Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Kaiser Permanente

Status and phase: Completed; Phase 4

Conditions: Uterine Prolapse; Cystocele; Urinary Incontinence

Treatments: Procedure: sutured anterior vaginal prolapse repair; Device: grafted anterior prolapse repair

Study type: Interventional

Funder types: Other

Identifiers

NCT00535301

4348

Details and patient eligibility

About

The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.

Full description

Successful correction of anterior vaginal prolapse remains one of the most challenging aspects of pelvic reconstructive surgery. Up to 70% have recurrent prolapse following anterior colporrhaphy. The low success rate has consequently led to widespread use of grafts in anterior vaginal prolapse repair. While both biologic grafts and polyglactin 910 mesh have yielded disappointing results, uncontrolled studies have demonstrated low recurrence rates with polypropylene mesh reinforcement.

The Perigee Transobturator Prolapse Repair System (Perigee TPRS) (American Medical Systems, Minnetonka, Minnesota) is used to repair anterior vaginal prolapse via a transobturator approach. Specially-designed helical needles are utilized to attach either a porcine dermal (InteXenTM) or soft polypropylene (InteProTM) graft to the pelvic sidewall at four points. We designed this randomized control trial to compare the anatomic success rates, effect on quality of life and sexual symptom scores, and rates of adverse events of the Perigee TPRS with polypropylene mesh to that of anterior colporrhaphy.

Enrollment: 75 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• stage II or greater anterior vaginal prolapse requiring surgical correction
• age 21 years and older

Exclusion criteria

• less than Stage II anterior vaginal prolapse
• decline participation
• pregnant or contemplating future pregnancy
• prior anterior vaginal prolapse repair with biologic or synthetic graft
• active or latent systemic infection
• compromised immune system
• previous pelvic irradiation or cancer
• known hypersensitivity to polypropylene
• uncontrolled diabetes mellitus
• unable or unwilling to give valid informed consent
• unable or unwilling to comply with the protocol
• scheduled to undergo concomitant Burch colposuspension or pubovaginal sling

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

Anterior Colporrhaphy (sutured repair)

Placebo Comparator group

Description:

Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures.

Treatment:

Procedure: sutured anterior vaginal prolapse repair

Perigee (grafted repair)

Active Comparator group

Description:

Anterior vaginal prolapse repair with graft

Treatment:

Device: grafted anterior prolapse repair