Vaginal ProlapsePhase 4NCT00196495
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
A Phase 4 study testing Polypropylene Mesh in people with Vaginal Prolapse, run by Ethicon, Inc..
Trial summary
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- Polypropylene Mesh
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Nov 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse).
- Patient who is at leat 21 years of age.
- Patient whose family is complete.
- Patient may not have uncontrolled diabetes.
Who cannot join
- Patients may not have coagulation disorders.
About this study
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.
- Conditions
- Vaginal Prolapse
- Being tested
- Polypropylene Mesh
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypropylene MeshDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
Secondary outcomes (4)
Intraoperative complication
Patient tolerance of the synthetic mesh placed
Postoperative complications
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Weisberg, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196495
- Sponsor's protocol ID
- 2003-016
- Status last verified
- Dec 2006
- First submitted
- 12 Sep 2005
- Last updated
- 18 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
- ClinicalTrials.gov ID
- NCT00196495
- Acronym / sponsor ID
- 2003-016
- Conditions
- Vaginal Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Nov 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse).
- Patient who is at leat 21 years of age.
- Patient whose family is complete.
- Patient may not have uncontrolled diabetes.
Key exclusion criteria (1 listed)
- Patients may not have coagulation disorders.
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 | Device | – |
Primary outcome
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
4 secondary outcomes
Intraoperative complication
Patient tolerance of the synthetic mesh placed
Postoperative complications
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2006.
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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.
Martin Weisberg, MD study director
Ethicon, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polypropylene Mesh in people with Vaginal Prolapse, run by Ethicon, Inc..
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 4 inclusion and 1 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 18 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.. 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 18 Dec 2006.