NCT01166373

The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study

Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: Extended Operations & Pelvic Muscle Training Of Apical Support Loss Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: NICHD Pelvic Floor Disorders Network · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed. We propose to test the following null hypotheses: 1. There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery. 2. The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.

Detailed description

The goal of this long-term follow-up study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study is a randomized trial designed to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS) and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence (SUI). The OPTIMAL study includes a two-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. A further goal of E-OPTIMAL is to investigate a strategy for improving enrollment and retention in long-term studies of women undergoing surgery for pelvic organ prolapse and SUI, by randomizing subjects to two different recruitment methods. The primary aims of this extension study are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and stress urinary incontinence: 1. time to surgical failure; 2. the long-term functional and health-related quality of life (QOL), adjusted for PMT treatment group; 3. the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms (urinary, bowel, and prolapse), adjusted for PMT treatment group. An additional primary aim (aim 4) is to determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention in E-OPTIMAL. We will utilize a conceptual framework that assesses three concepts (motivation, barriers and pragmatic issues) at two levels (study level and personal/individual level). This conceptual framework was developed following a review of the scant available literature on the topic, as well as during discussions with investigators who are experienced in recruiting and retaining participants in pelvic floor disorders studies.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
BEHAVIORAL	Enrollment video	Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process
PROCEDURE	SSLF	sacrospinous ligament fixation to suspend the vaginal apex
PROCEDURE	ULS	uterosacral ligament suspension to suspend the vaginal apex
BEHAVIORAL	PMT	perioperative behavioral therapy / pelvic muscle training with formal individualized PMT program that begins two to four weeks prior to surgery and continues for three months after surgery
OTHER	Usual Care	usual care both before and after prolapse surgery with respect to pelvic muscle training

Timeline

• Start date: 2010-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2010-07-21
• Last updated: 2020-09-28
• Results posted: 2020-09-28

Locations

7 sites across 1 country: United States