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Introduction and Hypothesis: Vaginal prolapse mesh may effectively restore vaginal anatomy. The aim of this study was to investigate how the in vivo mesh position correlates to clinical outcomes., Methods: Seventy-one women operated on using Uphold mesh for apical pelvic organ prolapse (POP-Q, C ≥ stage II) were examined 5 years after surgery by introital-perineal 2D ultrasound in a midsagittal plane at rest and Valsalva. The horizontal line and pubis symphysis were considered the reference for all measures. Ultrasound measures were statistically compared to clinical outcomes: POP-Q, Pelvic Floor Distress Inventory (PFDI-20) and subscales [Pelvic Organ Distress Inventory (PODI-6), and Urinary Distress Inventory (UDI-6)] and the VAS scale for pain., Results: Original mesh length was preserved by 86% and correlated to improved pain as estimated by VAS scale (r 0.321). Valsalva was associated with a lowering of the superior and inferior mesh margins by 7.3 and 6.1 mm, respectively (p < 0.001) but a reduction of total mesh length by only 1 mm (30.2 ± 5.2 to 29.2 ± 4.7 mm, p < 0.001). Mobility of the anterior vaginal wall (bladder neck and midurethra) at Valsalva was parallel to downward movement of the mesh inferior margin (r 0.346 and 0.314) but inversely correlated to total UDI-6 (r - 0.254 and - 0.263). Mobility of the midurethra was inversely correlated to bladder emptying (PFDI-20 Question 19, r - 0.245)., Conclusions: Five years after surgery, preserved original length of the mesh with apical support was correlated to improved anatomical and patient-reported outcomes. Mesh support to the vaginal apex was associated with improved bladder emptying and total urinary distress outcomes but not stress urinary incontinence., (© 2021. The Author(s).)

Purpose: The aim of this study was to compare long-term effects of high-volume surgery at a single-center to multicenter use when using a mesh-capturing device for pelvic organ prolapse (POP) repair., Methods: Five years after surgery 101 (88%) at the single center were compared with 164 (81.2%) in the multicenter trial. Outcome measurements included clinical examination, prolapse-specific symptom questionnaires [Pelvic Floor Distress Inventory 20 (PFDI-20), Pelvic Floor Impact Questionnaire-short form (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)] and pain estimation by VAS (0-10)., Results: Optimal apical segment outcome was 95% in the single- compared to 83.3% in the multicenter study (p < 0.001). POP recurrence in the anterior and posterior walls (POP-Q, Ba and Bp ≥ 0) was more common at the multicenter as compared to the single center [(19.8% vs 5.4%) and (26% vs 2.7%), (p < 0.001)]. Reoperations for POP and mesh-related complications were more frequent in the multicenter study [31/202 (15.3%) vs 7/116 (6.1%), p < 0.001]. Total PFDI-20, PFIQ-7 and PISQ-12 scores were comparable between the cohorts. There were no significant differences in overall pain scores in-between the cohorts during follow-up. At the single center, 1/81 patients (1.2%) had VAS 7/10, i.e. severe pain, as compared to 3/131 (2.3%) in the multicenter study (p = 0.277)., Conclusions: Despite the high objective and subjective long-term effectiveness of the procedure in both regular use, and at a high-volume center, centralizing the use of a standardized capturing-device guided transvaginal mesh for POP repair reduced secondary interventions by more than half.

