Dataset Information

Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial.

ABSTRACT: OBJECTIVE:The 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. METHODS:Patient 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. RESULTS:Randomization and surgical treatment of 360 participants are complete, and the study is in the follow-up phase. CONCLUSIONS:This 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.

SUBMITTER: Menefee S

PROVIDER: S-EPMC7326314 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial.

Menefee Shawn S Richter Holly E HE Myers Deborah D Weidner Alison A Moalli Pamela P Harvie Heidi H Rahn David D Jeppson Peter P Paraiso Marie M Thomas Sonia S Mazloomdoost Donna D

Female pelvic medicine & reconstructive surgery 20200701 7

<h4>Objective</h4>The 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.<h4>Methods</h4>Patient selection criteria, primary and secondary outcome measures including patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, ad ...[more]

PMID: 31860566

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Project description:ObjectiveTo retrospectively compare surgical success and complications between vaginal vault prolapse compared with uterovaginal prolapse in women who underwent apical prolapse repair for stage II-IV prolapse.MethodsWomen in one of three Pelvic Floor Disorders Network prolapse surgical trials were included. Absence of bothersome bulge symptoms, no prolapse beyond the hymen, and no subsequent prolapse treatment defined success and was our primary outcome. Secondary outcomes included comparison of quality-of-life measures, anatomic changes, and adverse events. Pelvic organ prolapse quantification (POP-Q) and quality-of-life measures were administered at baseline and 1-2 years postoperatively. Comparisons were controlled for study site, age, body mass index, baseline POP-Q, apical and anterior or posterior repair performed, and prior prolapse repair. Outcomes measured at multiple time points were analyzed using longitudinal models to assess whether differences existed across study follow-up.ResultsFour hundred twenty-one women underwent vault prolapse, and 601 underwent uterovaginal prolapse apical repair. The vault prolapse group was older, more likely to be white, and to have prior urinary incontinence or prolapse repair, stage IV prolapse, and more prolapse bother on a validated scale (all P≤.034). The vault prolapse group was more likely to undergo sacrocolpopexy (228/421 [54%] vs 93/601 [15%]); the uterovaginal prolapse group was more likely to undergo vaginal repair (508/601 [85%] vs 193/421 [46%] P<.001). There were no differences in success (odds ratio [OR] 0.76 for vault prolapse vs uterovaginal prolapse, 95% CI 0.51-1.15, P=.20), changes in Pelvic Organ Prolapse Distress Inventory scores (-79.4 vs -79.8, P=.89), postoperative POP-Q point C measurements (-7.0 vs -7.1 cm, P=.41), or serious adverse events (86/421 [20%] vs 90/601 [15%], P=.86) between groups. Among women who underwent a vaginal approach for repair of vault prolapse (n=193) or uterovaginal prolapse (n=508), there were no differences in success rates (OR 0.67, 95% CI 0.43-1.04, P=.09) at 1-2 years postoperatively.ConclusionSurgical success of stage II-IV vault prolapse and uterovaginal prolapse apical repair was similar whether performed vaginally or abdominally at 1-2 years postoperatively.

Project description:IntroductionLaparoscopic sacral colpopexy is the gold standard technique for apical prolapse correction but it is a technically challenging procedure with rare but severe morbidity. Laparoscopic high uterosacral ligament suspension could be a valid technically easier alternative using native tissue.Material and methodsIn the period from 2015 to 2018, 600 women were submitted to laparoscopic sacral colpopexy while 150 to laparoscopic high uterosacral ligament suspension in three Italian urogynecology referral centers. We enrolled women with apical prolapse stage ≥2 alone or multicompartment descensus. To reduce allocation bias, we performed a propensity matched analysis. Women undergoing laparoscopic high uterosacral ligament suspension surgery were matched 1:2 to women undergoing laparoscopic sacral colpopexy. The cumulative proportion of relapse-free women in time was analyzed by the Kaplan-Meier method. The primary objective of this multicenter case-control retrospective study was to compare the recurrence rate while the secondary objectives were to compare feasibility, safety, and efficacy of laparoscopic sacral colpopexy and laparoscopic high uterosacral ligament suspension in surgical treatment of pelvic organ prolapse.ResultsThree hundred and nine women were enrolled (103 laparoscopic high uterosacral ligament suspension; 206 laparoscopic sacral colpopexy). Median operatory time was significantly shorter in the laparoscopic high uterosacral ligament suspension group (P = 0.0001). No statistically significative difference was found in terms of estimated blood loss, admission time, intraoperative, and major early postoperative complications, postoperative pelvic pain, dyspareunia and de novo stress urinary incontinence. Surgical approach was the only independent risk factor for prolapse recurrence (RR = 6.013 [2.965-12.193], P = 0.0001). The objective cure rate was higher in the laparoscopic sacral colpopexy group (93.7 vs. 68%, 193/206 vs. 70/103, P = 0.0001) with a highly reduced risk of recurrence (RR = 5.430 [1.660-17.765]). Median follow up was 22 months.ConclusionBoth techniques are safe, feasible, and effective. Laparoscopic sacral colpopexy remains the best choice in treatment of multicompartment and advanced pelvic organ prolapse while laparoscopic high uterosacral ligament suspension could be appropriate for moderate and isolated apical prolapse when laparoscopic sacral colpopexy is not suitable for the patient or to prevent prolapse in women at high risk at the time of the hysterectomy.

Project description:ImportanceMore than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.ObjectiveTo compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence.Design, setting, and participantsMulticenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%.InterventionsThe surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188).Main outcomes and measuresThe primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success.ResultsAt 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months.Conclusions and relevanceTwo years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.Trial registrationclinicaltrials.gov Identifier: NCT00597935.

Dataset Information

Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial.

Publications

Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial.

Similar Datasets

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