Anterior Vaginal Wall ProlapsePhase 3NCT00420225
Mesh Repair of Anterior Vaginal Wall Prolapse
A Phase 3 study testing Low-weight prolypropylene mesh in people with Anterior Vaginal Wall Prolapse, run by Tampere University at 1 site in Finland.
Trial summary
The purpose of this study is to determine whether reenforcement with polypropylen mesh compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in fewer recurrences. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Anterior Vaginal Wall Prolapse
- What is being tested?
- Low-weight prolypropylene mesh
- Type of treatment
- Medical device
- How many people
- 202 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2003to May 2008
- Phase
- Phase 3
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery
Who cannot join
- an apical defect indicating concomitant vaginal fixation, or stress urinary incontinence necessitating surgery, or her main symptomatic prolapse component was in the posterior vaginal wall.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Tampere University Hospital, Department of Obstetrics and Gynaecology
Tampere, 33521
About this study
Official title: Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse: A Prospective Randomized Study
The purpose of this study is to determine whether reenforcement with polypropylen mesh compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in fewer recurrences.
Read the detailed description
Anterior vaginal wall prolapse is the most common type of pelvic organ prolapse in postmenopausal women. This anatomic defect has traditionally been repaired with anterior colporrhaphy plication, a series of interrupted stitches being the main surgical component. The procedure is associated with a high recurrence rate, up to 32 % even after using paravaginal repair along with anterior colporrhaphy.It has been sought to resolve the problem of recurrence using artificial mesh as in the repair of abdominal hernias.
Comparison: Anterior vaginal wall repair with or without reinforcement with polypropylene mesh were compared in a prospective randomized study
- Conditions
- Anterior Vaginal Wall Prolapse
- Being tested
- Low-weight prolypropylene mesh
- Keywords
- Cystocele, surgery, mesh, genital prolapse
- Medical subject headings
- Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-weight prolypropylene meshDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of anterior vaginal wall prolapse
Secondary outcomes (3)
Postvoidal residual urine
Symptom resolution
Complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startApr 2003
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Vaginal Wall 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Investigators
- Kari Nieminen, Principal investigator, Tampere University Hospital, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420225
- Sponsor's protocol ID
- Tampere University Hospital
- Status last verified
- Jan 2007
- First submitted
- 9 Jan 2007
- Last updated
- 11 Jan 2007
- Results posted
- No
Publications
Nieminen K, Hiltunen R, Heiskanen E, Takala T, Niemi K, Merikari M, Heinonen PK. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1611-6. doi: 10.1007/s00192-008-0707-7. Epub 2008 Aug 21.
PubMed 18716704
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00420225
- Acronym / sponsor ID
- Tampere University Hospital
- Conditions
- Anterior Vaginal Wall Prolapse
- Keywords
- Cystocele, surgery, mesh, genital prolapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- May 2008
- First posted
- 11 Jan 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.
The purpose of this study is to determine whether reenforcement with polypropylen mesh compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in fewer recurrences.
Detailed description
Anterior vaginal wall prolapse is the most common type of pelvic organ prolapse in postmenopausal women. This anatomic defect has traditionally been repaired with anterior colporrhaphy plication, a series of interrupted stitches being the main surgical component. The procedure is associated with a high recurrence rate, up to 32 % even after using paravaginal repair along with anterior colporrhaphy.It has been sought to resolve the problem of recurrence using artificial mesh as in the repair of abdominal hernias.
Comparison: Anterior vaginal wall repair with or without reinforcement with polypropylene mesh were compared in a prospective randomized study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery
Key exclusion criteria (1 listed)
- an apical defect indicating concomitant vaginal fixation, or stress urinary incontinence necessitating surgery, or her main symptomatic prolapse component was in the posterior vaginal wall.
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 |
|---|---|---|
| Low-weight prolypropylene mesh | Device | – |
Primary outcome
Recurrence of anterior vaginal wall prolapse
3 secondary outcomes
Postvoidal residual urine
Symptom resolution
Complications
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 11 Jan 2007.
- Derived from this study: PubMed 18716704Nieminen K, Hiltunen R, Heiskanen E, Takala T, Niemi K, Merikari M, Heinonen PK. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1611-6. doi: 10.1007/s00192-008-0707-7. Epub 2008 Aug 21.
Related trials for Anterior Vaginal Wall Prolapse
Recruiting
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Pelvic Organ Prolapse, Cystocele
Active, not recruitingObservational study
To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.
Pelvic Organ Prolapse, Pelvic Organ Prolapse Vaginal Surgery
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.
Kari Nieminen principal investigator
Tampere University Hospital, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-weight prolypropylene mesh in people with Anterior Vaginal Wall Prolapse, run by Tampere University at 1 site in Finland.
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: finished, as of the sponsor's last update on 11 Jan 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 Finland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Recurrence of anterior vaginal wall prolapse. 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 NCT00420225, which also lists 1 linked publication.
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 11 Jan 2007.