Clinical trial NCT01166373: The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: prolapse
urinary incontinence
uterosacral vaginal vault ligament suspension
sacrospinous ligament fixation
behavioral therapy
pelvic muscle training
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
First posted: 2010-07-21
Enrollment: 285
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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.

Detailed description: 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:

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Surgical Failure
timeFrame: 6 months and 1, 2, 3, 4, and 5 years
measure: Recruitment Into E-OPTIMAL
timeFrame: At 24 Months post OPTIMAL Treatment
measure: Retention in E-OPTIMAL
timeFrame: 3, 4, and 5 Years Post OPTIMAL Treatment
Secondary outcomes:
measure: Anatomic Failure
timeFrame: 6 months and 1, 2, 3, 4, and 5 years
measure: Bothersome Bulge Symptoms
timeFrame: 6 months and 1, 2, 3, 4, and 5 years
measure: Retreatment for Pelvic Organ Prolapse
timeFrame: 6 months and 1, 2, 3, 4, and 5 years
Other outcomes:
measure: Number of Participants With Granulation Tissue
timeFrame: 2, 3, 4, and 5 years
measure: Number of Participants With Suture Exposure
timeFrame: 2, 3, 4, and 5 years
measure: Number of Participants With Midurethral Sling Erosion or Exposure
timeFrame: 2, 3, 4, and 5 years
measure: Number of Participants With Pelvic Organ Prolapse Surgery
timeFrame: 2, 3, 4, and 5 years
measure: PGI-I
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline CRAIQ Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline POPIQ Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline UIQ Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline CRADI Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline POPDI Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline UDI Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline Hunskaar Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline SF-36 Physical Health Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline SF-36 Mental Health Score
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: Change From Baseline Brink Score
timeFrame: 6 months, and 2, 3, 4, and 5 years
measure: POP-Q Point Ba
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: POP-Q Point Bp
timeFrame: 6 months, and 1, 2, 3, 4, and 5 years
measure: POP-Q Point C
timeFrame: 6 months, and 1 2, 3, 4, and 5 years
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: La Jolla
country: United States
facility: University of California, San Diego Medical Center
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: The Cleveland Clinic
name: Matthew D. Barber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Eric Jelovsek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.