Vaginal ProlapseNCT00442247
A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
A study testing Pelvicol in people with Vaginal Prolapse, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- Pelvicol
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2004to Dec 2008
- Phase
- Interventional
- 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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology
Who cannot join
- Recurrent vaginal prolapse, wault prolapse
Trial locations and contacts
1 site in 1 country.
About this study
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.
Read the detailed description
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. However, is is now known whether these methods are superior to the replication of the pubocervicale fascia, a method which is well described and have been used for many years. Furthermore, most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation.
- Conditions
- Vaginal Prolapse
- Being tested
- Pelvicol
- Keywords
- anterior vaginal wall prolapse, Pelvicol, biomesh, Anterior vaginal wall prolapse
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelvicolDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in POP-Q measurements for vaginal prolapse
Secondary outcomes (1)
Affect on bladder function after surgery for anterior vaginal wall prolapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startSep 2004
- Study completionDec 2008
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.
- More trials run by Zealand University HospitalThe 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
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ulla Hviid, MD, Principal investigator, Roskilde County Hospital, Dept. of Obstetrics and Gynecology, Roskilde University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442247
- Sponsor's protocol ID
- Feb-UH-2007
- Status last verified
- Feb 2007
- First submitted
- 28 Feb 2007
- Last updated
- 1 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
- ClinicalTrials.gov ID
- NCT00442247
- Acronym / sponsor ID
- Feb-UH-2007
- Conditions
- Vaginal Prolapse
- Keywords
- anterior vaginal wall prolapse, Pelvicol, biomesh, Anterior vaginal wall prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Dec 2008
- First posted
- 1 Mar 2007 (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.
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.
Detailed description
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. However, is is now known whether these methods are superior to the replication of the pubocervicale fascia, a method which is well described and have been used for many years. Furthermore, most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology
Key exclusion criteria (1 listed)
- Recurrent vaginal prolapse, wault prolapse
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 |
|---|---|---|
| Pelvicol | Device | – |
Primary outcome
Difference in POP-Q measurements for vaginal prolapse
1 secondary outcome
Affect on bladder function after surgery for anterior vaginal wall prolapse
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
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Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
Pelvic Organ Prolapse (POP)
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.
Ulla Hviid, MD principal investigator
Roskilde County Hospital, Dept. of Obstetrics and Gynecology, Roskilde University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvicol in people with Vaginal Prolapse, run by Zealand University Hospital at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 2007. 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 Denmark. 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.
Are results available for this study?
Results are not available in the source record.
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?
Difference in POP-Q measurements for vaginal prolapse. 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 1 Mar 2007.