the best outcomes with use of the mesh. Current evidence shows how surgical mesh fails biomechanically when used in the pelvic floor and materials with improved performance can be developed using modern material processing and tissue engineering techniques.

Background Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies). Objective To report participants’ sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and surgery rates are lower if UDS is included. Design, setting, and participants A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments. Intervention Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm). Outcome measurements and statistical analysis The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick’s test, and questionnaire items were compared using Pearson’s correlation coefficient. Results and limitations Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure. Conclusions Men being considered for surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function. Patient summary We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.

Context Urogenital fistula is a global healthcare problem, predominantly associated with obstetric complications in low-resourced countries and iatrogenic injury in well-resourced countries. Currently, the published evidence is of relatively low quality, mainly consisting retrospective case series. Objective We evaluated the available evidence for aetiology, intervention, and outcomes of urogenital fistulae worldwide. Evidence acquisition We performed a systematic review of the PubMed and Scopus databases, classifying the evidence for fistula aetiology, repair techniques, and outcomes of surgery. Comparisons were made between fistulae treated in well-resourced countries and those in low-resourced countries. Evidence synthesis Over a 35-yr period, 49 articles were identified using our search criteria, which were included in the qualitative analysis. In well-resourced countries, 1710/2055 (83.2%) of fistulae occurred following surgery, whereas in low-resourced countries, 9902/10398 (95.2%) were associated with childbirth. Spontaneous closure can occur in up to 15% of cases using catheter drainage and conservative approaches are more likely to be successful for nonradiotherapy fistulae. Of patients undergoing repairs in well-resourced countries, the median overall closure rate was 94.6%, while in low-resourced countries, this was 87.0%. Closure was significantly more likely to be achieved using a transvaginal approach then a transabdominal technique (90.8% success vs 83.9%, Fisher's exact test; p =0.0176). Conclusions It is difficult to conclude whether any specific route of surgery has advantage over any other, given the selection of patients to a particular procedure is based upon individual fistula characteristics. However, surgical repair should be carried out by experienced fistula surgeons, well versed in all techniques as the primary attempt at repair is likely to be the most successful. Patient summary Urogenital fistulae are a common problem worldwide; however, the available evidence on fistula management is poor in quality. We searched the current literature and identified that 95% of fistulae occur following childbirth in low-resourced countries, whereas 80% of fistulae are associated with surgery in well-resourced countries, where successful repair is also more likely to be achieved. The first attempt at repair is often the most successful and therefore fistula surgery should be centralised to hospitals with the most experience.

Serious complications can develop with the mesh implants used for stress urinary incontinence and pelvic organ prolapse surgery. We evaluated 2 materials currently in clinical use and 2 alternative materials using a rabbit abdominal model to assess host response and biomechanical properties of the materials before and after implantation.Poly-L-lactic acid and polyurethane meshes were electrospun to be compared to commercially available polypropylene and polyvinylidene fluoride meshes. A total of 40 immunocompetent full-thickness abdominal wall defect rabbit models were used, including 8 in each of the poly-L-lactic acid, polyurethane, polyvinylidene fluoride and polypropylene experimental groups, and sham controls. Two 20 mm defects were created per animal and primarily repaired. The experimental groups then underwent onlay of each repair material while sham controls did not. Four rabbits per group were sacrificed at days 30 and 90. Abdominal wall specimens containing the defect with or without repair material were explanted to be assessed by histology (hematoxylin and eosin staining, and immunohistochemistry) and biomechanical testing at 30 and 90 days.At 90 days of implantation tissues repaired with all 4 materials showed biomechanical properties without significant differences. However, polypropylene and polyvinylidene fluoride meshes demonstrated a sustained chronic inflammatory response profile by 90 days. In contrast, poly-L-lactic acid and polyurethane meshes integrated well into host tissues with a decreased inflammatory response, indicative of constructive remodeling.Poly-L-lactic acid and polyurethane alternative materials achieved better host integration in rabbit models than current synthetic repair materials.

Urethral stricturing is a narrowing of the urethral lumen as a result of ischaemic spongiofibrosis. The main challenge of currently available treatment options is recurrence of the stricture. Recent advancements in the treatment of urethral strictures mainly came from the fields of regenerative medicine and tissue engineering. Research efforts have primarily focused on decreasing the recurrence of stricture after internal urethrotomy and constructing tissue-engineered urethral substitutes to improve clinical outcomes of urethroplasty surgeries. The aim of this article is to review the most recent advancements in the management of urethral stricture disease in men.

