Trial Outcomes & Findings for Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair (NCT NCT00535301)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

three years

Results posted on

2015-04-22

Participant Flow

Subjects were recruited from the Female Pelvic Medicine and Reconstructive Surgery Clinic at Kaiser Permanente Bellflower Medical Center between January 2005 and April 2006.

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.

Participant milestones

Participant milestones
Measure	Anterior Colporrhaphy Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Perigee Anterior vaginal prolapse repair with graft
Overall Study STARTED	38	38
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anterior Colporrhaphy n=38 Participants Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Perigee n=38 Participants Anterior vaginal prolapse repair with graft	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 9.5 • n=5 Participants	61 years STANDARD_DEVIATION 10.5 • n=7 Participants	60 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	38 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: three years

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

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.

Outcome measures

Outcome measures
Measure	Anterior Colporrhaphy n=38 Participants Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Perigee n=38 Participants Anterior vaginal prolapse repair with graft
Recurrent Stage II or Greater Anterior Vaginal Prolapse	24 participants	11 participants

SECONDARY outcome

Timeframe: perioperative

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

Outcome measures

Outcome measures
Measure	Anterior Colporrhaphy n=38 Participants Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Perigee n=38 Participants Anterior vaginal prolapse repair with graft
Operative Time	120 minutes Interval 60.0 to 150.0	135 minutes Interval 65.0 to 210.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anterior Colporrhaphy n=38 Participants Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)	Perigee n=38 Participants Anterior vaginal prolapse repair with graft
Vaginal Mesh Exposure	0 participants	4 participants

Adverse Events

Anterior Colporrhaphy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Perigee

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John N. Nguyen, MD

SCPMG/Kaiser Permanente

Phone: 562-657-2642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place