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This manuscript from Chapter 1 of the International Urogynecology Consultation (IUC) on Pelvic Organ Prolapse (POP) reports on the patients' perception of disease burden associated with pelvic organ prolapse.An international group containing a team of eight urogynaecologists, a physiotherapist and a statistician performed a search of the literature using pre-specified search terms in PubMed and Embase (January 2000 to August 2020). The division of sections within this report includes: (1) perception of POP and the relationship with body image and poor health; (2) a vaginal bulge as it impacts health and wellbeing in women; (3) the impact of POP on sexual life; (4) body image and pelvic floor disorders; (5) POP and mood; (6) appropriate use of treatment goals to better meet patients' expected benefits; (7) using health-related quality of life questionnaires to quantify patients' perception of POP; (8) The financial burden of POP to patients and society. Abstracts were reviewed and publications were eliminated if not relevant or did not include populations with POP or were not relevant to the subject areas as noted by the authors. The manuscripts were next reviewed for suitability using the Specialist Unit for Review Evidence (SURE) checklists for cohort, cross-sectional and case-control epidemiologic studies.The original individual literature searches yielded 2312 references of which 190 were used in the final manuscript. The following perceptions were identified: (1) women were found to have varying perceptions of POP including shame and embarrassment. Some regard POP as consequence of aging and consider there is no effective therapy. (2) POP is perceived as a vaginal bulge and affects lifestyle and emotional wellbeing. The main driver for treatment is absence of bulge sensation. (3) POP is known to affect frequency of sexual intercourse but has less impact on satisfaction. (4) Prolapse-specific body image and genital self-image are important components of a women's emotional, physical and sexual wellbeing. (5) POP is commonly associated with depression and anxiety symptoms which impact HRQoL although are not correlated with objective anatomical findings. (6) Patient-centered treatment goals are useful in facilitating communication, shared decision-making and expectations before and after reconstructive surgery. (7) Disease-specific HRQoL questionnaires are important tools to assess bother and outcome following surgery, and there are now several tools with Level 1 evidence and a Grade A recommendation. (8) The cost of POP to the individual and to society is considerable in terms of productivity. In general, conservative measures tend to be more cost-effective than surgical intervention.Patients' perception of POP varies in different patients and has a far-reaching impact on their overall state of health and wellbeing. However, recognizing that it is a combination of body image and overall health (which affects mental health) allows clinicians to better tailor expectations for treatment to individual patients. There are HRQoL tools that can be used to quantify these impacts in clinical care and research. The costs to the individual patient (which affects their perception of POP) is an area that is poorly understood and needs more research.

Objective In July 2018, NHS England, introduced a pause on vaginal mesh, including the mid-urethral sling (MUS) for treatment of stress urinary incontinence (SUI). NICE guidelines recommend MUS as one of the surgical options for SUI. The aim of our study was to investigate healthcare professionals choices for surgical treatment of SUI, if conservative measures failed. Study design The urogynaecology department at our tertiary level hospital devised a questionnaire using SurveyMonkey. This was distributed via email to 1058 healthcare professionals of different medical backgrounds. The surgical options were based on the NICE guideline and its patient decision making aid. We also used surgical information from the British society of Urogynaecology (BSUG) and British association of urological surgeons (BAUS). Results We received 214 responses of which 204 were complete. Twenty six percent of replies were from obstetricians and gynaecologists, 36 % had over 20 years experience and 79 % were female. Forty four percent had no previous knowledge of surgical options. Mid-urethral sling was the most popular choice based on description, success and specific complications. Urethral bulking agent was the only option that increased in popularity after describing complications. Twenty two percent would avoid surgery due to the risk of complications. Conclusion This is the first study evaluating healthcare professionals surgical choice for SUI. Despite negative media publicity and NHS pause on MUS, it was still the most popular choice before and after informing of specific complications. The urethral bulking agent was the only surgical treatment, which increased in popularity after considering complications.