Anterior urethral strictures are a common urological problem and urethrotomy has limited efficacy if repeated treatment is needed. An increasing number of studies have shown that mitomycin C has potential as an adjunct to urethrotomy for improving its success rate.

Background Botulinum neurotoxin (BotN) is used to treat detrusor overactivity (DO) refractory to medical treatment. Catheterised patients with symptoms of bladder spasm and catheter bypass leakage are challenging to manage and the efficacy of BotN is not established. Objective To review our experience using intravesical BotN to treat refractory bladder pain and catheter bypass leakage in patients with long-term indwelling catheters. Design, setting, and participants We carried out a review of data prospectively collected for patients with indwelling urethral or suprapubic catheters receiving BotN for the treatment of bladder spasms and catheter bypass leakage in a UK tertiary centre. An unvalidated structured questionnaire was used to ascertain quality of life (QoL) outcomes. Outcome measurements and statistical analysis Qualitative data were collected for patient-reported symptoms and QoL. Paired Student t tests were applied for statistical analysis. Results and limitations Of the 54 catheterised patients who received BotN, 14 (26%) were male and 40 (74%) were female. The mean follow-up was 38 mo. Of the patients, 34 (63%) had a neurological aetiology and 94% had experienced failure of medical therapy before BotN administration. The BotN starting dose was 100 or 200 U and 17 patients (31%) required dose escalation. All 34 neurogenic and six non-neurogenic patients started on 200 U. After treatment, 63% of patients managed their catheter with intermittent drainage and 37% managed on free drainage; 51 patients (94%) reported that their symptoms were controlled and 38% reported being treated for a urinary tract infection following BotN. Patients reported a mean improvement in QoL of 7.7/10 following BotN, while 83% reported a significant reduction in urine leakage (p = 0.0001). Conclusions Outpatient intravesical BotN is safe and efficacious for patients with long-term catheters suffering from bladder pain and catheter bypass leakage. Patient summary Outpatient administration of intravesical botulinum toxin is a safe and effective treatment for patients with a long-term indwelling catheter with bothersome urine storage symptoms. Attention should be paid to urine microbiology results before treatment to ensure appropriate prophylactic antibiotic treatment to reduce the incidence of urinary tract infections.

Urethral stricture disease is increasingly common occurring in about 1% of males over the age of 55. The stricture tissue is rich in myofibroblasts and multi-nucleated giant cells which are thought to be related to stricture formation and collagen synthesis. An increase in collagen is associated with the loss of the normal vasculature of the normal urethra. The actual incidence differs based on worldwide populations, geography, and income. The stricture aetiology, location, length and patient's age and comorbidity are important in deciding the course of treatment. In this review we aim to summarise the existing knowledge of the aetiology of urethral strictures, review current treatment regimens, and present the challenges of using tissue-engineered buccal mucosa (TEBM) to repair scarring of the urethra. In asking this question we are also mindful that recurrent fibrosis occurs in other tissues—how can we learn from these other pathologies? Keywords: Urethral strictures, Fibrosis, Tissue-engineered buccal mucosa, Augmentation urethroplasty

Stress urinary incontinence (SUI) is a largely ousted but significant medical, social, and economic problem. Surveys suggest that nowadays approximately 10% of the male and 15% of the female population suffer from urinary incontinence at some stage in their lifetime. In women, two major etiologies contribute to SUI: degeneration of the urethral sphincter muscle controlling the closing mechanism of the bladder outflow and changes in lower pelvic organ position associated with degeneration of connective tissue or with mechanical stress, including obesity and load and tissue injury during pregnancy and delivery. In males, the reduction of the sphincter muscle function is sometimes due to surgical interventions as a consequence of prostate cancer treatment, benign prostate hyperplasia, or of neuropathical origin. Accordingly, for women and men different therapies were developed. In some cases, SUI can be treated by physical exercise, electrophysiological stimulation, and pharmacological interventions. If this fails to improve the situation, surgical interventions are required. In standard procedures, endoprostheses for mechanical support of the weakened tissue or mechanical valves for a bladder outflow control are implanted. In 20% of cases treated, repeat procedures are required as implants yield all sorts of side effects in time. Based on preclinical studies, the application of an advanced therapy medicinal product (ATMP) such as implantation of autologous cells may be a curative and long-lasting therapy for SUI. Cellular therapy could also be an option for men suffering from incontinence caused by injury of the nerves controlling the muscular sphincter system. Here we briefly report on human progenitor cells, especially on mesenchymal stromal cells (MSCs), their expansion and differentiation to smooth muscle or striated muscle cells in vitro, labeling of cells for in vivo imaging, concepts of improved, precise, yet gentle application of cells in muscle tissue, and monitoring of injected cells in situ.