Objective: To assess whether there is any association between the implantation of synthetic polypropylene mesh slings for the treatment of stress urinary incontinence (SUI) and risk of cancer., Methods: We performed a nationwide cohort study based on the general female population in Sweden. All women entered the observational period as unexposed on January 1, 1997, and contributed person-time as unexposed unless they underwent a midurethral sling procedure for SUI, after which they contributed person-time as exposed until first occurrence of any cancer, death, emigration, or end of the observational period (December 31, 2009). Occurrence of primary cancer was ascertained from the Cancer Register. Hazard ratios (HRs) with 95% CIs were calculated by Cox proportional hazards regression., Results: The final study population included 5,385,186 women, including 20,905 exposed, encompassing a total of 44,012,936 person-years at risk. Other than an inverse association with rectal cancer (HR 0.5, 95% CI 0.3-0.8), there were no significant differences in risk between exposed and unexposed women for pelvic organ cancers including ovarian (HR 0.8, 95% CI 0.5-1.2), endometrial (HR 1.1, 95% CI 0.8-1.4), cervical (HR 0.4, 95% CI 0.2-1.0), bladder, and urethra (HR 0.7, 95% CI 0.4-1.2). No significant association was observed between exposed women and primary cancer in any organ system when compared with unexposed women. The relative risk for cancer after exposure showed little variation over time except for an inverse overall correlation within the first 4 years of surgery (HR 0.7, 95% CI 0.7-0.8). The incidence rates per 100,000 person-years (95% CIs) for exposed vs unexposed women were 20.5 (14.3-29.5) vs 21.0 (20.6-21.5) for rectal cancer, 25.5 (18.4-35.3) vs 19.8 (19.4-20.2) for ovarian cancer, 65.0 (53.0-79.8) vs 33.1 (32.6-33.7) for endometrial cancer, 5.7 (2.8-11.3) vs 11.9 (11.6-12.2) for cervical cancer, and 19.1 (13.1-27.8) vs 13.3 (13.0-13.7) for bladder and urethra cancer., Conclusion: Our results suggest that midurethral polypropylene sling surgery for SUI is not associated with an increased cancer risk later in life.

Introduction and Hypothesis: The aim of this study was to compare the results of pelvic organ prolapse repair using a capturing device-guided transvaginal mesh in a single- vs multicenter setting., Methods: One hundred and twelve women operated by two surgeons at one center (2-year follow-up) were compared with 207 women operated on by 26 surgeons at 24 centers (1-year follow-up). Patients were screened at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system. Outcome measurements included POP-Q evaluations, prolapse-specific symptom questionnaires, and surgical data., Results: At the end of follow-up 95 out of 98 (96.9%) had an optimal anatomical outcome at the apical segment (POP-Q stage 0-1) in the single center compared with 154 out of 164 (93.9%) in the multicenter study (P = 0.03). There were no serious complications in the single-center study compared with 9 out of 207 (4.3%) in the multicenter study. In patients undergoing surgery for recurrence, the risk ratio for complications overall was 4:1 in favor of the single-center study. There were no significant differences between the studies in any subjective symptom scale., Conclusions: Compared with multicenter use, large volumes at a single site only resulted in minor improvements of anatomical outcomes and no significant differences with regard to patient-reported outcomes on pelvic organ function or related quality of life. Instead, the greatest benefit of single-center use was the significantly decreased complication rates.

Objective: To study the effects on quality of life in women operated for apical pelvic organ prolapse using the Vaginal Uphold™ System., Study Design: In this prospective cohort study, women (n=207) with symptomatic apical prolapse, with or without cystocele, were operated using the Uphold™ Vaginal Support System. Follow-up for quality of life was performed at 12 months after surgery, and assessed by the PFDI-20, and PFIQ-7, and sexual function by the PISQ-12. We used odds ratios (ORs) with 95% confidence intervals (CIs) for outcome association analyses using logistic regression., Results: At one-year follow-up majority of women experienced an overall postoperative improvement in quality of life (p<0.001). One year after surgery Uphold™ operation alone increased the risk for prolapse related bother as compared to Uphold™ combined with anterior colporraphy (POP-IQ-7; OR 2.1; 95% CI 1.01-4.3). The frequency of dyspareunia decreased postoperatively (p=0.004), however, after one-year, overall sexual function deteriorated significantly (p<0.001). The worsening in sexual function scores was mainly attributed to the partner related domain, whereas the behavioral-emotive and physical domains showed no significant changes., Conclusion: Apical prolapse repair using Uphold™ improved quality of life among our patients but worsened overall sexual function postoperatively., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Introduction and Hypothesis: The objective was to assess safety and clinical outcomes in women operated on using the Uphold™ Lite Vaginal Support System., Methods: We carried out a 1-year, multicenter, prospective, single cohort study of 207 women with symptomatic Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 apical pelvic organ prolapse, with or without concomitant anterior vaginal wall prolapse. Safety data were collected using a standardized questionnaire. Anatomical outcome was assessed by the POP-Q and subjective outcomes by the Pelvic Floor Distress Inventory after 2 months and 1 year using a one-way repeated measures analysis of variance. Pain was evaluated using a visual analog scale., Results: The overall rate of serious complications was 4.3 % (9 out of 207 patients), including 3 patients with bladder perforations, 1 with bleeding >1,000 ml, 2 who had undergone re-operations with complete mesh removal because of pain, and 3 surgical interventions during follow-up because of mesh exposure. POP-Q stage ≤1 after 1 year was 94 % and subjective symptom relief was reported by 91 % of patients (p < 0.001). Pain after 2 months and 1 year was 60 % lower compared with the preoperative mean (p < 0.001). Minor complications occurred in 20 women (9.7 %) and were dominated by lower urinary tract dysfunction. No predisposing risk factors for complications were found., Conclusions: The Uphold™ Lite procedure in women with apical pelvic organ prolapse provided satisfactory restoration of vaginal topography and symptom relief. However, serious complication rates were largely comparable with those of other transvaginal mesh kits.

