The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study

NCT01166373 | Completed Results DMC

• 1 other identifier: 16P01S
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 7

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. 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. 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.

Conditions

Pelvic Organ Prolapse

Keywords

prolapse; urinary incontinence; uterosacral vaginal vault ligament suspension; sacrospinous ligament fixation; behavioral therapy; pelvic muscle training

Outcome Measures

Primary Outcomes (3)

• Surgical Failure

  Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)

  6 months and 1, 2, 3, 4, and 5 years

• Recruitment Into E-OPTIMAL

  Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL.

  At 24 Months post OPTIMAL Treatment

• Retention in E-OPTIMAL

  Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study).

  3, 4, and 5 Years Post OPTIMAL Treatment

Secondary Outcomes (3)

• Anatomic Failure

  6 months and 1, 2, 3, 4, and 5 years

• Bothersome Bulge Symptoms

  6 months and 1, 2, 3, 4, and 5 years

• Retreatment for Pelvic Organ Prolapse

  6 months and 1, 2, 3, 4, and 5 years

Other Outcomes (18)

• Number of Participants With Granulation Tissue

  2, 3, 4, and 5 years

• Number of Participants With Suture Exposure

  2, 3, 4, and 5 years

• Number of Participants With Midurethral Sling Erosion or Exposure

  2, 3, 4, and 5 years

Study Arms (6)

Enrollment video arm

EXPERIMENTAL

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

No video intervention arm

NO INTERVENTION

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.

ULS

EXPERIMENTAL

Uterosacral Ligament Suspension was one of the randomized surgical treatments in the OPTIMAL study

Procedure: ULS

SSLF

EXPERIMENTAL

Sacrospinous Ligament Fixation was one of the randomized surgical treatments in the OPTIMAL study.

Procedure: SSLF

PMT

EXPERIMENTAL

Perioperative Behavioral Therapy/Pelvic Muscle Training was one of the randomized non-surgical (behavioral) interventions in the OPTIMAL study.

Behavioral: PMT

Usual Care

OTHER

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

Interventions

Enrollment video BEHAVIORAL

Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process

Enrollment video arm

SSLF PROCEDURE

sacrospinous ligament fixation to suspend the vaginal apex

SSLF

ULS PROCEDURE

uterosacral ligament suspension to suspend the vaginal apex

ULS

PMT BEHAVIORAL

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

PMT

Usual Care OTHER

usual care both before and after prolapse surgery with respect to pelvic muscle training

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Completion of the Year 2 OPTIMAL in-person visit

You may not qualify if:

• 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.

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead

Study Sites (7)

University of Alabama

Birmingham, Alabama, 35249, United States

Location

University of California, San Diego Medical Center

La Jolla, California, 92037, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (4)

• 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.

  PMID: 33030871 DERIVED

• 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.

  PMID: 32146521 DERIVED

• 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.

  PMID: 31347384 DERIVED

• 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.

  PMID: 29677302 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Marie Gantz
• Organization: RTI International

mgantz@rti.org

919-597-5110

Study Officials

• Matthew D. Barber, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Eric Jelovsek, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 28, 2020
• Results First Posted: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)