The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study (E-OPTIMAL)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Meikle, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01166373
First received: July 19, 2010
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.

Condition Intervention
Pelvic Organ Prolapse
Behavioral: Enrollment video
Procedure: SSLF
Procedure: ULS
Behavioral: PMT
Other: No PMT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Long-Term Effectiveness Of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Time to surgical failure [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Efficacy measures (secondary measures for surgical intervention) [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
    1. Anatomic outcomes of each vaginal segment
    2. Time to anatomic prolapse recurrence
    3. Time to symptomatic prolapse recurrence
    4. 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
    5. Re-operation rates for complications, prolapse, stress urinary incontinence;
    6. Non-surgical treatment for pelvic floor disorders;
    7. 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 ] [ Designated as safety issue: Yes ]

    Long-term adverse events specific to the surgical procedure:

    1. Vaginal granulation tissue, suture erosion or mesh exposure /erosion requiring treatment
    2. 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 ] [ Designated as safety issue: No ]
    1. The proportion of patients who enroll in E-OPTIMAL
    2. The proportion who complete follow-up at 3, 4 and 5 years after surgery
    3. Total number of data collection events (clinic visits, site and QOL calls), number of in-person clinic visits, and number of QOL calls completed
    4. Satisfaction with the study informed consent process
    5. Study-level and personal-level motivation and barriers to enrollment in E-OPTIMAL

  • PMT intervention measures [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
    1. The anatomic outcomes of each vaginal segment
    2. Hunskaar Incontinence Severity Index
    3. change from baseline in Urogenital Distress Inventory (UDI) and Colorectal-anal Distress Inventory (CRADI) subscales
    4. Patient Global Impression of Improvement (PGI-I)
    5. Reoperation for stress urinary incontinence
    6. Postoperative treatment for overactive bladder symptoms
    7. QOL: Short Form 36 (SF-36) & Pelvic floor impact questionnaire (PFIQ)
    8. Brink's scale


Estimated Enrollment: 218
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: ULS
Uterosacral Ligament Suspension was one of the randomized surgical treatments in the OPTIMAL study
Procedure: ULS
uterosacral ligament suspension to suspend the vaginal apex
Experimental: SSLF
Sacrospinous Ligament Fixation was one of the randomized surgical treatments in the OPTIMAL study.
Procedure: SSLF
sacrospinous ligament fixation to suspend the vaginal apex
Experimental: PMT
Perioperative Behavioral Therapy/Pelvic Muscle Training was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.
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
No Intervention: No PMT
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: No PMT
usual care both before and after prolapse surgery with respect to pelvic muscle training

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166373

Locations
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
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
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
Sponsors and Collaborators
Investigators
Principal Investigator: Matthew D. Barber, MD The Cleveland Clinic
Principal Investigator: J. Eric Jelovsek, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Meikle, Medical Officer, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01166373     History of Changes
Other Study ID Numbers: 16P01S
Study First Received: July 19, 2010
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
prolapse
urinary incontinence
uterosacral vaginal vault ligament suspension
sacrospinous ligament fixation
behavioral therapy
pelvic muscle training

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014