Introduction and Hypothesis: The optimal surgery for lateral defects is not well defined. Our objective was to assess the effects of anterior trocar-guided transvaginal mesh repair versus anterior colporrhaphy in women with lateral defects., Methods: This subanalysis from a randomized controlled trial of mesh kit versus anterior colporrhaphy assessed 99 patient diagnosed at baseline with lateral defects in the anterior vaginal wall. Thirty-nine patients underwent anterior colporrhaphy and 60 anterior trocar-guided transvaginal mesh surgery., Results: One year after surgery, a persistent lateral defect was significantly more common after colporrhaphy compared with transvaginal mesh [11/32 (34.4 %) vs 1/42 (2.4 %), risk ratio (RR) 14.4, 95 % confidence interval (CI) 2.0-106.1; P < 0.001)] However, there were no significant differences between treatment groups with regard to subjective symptoms as reflected by the overall Urogenital Distress Inventory scores, with mean difference from baseline 37.3 ± 50.6 in the colporrhaphy group vs 39.0 ± 45.8 in the mesh group (p = 0.61)., Conclusions: Use of a transvaginal mesh kit increases the odds for anatomical correction of lateral defects compared with anterior colporrhaphy but does not necessarily improve lower urinary tract symptoms.

Aims: To identify risk factors for mesh exposures after anterior pelvic organ prolapse repair using a standardized trocar guided polypropylene mesh kit., Methods: A secondary risk analysis combining patients from two prospective multicenter studies. Main outcome was clinical host-vs-implant reactions one year after surgery using a macroscopic inflammatory scale., Results: 353 patients were included in the study. Mean age at surgery was 65.3 (± 9.6 SD) years and surgery was performed as a primary procedure in 224/353 (63.5%) patients. Mesh exposures, of which the majority were mild-moderate, occurred in a total of 30/349 patients (8.6%). Multivariate logistic regression showed increased odds for mesh exposures for women who smoked before surgery (OR 3.48, 95% CI 1.18-10.28), who had given birth to more than two children (OR 2.64, 95% CI 1.07-6.51) and those with somatic inflammatory disease (OR 5.11, 95% CI 1.17-22.23). Age, body mass index, and menopausal status showed no significant association with clinical mesh exposures., Conclusions: Smoking, multiple childbirth, and somatic inflammatory disease are possible risk factors for mesh exposure after trocar guided mesh kit surgery for anterior pelvic organ prolapse. Preoperative smoking cessation may decrease the risk for exposures., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy., Methods: In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery., Results: Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group., Conclusions: As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).

Aims: To assess the effects of trocar guided transvaginal mesh on lower urinary tract symptoms after anterior vaginal wall prolapse repair., Methods: One hundred twenty-one patients undergoing anterior transvaginal mesh surgery was prospectively evaluated at baseline and 1 year after surgery using the urogenital distress inventory (UDI)., Results: Overall UDI scores declined from 91 before surgery to 31 one year after surgery (P < 0.001). UDI subscales for obstructive and irritative symptoms improved 1 year after surgery (P < 0.001 for both) while stress symptoms did not (P = 0.11)., Conclusion: Trocar guided transvaginal mesh surgery for anterior vaginal wall prolapse was associated with an overall resolution of most symptoms associated with overactive bladder syndrome and bladder outlet obstruction. These beneficial effects should be weighed against an increased risk for stress urinary incontinence related to the procedure., (© 2010 Wiley-Liss, Inc.)

