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This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus.
An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacrocolpopexy | Other | This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair. |
|
| Sacrocolpopexy and concomitant level III support procedure | Active Comparator | This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Level III support procedure | Procedure | A level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy. |
| Measure | Description | Time Frame |
|---|---|---|
| Enlarged Genital Hiatus at 6 months postoperatively | Proportion of subjects with enlarged genital hiatus on pelvic exam | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Composite prolapse recurrence | Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary. | 12 months |
| Subjective prolapse recurrence |
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Inclusion Criteria:
Exclusion Criteria: subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above
*Note: we will NOT exclude patients based on prior surgical history (including prior posterior colporrhaphy)*
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29425837 | Background | Bradley MS, Askew AL, Vaughan MH, Kawasaki A, Visco AG. Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus. Am J Obstet Gynecol. 2018 May;218(5):514.e1-514.e8. doi: 10.1016/j.ajog.2018.01.046. Epub 2018 Feb 6. | |
| 24368486 | Background | Nosti PA, Umoh Andy U, Kane S, White DE, Harvie HS, Lowenstein L, Gutman RE. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):33-7. doi: 10.1097/SPV.0000000000000036. |
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There is no plan to make IPD available to other researchers
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Postoperative pelvic exams measuring anatomic recurrence of pelvic organ prolapse will be performed by a qualified examiner masked to the original surgery randomization.
| Minimally Invasive Sacrocolpopexy | Procedure | All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse. |
|
| Transperineal ultrasound of the Pelvic Floor | Other | Subjects from either arm will be invited to participate in this exploratory arm of the study. If they choose to participate, they will have a preoperative ultrasound performed and an ultrasound performed at the time of their 6 month visit. |
|
Any symptomatic recurrence of prolapse on questionnaire
| 24 months |
| Dyspareunia postoperatively | Incidence of pain with sex (dyspareunia), ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)].This questionnaire indicates worse pain with sex with higher score. | 6, 12 months postoperatively |
| Sexual Function postoperatively | Assessment of sexual function, ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)]. This questionnaire helps us determine what impact pelvic organ prolapse has on sexual activity. | 6, 12 months postoperatively |
| Pelvic Floor Distress Inventory Change | Measurement of pelvic floor distress change, using the Pelvic Floor Distress Inventory questionnaire (PFDI-20) which is a validated questionnaire used for pelvic floor disorders and their impact on patient quality of life. | baseline, 6, 12 months postoperatively |
| Levator Hiatal Area | Measurement of the levator hiatus on transperineal ultrasound | baseline, 6 months postoperatively |
| 22397900 | Background | Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 May;206(5):435.e1-5. doi: 10.1016/j.ajog.2012.01.035. Epub 2012 Feb 1. |
| 29742664 | Background | Vaughan MH, Siddiqui NY, Newcomb LK, Weidner AC, Kawasaki A, Visco AG, Bradley MS. Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension. Obstet Gynecol. 2018 Jun;131(6):1137-1144. doi: 10.1097/AOG.0000000000002593. |
| 29210807 | Background | Carter-Brooks CM, Lowder JL, Du AL, Lavelle ES, Giugale LE, Shepherd JP. Restoring Genital Hiatus to Normative Values After Apical Suspension Alone Versus With Level 3 Support Procedures. Female Pelvic Med Reconstr Surg. 2019 May/Jun;25(3):226-230. doi: 10.1097/SPV.0000000000000528. |
| 31449806 | Background | Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23. |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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