Clinical trial NCT00535301: Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
Official title: Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystocele
Uterine Prolapse
Urinary Incontinence
Keywords: cystocele
uterine prolapse
urinary incontinence
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent Stage II or Greater Anterior Vaginal Prolapse
timeFrame: three years
Secondary outcomes:
measure: Operative Time
timeFrame: perioperative
measure: Vaginal Mesh Exposure
timeFrame: perioperative
Other outcomes:
Locations:
city: Downey
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Southern California Permanente Medical Group
name: John N Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gauruder-Burmester A, Koutouzidou P, Rohne J, Gronewold M, Tunn R. Follow-up after polypropylene mesh repair of anterior and posterior compartments in patients with recurrent prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Sep;18(9):1059-64. doi: 10.1007/s00192-006-0291-7. Epub 2007 Jan 12.
citation: Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol. 2008 Apr;111(4):891-8. doi: 10.1097/AOG.0b013e31816a2489.