Trial Outcomes & Findings for Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (NCT NCT01393171)

Results Overview

The primary outcome as the number of participants with optimal anterior vaginal support at two year defined as POPQ point Ba \< -1.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

99 participants

Primary outcome timeframe

2 years

Results posted on

2023-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Polypropylene Mesh Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation	Anterior Colporrhaphy Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture.	Porcine Dermis Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation
Overall Study STARTED	36	32	31
Overall Study COMPLETED	28	24	26
Overall Study NOT COMPLETED	8	8	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polypropylene Mesh n=28 Participants Site-specific cystocele repair with polypropylene mesh augmentation Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation	Anterior Colporrhaphy n=24 Participants Anterior vaginal prolapse repair with anterior colporrhaphy with no graft. Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture.	Porcine Dermis n=26 Participants Site-specific cystocele repair with porcine dermis augmentation Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation	Total n=78 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 7 • n=28 Participants	61 years STANDARD_DEVIATION 11 • n=24 Participants	60 years STANDARD_DEVIATION 10 • n=26 Participants	64 years STANDARD_DEVIATION 10 • n=78 Participants
Sex: Female, Male Female	28 Participants n=28 Participants	24 Participants n=24 Participants	26 Participants n=26 Participants	78 Participants n=78 Participants
Sex: Female, Male Male	0 Participants n=28 Participants	0 Participants n=24 Participants	0 Participants n=26 Participants	0 Participants n=78 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 2 years

The primary outcome as the number of participants with optimal anterior vaginal support at two year defined as POPQ point Ba \< -1.

Outcome measures

Outcome measures
Measure	Polypropylene Mesh n=28 Participants Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation	Anterior Colporrhaphy n=24 Participants Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture.	Porcine Dermis n=26 Participants Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation
Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis	5 Participants	14 Participants	12 Participants

SECONDARY outcome

Timeframe: 2 years

Number of participants with one or more adverse events at two years will also be compared between the three groups.

Outcome measures

Outcome measures
Measure	Polypropylene Mesh n=28 Participants Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation	Anterior Colporrhaphy n=24 Participants Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture.	Porcine Dermis n=26 Participants Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation
Number of Participants With One or More Adverse Events at Two Years	7 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 year

Secondary Outcome Include: The number of participants with Overall Failure which includes subjective symptoms of vaginal bulge and POP-Q point of Ba \> -1 on exam. This secondary outcome represents a composite outcome.

Outcome measures

Outcome measures
Measure	Polypropylene Mesh n=28 Participants Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation	Anterior Colporrhaphy n=24 Participants Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture.	Porcine Dermis n=28 Participants Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation
Number of Participants With Overall Failure	1 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 2-year compared to baseline scores

The difference in the Pelvic Floor Distress Inventory 20 (PFDI-20) and Pelvic Floor Impact Questionnaire 7 (PFIQ-7) score at 2 years compared to baseline values. The total score of each instrument ranges from 0 to 300 with higher scores indicating a greater degree of bother (ie, worse quality of life). The difference between baseline and 2-year scores were measured to account for differences in baseline scores among participants. A negative change in score indicates decreased bother after surgery and thus improved outcome; the greater the reduction in score, the greater reduction in bother and thus the better the outcome.

Outcome measures

Outcome measures
Measure	Polypropylene Mesh n=28 Participants Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation	Anterior Colporrhaphy n=24 Participants Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture.	Porcine Dermis n=26 Participants Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation
Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 PFIQ-7	-57 score on a scale Interval -100.0 to -11.0	-33 score on a scale Interval -86.0 to -10.0	-55 score on a scale Interval -95.0 to 10.0
Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 PFDI-20	-63 score on a scale Interval -100.0 to 13.0	-58 score on a scale Interval -87.0 to -8.0	-77 score on a scale Interval -100.0 to 46.0

SECONDARY outcome

Timeframe: 2 year

The difference in Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 (PISQ-12) scores at 24 months compared to baseline scores. The total score ranges from 0 to 48 with higher scores indicating better sexual function. The difference in PISQ-12 score was calculated to account for baseline variation in scores among participants. A positive change indicates improved sexual function while a negative change indicates worsened sexual function after surgery.

Outcome measures

Outcome measures
Measure	Polypropylene Mesh n=28 Participants Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation	Anterior Colporrhaphy n=24 Participants Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture.	Porcine Dermis n=26 Participants Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation
Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12	0 score on a scale Interval -28.0 to 36.0	0 score on a scale Interval -32.0 to 16.0	1 score on a scale Interval -35.0 to 24.0

Adverse Events

Polypropylene Mesh

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Anterior Colporrhaphy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Porcine Dermis

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Polypropylene Mesh n=28 participants at risk Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation	Anterior Colporrhaphy n=24 participants at risk Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture.	Porcine Dermis n=26 participants at risk Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation
Surgical and medical procedures Vaginal implant exposure	17.9% 5/28 • Number of events 5 • 2 years	0.00% 0/24 • 2 years	3.8% 1/26 • Number of events 1 • 2 years
Renal and urinary disorders De novo stress urinary incontinence	0.00% 0/28 • 2 years	4.2% 1/24 • Number of events 1 • 2 years	7.7% 2/26 • Number of events 2 • 2 years
Reproductive system and breast disorders De novo dyspareunia	7.1% 2/28 • Number of events 2 • 2 years	12.5% 3/24 • Number of events 3 • 2 years	7.7% 2/26 • Number of events 2 • 2 years

Additional Information

Dr John Nguyen

Kaiser Permanente

Phone: 562-657-2642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place