Background Urethral strictures can be difficult to diagnose at an early stage because the urinary flow rate does not diminish until the urethral calibre is ≤3mm. In the past, posturethral surgery follow-up has relied upon flow rates and contrast imaging. Objective To evaluate the role of flexible urethroscopy in the follow-up of patients undergoing urethroplasty. Design, setting, and participants Prospective flexible urethroscopy follow-up of 144 male patients who underwent urethroplasty by a single surgeon over a 10-yr period at a tertiary referral centre. Intervention Flexible urethroscopy at 3, 6, and 12 mo postoperatively, and annually thereafter. Outcome measurements and statistical analysis Type of recurrence, based on urethroscopy findings, and further interventions were measured. Actuarial analysis was performed using Kaplan-Meier curves and a log-rank test. Results and limitations All 144 patients underwent flexible urethroscopy follow-up over a median postoperative follow-up of 22 mo (range: 1–96 mo). No further intervention was required for 117 patients (81.25%); 27 (18.75%) developed recurrences that required further treatment. Recurrences included diaphragms (13 patients) or significant restenosis (14 patients). Diaphragms were treated by urethrotomy, gentle dilatation, or a short course of intermittent self-dilatation. Restenosis required repeated simple procedures or surgical revision. Most recurrences (26 of 27, 96%) were detected within the first year. Urinary peak flow-rate data were available for 11 of 27 of these recurrences; 7 patients had flow rates >15ml/s. Anastomotic procedures had greater success than augmentation urethroplasty ( p =0.0136); there was no significant difference in outcomes between redo and non-redo surgery ( p =0.2093) Conclusions Endoscopic follow-up of patients after urethroplasty enables earlier identification and treatment of recurrences compared to the use of urinary flow rates alone. It also enables the identification of two different morphologic recurrence patterns that require different types of intervention. Patient summary Endoscopy detects most stricture recurrences within 1 yr after urethroplasty and is more sensitive than using urinary flow rates alone.

Pelvic fracture urethral injuries comprise one of the most challenging reconstructive procedures in urology. The obliterated or stenosed urethra can usually be effectively repaired by an end-to-end anastomosis (bulbomembranous anastomosis). To achieve this, a progression of surgical steps can be used to make a tension-free anastomosis. Before undertaking surgery it is important to comprehensively assess the patient to define their anatomical defects, in particular the site of the stenosis, the length of the distraction injury and the integrity of the bladder neck, and thus guide preoperative decision-making. Contemporary reports suggest that most pelvic fracture urethral distraction defects (PFUDD) can be adequately managed by a perineal approach. Nevertheless it is essential that all surgeons treating these injuries are familiar with the whole spectrum of operative steps that are necessary to repair PFUDD.

Detrusor underactivity (DU) is an important contributor to lower urinary tract symptoms (LUTS). While DU has been defined in the literature in urodynamic terms, current definitions lack specific parameters. In addition, the clinical syndrome associated with and manifesting itself as DU, underactive bladder (UAB), has not been well defined in the literature. In the absence of a precise definition of UAB, it is difficult to appreciate the true nature and burden of this condition. We review the evidence regarding the epidemiology, pathogenesis, diagnosis, and treatment of DU and UAB and discuss the challenges in gathering data in the absence of precise definitions. DU may be idiopathic or caused by ageing, medications, or a number of causes of neurogenic, myogenic, or iatrogenic origin. Treatments are largely palliative due to a lack of curative options, and include watchful waiting, catheterization, medications, and surgical interventions. In light of the evidence available in the literature, we propose that a new symptom-based definition of UAB syndrome should be developed as a first step in furthering more standardized research. Further discussion on this proposed definition to reach expert consensus will enable researchers to gather more robust data, allowing greater insights into DU and UAB diagnosis and treatment.

