Anterior Vaginal Wall Prolapse, Cystocele, Pelvic Organ Prolapse
Conditions
Keywords
Anterior Vaginal Prolapse, Cystocele, Pelvic Organ Prolapse
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPolypropylene mesh (Polyform by Boston Scientific)
Site-specific cystocele repair with polypropylene mesh augmentation
PROCEDUREPorcine Dermis (Pelvicol by CRBard)
Site-specific cystocele repair with porcine dermis augmentation
PROCEDUREAnterior Colporrhaphy
Anterior vaginal prolapse repair with suture.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Stage 2 or \> anterior vaginal prolapse requiring surgical correction. * \>18 years old * willing to return for follow-up visits.
Exclusion criteria
* Less than stage II or \> anterior vaginal prolapse, * decline to participate, * pregnant or contemplating future pregnancy, * anti-incontinence procedure other than midurethral sling (ie, Burch colposuspension, pubovaginal sling, or needle suspension) is planned as part of their surgical procedures, * any contra-indication to receiving mesh or porcine dermis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis | 2 years | The primary outcome as the number of participants with optimal anterior vaginal support at two year defined as POPQ point Ba \< -1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Adverse Events at Two Years | 2 years | Number of participants with one or more adverse events at two years will also be compared between the three groups. |
| Number of Participants With Overall Failure | 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. |
| Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 | 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. |
| Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polypropylene Mesh Site-specific cystocele repair with polypropylene mesh augmentation
Polypropylene mesh (Polyform by Boston Scientific): Site-specific cystocele repair with polypropylene mesh augmentation | 28 |
| Anterior Colporrhaphy Anterior vaginal prolapse repair with anterior colporrhaphy with no graft.
Anterior Colporrhaphy: Anterior vaginal prolapse repair with suture. | 24 |
| Porcine Dermis Site-specific cystocele repair with porcine dermis augmentation
Porcine Dermis (Pelvicol by CRBard): Site-specific cystocele repair with porcine dermis augmentation | 26 |
| Total | 78 |
Baseline characteristics
| Characteristic | Polypropylene Mesh | Anterior Colporrhaphy | Porcine Dermis | Total |
|---|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 7 | 61 years STANDARD_DEVIATION 11 | 60 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 24 Participants | 26 Participants | 78 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 7 / 28 | 4 / 24 | 5 / 26 |
| serious Total, serious adverse events | 0 / 28 | 0 / 24 | 0 / 26 |
Outcome results
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polypropylene Mesh | Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis | 5 Participants |
| Anterior Colporrhaphy | Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis | 14 Participants |
| Porcine Dermis | Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis | 12 Participants |
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.
Time frame: 2 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Polypropylene Mesh | Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 | 0 score on a scale |
| Anterior Colporrhaphy | Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 | 0 score on a scale |
| Porcine Dermis | Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12 | 1 score on a scale |
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.
Time frame: 2-year compared to baseline scores
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Polypropylene Mesh | 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 |
| Polypropylene Mesh | 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 |
| Anterior Colporrhaphy | Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 | PFDI-20 | -58 score on a scale |
| Anterior Colporrhaphy | Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 | PFIQ-7 | -33 score on a scale |
| Porcine Dermis | Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 | PFDI-20 | -77 score on a scale |
| Porcine Dermis | Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7 | PFIQ-7 | -55 score on a scale |
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polypropylene Mesh | Number of Participants With One or More Adverse Events at Two Years | 7 Participants |
| Anterior Colporrhaphy | Number of Participants With One or More Adverse Events at Two Years | 4 Participants |
| Porcine Dermis | Number of Participants With One or More Adverse Events at Two Years | 5 Participants |
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.
Time frame: 2 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polypropylene Mesh | Number of Participants With Overall Failure | 1 Participants |
| Anterior Colporrhaphy | Number of Participants With Overall Failure | 3 Participants |
| Porcine Dermis | Number of Participants With Overall Failure | 3 Participants |