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| ID | Type | Description | Link |
|---|---|---|---|
| KPSC IRB 4358 | Other Identifier | Kaiser Permanente |
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The purpose of this study is to evaluate the success rate of cystocele repair using polypropylene mesh or porcine dermis compared to that of anterior colporrhaphy in a prospective randomized fashion. The study will be performed in a randomized, prospective, single-blinded fashion.
Study participants will be recruited from the urogynecology clinic at Kaiser Permanente Medical Center Bellflower and San Diego. Clinical evaluation of each patient will include a standardized history, voiding diary, quality of life (UDI-6 & IIQ-7)10 and sexual function (PISQ-12)11-12 questionnaires (Attachment 1), urinalysis, gynecologic and pelvic organ prolapse quantification (POPQ) examinations. Patients will be randomized by a computer-generated randomization schedule, with allocation to either anterior colporrhaphy or site-specific cystocele repair with polypropylene mesh augmentation or site-specific cystocele repair with porcine dermis augmentation. The allocated treatment arm will be concealed in a sealed opaque envelope until the day of surgery. Patients will be given vaginal estrogen cream starting six weeks prior to surgery. Intravenous antibiotic prophylaxis will be given preoperatively and continued postoperatively for 24 hours. Vaginal infiltration will be performed with 0.25% bupivacaine and epinephrine (1:200,000) solution. Anterior colporrhaphy is performed by making a midline incision through the anterior vaginal mucosa, dissecting the vaginal epithelium from the underlying muscularis, and midline plication of the muscularis with No. 2-0 polydioxanone sutures (Ethicon, Somerville, NJ). The excess vaginal mucosa is then excised and the margins of the vagina reapproximated in the midline using No. 2-0 polyglactin (Vicryl) sutures. Patients who are randomized to polypropylene mesh or porcine dermis repair will undergo a site-specific defect repair of the vaginal muscularis with No. 2-0 polydioxanone sutures after midline vaginal incision and lateral dissection. A piece of the assigned material will be fashioned to fit the repaired space and anchored bilaterally to the arcus tendineus fascia pelvis with interrupted No. 2-0 polydioxanone sutures. Other operative procedures will be performed as indicated. TVT or TVT-O procedures (Gynecare Inc., Somerville, NJ) will be performed for stress urinary incontinence as previously described through a separate midurethral vaginal incision. The vagina will be packed for 24 hours. All patients will be discharged when they are able to ambulate and tolerate a solid diet and oral pain medication.
The two groups will be evaluated at 6 weeks, 6 months, 1 and 2 years after surgery. A trained clinical nurse/clinical fellow, whom has been proctored in performance of POP-Q exams, will perform postoperative POPQ staging in all patients. A research nurse blinded to the subject's group assignment will administer preoperative and postoperative quality of life and sexual function questionnaires. The primary outcome of this investigation will be postoperative anterior vaginal support. Anatomic success is defined as point Ba< -1. Secondary outcomes including hospital data, complications, subjective continence, quality of life and sexual function, and overall satisfaction with surgery, will also be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polypropylene Mesh | Active Comparator | Site-specific cystocele repair with polypropylene mesh augmentation |
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| Anterior Colporrhaphy | Placebo Comparator | Anterior vaginal prolapse repair with anterior colporrhaphy with no graft. |
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| Porcine Dermis | Active Comparator | Site-specific cystocele repair with porcine dermis augmentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polypropylene mesh (Polyform by Boston Scientific) | Device | Site-specific cystocele repair with polypropylene mesh augmentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis | The primary outcome as the number of participants with optimal anterior vaginal support at two year defined as POPQ point Ba < -1. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events at Two Years | Number of participants with one or more adverse events at two years will also be compared between the three groups. | 2 years |
| Number of Participants With Overall Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John N. Nguyen, MD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Downey | California | 90242 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11744900 | Background | Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol. 2001 Dec;185(6):1299-304; discussion 1304-6. doi: 10.1067/mob.2001.119081. | |
| 21561348 | Background | Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Polypropylene Mesh | Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation |
| FG001 | Anterior Colporrhaphy | Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Porcine Dermis (Pelvicol by CRBard) | Procedure | Site-specific cystocele repair with porcine dermis augmentation |
|
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| Anterior Colporrhaphy | Procedure | Anterior vaginal prolapse repair with suture. |
|
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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.
| 2 year |
| Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 | 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. | 2-year compared to baseline scores |
| Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 | 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. | 2 year |
| San Diego |
| California |
| 92110 |
| United States |
| 17010297 | Background | Simsiman AJ, Luber KM, Menefee SA. Vaginal paravaginal repair with porcine dermal reinforcement: correction of advanced anterior vaginal prolapse. Am J Obstet Gynecol. 2006 Dec;195(6):1832-6. doi: 10.1016/j.ajog.2006.07.005. Epub 2006 Sep 28. |
| 22067717 | Result | Menefee SA, Dyer KY, Lukacz ES, Simsiman AJ, Luber KM, Nguyen JN. Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1337-1344. doi: 10.1097/AOG.0b013e318237edc4. |
| FG002 | Porcine Dermis | Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Polypropylene Mesh | Site-specific cystocele repair with polypropylene mesh augmentation Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation |
| BG001 | Anterior Colporrhaphy | Anterior vaginal prolapse repair with anterior colporrhaphy with no graft. Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture. |
| BG002 | Porcine Dermis | Site-specific cystocele repair with porcine dermis augmentation Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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 | Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis | The primary outcome as the number of participants with optimal anterior vaginal support at two year defined as POPQ point Ba < -1. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Number of Participants With One or More Adverse Events at Two Years | Number of participants with one or more adverse events at two years will also be compared between the three groups. | Posted | Count of Participants | Participants | 2 years |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Failure | 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. | Posted | Count of Participants | Participants | 2 year |
|
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| Secondary | Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 2-year compared to baseline scores |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 2 year |
|
2 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 | Polypropylene Mesh | Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation | 0 | 28 | 0 | 28 | 7 | 28 |
| EG001 | Anterior Colporrhaphy | Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture. | 0 | 24 | 0 | 24 | 4 | 24 |
| EG002 | Porcine Dermis | Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation | 0 | 26 | 0 | 26 | 5 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal implant exposure | Surgical and medical procedures | Systematic Assessment | Number of patients with vaginal exposure of implant (mesh or porcine graft) |
| |
| De novo stress urinary incontinence | Renal and urinary disorders | Systematic Assessment | Number of participants with de novo stress urinary incontinence |
| |
| De novo dyspareunia | Reproductive system and breast disorders | Systematic Assessment | Number of participants with de novo dyspareunia |
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Small sample size that did not permit evaluation of differences between permanent mesh and xenografts.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr John Nguyen | Kaiser Permanente | 562-657-2642 | john.n.nguyen@kp.org |
| ID | Term |
|---|---|
| D052858 | Cystocele |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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