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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Colporrhaphy (sutured repair) | Placebo Comparator | Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures. |
|
| Perigee (grafted repair) | Active Comparator | Anterior vaginal prolapse repair with graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| grafted anterior prolapse repair | Device | anterior vaginal prolapse repair with graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Calculated as time from first incision to time of closure of last incision. | perioperative |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John N Nguyen, MD | Southern California Permanente Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Downey | California | 90242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17219252 | Background | 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. doi: 10.1007/s00192-006-0291-7. Epub 2007 Jan 12. | |
| 18378748 | Derived |
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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.
Subjects were recruited from the Female Pelvic Medicine and Reconstructive Surgery Clinic at Kaiser Permanente Bellflower Medical Center between January 2005 and April 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anterior Colporrhaphy | Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) |
| FG001 | Perigee | Anterior vaginal prolapse repair with graft |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anterior Colporrhaphy | Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) |
| BG001 | Perigee | Anterior vaginal prolapse repair with graft |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to Treat. Stage II or greater anterior vaginal prolapse was defined as POPQ Ba equal to or greater than -1. | Posted | Number | participants | three years |
|
three years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anterior Colporrhaphy | Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) |
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-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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John N. Nguyen, MD | SCPMG/Kaiser Permanente | 562-657-2642 | john.n.nguyen@kp.org |
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| ID | Term |
|---|---|
| D052858 | Cystocele |
| D014596 | Uterine Prolapse |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| sutured anterior vaginal prolapse repair | Procedure | anterior vaginal prolapse repair with suture |
|
|
| perioperative |
| Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol. 2008 Apr;111(4):891-8. doi: 10.1097/AOG.0b013e31816a2489. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Perigee | Anterior vaginal prolapse repair with graft |
|
|
|
| Secondary | Operative Time | Calculated as time from first incision to time of closure of last incision. | Posted | Median | Inter-Quartile Range | minutes | perioperative |
|
|
|
|
| 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. | Posted | Number | participants | perioperative |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Perigee | Anterior vaginal prolapse repair with graft | 0 | 38 | 0 | 37 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |