Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse.
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ABSTRACT:
SUBMITTER: Maher C
PROVIDER: S-EPMC6489145 | biostudies-literature | 2016 Feb
REPOSITORIES: biostudies-literature
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Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse.
Maher Christopher C Feiner Benjamin B Baessler Kaven K Christmann-Schmid Corina C Haya Nir N Marjoribanks Jane J
The Cochrane database of systematic reviews 20160209
<h4>Background</h4>A wide variety of grafts have been introduced with the aim of improving the outcomes of traditional native tissue repair (colporrhaphy) for vaginal prolapse.<h4>Objectives</h4>To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair for vaginal prolapse.<h4>Search methods</h4>We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Control ...[more]
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Project description:ObjectiveTo systematically review outcomes after mesh sacrocolpopexy compared with native tissue vaginal repairs in women with apical prolapse.Data sourcesWe searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov through June 4, 2012.Methods of study selectionFor anatomic and functional analyses, we included studies comparing mesh sacrocolpopexy to native tissue vaginal repairs with at least 6 months follow-up. The primary outcome was anatomic "success" after surgery. Secondary outcomes were reoperation and symptom outcomes. We included large case series and comparative studies with shorter follow-up to increase power for adverse event analyses.Tabulation, integration, and resultsEvidence quality was assessed with the Grades for Recommendation, Assessment, Development and Evaluation system. Meta-analyses were performed when at least three studies reported the same outcome. We included 13 comparative studies for anatomic success, reoperation, and symptom outcomes. Moderate-quality evidence supports improved anatomic outcomes after mesh sacrocolpopexy; very low-quality evidence shows no differences in reoperation between sacrocolpopexy and native tissue vaginal repairs. Evidence was insufficient regarding which procedures result in improved bladder or bowel symptoms. Low-quality evidence showed no differences in postoperative sexual function. Adverse event data were compiled and meta-analyzed from 79 studies. When including larger noncomparative studies, ileus or small bowel obstruction (2.7% compared with 0.2%, P<.01), mesh or suture complications (4.2% compared with 0.4%, P<.01), and thromboembolic phenomena (0.6% compared with 0.1%, P=.03) were more common after mesh sacrocolpopexy compared with native tissue vaginal repairs.ConclusionWhen anatomic durability is a priority, we suggest that mesh sacrocolpopexy may be the preferred surgical option. When minimizing adverse events or reoperation is the priority, there is no strong evidence supporting one approach over the other.
| S-EPMC4352548 | biostudies-literature
Project description:The aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse.This is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ? +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80% with 5% cutoff point (p < 0.05) for statistical significance.The groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5% (95% confidence interval 0.068-0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5% of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.
| S-EPMC3824218 | biostudies-literature
Project description:Introduction and hypothesisThe present study describes an extended follow-up study after 12 years and focusses on subjective outcomes of women who underwent surgery for recurrent pelvic organ prolapse in the randomized index study.MethodsOne hundred and ninety-four (194) women had been randomized in the original study and in the present study, 45 (47%) in the vaginal mesh repair versus 43 (43%) women with conventional vaginal native tissue repair completed the long-term questionnaires. The mesh used was a first-generation non-absorbable mesh kit. All types of conventional vaginal native tissue repairs were allowed, and additional vaginal native tissue repairs were allowed in the mesh group. The questionnaires as applied at baseline were used. The Patient Global Impression of Improvement questionnaire (PGI-I) was the primary outcome.ResultsAt 12 years, 30 (71%) women in the mesh group versus 23 (59%) women in the native tissue repair group reported to be PGI-I (very) much improved (p=0.24). There were no differences found in any of the questionnaire domains. There was, however, a higher number of women who had had additional operations for recurrent pelvic organ prolapse, stress urinary incontinence, and/or exposure in the mesh group: 18 women (40%) in the mesh group versus 8 women (19%) in the native tissue repair group (p=0.03).ConclusionsThere was no difference in subjective outcome between the groups, but there was a statistically significant higher number of women who had needed further operations. This study confirms that vaginal mesh should not be used in all women with recurrent pelvic organ prolapse.
