eOptimal

Overview

Status: Enrolling by invitation
Keywords: Vaginal Prolapse
IRB Number: 00041440
Specialty: Urogyn and Pelvic Reconstructive Surgery
Sub Specialties:

Brief Summary

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).[1] 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. This enrollment aim (aim 4) is a randomized trial in which the coordinator will randomize a potential participant (that is, a woman presenting for her 2-year follow-up visit in the initial trial, OPTIMAL) to either video plus review of written consent versus review of written consent alone without the knowledge of the potential participant. Participants will not be made aware of this study aim, as their knowledge of the aim could impact outcomes (proportion that enrolled and were retained over time). During the planning phase of this study aim, the 7 PFDN sites communicated with IRB directors at each site and were unanimously given unofficial approval to conduct Aim 4 in this way
 
Primary Aims. 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.
 
Secondary Aims. The secondary aims of this study are:
 
1. To describe the recurrence, reoperation, and re-treatment rates for any pelvic floor dysfunction and for prolapse only, and identify their predictors by surgical intervention and PMT intervention.
 
2. To determine independent risk factors (e.g., age, co-morbidities), in addition to anatomic surgical failure at 2 years, for new or worsening pelvic floor symptoms (based on the MID of UDI and 0.5 effect size of POPDI and CRADI) over time (years 3-5 after surgery).
 
3. To describe the annual and cumulative incidence, resolution, and persistence of pelvic floor support in each compartment (anterior, posterior, and apex) by surgical intervention and PMT intervention.
 
4. To describe the rate of long-term negative outcomes related to SSLF and ULS, including suture and mesh erosion.
 
5. To describe the long-term effect of PMT on pelvic muscle strength and determine its correlation with symptom resolution
 
6. To describe the motivation and barriers for individual women’s participation in women’s health research as well the specific E-OPTIMAL study.
 
We propose to test the following null hypotheses:
 
1. There will be no difference in time to surgical failure between ULS and SSLF up to 5 years after surgery (Specific aim 1)
 
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 (Specific aim 4).
 

Principal Investigator: Ingrid Nygaard
Department: Urogynecology
Co Investigator: Yvonne Hsu
Co Investigator: Peggy Norton
Co Investigator: Jan Baker

Contact Information

Name:Linda Griffen
Phone: 801-581-7038
Email: linda.griffen@hsc.utah.edu

Inclusion Criteria

1. Completion of the Year 2 OPTIMAL in-person visit

Exclusion Criteria

1. Inability to provide informed consent.
 
2. Subjects who are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation) at the time of enrollment into E-OPTIMAL. Note: Subjects unable to return for annual visits are not excluded as they can participate in the telephone interview. However, every attempt will be made to encourage in-person participation.