Vaginal ProlapsePhase 4VAMP-ANCT00557882
Efficacy Study of Vaginal Mesh for Anterior Prolapse
A Phase 4 study testing synthetic polypropylene mesh in people with Vaginal Prolapse and Uterine Prolapse, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for anterior prolapse compared to traditional vaginal… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Vaginal Prolapse, Uterine Prolapse, Cystocele
- What is being tested?
- synthetic polypropylene mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Nov 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women age > 21
- diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery
- available for 12 months of follow-up
- able to complete study questionnaires and assessments.
- available for 12 months follow-up
Who cannot join
- Uterus in place.
- No anterior vaginal prolapse.
- Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.
- Current intermittent self catheterization.
- Pregnancy or desire for future fertility.
- Presence of an adnexal or ovarian mass.
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- Shortened vagina.
- Other laparoscopic or abdominal/pelvic surgery in the past 3 months.*
- Known neurologic or medical condition affecting bladder function, e.g. multiple sclerosis, spinal cord injury.
- Need for surgery requiring an abdominal incision.
- <12 months post-partum. (Enrollment can be deferred until time requirement has been met).
Trial locations and contacts
1 site in 1 country.
United States1 site
Wahington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.
Read the detailed description
Multiple vaginal, abdominal and laparoscopic procedures have been described for surgical correction of pelvic support problems. However, conventional pelvic reconstructive surgeries have been associated with a 20-30% prolapse recurrence rate. The anterior vaginal wall is the site most often recognized as the area of vaginal prolapse recurrence. Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction in an attempt to improve surgical cure rates. Unfortunately, safety and efficacy data have lagged behind the technical advancements.
This trial will randomize women with advanced anterior wall prolapse to two treatment arms: vaginal reconstructive surgery with mesh and vaginal reconstructive surgery without mesh. The primary outcome is cure of anterior wall prolapse at one year. Secondary outcomes are cure of apical and posterior wall prolapse, quality-of-life measures and complication rates. Patients will be approached for recruitment only after they have made the decision to undergo vaginal surgery for anterior prolapse. The patient and examiner will be blinded to the surgical treatment assignment. Interim measurement of primary and secondary outcomes will be conducted three months post-operatively. Additional follow-up will be conducted at one-year intervals subsequent to the expected one-year endpoint.
- Conditions
- Vaginal Prolapse, Uterine Prolapse, Cystocele, Pelvic Organ Prolapse
- Being tested
- synthetic polypropylene mesh
- Keywords
- prolapse, uterus, mesh, bladder
- Medical subject headings
- Uterine Prolapse, Cystocele, Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synthetic polypropylene meshDevice
Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
| Study group | Role | What they receive |
|---|---|---|
| mesh | Active comparator | Vaginal reconstructive surgery with synthetic polypropylene mesh Receives: Device: synthetic polypropylene mesh |
| no mesh | Active comparator | Vaginal reconstructive surgery without mesh Receives: Device: synthetic polypropylene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure for Objective Treatment Success is Anterior Prolapse, Point Ba at Stage 0 or 1 (Defined as Maximal Descent of the Anterior Wall to Greater Than 1 cm Above the Hymen) at One Year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2009
- Study completionNov 2011
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.
- Other trials for Vaginal ProlapseStudies of the same condition, open and under way.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew I Sokol, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557882
- Sponsor's protocol ID
- 2006-336
- Acronym
- VAMP-A
- Status last verified
- Oct 2020
- First submitted
- 13 Nov 2007
- Last updated
- 30 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Vaginal Mesh for Anterior Prolapse
- ClinicalTrials.gov ID
- NCT00557882
- Acronym / sponsor ID
- VAMP-A / 2006-336
- Conditions
- Vaginal Prolapse, Uterine Prolapse, Cystocele, Pelvic Organ Prolapse
- Keywords
- prolapse, uterus, mesh, bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Posted 30 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.
Detailed description
Multiple vaginal, abdominal and laparoscopic procedures have been described for surgical correction of pelvic support problems. However, conventional pelvic reconstructive surgeries have been associated with a 20-30% prolapse recurrence rate. The anterior vaginal wall is the site most often recognized as the area of vaginal prolapse recurrence. Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction in an attempt to improve surgical cure rates. Unfortunately, safety and efficacy data have lagged behind the technical advancements.
This trial will randomize women with advanced anterior wall prolapse to two treatment arms: vaginal reconstructive surgery with mesh and vaginal reconstructive surgery without mesh. The primary outcome is cure of anterior wall prolapse at one year. Secondary outcomes are cure of apical and posterior wall prolapse, quality-of-life measures and complication rates. Patients will be approached for recruitment only after they have made the decision to undergo vaginal surgery for anterior prolapse. The patient and examiner will be blinded to the surgical treatment assignment. Interim measurement of primary and secondary outcomes will be conducted three months post-operatively. Additional follow-up will be conducted at one-year intervals subsequent to the expected one-year endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesh | Active comparator | Device: synthetic polypropylene meshVaginal reconstructive surgery with synthetic polypropylene mesh |
| no mesh | Active comparator | Device: synthetic polypropylene meshVaginal reconstructive surgery without mesh |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- women age > 21
- diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery
- available for 12 months of follow-up
- able to complete study questionnaires and assessments.
- available for 12 months follow-up
Key exclusion criteria (11 listed)
- Uterus in place.
- No anterior vaginal prolapse.
- Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.
- Current intermittent self catheterization.
- Pregnancy or desire for future fertility.
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 |
|---|---|---|
| synthetic polypropylene meshMesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine. | Device | mesh, no mesh |
Primary outcome
The Primary Outcome Measure for Objective Treatment Success is Anterior Prolapse, Point Ba at Stage 0 or 1 (Defined as Maximal Descent of the Anterior Wall to Greater Than 1 cm Above the Hymen) at One Year.
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click clinical trials for more information about this study " A Randomized Clinical trial of Vaginal Mesh for Prolapse"Link provided by the sponsor.
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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.
Andrew I Sokol, MD principal investigator
Medstar Health Research Institute
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 synthetic polypropylene mesh in people with Vaginal Prolapse and Uterine Prolapse, run by Medstar Health Research Institute 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 5 inclusion and 11 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 30 Oct 2020. 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. 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 30 Oct 2020). 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?
The Primary Outcome Measure for Objective Treatment Success is Anterior Prolapse, Point Ba at Stage 0 or 1 (Defined as Maximal Descent of the Anterior Wall to Greater Than 1 cm Above the Hymen) at One Year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2020.