Synthetic or biological materials can be used for the surgical repair of pelvic organ prolapse (POP) or stress urinary incontinence (SUI). While non-degradable synthetic mesh has a low failure rate, it is prone to complications such as infection and erosion, particularly in the urological/gynecological setting when subject to chronic influences of gravity and intermittent, repetitive strain. Biological materials have lower complication rates, although allografts and xenografts have a high risk of failure and the theoretical risk of infection. Autografts are used successfully for the treatment of SUI and are not associated with erosion; however, can lead to morbidity at the donor site. Tissue engineering has thus become the focus of interest in recent years as researchers seek an ideal tissue remodeling material for urogynecological repair. Herein, we review the directions of current and future research in this exciting field. Electrospun poly-L-lactic acid (PLA) and porcine small intestine submucosa (SIS) are two promising scaffold material candidates. Adipose-derived stem cells (ADSCs) appear to be a suitable cell type for scaffold seeding, and cells grown on scaffolds when subjected to repetitive biaxial strain show more appropriate biomechanical properties for clinical implantation. After implantation, an appropriate level of acute inflammation is important to precipitate moderate fibrosis and encourage tissue strength. New research directions include the use of bioactive materials containing compounds that may help facilitate integration of the new tissue. More research with longer follow-up is needed to ascertain the most successful and safe methods and materials for pelvic organ repair and SUI treatment.

The recent International Consultation on Urological Disease (ICUD) panel 2010 confirmed that a urethral stricture is defined as a narrowing of the urethra consequent upon ischaemic spongiofibrosis, as distinct from sphincter stenoses and a urethral disruption injury. Whenever possible, an anastomotic urethroplasty should be performed because of the higher success rate as compared to augmentation urethroplasty. There is some debate currently regarding the critical stricture length at which an anastomotic procedure can be used, but clearly the extent of the spongiofibrosis and individual anatomical factors (the length of the penis and urethra) are important, the limitation for this being extension of dissection beyond the peno-scrotal junction and the subsequent production of chordee. More recently, there has been interest in whether to excise and anastomose or to carry out a stricturotomy and reanastomosis using a Heineke-Miculicz technique. Augmentation urethroplasty has evolved towards the more extensive use of oral mucosa grafts as compared to penile skin flaps, as both flaps and grafts have similar efficacy and certainly the use of either dorsal or ventral positioning seems to provide comparable results. It is important that the reconstructive surgeon is well versed in the full range of available repair techniques, as no single method is suitable for all cases and will enable the management of any unexpected anatomical findings discovered intra-operatively.

Purpose Autologous buccal mucosa is commonly utilized in the surgical treatment of urethral strictures. Extensive strictures require a larger quantity of tissue, which may lead to donor site morbidity. This review assesses progress in producing tissue engineered buccal mucosa as an alternative graft material. Results Few clinical studies have introduced cells onto biological or synthetic scaffolds and implanted resulting constructs in patients. The available studies show that buccal mucosa cells on acellular human dermis or on collagen matrix lead to good acute stage tissue integration. Urothelial cells on a synthetic substrate also perform well. However while some patients do well many years post-grafting, others develop stricture recurrence. Acellular biomaterials used to treat long urethral defects in animals commonly lead to fibrosis. Conclusions Tissue engineered buccal mucosa shows promise as a substitute for native tissue. The fibrosis which occurs months post-implantation may reflect the underlying disease process recurring in these patients.

BackgroundThe position of invasive urodynamic testing in the diagnostic pathway for urinary incontinence (UI) is unclear. Systematic reviews have called for further trials evaluating clinical utility, although a preliminary feasibility study was considered appropriate.ObjectivesTo inform the decision whether or not to proceed to a definitive randomised trial of invasive urodynamic testing compared with clinical assessment with non-invasive tests, prior to surgery in women with stress UI (SUI) or stress predominant mixed UI (MUI).DesignA mixed-methods study comprising a pragmatic multicentre randomised pilot trial; economic evaluation; survey of clinicians’ views about invasive urodynamic testing; qualitative interviews with clinicians and trial participants.SettingUrogynaecology, female urology and general gynaecology units in Newcastle, Leicester, Swansea, Sheffield, Northumberland, Gateshead and South Tees.ParticipantsTrial recruits were women with SUI or stress predominant MUI who were considering surgery after unsuccessful conservative treatment. Relevant clinicians completed two online surveys. Subsets of survey respondents and trial participants took part in separate qualitative interview studies.InterventionsPilot trial participants were randomised to undergo clinical assessment with non-invasive tests (control arm); or assessment as controls, plus invasive urodynamic testing (intervention arm).Main outcome measuresConfirmation that units can identify and recruit eligible women; acceptability of investigation strategies and data collection tools; acquisition of outcome data to determine the sample size for a definitive trial. The proposed primary outcome for the definitive trial was International Consultation on Incontinence Modular Questionnaire (ICIQ) Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) (total score) 6 months after surgery or the start of non-surgical treatment; secondary outcomes included: ICIQ-FLUTS (subscales); ICIQ Urinary Incontinence Short Form; ICIQ Lower Urinary Tract Symptoms Quality of Life; Urogenital Distress Inventory; EuroQol-5D; costs, quality-adjusted life-years (QALYs) and incremental cost per QALY, Short Form 12; 3-day bladder diary.ResultsOf 284 eligible women, 222 (78%) were recruited; 165/219 (75%) returned questionnaires at baseline and 125/200 (63%) who were sent questionnaires at follow-up. There were few missing data items in returned questionnaires, with individual outcome scales calculable for 81%–94%. Most women underwent surgery; management plans were changed in 19 (19%) participants following invasive urodynamic testing. Participant Costs Questionnaires were returned by 53% 6 months after treatment; complete data to undertake cost–utility analysis were available in 27% (intervention) and 47% (control). While insufficient to recommend changes in practice, the results suggest further research would be valuable. All clinicians responding to the survey had access to invasive urodynamic testing, and most saw it as essential prior to surgery in women with SUI with or without other symptoms; nevertheless, 70% considered the research question underlying INVESTIGATE important and most were willing to randomise patients in a definitive trial. Participants interviewed were positive about the trial and associated documentation; the desire of some women to avoid invasive urodynamic testing contrasted with opinions expressed by clinicians through both survey and interview responses.ConclusionsAll elements of a definitive trial and economic evaluation were rehearsed; several areas for protocol modification were identified. Such a trial would require to 400–900 participants, depending on the difference in primary outcome sought.Future workA definitive trial of invasive urodynamic testing versus clinical assessment prior to surgery for SUI or stress predominant MUI should be undertaken.Trial registrationCurrent Controlled Trials ISRCTN71327395.FundingThe National Institute for Health Research Health Technology Assessment programme.

Background Surgery for stress urinary incontinence (SUI) has been dominated recently by synthetic midurethral tapes. Increasing recognition of serious complications associated with nonabsorbable polypropylene mesh has led to resurgence in interest in alternative approaches, such as the autologous fascial sling (AFS). Despite being an efficacious and durable option in women with recurrent and complex SUI, there has been a reluctance to consider AFS in women with primary SUI due to a perception that it is only appropriate for treating patients with intrinsic sphincter deficiency (ISD) and is associated with high rates of urinary retention and de novo storage symptoms. Objective The video presented demonstrates the technique for a loosely applied midurethral AFS. In contrast to AFS applied at the bladder neck, this technical modification in patients who demonstrate primary SUI without ISD avoids high rates of de novo storage symptoms and urinary retention. Design, setting, and participants A retrospective review of data on patients undergoing AFS at a tertiary referral unit. Surgical procedure AFS placement in a "loose" fashion using a short length of fascia suspended on a suture bilaterally at the midurethral level rather than at the bladder neck and only using more tension in patients with ISD. Measurements Subjective cure rate, rates of postoperative storage symptoms, and urinary retention necessitating intermittent self-catheterisation (ISC). Results and limitations A total of 106 patients underwent AFS; the mean follow-up period was 9 mo. The mean age was 52.6 (range 24–83) yr. In total, 46.2% had primary SUI, whilst all of the remaining 53.8% had undergone prior surgical intervention. Overall subjective cure occurred in 79.2% of patients; a further 15.1% described significant subjective improvement in symptoms, whilst 5.7% reported no change in symptoms. In those with primary SUI, rates of subjective cure, improvement, and nonresolution of symptoms were 87.8%, 12.2%, and 0%, respectively. In individuals with prior surgical intervention, rates of subjective cure, improvement, and nonresolution of symptoms were 72.0%, 17.5%, and 10.5%, respectively. De novo storage symptoms occurred in 8.2% of those with primary SUI compared with 14.0% of those with prior surgical intervention. Only 2.0% patients with primary SUI needed to perform ISC beyond 2 wk compared with 10.5% of those after prior surgery. Conclusions A midurethral AFS appears to be effective and safe both in women with primary SUI who want to avoid the placement of permanent material and its attendant risks, and in more complex cases where this is less appropriate. Patient summary A graft taken from the covering of the abdominal muscle or the outer aspect of the thigh is an alternative to a synthetic vaginal mesh in women who have stress urinary incontinence requiring surgical treatment. Placing the graft loosely at the midpoint of the urethral tube, rather than at the bladder neck, reduces the risk of postoperative voiding difficulty and overactive bladder symptoms. Long-term data have suggested an outcome at least as good as a synthetic nonabsorbable tape without the potential for sling erosion into adjacent structures, as it avoids the use of nonabsorbable material.