Aims Nocturnal polyuria (NP) is defined by the International Continence Society (ICS) as "excessive production of urine during the main sleep period" and is one of the main causes of nocturia. The ICS recognized that "excessive" is not clearly defined and that this needs to be highlighted in both clinical and research settings. The aim of this study was to identify different definitions of NP and apply them to a population of women attending the Urogynaecology clinic. Methods This was a retrospective study of complete bladder diaries collected from women attending a tertiary Urogynaecology Unit. Six different definitions were identified and were divided into "absolute," "relative," and "functional definitions." Prevalence data were calculated and values generated for sensitivity, specificity, positive and negative predictive values when related to women voiding ≥ 2 times per night. Results Complete bladder diaries were obtained from 1398 women, over 6 years, with a mean age of 57 years. Prevalence varied across the definitions from 21.5% (absolute definition) to 77% (relative definition). Sensitivity ranged from 43% (absolute) to 87% (relative). The definitions that showed the highest combined sensitivity and specificity were the functional definitions. Conclusion From this study it is clear that more work needs to be done to arrive at a consensus for defining NP to enable accurate diagnosis and development of treatment pathways. We propose that a relative definition may provide a more clinically relevant method of defining NP.

Overactive bladder is a common problem women suffer from, with its incidence increasing with age. The mainstay of treatment is antimuscarinic medication. There is growing evidence that antimuscarinics may increase the risk of cognitive impairment, dementia, and even death.This review explores the evidence that antimuscarinics increase the risk of cognitive impairment, dementia, and death. It evaluates how best to treat overactive bladder the older woman.The evidence suggests that antimuscarinics increase the risk of cognitive impairment and dementia in the older adult. Care should be taken to use an antimuscarinic that is less likely to cross the blood-brain barrier and thus reduce the risk of these significant adverse events. A patient's anticholinergic load also needs to be considered when treating this group. Other treatment options such as fluid management, bladder retraining, vaginal estrogens, mirabegron, Onabotulinum toxin A and neuromodulation can be used instead.

The most appropriate method for repairing posterior vaginal wall prolapse is still debatable. Women with symptomatic prolapse scheduled to undergo surgical repair in the posterior compartment were randomised to standard posterior colporrhaphy (SPC) or fascial and vaginal epithelial plication (FEP). Participants were assessed with the Prolapse Quality of Life (P-QOL) questionnaire, pelvic organ prolapse quantification (POP-Q) examination and three-dimensional ultrasound (3D US) prior to surgery and 6 months postoperatively. The research hypothesis is that 3D US of the pelvic floor is a reliable tool in comparing the anatomical outcomes of the two different surgical techniques. Differences in anatomical outcomes, assessed clinically and by ultrasonographic evaluation, were compared between the two groups using the Independent Mann-Whitney

Overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection or other obvious pathology. The mainstay of treatment of OAB is anticholinergic/antimuscarinic medication. These drugs block muscarinic receptors throughout the body, not only the bladder, including in the brain, which may lead to cognitive side effects. Anticholinergic load or burden is the cumulative effect of taking drugs that are capable of producing anticholinergic adverse effects. The elderly are more susceptible to these effects, especially as there is increased permeability of the blood brain barrier. The anticholinergic drugs for OAB are able to enter the central nervous system and lead to central side effects. There is increasing evidence that a high anticholinergic load is linked to the development of cognitive impairment and even dementia. Some studies have found an increased risk of mortality. In view of this, care is needed when treating OAB in the elderly. Trospium chloride is a quaternary amine anticholinergic, which has a molecular structure, which theoretically means it is less likely to cross the blood brain barrier and exert central side effects. Alternatively, mirabegron can be used, which is a beta-3 adrenoceptor agonist, which does not add to the anticholinergic load or exert central nervous system side effects. Conservative therapy can be used as an alternative to pharmacological treatment in the form of behavioral modification, fluid management and bladder retraining. Neuromodulation or the use of botox can also be alternatives, but success may be less in the older adult and will require increased hospital attendances.

