Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse (POP)

In brief

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are: 1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and 2. 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.

Key facts

Study ID

NCT00597935

Run by

NICHD Pelvic Floor Disorders Network

People needed

374

Starts

2008-02-01

Expected to finish

2013-07-01

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Stage 2 to 4 prolapse
• Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C > -TVL/2) [TVL stands for total vaginal length]
• Vaginal bulge symptoms as indicated by an affirmative response to either questions on the Pelvic Floor Distress Inventory (PFDI)
• Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.
• Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale
• Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months
• A tension free vaginal tape (TVT) is planned to treat stress urinary incontinence.
• A pelvic muscle training (PMT) visit can be performed at least 2 weeks and not more than 4 weeks before surgery.
• Available for 24-months of follow-up.
• Able to complete study assessments, per clinician judgment
• Able and willing to provide written informed consent

You may not qualify if…

• Contraindication to sacrospinous ligament fixation (SSLF), uterosacral vaginal vault ligament suspension (ULS), or TVT in the opinion of the treating surgeon.
• History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.)
• Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.
• History of previous synthetic sling procedure for stress incontinence.
• Previous adverse reaction to synthetic mesh.
• Urethral diverticulum, current or previous (i.e., repaired)
• History of femoral to femoral bypass.
• Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.
• History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.
• Subject wishes to retain her uterus. [Both ULS and SLS include removal of the uterus, if not previously removed]

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Kaiser Permanente Bellflower — Bellflower, California, United States
• University of California, San Diego Medical Center — La Jolla, California, United States
• Kaiser Permanente — San Diego, 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

Full record on ClinicalTrials.gov

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