| S-EPMC10287778 | biostudies-literature
Project description:Introduction and hypothesisOur aim was to evaluate clinically relevant long-term outcomes of transvaginal mesh or native tissue repair in women with recurrent pelvic organ prolapse (POP).MethodsWe performed a 7-year follow-up of a randomized controlled trial on trocar-guided mesh placement or native tissue repair in women with recurrent POP. Primary outcome was composite success, defined as absence of POP beyond the hymen, absence of bulge symptoms, and absence of retreatment for POP. Secondary outcomes were adverse events, pain, and dyspareunia. Multiple imputation was used for missing data of composite success and pain; estimates are presented with 95% confidence intervals (CI).ResultsBetween August 2006 and July 2008, 194 women were randomized; 190 underwent surgery. At 7 years, 142 (75%) were available for analysis, of whom, the primary outcome could be calculated in 127. Composite success was 53% (95% CI 41, 66) for mesh and 54% (95% CI 42, 65) for native tissue. Repeat surgery for POP was 25% for mesh and 16% for native tissue (difference 9%; 95% CI -5, 23) and occurred in untreated compartments in the mesh group and treated compartments in the native tissue group. Mesh exposure rate was 42%; pain with mesh 39% and native tissue 50% (difference - 11%, 95% CI -27, 6); dyspareunia with mesh 20% and native tissue 17% (difference 3%, 95% CI -9, 17).ConclusionsSeven-year composite success rates appeared similar for mesh and native tissue. Mesh did not reduce long-term repeat surgery rates due to de novo POP in nonmesh-treated vaginal compartments. Mesh exposure rates were high, though significant differences in pain and dyspareunia were not detected.Clinical trial registrationClinicalTrials.gov , NCT00372190.
| S-EPMC5948295 | biostudies-literature
Project description:ImportanceSurgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain.ObjectiveTo compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair.Design, setting, and participantsThis randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020.InterventionsThe intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation).Main outcomes and measuresThe primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events.ResultsOf 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen.Conclusions and relevanceAdjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair.Trial registrationClinicalTrials.gov Identifier: NCT02431897.
| S-EPMC10427941 | biostudies-literature
Project description:ObjectiveThe objective of this study was to present the design of the Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial (ASPIRe), which compares the efficacy and safety of 3 apical repairs: native tissue (NT) transvaginal repair, transvaginal mesh, and sacral colpopexy.MethodsPatient selection criteria, primary and secondary outcome measures including patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, adverse events collection and adjudication, and cost analysis will be described for this multi-centered randomized trial. Given the unique risks/benefits of each technique, a noninferiority design will be used to compare apical transvaginal mesh to mesh sacral colpopexy. A superiority design will be used to compare the 2 mesh repairs to NT transvaginal apical repair. Survival analysis will be used to assess a composite primary outcome for success composed of a subjective measure (no prolapse symptoms), objective measure (no prolapse beyond the hymen), and no prolapse retreatment, with a minimum follow-up of 36 months. Secondary outcome measures collected every 6 months include assessment of validated general and condition-specific quality of life measures, global impression of improvement, satisfaction and regret, body image, and sexual function.ResultsRandomization and surgical treatment of 360 participants are complete, and the study is in the follow-up phase.ConclusionsThis report will provide valuable insight on the design of a novel 3-arm surgical trial using mesh versus NT to repair vaginal vault prolapse. This trial will provide level 1 evidence on the risks and benefits of mesh augmented versus NT apical repairs.
| S-EPMC7326314 | biostudies-literature
Project description:ObjectivesTo provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair.MethodsStudy population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months. Time-to-failure postoperatively will be compared in the 2 groups with continued surveillance to 36 months. Secondary outcomes assessed at baseline, preoperatively (ie, after at least 5 weeks of study cream), and postoperatively at 6 month intervals include validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image. Challenges unique to this study include design and manufacture of placebo and defining and measuring study drug adherence.ResultsRecruitment of 204 women is complete with 197 randomized. There have been 174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit.ConclusionsThis trial will contribute evidence-based information regarding the effect of perioperative vaginal estrogen as an adjunct therapy to standardized transvaginal native tissue prolapse surgical repair.