Overactive bladder (OAB) negatively affects work productivity and quality of life in sufferers. Its overall impact is likely to increase as a result of increasing prevalence in an ageing population. The pathophysiology of OAB is not completely understood but the β3-adrenoceptor, which is highly expressed in the urinary bladder, is thought to be important for mediating human detrusor relaxation during the storage phase. Clinical trial results have demonstrated that mirabegron, a selective β3-adrenoceptor agonist offers substantial clinical efficacy and good adherence rates over 12 months. Furthermore, due to its different mechanism of action, it is likely to offer a favourable tolerability profile when compared with antimuscarinic agents, resulting in improved persistence over long-term treatment. Finally, from a health economic perspective, despite its higher drug acquisition cost, mirabegron has been found to be cost-effective, owing to the greater increase in quality-adjusted-life-years gained, when compared to antimuscarinic medications. The PubMed database was searched for English language articles published between 1 January 2005 to 31 January 2022, on the subject of mirabegron. Search terms included "mirabegron", "overactive bladder", "β3-adrenoceptor agonist", "urinary incontinence". This review summarises the evidence for mirabegron as a treatment option for the management of OAB.

Oral pharmacotherapy consisting of antimuscarinics, β3-adrenoreceptor agonists, or combinations of these agents forms the mainstay of overactive bladder (OAB) management.To evaluate the efficacy and safety of combination therapy in patients with OAB.A literature search was conducted in June 2018 using Embase, MEDLINE, and Cochrane databases via Ovid and relevant congress abstracts. Studies reporting the efficacy/safety of two antimuscarinics or a β3-adrenoreceptor agonist plus an antimuscarinic were included.Publications reported on clinical efficacy, safety, and health-related quality of life (HRQoL) for mirabegron (M) plus solifenacin (S) from three 12-wk randomised controlled trials (RCTs)-SYMPHONY, SYNERGY, and BESIDE-and a 12-mo RCT, SYNERGY II. SYMPHONY reported statistically significant improvements in clinical symptoms and HRQoL with combination therapy versus solifenacin 5 mg (S5) and placebo. In SYNERGY, there were consistent improvements in urinary incontinence (UI) episodes/24 h and micturitions/24 h (coprimary endpoints), and in secondary efficacy parameters with mirabegron 25 mg (M25) + S5 and mirabegron 50 mg (M50) + S5 versus respective monotherapies. In patients with an inadequate response to S5 monotherapy (BESIDE), greater improvements in UI (primary endpoint) were noted for M50 + S5 versus S5 (p = 0.001). Combination therapy was noninferior to solifenacin 10 mg (S10) for reduction in UI and superior to S10 for improvement in micturition frequency (p 0.001), and resulted in greater improvements from baseline in OAB-5 Dimension scores versus S5 and S10 (p 0.01). In SYNERGY II, clinically meaningful and sustained improvements in clinical outcomes were observed for M50 + S5 versus M50 or S5. Combination therapy was well tolerated in all four trials. The incidence of adverse events (AEs) was similar across groups, and there were no notable differences in the incidence of specific AEs. Positive efficacy outcomes were observed in five studies of dual antimuscarinic therapy (trospium + solifenacin).Mirabegron plus solifenacin provides effective, well-tolerated treatment for patients with OAB. Limited data for dual antimuscarinic therapy suggest a benefit in patients with moderate-to-severe symptoms.Overactive bladder (OAB) is treated with medicines called antimuscarinics, such as solifenacin, propiverine, or trospium, or another β-adrenoreceptor agonist medicine called mirabegron, which works in a different way. We looked at published scientific studies of patients with OAB treated with mirabegron plus solifenacin together, or with two antimuscarinics. We found that mirabegron plus solifenacin can help reduce symptoms and improve quality of life. Patients tolerate this treatment well, with few patients experiencing side effects.

Overactive bladder (OAB) is a common and distressing condition which is known to increase with age and to have a significant effect on quality of life (QoL). Whilst OAB is a symptomatic diagnosis, many patients will require basic investigations prior to initiating the appropriate management. This paper will explore the prevalence and pathophysiology of OAB as well as diagnosis and management of the condition. There is increasing evidence that local oestrogen therapy may be beneficial in the management of postmenopausal women with OAB, either when used alone or as combination therapy with an antimuscarinic drug. This paper will review the postulated mechanisms of action as well as exploring the available evidence base supporting efficacy. There is now a substantial evidence base to support the use of local vaginal oestrogen therapy in postmenopausal women with OAB either in isolation or alternatively as an adjunctive therapy when used with antimuscarinic medication. Available evidence supports an improvement in lower urinary tract symptoms as well as a significant improvement in health-related quality of life (HRQoL).

