Anterior Vaginal Wall ProlapseOARSNCT01393171
Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
A study testing Polypropylene mesh (Polyform by Boston Scientific), Porcine Dermis (Pelvicol by CRBard) and Anterior Colporrhaphy in people with Anterior Vaginal Wall Prolapse and Cystocele, run by Kaiser Permanente at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Vaginal Wall Prolapse, Cystocele, Pelvic Organ Prolapse
- What is being tested?
- Polypropylene mesh (Polyform by Boston Scientific), Porcine Dermis (Pelvicol by CRBard) and Anterior Colporrhaphy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stage 2 or > anterior vaginal prolapse requiring surgical correction.
- >18 years old
- willing to return for follow-up visits.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente
Downey, California, 90242
Kaiser Permanente
San Diego, California, 92110
About this study
Official title: Prospective Randomized Trial of Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
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.
Read the 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.
- Being tested
- Polypropylene mesh (Polyform by Boston Scientific), Porcine Dermis (Pelvicol by CRBard), Anterior Colporrhaphy
- Keywords
- Anterior Vaginal Prolapse, Cystocele, Pelvic Organ Prolapse
- Medical subject headings
- Cystocele, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypropylene mesh (Polyform by Boston Scientific)Device
Also called Polyform by Boston Scientific
Site-specific cystocele repair with polypropylene mesh augmentation
Porcine Dermis (Pelvicol by CRBard)Procedure or surgery
Also called Pelvicol by CRBard
Site-specific cystocele repair with porcine dermis augmentation
Anterior ColporrhaphyProcedure or surgery
Also called Cystocele repair
Anterior vaginal prolapse repair with suture.
| Study group | Role | What they receive |
|---|---|---|
| Polypropylene Mesh | Active comparator | Site-specific cystocele repair with polypropylene mesh augmentation Receives: Device: Polypropylene mesh (Polyform by Boston Scientific) |
| Anterior Colporrhaphy | Placebo comparator | Anterior vaginal prolapse repair with anterior colporrhaphy with no graft. Receives: Procedure: Anterior Colporrhaphy |
| Porcine Dermis | Active comparator | Site-specific cystocele repair with porcine dermis augmentation Receives: Procedure: Porcine Dermis (Pelvicol by CRBard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 2 years
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.
Measured: 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.
Measured: 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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJan 2006
- Primary completionDec 2015
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anterior Vaginal Wall ProlapseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John N. Nguyen, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393171
- Sponsor's protocol ID
- IRB4358
- Other IDs
- KPSC IRB 4358
- Acronym
- OARS
- Status last verified
- Oct 2023
- First submitted
- 28 Jun 2011
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 11744900Altman 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.
PubMed 21561348Simsiman 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.
PubMed 17010297Menefee 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.
PubMed 22067717
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Anterior Colporrhaphy Versus Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
- ClinicalTrials.gov ID
- NCT01393171
- Acronym / sponsor ID
- OARS / IRB4358
- Keywords
- Anterior Vaginal Prolapse, Cystocele, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polypropylene Mesh | Active comparator | Device: Polypropylene mesh (Polyform by Boston Scientific)Site-specific cystocele repair with polypropylene mesh augmentation |
| Anterior Colporrhaphy | Placebo comparator | Procedure: Anterior ColporrhaphyAnterior vaginal prolapse repair with anterior colporrhaphy with no graft. |
| Porcine Dermis | Active comparator | Procedure: Porcine Dermis (Pelvicol by CRBard)Site-specific cystocele repair with porcine dermis augmentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage 2 or > anterior vaginal prolapse requiring surgical correction.
- >18 years old
- willing to return for follow-up visits.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypropylene mesh (Polyform by Boston Scientific)Also: Polyform by Boston ScientificSite-specific cystocele repair with polypropylene mesh augmentation | Device | Polypropylene Mesh |
| Porcine Dermis (Pelvicol by CRBard)Also: Pelvicol by CRBardSite-specific cystocele repair with porcine dermis augmentation | Procedure or surgery | Porcine Dermis |
| Anterior ColporrhaphyAlso: Cystocele repairAnterior vaginal prolapse repair with suture. | Procedure or surgery | Anterior Colporrhaphy |
Primary outcome
Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis
Time frame: 2 years
The primary outcome as the number of participants with optimal anterior vaginal support at two year defined as POPQ point Ba < -1.
4 secondary outcomes
Number of Participants With One or More Adverse Events at Two Years
Time frame: 2 years
Number of Participants With Overall Failure
Time frame: 2 year
Change in Quality of Life Measured by the Pelvic Floor Distress Inventory 20 and Pelvic Floor Impact Questionnaire 7
Time frame: 2-year compared to baseline scores
Change in Postoperative Sexual Function Measured by Pelvic Organ Prolapse/Urinary Incontinence Questionnaire 12
Time frame: 2 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11744900Weber 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.
- Background: PubMed 21561348Altman 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.
- Background: PubMed 17010297Simsiman 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.
- Results publication: PubMed 22067717Menefee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John N. Nguyen, MD principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polypropylene mesh (Polyform by Boston Scientific), Porcine Dermis (Pelvicol by CRBard) and Anterior Colporrhaphy in people with Anterior Vaginal Wall Prolapse and Cystocele, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01393171, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.