Aims: To investigate the urodynamic effects of anterior vaginal wall prolapse surgery using either trocar guided transvaginal mesh or colporraphy., Methods: A prospective, randomized multicenter trial enrolling 50 patients: 27 underwent anterior colporrhaphy and 23 anterior trocar guided transvaginal mesh. Urodynamic assessment was performed pre- and two months postoperatively., Results: De novo stress urinary incontinence was significantly more common after trocar guided transvaginal mesh surgery compared to colporraphy. In comparison to baseline urodynamics, transvaginal mesh surgery resulted in a significant decrease in maximal urethral closing pressures (MUCP) whereas conventional anterior colporraphy had no significant effect on urodynamic parameters., Conclusion: Trocar guided transvaginal mesh of anterior vaginal wall prolapse results in a lowering of MUCPs and increases the risk for de novo stress urinary incontinence compared to colporraphy., ((c) 2009 Wiley-Liss, Inc.)

Purpose: We prospectively evaluated the histological inflammatory response to the large polypropylene transvaginal mesh used for pelvic organ prolapse surgery., Materials and Methods: Ten patients and 8 controls underwent vaginal punch biopsy sampling before surgery and patients also underwent it 1 year after pelvic reconstructive surgery using polypropylene mesh. Foreign body response to the mesh was assessed using a combination of histological, semiquantitative and computerized image based analysis., Results: Compared to preoperative histology there was a significant postoperative increase in macrophage and mast cell counts (p = 0.03 and 0.01) but no significant changes in the count of cells involved primarily in the infectious cell response or collagen density and the elastin area fraction at the mesh-tissue interface (p = 0.2 and 0.3, respectively). Three cases of mild granuloma formation and 2 of mild erosion were observed. There was no significant change in epithelial thickness when comparing preoperative and postoperative samples., Conclusions: When used for pelvic reconstructive surgery, macroporous monofilament polypropylene mesh induces a mild but persistent foreign body reaction.

Objective: To estimate sexual dysfunction before and after trocar-guided transvaginal mesh surgery for pelvic organ prolapse., Methods: Sexually active women participating in a prospective multicenter study were recruited at 26 centers. All participants underwent a standardized surgical procedure and were evaluated before (n=105) and 1 year after (n=84) surgery using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Nonparametric statistics were used for comparisons., Results: Mean age at surgery was 61.5 years (standard deviation [SD] 7.6), median parity was 2 (range, 1-6), and mean body mass index was 26.8 (SD 4.3) (body mass index is calculated as weight (kg)/[height m]). Anterior transvaginal mesh repair was performed in 46 patients (44%), posterior in 26 patients (25%), and combined anterior and posterior in 33 patients (31%). Overall sexual function scores worsened from 15.5 (SD 8.0) at baseline to 11.7 (SD 6.9) 1 year after surgery (P<.001). The trend toward deteriorating sexual function scores was similar for all three surgical procedures. There was an overall worsening of all symptoms in the behavioral-emotive and partner-related items, whereas improvements were observed in physical function. Overall rates and severity of dyspareunia in specific neither improved nor worsened., Conclusion: Sexual function scores deteriorate 1 year after trocar-guided transvaginal mesh surgery. The worsening was attributed primarily to a worsening in behavioral-emotive and partner-related items. Anatomical cure after surgery was not associated with improved PISQ scores., Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844, Level of Evidence: II.

Objective: To prospectively assess clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh., Methods: This was a prospective multicenter cohort study performed throughout 26 clinics. Evaluation at baseline, 2 months, and 1 year after surgery included prolapse grading using the pelvic organ prolapse quantification system (POP-Q) and symptom assessment using the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6). For the purpose of this study, postoperative POP-Q stage 0-I was considered anatomic cure., Results: Two-hundred sixty-one patients were included in the study; 232 (89%) attended the 1-year follow-up. Mean+/-standard deviation age at surgery was 66.3+/-9.4 years. Anatomic cure 1 year after surgery was observed in 96 of 121 women (79%) after anterior repair with mesh (P<.001), and 56 of 68 (82%) after posterior repair with mesh (P<.001). For combined anterior and posterior mesh repair, cure was 51 of 63 (81%) and 54 of 63 (86%) for the anterior and posterior compartment, respectively (P<.001 for both). Bladder and rectal perforations occurred in 9 of 252 patients (3.4%). Vaginal erosions, the majority mild to moderate, occurred in 26 of 232 cases (11%). Surgical intervention due to mesh exposure occurred in seven cases (2.8%). There were significant quality-of-life improvements in all domains of the IIQ-7. Despite significant improvements in UDI-6 scores, symptoms specific for stress urinary incontinence were not ameliorated., Conclusion: Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery., Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844, Level of Evidence: II.

Objective: To describe the perioperative morbidity associated with transvaginal mesh repair of pelvic organ prolapse., Methods: During a 6-month time period, 25 centers registered all surgical procedures using a commercially available mesh. The frequency and type of perioperative complications, during surgery and the associated hospital stay, were documented using a standardized protocol., Results: During the inclusion period, 248 women underwent transvaginal mesh surgery: anterior repair in 106 patients (43%), posterior repair in 71 (29%), combined anterior and posterior repair in 20 (8%), and total repair in 51 (21%). Mean age was 67.8 years (+/-10.3 standard deviation) and median parity was 2 (range 0-6). Surgery for prolapse recurrence was performed in 56% of the patients (n=140), and 91% (n=225) had undergone at least one previous pelvic floor surgical procedure. Serious complications occurred in 4.4% of patients (n=11) and were dominated by visceral injury (10 of 11 cases). One case of bleeding in excess of 1,000 mL occurred. Minor complications occurred in 14.5% of patients (n=36), and the majority were urinary tract infections, urinary retention, and postoperative fever. A multivariable risk analysis showed that concurrent pelvic floor surgery was associated with an increased risk for minor complications, odds ratio 2.8 (95% confidence interval 1.1-6.9). There were no other predictors of outcomes when assessing the association with age, parity, weight, previous pelvic floor surgery, previous hysterectomy, or concurrent hysterectomy., Conclusion: Perioperative serious complications are uncommon after transvaginal mesh procedures although particular care should be taken to detect visceral injury at the time of surgery., Level of Evidence: III.

Objectives: To assess the clinical outcome after abdominal sacrocolpopexy using a porcine dermal graft compared with a synthetic mesh., Methods: Patients with vaginal vault prolapse Stage II or worse (Baden-Walker staging), underwent sacrocolpopexy using a synthetic mesh (n = 25) or porcine collagen graft (n = 27). The subjective outcome was measured using validated questionnaires., Results: The mean clinical follow-up from surgery was 7.1 months for the xenograft compared with 7.4 months for the synthetic cohort. At clinical follow-up, vaginal vault prolapse Stage II was present in 8 (29%) of 27 patients in the xenograft cohort and 6 (24%) of 25 patients in the synthetic mesh cohort (no significant difference). The mean follow-up from surgery to survey was 2.5 years in the xenograft cohort and 4.3 years in the synthetic cohort. None of the patients in either cohort had undergone a secondary sacrocolpopexy. No significant differences were found between the cohorts regarding surgical morbidity other than more patients experiencing fever for 1 to 3 days in the xenograft cohort (P < 0.001). No significant differences were found in lower urinary tract symptoms, anorectal symptoms, or quality-of-life variables between the two cohorts., Conclusions: Abdominal sacrocolpopexy using a porcine dermal graft was comparable to synthetic mesh in terms of subjective and anatomic outcomes at mid to long-term follow-up.

Unlabelled: Although the etiology of rectocele remains debated, surgical innovations are currently promoted to improve anatomic outcome while avoiding dyspareunia and alleviating rectal emptying difficulties following rectocele surgery. Use of biomaterials in rectocele repair has become widespread in a short time, but the clinical documentation of their effectiveness and complications is limited. Medline and the Cochrane database were searched electronically from 1964 to May 2005 using the Pubmed and Ovid search engines. All English language publications including any of the search terms "rectocele," "implant," "mesh," "biomaterial," "prolapse," "synthetical," "pelvic floor," "biological," and "compatibility" were reviewed. This review outlines the basic principles for use of biomaterials in pelvic reconstructive surgery and provides a condensation of peer-reviewed articles describing clinical use of biomaterials in rectocele surgery. Historical and new concepts in rectocele surgery are discussed. Factors of importance for human in vivo biomaterial compatibility are presented together with current knowledge from clinical studies. Potential risks and problems associated with the use of biomaterials in rectocele and pelvic reconstructive surgery in general are described. Although use of biomaterials in rectocele and other pelvic organ prolapse surgery offers exciting possibilities, it raises treatment costs and may be associated with unknown and potentially severe complications at short and long term. Clinical benefits are currently unknown and need to be proven in clinical studies., Target Audience: Obstetricians & Gynecologists, Family Physicians, Target Audience: After completion of this article, the reader should be able to explain that the objective of surgical treatment is to improve anatomic outcome and alleviate rectal emptying difficulties, describe the efficacy of biomaterials in rectocele repair, and summarize the potential risks and problems associated with use of biomaterials in rectocele and pelvic reconstructive surgery.