Overactive bladder (OAB) is a common and distressing condition which is known to increase with age and has a significant effect on quality of life. Whilst OAB is a symptomatic diagnosis, many patients will require basic investigations prior to initiating the appropriate management. This article will review the initial clinical assessment and management of women complaining of OAB including conservative measures and drug therapy, and will also focus on the role of estrogen. In addition, the management of refractory OAB will also be discussed including more invasive strategies such as neuromodulation, Botulinum Toxin, and reconstructive surgery.

Aims To investigate the safety and efficacy of litoxetine, a serotonin reuptake inhibitor, in treating urinary incontinence (UI) and mixed urinary incontinence (MUI). Methods Two randomized, double-blind, placebo-controlled clinical trials (RCT1 and RCT2) were conducted. RCT1, which included 196 women aged 18-75 with MUI randomized 1:1:1:1 to receive 10, 20, or 40 mg litoxetine or placebo orally twice daily (BID) for 12 weeks, investigated the efficacy (including changes in patient reported outcomes) and safety of litoxetine compared to placebo. RCT2, which included 82 men and women aged 18-70 with any UI type randomly assigned 2:1 to receive 30 mg litoxetine or placebo orally BID for 8 weeks including a 2 week dose titration period, investigated the safety (including psychiatric safety) and efficacy of litoxetine compared to placebo. Efficacy was measured as the change in number of incontinence episodes per week and assessed using an analysis of covariance with missing data imputed by Predictive Mean Matching. Safety was assessed by adverse events (AEs) and physical examinations and analyzed using descriptive statistics. Results The 30-mg and placebo groups in RCT2 showed no difference in frequency of AEs, and litoxetine reduced the number of incontinence episodes per week compared to placebo. Although RCT1 suffered an unexpectedly high placebo response, and therefore did not meet the primary efficacy endpoint, 71% of participants receiving 40 mg litoxetine reported a clinically meaningful improvement in the King's Health Questionnaire. Conclusions Litoxetine may be a safe, effective and well-tolerated treatment for patients with UI.

Overactive bladder (OAB) is a symptom complex of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence. Consequently it is a subjective diagnosis, and only two thirds of women will subsequently be found to have an underlying objective diagnosis of detrusor overactivity.

Objective Anticholinergic drugs are the mainstay treatment of OAB. Anticholinergic load is the cumulative effect of taking anticholinergic medication. Recent evidence suggests that in the elderly this can have a detrimental affect, with the potential to develop dementia. A previous study found that knowledge of anticholinergic load was lacking in our healthcare professionals. The aim of this study was to assess knowledge of pharmacists, who in the UK have the potential where qualified to prescribe as well as dispense. Study design A questionnaire was formulated based on the previous study. It was sent out to 418 pharmacists from; a south London hospital trust, a south London clinical commissioning group and United Kingdom Clinical Pharmacists Association. Results Seventy-five pharmacists completed the questionnaire. Solifenacin and tolterodine was the most popular drug prescribed in the elderly without dementia, whilst mirabegron was the most popular in the elderly with dementia. One pharmacist suggested using oxybutynin. Sixty-two percent discuss anticholinergic load with the patients, 40 % advice prescribers and 42 % consider anticholinergic load when dispensing the drug. Fifteen percent have had patients report confusion/memory loss. Thirty percent know how to assess anticholinergic load. Only 15 % felt dementia was a concern with anticholinergic drugs. Worryingly, 54 % though mirabegron exerted anticholinergic effects. Conclusion This is the first study looking at pharmacist knowledge on the use of anticholinergic medication for OAB in elderly women. Knowledge amongst all healthcare professionals including pharmacists is lacking and needs to be improved.

