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

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.

Conditions

• Pelvic Organ Prolapse

Interventions

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

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network

  lead NETWORK

Principal Investigators

• Matthew D. Barber, MD · The Cleveland Clinic

• Eric Jelovsek, MD · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• United States

Study Locations