Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT00535301
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystocele; Uterine Prolapse; Urinary Incontinence	Device: grafted anterior prolapse repair; Procedure: sutured anterior vaginal prolapse repair	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Anterior Colporrhaphy (sutured repair) Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures.	Procedure: sutured anterior vaginal prolapse repair; anterior vaginal prolapse repair with suture; Other Names: cystocele repair
Active Comparator: Perigee (grafted repair) Anterior vaginal prolapse repair with graft	Device: grafted anterior prolapse repair; anterior vaginal prolapse repair with graft; Other Names: Perigee Transobturator Prolapse Repair System

Outcome Measures

Primary Outcome Measures

1. Recurrent Stage II or Greater Anterior Vaginal Prolapse [three years]

   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.

Secondary Outcome Measures

1. Operative Time [perioperative]

   Calculated as time from first incision to time of closure of last incision.

2. Vaginal Mesh Exposure [perioperative]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente	Downey	California	United States	90242

Sponsors and Collaborators

• Kaiser Permanente

Investigators

• Principal Investigator: John N Nguyen, MD, Southern California Permanente Medical Group

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT00535301
• Other Study ID Numbers: 4348
• First Posted: Sep 26, 2007
• Last Update Posted: Apr 22, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Kaiser Permanente: cystocele; uterine prolapse; urinary incontinence
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Cystocele; Uterine Prolapse; Prolapse

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the Female Pelvic Medicine and Reconstructive Surgery Clinic at Kaiser Permanente Bellflower Medical Center between January 2005 and April 2006.
Pre-assignment Detail	Exclusion criteria were less than stage II anterior vaginal prolapse, current or future pregnancy, prior grafted anterior prolapse repair, impaired wound healing, known hypersensitivity to polypropylene, unable or unwilling to give valid informed consent or if scheduled to undergo concomitant Burch colposuspension or pubovaginal sling.

Arm/Group Title	Anterior Colporrhaphy	Perigee
Arm/Group Description	Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Anterior vaginal prolapse repair with graft
Period Title: Overall Study
STARTED	38	38
COMPLETED	33	33
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Anterior Colporrhaphy	Perigee	Total
Arm/Group Description	Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Anterior vaginal prolapse repair with graft	Total of all reporting groups
Overall Participants	38	38	76
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	26 68.4%	28 73.7%	54 71.1%
>=65 years	12 31.6%	10 26.3%	22 28.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (9.5)	61 (10.5)	60 (10.5)
Sex: Female, Male (Count of Participants)
Female	38 100%	38 100%	76 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	38 100%	38 100%	76 100%

Outcome Measures

1. Primary Outcome

Title	Recurrent Stage II or Greater Anterior Vaginal Prolapse
Description	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.
Time Frame	three years

Outcome Measure Data

Analysis Population Description

Intention to Treat. Stage II or greater anterior vaginal prolapse was defined as POPQ Ba equal to or greater than -1.

Arm/Group Title	Anterior Colporrhaphy	Perigee
Arm/Group Description	Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Anterior vaginal prolapse repair with graft
Measure Participants	38	38
Number [participants]	24 63.2%	11 28.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anterior Colporrhaphy, Perigee
	Comments	Sample size was calculated based on previously-published anatomic success rates of standard anterior colporrhaphy (50%) and polypropylene mesh-reinforced anterior vaginal repair (85%) (1-10). Assuming a 2-sided hypothesis test with 5% type I error and 80% power, 33 patients in each group would be required to detect an absolute difference of 35% or more in recurrent stage II prolapse. Assuming a 15% drop-out rate, we sought to enroll 76 patients into the clinical trial.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.24
	Confidence Interval	(2-Sided) 95%; 0.1 to 0.6
	Parameter Dispersion	Type: Standard Deviation; Value: 2
	Estimation Comments

2. Secondary Outcome

Title	Operative Time
Description	Calculated as time from first incision to time of closure of last incision.
Time Frame	perioperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anterior Colporrhaphy (Sutured Repair)	Perigee (Grafted Repair)
Arm/Group Description	Sutured anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Anterior vaginal prolapse repair with graft
Measure Participants	38	38
Median (Inter-Quartile Range) [minutes]	120	135

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anterior Colporrhaphy, Perigee
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Vaginal Mesh Exposure
Description	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.
Time Frame	perioperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anterior Colporrhaphy	Perigee
Arm/Group Description	Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Anterior vaginal prolapse repair with graft
Measure Participants	38	38
Number [participants]	0 0%	4 10.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anterior Colporrhaphy, Perigee
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	three years
Arm/Group Title	Anterior Colporrhaphy		Perigee
Arm/Group Description	Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)		Anterior vaginal prolapse repair with graft
All Cause Mortality
	Anterior Colporrhaphy		Perigee
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Anterior Colporrhaphy		Perigee
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Anterior Colporrhaphy		Perigee
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/37 (0%)

Limitations/Caveats

-Small number of subjects, Single surgeon, Medium follow-up, Limited ability to detect uncommon adverse events and small differences in quality of life and sexual symptom scores, Concurrent pelvic reconstructive and anti-incontinence procedures

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.