Background Urethral caruncles are lesions occurring at the urethral orifice, around the posterior lip of the urethra. They are the most common benign growth of the female urethra. They are often asymptomatic and found incidentally on clinical examination. When symptomatic they commonly present with bleeding. Treatment includes vaginal oestrogens or, failing that, surgical excision. We present an unusual finding after excision of a urethral caruncle. Case A patient with a background of stress urinary incontinence had numerous pelvic surgeries, including colposuspension, tension-free vaginal tape (TVT) and Macroplastique (a urethral bulking agent). She developed bleeding from a 3 cm urethral caruncle, which did not improve with vaginal oestrogens. She proceeded to have a surgical excision of the caruncle. Histology revealed a foreign material with surrounding foreign-body-type multinucleate giant cell reaction. The material was compatible with Macroplastique. Conclusion This case report describes an unusual and unexpected histological finding. Macroplastique is injected in the urethra, 10–15 mm from the bladder neck. We suspect the caruncle dragged the Macroplastique material out through the urethral meatus. If urethral caruncles are not adequately treated with vaginal oestrogens, surgery should be considered., Highlights • Urethral caruncles are lesions occurring at the urethral orifice, around the posterior lip of the urethra • They are the most common benign growths of the female urethra • When symptomatic they commonly present with bleeding. • Treatment includes topical oestrogens or failing that, surgical excision. • The presence of a urethral bulking agent in a caruncle, which did not respond to topical oestrogen, is reported.

The way in which gynaecology services are provided in the UK has drastically changed within a short space of time due to the global COVID-19 pandemic. Gynaecologists are not considered front-line staff in the treatment of the novel coronavirus unlike our intensive care or accident and emergency colleagues. However, the impact this is having on those with chronic problems is significant, and the morbidity associated with missed malignancies could be problematic. This article summarises the strategies developed at King’s College Hospital to remodel services to best provide optimum treatment to patients in this new era.

Background Stress urinary incontinence is a common problem affecting women's quality of life. The retropubic mid-urethral sling accounts for the majority of surgical interventions for stress incontinence. Complications of the procedure are rare. We present an unusual late complication with tension-free vaginal tape (TVT). Case Two years after insertion of a TVT for stress incontinence, a patient noticed a foreign body intermittently exiting through her anus. Initial clinical examinations and investigations were unremarkable. Five years after insertion she represented with faecal matter in the vagina and a TVT erosion. Imaging confirmed a colo-vaginal fistula. She underwent a vaginal excision of the TVT but this did not cure her problem and she subsequently had a laparoscopic sigmoid colectomy. Thereafter she remained well and asymptomatic. Conclusion This case report describes an unusual late complication. It is likely that the left arm of the mesh entered the serosa of the sigmoid colon and eroded into it over time. Complications associated with TVT are rare, but when they occur they need to be recorded. Only surgeons who have experience and expertise in the procedure should perform it, such as subspecialty trained urogynaecologists., Highlights • Tension-free vaginal tape (TVT) is the most popular surgical treatment of stress urinary incontinence (SUI). • Bowel injury/complications, though rare, can occur with delayed presentation. • Thorough investigation is needed to explore unusual TVT complications. • Complex complications should involve a multidisciplinary approach to treatment.

Purpose Overactive Bladder (OAB) is a common condition that is known to have a significant impact on Health Related Quality of Life (HRQoL). Whilst all patients will initially benefit from lifestyle modifications and behavioural therapy in the first instance drug therapy remains integral in management pathways. The purpose of this review paper is to reappraise the evidence based approach to the management of OAB in addition to exploring a new treatment algorithm for the escalation of treatment in those patients with refractory symptoms. Design Literature Review RESULTS: Antimuscarinic drugs are currently the most commonly used medication although the introduction of mirabegron, a β3 agonist, has provided an alternative and also allowed combination therapy in those patients who have failed to improve on primary therapy or who have troublesome side effects. For those patients with symptoms of refractory OAB more invasive therapies including OnabotulinumtoxinA, sacral neuromodulation and Percutaneous Tibial Nerve Stimulation (PTNS) may be indicated. Conclusion We propose a new, evidence based, treatment algorithm for the management of OAB in patients who remain refractory to first line therapy.

Overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection or other obvious pathology. The mainstay of treatment of OAB is anticholinergic/antimuscarinic medication. These drugs block muscarinic receptors throughout the body, not only the bladder, including in the brain, which may lead to cognitive side effects. Anticholinergic load or burden is the cumulative effect of taking drugs that are capable of producing anticholinergic adverse effects. The elderly are more susceptible to these effects, especially as there is increased permeability of the blood brain barrier. The anticholinergic drugs for OAB are able to enter the central nervous system and lead to central side effects. There is increasing evidence that a high anticholinergic load is linked to the development of cognitive impairment and even dementia. Some studies have found an increased risk of mortality. In view of this, care is needed when treating OAB in the elderly. Trospium chloride is a quaternary amine anticholinergic, which has a molecular structure, which theoretically means it is less likely to cross the blood brain barrier and exert central side effects. Alternatively, mirabegron can be used, which is a beta-3 adrenoceptor agonist, which does not add to the anticholinergic load or exert central nervous system side effects. Conservative therapy can be used as an alternative to pharmacological treatment in the form of behavioral modification, fluid management and bladder retraining. Neuromodulation or the use of botox can also be alternatives, but success may be less in the older adult and will require increased hospital attendances.

Urodynamics is the study of the storage and evacuation of urine from the urinary tract. The aim is to reproduce the patient’s symptoms and provide a pathophysiological explanation for them by identifying all factors that contribute to the lower urinary tract dysfunction, including those that are asymptomatic. Urodynamics consists of various tests, each of which is designed to assess a different aspect of lower urinary tract function. There is a lack of evidence regarding when urodynamics should be used in the non-neurogenic bladder. Some small randomised controlled trials suggest that urodynamics does not alter the outcome of surgery for stress urinary incontinence when compared with office evaluation alone. However, this is widely felt to be inaccurate and many health-care professionals still advocate the use of urodynamics prior to any invasive treatment, especially surgery on the lower urinary tract. There have been few technological advances in urodynamics in recent years. Air-charged rather than fluid-filled catheters were thought to help reduce artefact, but the evidence is unclear, and there is doubt over their accuracy. Ambulatory urodynamics is carried out over a longer period of time, enabling physiological bladder filling, but it remains invasive and artificial. To attempt to replicate symptoms more accurately, there have been efforts to develop wireless devices to measure detrusor pressure directly. These may be promising but are far from suitable in humans at present. Urodynamics continues to provide useful information for assessing lower urinary tract function, but further large studies are required to assess its value and develop innovations to improve the accuracy of the tests and acceptability to patients.

Aims SYNERGY II was a 12‐month phase III trial in patients with overactive bladder (OAB) symptoms that investigated the safety and efficacy of the combination of mirabegron and solifenacin in comparison with each monotherapy. This analysis evaluated the trial findings using four age subgroups (1 bpm were noted in the combination and mirabegron younger age groups only. No clinically significant findings were observed in the other safety parameters. The efficacy variables improved with all treatments and the greatest improvements were typically observed with combination therapy. Conclusions Mirabegron and solifenacin combination therapy was a well‐tolerated and effective treatment for patients with OAB symptoms irrespective of their age.

Nocturia, defined as waking at night to pass urine, is a common condition which increases with age. Whilst nocturia is known to have an important effect on quality of life, more recent evidence has linked the symptom with significant morbidity and mortality due to the effects of sleep deprivation on glucose metabolism and the immune system. The causes of nocturia are multifactorial and may be related to urine overproduction, storage disorders and primary sleep disorders. The commonest underlying pathology, however, is nocturnal polyuria, which may be associated with a number of medical conditions. This review explores the underlying causes of nocturia and nocturnal polyuria and, by doing so, describes a multidisciplinary approach to managing patients effectively.

