CompletedNot Applicable

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

United States374 participantsStarted 2008-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 …

What they're measuring

Surgical Success

Timeframe: 24 months

Anatomic Failure

Timeframe: 24 months

Urinary Distress Inventory at 6 Months

Timeframe: 6 months

Trial details

NCT IDNCT00597935

SponsorNICHD Pelvic Floor Disorders Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2013-07

Results submitted2020-09-01