Context: Surgical nonautologous meshes have been used for several decades to repair abdominal wall herniae. Implantable materials have been adopted for the treatment of female and male stress urinary incontinence (SUI) and female pelvic organ prolapse (POP). Objective: A consensus review of existing data based on published meta-analyses and reviews. Evidence acquisition: This document summarises the deliberations of a consensus group meeting convened by the European Association of Urology (EAU) and the European Urogynecological Association, to explore the current evidence relating to the use of polypropylene (PP) materials used for the treatment of SUI and POP, with reference to the 2016 EAU guidelines (European Association of Urology 2016), the European Commission's SCENIHR report on the use of surgical meshes (SCENIHR 2015), other available high-quality evidence, guidelines, and national recommendations. Evidence synthesis: Current data suggest that the use of nonautologous durable materials in surgery has well-established benefits but significant risks, which are specific to the condition and location they are used for. Various graft-related complications have been described-such as infection, chronic pain including dyspareunia, exposure in the vagina, shrinkage, erosion into other organs of xenografts, synthetic PP tapes (used in SUI), and meshes (used in POP)-which differ from the complications seen with abdominal herniae. Conclusions: When considering surgery for SUI, it is essential to evaluate the available options, which may include synthetic midurethral slings (MUSs) using PP tapes, bulking agents, colposuspension, and autologous sling surgery. The use of synthetic MUSs for surgical treatment of SUI in both male and female patients has good efficacy and acceptable morbidity. Synthetic mesh for POP should be used only in complex cases with recurrent prolapse in the same compartment and restricted to those surgeons with appropriate training who are working in multidisciplinary referral centres. Patient summary: Synthetic slings can be safely used in the surgical treatment of stress incontinence in both male and female patients. Patients need to be aware of the alternative therapy and potential risks and complications of this therapy. Synthetic mesh for treating prolapse should be used only in complex cases with recurrent prolapse in specialist referral centres. (C) 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved

Objective To compare the long-term outcomes of a tension-free vaginal tape (TVT; Gynecare™, Somerville, NJ, USA), autologous fascial sling (AFS) and xenograft sling (porcine dermis, Pelvicol™; Bard, Murray Hill, NJ, USA) in the management of female stress urinary incontinence (SUI). Patients and Methods A multicentre randomised controlled trial carried out in four UK centres from 2001 to 2006 involving 201 women requiring primary surgery for SUI. The women were randomly assigned to receive TVT, AFS or Pelvicol. The primary outcome was surgical success defined as ‘women reporting being completely ‘dry’ or ‘improved’ at the time of follow-up’. The secondary outcomes included ‘completely dry’ rates, changes in the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL EQ-5D questionnaire scores. Results In all, 162 (80.6%) women were available for follow-up with a median (range) duration of 10 (6.6–12.6) years. ‘Success’ rates for TVT, AFS and Pelvicol were 73%, 75.4% and 58%, respectively. Comparing the 1- and 10-year ‘success’ rates, there was deterioration from 93% to 73% (P < 0.05) in the TVT arm and 90% to 75.4% (P < 0.05) in the AFS arm; ‘dry’ rates were 31.7%, 50.8% and 15.7%, respectively. Overall, the ‘dry’ rates favoured AFS when compared with Pelvicol (P < 0.001) and TVT (P = 0.036). The re-operation rate for persistent SUI was 3.2% (two patients) in the TVT arm, 13.1% (five) in the Pelvicol arm, while none of the patients in the AFS arm required further intervention. Conclusions Our study indicates there is not enough evidence to suggest a difference in long-term success rates between AFS and TVT. However, there is some evidence that ‘dry’ rates for AFS may be more durable than TVT.

