The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study (E-OPTIMAL)
|ClinicalTrials.gov Identifier: NCT01166373|
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : August 24, 2016
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:
- 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.
- 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.
|Condition or disease||Intervention/treatment|
|Pelvic Organ Prolapse||Behavioral: Enrollment video Procedure: SSLF Procedure: ULS Behavioral: PMT Other: Usual Care|
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:
- time to surgical failure;
- the long-term functional and health-related quality of life (QOL), adjusted for PMT treatment group;
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||April 2010|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
Experimental: Enrollment video arm
Arm of subjects that will be shown a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process.
Behavioral: Enrollment video
Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process
No Intervention: No video intervention arm
This group of subjects will not view a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process.
Uterosacral Ligament Suspension was one of the randomized surgical treatments in the OPTIMAL study
uterosacral ligament suspension to suspend the vaginal apex
Sacrospinous Ligament Fixation was one of the randomized surgical treatments in the OPTIMAL study.
sacrospinous ligament fixation to suspend the vaginal apex
Perioperative Behavioral Therapy/Pelvic Muscle Training was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
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
No Perioperative Behavioral Therapy/Pelvic Muscle Training (i.e., usual care) was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
Other: Usual Care
usual care both before and after prolapse surgery with respect to pelvic muscle training
- Time to surgical failure [ Time Frame: up to 5 years post surgery ]The primary outcome for the surgical intervention of OPTIMAL is time to surgical failure using the definition of surgical failure as used in OPTIMAL, i.e., anatomic assessment of prolapse using the Pelvic Organ Prolapse Quantitative(POPQ) system and the presence of bulge symptoms specific to prolapse, using Pelvic Floor Distress Inventory (PFDI) questions 4 & 5
- Enrollment primary outcome measure [ Time Frame: up to 5 years post surgery ]The primary outcome for E-OPTIMAL primary aim 4, the enrollment intervention, will be the proportion of eligible subjects who consent to enroll in E-OPTIMAL, and complete all 3 data collection events in year 3 of E-OPTIMAL follow-up (year 5 from enrollment in OPTIMAL).
- Development of prolapse symptoms [ Time Frame: up to 5 years post surgery ]The primary outcome of the PMT intervention will be the development of prolapse symptoms as measured by the pelvic organ prolapse distress inventory (POPDI) subscale of the Pelvic floor distress inventory (PFDI) and anatomic outcomes assessed up to 5 years after surgery. The primary anatomic outcome is identically defined to the primary anatomic outcome described for the surgical intervention and assessed as time to failure.
- Efficacy measures (secondary measures for surgical intervention) [ Time Frame: up to 5 years post surgery ]
- Anatomic outcomes of each vaginal segment
- Time to anatomic prolapse recurrence
- Time to symptomatic prolapse recurrence
- Pelvic symptoms: change from baseline in Urogenital Distress Inventory (UDI), Colorectal-anal Distress Inventory (CRADI), Pelvic Organ Prolapse Distress Inventory (POPDI) & Hunskaar Incontinence Severity Index
- Re-operation rates for complications, prolapse, stress urinary incontinence;
- Non-surgical treatment for pelvic floor disorders;
- QOL: Short Form 36 (SF-36) & Pelvic floor impact questionnaire (PFIQ)
- Safety measures (secondary measures for surgical intervention) [ Time Frame: up to 5 years post surgery ]
Long-term adverse events specific to the surgical procedure:
- Vaginal granulation tissue, suture erosion or mesh exposure /erosion requiring treatment
- Vaginal or perineal stricture (i.e., narrowing or scarring) prompting a treating physician to suggest, or the subject to request, treatment (surgical or non-surgical)
- Enrollment measures [ Time Frame: up to 5 years post surgery ]
- The proportion of patients who enroll in E-OPTIMAL
- The proportion who complete follow-up at 3, 4 and 5 years after surgery
- Total number of data collection events (clinic visits, site and QOL calls), number of in-person clinic visits, and number of QOL calls completed
- Satisfaction with the study informed consent process
- Study-level and personal-level motivation and barriers to enrollment in E-OPTIMAL
- PMT intervention measures [ Time Frame: up to 5 years post surgery ]
- The anatomic outcomes of each vaginal segment
- Hunskaar Incontinence Severity Index
- change from baseline in Urogenital Distress Inventory (UDI) and Colorectal-anal Distress Inventory (CRADI) subscales
- Patient Global Impression of Improvement (PGI-I)
- Reoperation for stress urinary incontinence
- Postoperative treatment for overactive bladder symptoms
- QOL: Short Form 36 (SF-36) & Pelvic floor impact questionnaire (PFIQ)
- Brink's scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166373
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35249|
|United States, California|
|University of California, San Diego Medical Center|
|La Jolla, California, United States, 92037|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Matthew D. Barber, MD||The Cleveland Clinic|
|Principal Investigator:||Eric Jelovsek, MD||The Cleveland Clinic|