Background The long-term potential of solifenacin and mirabegron combination treatment for patients with overactive bladder (OAB) has not been previously assessed. Objectives To evaluate the safety and efficacy of solifenacin succinate 5mg plus mirabegron 50mg tablets (combination treatment) versus solifenacin or mirabegron monotherapy in patients with OAB over 12 mo. Design, setting, and participants Randomised, double-blind, multicentre, phase 3 trial (SYNERGY II) of patients with "wet" OAB symptoms (urinary frequency and urgency with incontinence) for ≥3 mo. The study was conducted from March 2014 to September 2016; with 1829 patients randomised. The full analysis set was comprised of 1794 patients. Outcome measurements and statistical analysis The primary objective was safety, measured as treatment-emergent adverse events (TEAEs). Efficacy was measured as the change from baseline to the end of treatment in the mean number of incontinence episodes/24h and micturitions/24h. Results and limitations The median age was 60 yr (range 19–86 yr) and 1434 patients (80%) were female. Overall, 856 patients (47%) experienced ≥1 TEAE. TEAE frequency was slightly higher in the combination group (596 patients, 49%; mirabegron 126 patients, 41%; solifenacin 134 patients, 44%). Serious TEAEs were reported by 67 patients (3.7%); one was considered possibly treatment-related (mirabegron group, atrial fibrillation). Dry mouth was the most common TEAE (combination 74 patients, 6.1%; solifenacin 18 patients, 5.9%; mirabegron 12 patients, 3.9%). Combination therapy was statistically superior to mirabegron and solifenacin for the number of incontinence episodes (vs mirabegron: adjusted mean difference [AMD] −0.5, 95% confidence interval [CI] −0.7 to −0.2, p Conclusions Mirabegron and solifenacin combination treatment for OAB symptoms was well tolerated over 12 mo and led to efficacy improvements over each monotherapy. This innovative combination is a treatment option that could become widely used in the clinic. Patient summary This study looked at the safety and efficacy of a combination of solifenacin succinate 5mg plus mirabegron 50mg tablets over 12 mo in patients with the overactive bladder (OAB) symptoms of increased urination frequency, heightened urgency to urinate, and unintentional passing of urine. We compared this treatment with solifenacin succinate 5mg or mirabegron 50mg alone, and found that the combination treatment was well tolerated by patients and led to greater improvements in symptoms. This novel combination could be an improved treatment option in the clinical setting for patients with OAB. This study is registered at ClinicalTrials.gov as NCT02045862.

There have been concerns that treatment of overactive bladder with β3 -adrenoceptor agonists may potentially have detrimental cardiovascular (CV) side effects. We evaluated the CV safety of mirabegron, a β3 -adrenoceptor agonist, alone and in combination therapy with the antimuscarinic agent solifenacin. The SYNERGY trial was a multinational, multicenter, randomized, double-blind, parallel-group, placebo and active-controlled phase 3 trial. Patients were randomized to receive solifenacin 5 mg + mirabegron 50 mg (combination 5 + 50 mg), solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg monotherapy, mirabegron 25 mg monotherapy, mirabegron 50 mg monotherapy, or placebo for a 12-week double-blind treatment period. A total of 3398 patients were included in the study. Mean changes from baseline to the end of therapy in ECG parameters were similar across treatment groups, although there was an increase in heart rate of 1 beat/minute in the mirabegron treatment groups. There were no clinically meaningful differences in change from baseline in QTcF between monotherapies and placebo and between monotherapies and combination therapy. There were very few major CV events: 1 of 853 (0.1%) with a nonfatal myocardial infarction in the combination 5 + 25 mg group, 2 of 848 (0.2%) with a nonfatal stroke in the combination 5 + 50 mg group, and no events in the other groups. This CV safety analysis of the combination of mirabegron and solifenacin showed rates of CV events comparable with those for monotherapy treatments based on assessments of vital signs, electrocardiograms, and adjudicated CV events.

As the understanding of the mechanisms that underlie the overactive bladder have increased, so its diagnosis and management have become more complex. This article, based on a consensus group meeting, provides guidance on the current management of overactive bladder in primary care.

AIMS An International Consultation on Incontinence-Research Society (ICI-RS) Think Tank in 2015 discussed and evaluated the evidence of when stress incontinence surgery should be performed with prolapse surgery and highlighted evidence gaps, with the aim of recommending further clinical and research proposals. METHODS A review of the literature assessing randomized studies where women with vaginal prolapse have been randomized to vaginal prolapse surgery with or without continence surgery were evaluated. The different clinical presentations were also evaluated and their impact on outcome was critically reviewed. RESULTS There are three symptomatic groups of women with vaginal prolapse who are treated. The first group is continent women with vaginal prolapse. The second group has stress urinary incontinence (SUI) and vaginal prolapse. The last group has vaginal prolapse and have been found through testing to have occult SUI. The studies have reported a range of outcomes for each of these groups. There are different outcomes based on the surgical method used to correct the prolapse and also the different continence surgical techniques. There are insufficient studies to allow firm conclusions to be drawn. The economic impact of the different management pathways is also discussed although costs vary according to different national medical funding systems. CONCLUSIONS There is considerable uncertainty about the optimal method of managing women with vaginal prolapse and stress incontinence due to the different surgical techniques available. In particular the group of women with occult SUI are a challenge as the optimal diagnostic method has not yet been defined.

