The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
NCT ID: NCT01166373
Last Updated: 2020-09-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
285 participants
INTERVENTIONAL
2010-04-30
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial
NCT00597935
Can Pelvic Floor Muscle Training Reduce my Prolapse
NCT01612637
PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)
NCT01136889
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
NCT04547816
Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse
NCT00476892
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Enrollment video
Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process
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.
No interventions assigned to this group
ULS
Uterosacral Ligament Suspension was one of the randomized surgical treatments in the OPTIMAL study
ULS
uterosacral ligament suspension to suspend the vaginal apex
SSLF
Sacrospinous Ligament Fixation was one of the randomized surgical treatments in the OPTIMAL study.
SSLF
sacrospinous ligament fixation to suspend the vaginal apex
PMT
Perioperative Behavioral Therapy/Pelvic Muscle Training was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
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
Usual Care
No Perioperative Behavioral Therapy/Pelvic Muscle Training (i.e., usual care) was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
Usual Care
usual care both before and after prolapse surgery with respect to pelvic muscle training
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enrollment video
Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process
SSLF
sacrospinous ligament fixation to suspend the vaginal apex
ULS
uterosacral ligament suspension to suspend the vaginal apex
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
Usual Care
usual care both before and after prolapse surgery with respect to pelvic muscle training
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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.
Criteria for termination of participation:
(Due to evidence or likelihood that the subject can no longer consent for herself)
1. Subjects 75 years and older that fail the telephone mini-mental status examination. If the participant gets 5 or more of the 10 items "incorrect" the interviewer says "thank you very much for your time, that completes the interview for today." In other words, the interviewer in no way implies to the participant that they did not "pass" a test to continue. The interviewer contacts the appropriate site coordinator immediately after the interview to let them know of the outcome.
2. Subjects younger than 75 who appear to have cognitive deficits during the quality of life telephone interview will be administered the mini-mental status examination; those who fail will be excluded from further participation. (Proxy respondents will not be used.) Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
3. Subjects who become long-term residents of a skilled nursing facility.
4. Withdrawal of consent. Verbal assent will be obtained prior to each telephone interview and each in-person visit.
Note: Subjects that are unable to complete telephone interviews (for example, because of hearing loss) may complete the interview portion of the survey in person, either at the site or in the home.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NICHD Pelvic Floor Disorders Network
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthew D. Barber, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Eric Jelovsek, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama
Birmingham, Alabama, United States
University of California, San Diego Medical Center
La Jolla, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jakus-Waldman S, Brubaker L, Jelovsek JE, Schaffer JI, Ellington DR, Mazloomdoost D, Whitworth R, Gantz MG; NICHD Pelvic Floor Disorders Network (PFDN). Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair. Obstet Gynecol. 2020 Nov;136(5):933-941. doi: 10.1097/AOG.0000000000004092.
Meyer I, Whitworth RE, Lukacz ES, Smith AL, Sung VW, Visco AG, Ackenbom MF, Wai CY, Mazloomdoost D, Gantz MG, Richter HE; NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women's Health. Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence. Int Urogynecol J. 2020 Oct;31(10):2155-2164. doi: 10.1007/s00192-020-04271-y. Epub 2020 Mar 7.
Brubaker L, Jelovsek JE, Lukacz ES, Balgobin S, Ballard A, Weidner AC, Gantz MG, Whitworth R, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study. Clin Trials. 2019 Oct;16(5):481-489. doi: 10.1177/1740774519865541. Epub 2019 Jul 26.
Jelovsek JE, Barber MD, Brubaker L, Norton P, Gantz M, Richter HE, Weidner A, Menefee S, Schaffer J, Pugh N, Meikle S; NICHD Pelvic Floor Disorders Network. Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA. 2018 Apr 17;319(15):1554-1565. doi: 10.1001/jama.2018.2827.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16P01S
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.