The aim of this study was to evaluate quality of life, sexual function, and anatomical outcome after posterior vaginal wall prolapse repair using a collagen xenograft. Thirty-three patients were evaluated preoperatively and at 6 and 12 months follow-up (FU). Quality of life and sexual function were assessed using a self-reported questionnaire. Prolapse staging was performed using the pelvic organ prolapse quantification system (POPQ). Preoperatively 3 patients had stage I, 26 patients stage II, and 4 patients stage III prolapse of the posterior vaginal wall. Prolapse of the posterior vaginal wall > or = stage II was observed in 7 patients (21%) at the 6-month FU and in 13 patients (39%) at the 12-month FU. Mean point Bp was reduced from -1.1 preoperatively to -2.5 at 6 months FU (p < 0.01) and -1.8 at 12 months FU (p < 0.01). Previous abdominal surgery was associated with a less favorable anatomical outcome (odds ratio: 2.0, 95% confidence interval: 1.5-3.8). There were no significant changes in sexual function or dyspareunia during the 1-year FU. Preoperatively 76% of the patients reported a negative impact on quality of life as a result of genital prolapse. There was a significant improvement in several variables associated with quality of life at 6 and 12 months FU. Posterior vaginal wall prolapse repair using a collagen xenograft was associated with an unsatisfying anatomical outcome at 1-year FU although several quality of life-associated variables affecting psychosocial function were improved. Improvement was not restricted to postoperative restoration of vaginal topography, and previous surgery had a negative effect on anatomical outcome.

Purpose: This study was designed to evaluate rectocele repair using collagen mesh., Methods: 32 female patients underwent surgical repair using collagen mesh. Outcome was assessed in 29 patients and preoperative assessment included standardized questionnaire, clinical examination, and defecography. At the six-month follow-up, patients answered a standardized questionnaire and underwent clinical examination. At the 12-month follow-up, patients answered a standardized questionnaire, underwent clinical examination, and defecography., Results: Preoperatively, 26 patients had a Stage II and 3 patients had a Stage III rectocele. At the 6-month follow-up, five patients had rectocele > or = Stage II (P < 0.001) and at the 12-month follow-up, seven patients had rectocele > or = Stage II (P < 0.001) at clinical examination. At the preoperative defecography, all patients presented a rectocele. At the 12-month defecography, 14 patients had no rectocele (P < 0.001) and 15 had a rectocele. At the six-month follow-up, there was a significant decrease in rectal emptying difficulties, need of digital support of the posterior vaginal wall at defecation, and defecation frequency. At the 12-month follow-up, symptom improvement remained, but was less pronounced., Conclusions: Rectocele repair using collagen mesh improved anatomic support, but there is a substantial risk for recurrence with unsatisfactory anatomic and functional outcome one year after surgery. Rectocele repair using mesh was not associated with an increased risk of dyspareunia. Rectocele repair using biomaterial mesh reinforcement needs further evaluation before adopted into clinical practice.

Aim: To clinically and histologically evaluate inflammatory response following rectocele repair using porcine collagen mesh., Methods: Seventeen patients underwent rectocele repair using porcine collagen mesh. Inflammatory response was assessed by clinical and histological inflammatory grading pre- and postoperatively. Postoperative body temperature, complications and hospital stay was compared with 15 patients undergoing posterior colporraphy., Results: Postoperative clinical examination did not demonstrate any inflammatory reaction. There were no significant changes in fibroblast count (P = 0.43), connective tissue density grading (P = 0.54), macrophage count (P = 0.20), inflammatory cell count (P = 0.48), total cell count (P = 0.51), or inflammatory grading (P = 0.87) postoperatively compared with preoperative values. Body temperature was significantly elevated for both the study and control group, although higher for the study group, postoperatively day 1 (P < 0.001). There were no significant differences in hospital stay and postoperative complications., Conclusion: Porcine collagen mesh was not associated with an adverse inflammatory response at clinical or histological evaluation and appears to be a safe material when used for rectocele repair.