In this systematic review of the literature, a search of the PubMed database was conducted to identify articles dealing with augmentation/substitution urethral reconstruction of the anterior urethral stricture. The evidence was categorized by stricture site, surgical technique, and the type of tissue used. The committee appointed by the International Consultation on Urological Disease reviewed this data and produced a consensus statement relating to the augmentation and substitution of the anterior urethra. In this review article, the background pathophysiology is discussed. Most cases of urethral stricture disease in the anterior urethra are consequent on an ischemic spongiofibrosis. The choice of technique and the surgical approach are discussed along with the potential pros and cons of the use of a graft vs a flap. There is research potential for tissue engineering. The efficacy of the surgical approach to the urethra is reviewed. Whenever possible, a 1-stage approach is preferable from the patient's perspective. In some cases, with complex penile urethral strictures, a 2-stage procedure might be appropriate, and there is an important potential role for the use of a perineal urethrostomy in cases where there is an extensive anterior urethral stricture or where the patient does not wish to undergo complex surgery, or medical contraindications make this hazardous. It is important to have accurate outcome measures for the follow-up of patients, and in this context, a full account needs to be taken of patients' perspectives by the use of appropriate patient-reported outcome measures. The use of symptoms and a flow rate can be misleading. It is well established that with a normally functioning bladder, the flow rate does not diminish until the caliber of the urethra falls below 10F. The most accurate means of following up patients after stricture surgery are by the use of endoscopy or visualization by urethrography. Careful consideration needs to be made of the outcomes reported in the world literature, bearing in mind these aforementioned points. The article concludes with an overview of the key recommendations provided by the committee.

The term lower urinary tract symptoms (LUTS) encompasses a range of urinary symptoms, including storage symptoms (e.g. overactive bladder [OAB]) as well as voiding and post-micturition symptoms. Although treatment of male LUTS tends to focus on voiding symptoms, patients typically find storage symptoms the most bothersome. The core storage symptom is urgency, which drives the other main storage symptoms of increased daytime frequency, nocturia and incontinence. Although several validated questionnaires have been widely used to study urgency, few measure the two important storage parameters, urgency and frequency, in a single assessment. The total urgency and frequency score (TUFS) is a new validated tool that captures both variables and is derived from the Patient Perception of Intensity of Urgency Scale, which has been validated in patients with OAB and LUTS. The TUFS was first validated in OAB in the phase IIa BLOSSOM study, which was designed to assess the efficacy and safety of mirabegron, a β3 -adrenoceptor agonist, in 260 patients. The responsiveness of the TUFS to treatment has been confirmed in a further three large-scale randomized controlled trials of solifenacin in patients with OAB or LUTS. Changes in TUFS from baseline to end of treatment were consistent with changes in micturition diary variables in all four studies. Furthermore, the TUFS was significantly correlated with several health-related quality-of-life variables in the phase III NEPTUNE study. Thus, the TUFS appears to be useful for assessing improvements in major storage symptoms (urgency and frequency) in clinical trials.

AIM: To report the effects of radical hysterectomy and nerve-sparing techniques on lower urinary tract function in women. METHODS: A literature search was performed in Pubmed and Medline using the keywords bladder after radical hysterectomy, nerve sparing radical hysterectomy, and urinary dysfunction following radical hysterectomy. Significant results and citations were reviewed manually by the authors. RESULTS: The sympathetic and parasympathetic systems innervating the lower urinary tract may be disrupted due to resection of uterosacral and rectovaginal ligaments, the dorsal and lateral paracervix, the caudal part of the vesico-uterine ligaments, and the vagina. This supports the neurogenic etiology of early and late bladder dysfunction after radical surgery. Bladder disorders are also related to the extent of radical surgery. The neuropathopysiology of lower urinary tract symptoms after radical hysterectomy is not fully understood. Recent data have highlighted the role of urethral sphincter pressure in the etiology of postoperative incontinence. Various surgical approaches have been developed to preserve autonomic pelvic innervation. CONCLUSIONS: Nerve-sparing techniques appear to improve bladder function without compromising overall survival. Studies comparing the effects of nerve-sparing radical hysterectomy with standard surgery yielded encouraging results in respect of postoperative lower urinary tract function. Clinical trials with a long period of follow-up are required for better comprehension of the complex pathophysiology of bladder dysfunction after radical hysterectomy.