Aims: Nocturia or waking at night, to urinate is a common cause of awakenings and may lead to sleep disturbance, impaired somatic health, impaired quality of life, and increased mortality. The aim of this report is to point out and discuss the aspects and issues that need to be addressed to improve the care of nocturia. Methods: This paper is a report of the presentations and subsequent discussion of a Think Tank session at the annual International Consultation on Incontinence-Research Society (ICI-RS) in June 2018 in Bristol. Results and conclusion: Nocturia is a known risk factor for in-hospital falls. Unfortunately, its assessment in acutely hospitalized (older) people is not the current practice and ward-based care plans are not tailored to this symptom. A new care pathway for hospitalized patients who have nocturia should be considered. More research into the relation of cardiovascular disorders and nocturnal polyuria (NP) is warranted and management of NP patients may be improved by involving a cardiologist in their management. There is definitely a need for phenotyping nocturia in relation to bladder capacity, filling phase, and emptying phase symptoms and how to treat the different phenotypes. In the near future, smart automated monitoring devices and applications might help us to diagnose and treat nocturia with less efforts.

Objective To determine whether electronic bladder diaries are associated with a larger placebo effect than paper diaries in studies of overactive bladder (OAB). To identify any other factors in study design that may influence the placebo effect. Study design This is a secondary analysis of a previous systematic review and network meta-analysis on the efficacy and tolerability of mirabegron. Each study was analysed and placebo response rate (PRR) was calculated. Statistical analysis was used to look for associations with different factors and PRR. Results The PRR was considerable in the studies analysed (10.5 % when calculated for change in number of micturitions over 24 h and 41.2 % for change in urgency urinary incontinence episodes over 24 h). Paper bladder diaries were associated with a significantly larger placebo response rate than electronic (10.76 % vs 10.22 %), although this may be clinically small. The size of study had a moderate positive correlation with PRR. Length of bladder diary was not associated with increased PRR. Conclusions The PRR in studies of OAB is varied and significant. It is clear that it can be affected by factors in study design including type of bladder diary. When designing clinical studies this should be borne in mind. Equally, when attempting to optimise patient care, the benefit of the therapeutic encounter should be remembered.

Aims There is increasing evidence to suggest that thermomodulation may have a role in the management of women with lower urinary tract dysfunction (LUTD) and there has been widespread adoption of laser and radiofrequency (RF) therapies within clinical practice. However, in many areas of LUTD, the data are still limited and there remains a need for further evaluation of the safety and efficacy of thermal therapy. The aim of this study proposal is to report the findings of the International Consultation on Incontinence Research Society to clarify our current knowledge regarding the evidence for thermal therapy in LUTD and to set research priorities for the future. Methods Literature review based on the search terms: "laser," "radiofrequency," "genitourinary syndrome of the menopause" or "urogenital atrophy," "stress urinary incontinence (SUI)," "pelvic organ prolapse," "OAB" or "overactive bladder," and "urinary tract infection." Results The current available evidence, though of low or very low quality, appears promising for the use of laser therapy in the management of genitourinary syndrome of the menopause, there are some data to suggest a possible role in SUI although very little evidence for urogenital prolapse. At present, the evidence supporting the use of laser in OAB and recurrent urinary tract infection is limited or lacking, while the available evidence for RF in the management of all forms of LUTD is much less robust. Conclusions Laser and RF are being introduced clinically as a minimally invasive, low-risk interventions for women with LUTD although at present, the evidence supporting usage is limited. Consequently, there is an urgent need to demonstrate the safety and efficacy with prospective long-term studies including sham studies and comparative studies with current standard therapy.