N/A
N=374
The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT01166373 ↗Enrolled (actual)
374
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Surgical Failure — 17; 22; 20; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enrollment video (Behavioral); SSLF (Procedure); ULS (Procedure); PMT (Behavioral); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NICHD Pelvic Floor Disorders Network
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Failure |
17; 22; 20; 14; 73; 65 | — |
| PRIMARY Recruitment Into E-OPTIMAL |
142; 143; 11; 8 | — |
| PRIMARY Retention in E-OPTIMAL |
139; 135; 3; 8; 131; 124 | — |
| SECONDARY Anatomic Failure |
10; 12; 13; 11; 80; 74 | — |
| SECONDARY Bothersome Bulge Symptoms |
10; 12; 8; 5; 80; 73 | — |
| SECONDARY Retreatment for Pelvic Organ Prolapse |
1; 0; 1; 0; 90; 86 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Completion of the Year 2 OPTIMAL in-person visit
Exclusion Criteria
- Inability to provide informed consent.
- 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)
- 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.
- 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.
- Subjects who become long-term residents of a skilled nursing facility.
- 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.
Data sourced from ClinicalTrials.gov (NCT01166373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.