| S-EPMC7769931 | biostudies-literature
Project description:INTRODUCTION AND HYPOTHESIS: The objective of this study was to report 1 year anatomical and functional outcomes of trocar-guided total tension-free vaginal mesh (Prolift) repair for post-hysterectomy vaginal vault prolapse with one continuous piece of polypropylene mesh. METHODS: We conducted a prospective observational cohort study of 46 patients. A minimum sample size of 35 patients was needed to detect a recurrence rate of less than 20% at 12 months. Instruments of measurement used were pelvic organ prolapse quantification and validated questionnaires. RESULTS: Overall anatomical success was 91% (95% confidence interval 83-99), with significant improvement in experienced bother and quality of life. Mesh exposure occurred in seven patients (15%). No adverse effects on sexual function could be detected. CONCLUSIONS: Trocar-guided total tension-free vaginal mesh (Prolift) repair with one continuous piece of mesh for post-hysterectomy vaginal vault prolapse is well tolerated and anatomically and functionally highly effective. Results of controlled trials will determine its position in the operative armamentarium.
| S-EPMC2744794 | biostudies-other
Project description:We present the rationale for and design of a randomized controlled superiority trial comparing 2 vaginal surgical approaches for the treatment of uterovaginal prolapse. The Study of Uterine Prolapse Procedures Randomized Trial (SUPeR) trial compares the efficacy and safety of native tissue repair with vaginal hysterectomy and suture apical suspension versus uterine conservation with mesh hysteropexy through 36 to 60 months postoperatively for primary repair of uterovaginal prolapse.The selection of the primary outcome measure, timing of randomization, patient and evaluator masking to surgical intervention, collection and adjudication of adverse events, cost effectiveness evaluations, partnering with industry, and surgeon certification of competency to perform the 2 procedures is described. A composite primary outcome of success defined as no prolapse symptoms, no objective prolapse beyond the hymen, and no retreatment of prolapse, with a minimum of 36 months postsurgery follow-up using survival analyses is planned. Secondary outcomes measured at baseline and every 6 months postsurgery include validated condition-specific and general quality of life assessments, global impression of improvement, body image, and sexual function measures. Unique challenges during the trial design include maintenance of patient masking to the intervention with routine gynecologic health maintenance and maintenance of evaluator masking.Recruitment and randomization of 180 participants is complete, and participants are currently in the follow-up phase.This trial will provide information to help surgeons counsel patients and contribute evidence-based information regarding risks and benefits of 2 approaches for the treatment of uterovaginal prolapse.
| S-EPMC4919185 | biostudies-literature
Project description:Introduction and hypothesisTo evaluate the performance of mesh-augmented repair of anterior pelvic organ prolapse (POP) with or without apical vaginal wall involvement in women with recurrent or complex prolapse.MethodsThis multicenter cohort study included women undergoing surgery with Calistar S (Promedon, Argentina) for anterior POP between 2016 and 2018. The SCENIHR opinion was considered for patient selection, surgeon's experience and choice of implant. Patients were prospectively invited to assess effectiveness and safety by anamnesis, validated questionnaires and pelvic examination. A composite endpoint defined by POP-Q ≤ 1, absence of a vaginal bulge symptom and repeated surgery for POP was used to define treatment success. Descriptive statistics were applied. McNemar or Wilcoxon signed rank tests were used as paired samples tests. The significance level was set at 5%.ResultsA total of 107 non-fertile women with a mean age of 70.6 years were enrolled. Ninety-three (86.9%) women presented with recurrent prolapse. The mean follow-up time was 18.5 months. Treatment success was achieved in 76% of cases according the composite endpoint, with 98% reaching POP-Q ≤ 1 and a significant improvement in quality of life (p < 0.001). Mesh exposure occurred in six (5.6%) patients, although none required further surgery. Four (3.7%) patients reported dyspareunia, and a single (0.9%) patient displayed a prominence due to mesh folding.ConclusionsMesh-augmented repair of anterior POP is effective and safe in women with recurrent or complex prolapse. Hence, in a select patient population, the benefits of mesh-augmented POP repair still outweigh the risks.
| S-EPMC8009781 | biostudies-literature