CystocelePhase 4NCT00535301
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
A Phase 4 study testing grafted anterior prolapse repair and sutured anterior vaginal prolapse repair in people with Cystocele and Uterine Prolapse, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystocele, Uterine Prolapse, Urinary Incontinence
- What is being tested?
- grafted anterior prolapse repair and sutured anterior vaginal prolapse repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Apr 2008
- Phase
- Phase 4
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stage II or greater anterior vaginal prolapse requiring surgical correction
- age 21 years and older
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cystocele, Uterine Prolapse, Urinary Incontinence
- Being tested
- grafted anterior prolapse repair, sutured anterior vaginal prolapse repair
- Keywords
- cystocele, uterine prolapse, urinary incontinence
- Medical subject headings
- Cystocele, Uterine Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grafted anterior prolapse repairDevice
Also called Perigee Transobturator Prolapse Repair System
anterior vaginal prolapse repair with graft
sutured anterior vaginal prolapse repairProcedure or surgery
Also called cystocele repair
anterior vaginal prolapse repair with suture
| Study group | Role | What they receive |
|---|---|---|
| Anterior Colporrhaphy (sutured repair) | Placebo comparator | Anterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures. Receives: Procedure: sutured anterior vaginal prolapse repair |
| Perigee (grafted repair) | Active comparator | Anterior vaginal prolapse repair with graft Receives: Device: grafted anterior prolapse repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three years
Secondary outcomes (2)
Operative Time
Calculated as time from first incision to time of closure of last incision.
Measured: 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.
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJan 2005
- Primary completionApr 2008
- Study completionApr 2008
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 (2)Papers the sponsor has linked to this study.
- Other trials for CystoceleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 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, Southern California Permanente Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535301
- Sponsor's protocol ID
- 4348
- Status last verified
- Apr 2015
- First submitted
- 24 Sep 2007
- Last updated
- 22 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17219252Nguyen 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.
PubMed 18378748
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00535301
- Acronym / sponsor ID
- 4348
- Conditions
- Cystocele, Uterine Prolapse, Urinary Incontinence
- Keywords
- cystocele, uterine prolapse, urinary incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 28 Jul 2011
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Colporrhaphy (sutured repair) | Placebo comparator | Procedure: sutured anterior vaginal prolapse repairAnterior vaginal prolapse repair with anterior colporrhaphy (no graft) using sutures. |
| Perigee (grafted repair) | Active comparator | Device: grafted anterior prolapse repairAnterior vaginal prolapse repair with graft |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stage II or greater anterior vaginal prolapse requiring surgical correction
- age 21 years and older
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| grafted anterior prolapse repairAlso: Perigee Transobturator Prolapse Repair Systemanterior vaginal prolapse repair with graft | Device | Perigee (grafted repair) |
| sutured anterior vaginal prolapse repairAlso: cystocele repairanterior vaginal prolapse repair with suture | Procedure or surgery | Anterior Colporrhaphy (sutured repair) |
Primary outcome
Recurrent Stage II or Greater Anterior Vaginal Prolapse
Time frame: 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.
2 secondary outcomes
Operative Time
Time frame: perioperative
Vaginal Mesh Exposure
Time frame: perioperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17219252Gauruder-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.
- Derived from this study: PubMed 18378748Nguyen 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.
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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
Southern California Permanente Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing grafted anterior prolapse repair and sutured anterior vaginal prolapse repair in people with Cystocele and Uterine Prolapse, run by Kaiser Permanente at 1 site 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 2 inclusion and 12 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2011). 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?
Recurrent Stage II or Greater Anterior Vaginal Prolapse (time frame: three 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 NCT00535301, which also lists 2 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 22 Apr 2015.