Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Urinary Incontinence Clinical Trial

Official title:

Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535301
• Other study ID #: 4348
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2007
• Last updated: April 2, 2015
• Start date: January 2005
• Est. completion date: April 2008

Study information

• Verified date: April 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystocele
• Prolapse
• Urinary Incontinence
• Uterine Prolapse

Intervention

Device:
• grafted anterior prolapse repair
anterior vaginal prolapse repair with graft

Procedure:
• sutured anterior vaginal prolapse repair
anterior vaginal prolapse repair with suture

Locations

Country	Name	City	State
United States	Kaiser Permanente	Downey	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Jan 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Stage II or Greater Anterior Vaginal Prolapse	Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.	three years	No
Secondary	Operative Time	Calculated as time from first incision to time of closure of last incision.	perioperative	No
Secondary	Vaginal Mesh Exposure	Vaginal mesh exposure defined as appearance of mesh, placed during the index surgery, not covered by overlying vaginal epithelium on postoperative pelvic exams subsequent to the first postoperative exam. May be either symptomatic or asymptomatic. This was not differentiated in the statistical analysis.	perioperative	Yes