Cystocele, Urinary Incontinence, Uterine Prolapse
Conditions
Keywords
cystocele, uterine prolapse, urinary incontinence
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.
Interventions
DEVICEgrafted anterior prolapse repair
anterior vaginal prolapse repair with graft
PROCEDUREsutured anterior vaginal prolapse repair
anterior vaginal prolapse repair with suture
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | perioperative | Calculated as time from first incision to time of closure of last incision. |
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Anterior Colporrhaphy Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) | 38 |
| Perigee Anterior vaginal prolapse repair with graft | 38 |
| Total | 76 |
Baseline characteristics
| Characteristic | Perigee | Anterior Colporrhaphy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 26 Participants | 54 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 10.5 | 59 years STANDARD_DEVIATION 9.5 | 60 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 38 participants | 38 participants | 76 participants |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 76 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 37 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
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.
Time frame: three years
Population: Intention to Treat. Stage II or greater anterior vaginal prolapse was defined as POPQ Ba equal to or greater than -1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anterior Colporrhaphy | Recurrent Stage II or Greater Anterior Vaginal Prolapse | 24 participants |
| Perigee | Recurrent Stage II or Greater Anterior Vaginal Prolapse | 11 participants |
Comparison: 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.p-value: 0.00595% CI: [0.1, 0.6]Chi-squared
Secondary
Operative Time
Calculated as time from first incision to time of closure of last incision.
Time frame: perioperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anterior Colporrhaphy | Operative Time | 120 minutes |
| Perigee | Operative Time | 135 minutes |
p-value: 0.5Wilcoxon (Mann-Whitney)
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.
Time frame: perioperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anterior Colporrhaphy | Vaginal Mesh Exposure | 0 participants |
| Perigee | Vaginal Mesh Exposure | 4 participants |
p-value: <0.05Fisher Exact