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NCT00442247 Clinical Trial

A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

Vaginal Prolapse Clinical Trial

Official title:
A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00442247
Other study ID # Feb-UH-2007
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 28, 2007
Last updated February 28, 2007
Start date September 2004
Est. completion date December 2008

Study information
Verified date February 2007
Source Roskilde County Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 75 Years
Eligibility Inclusion Criteria:

- Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology

Exclusion Criteria:

- Recurrent vaginal prolapse, wault prolapse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Pelvicol

Locations
Country Name City State
Denmark Dept. of Obstetrics and Gynecology Roskilde

Sponsors (1)
Lead Sponsor Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in POP-Q measurements for vaginal prolapse
Secondary Affect on bladder function after surgery for anterior vaginal wall prolapse
See also
  Status Clinical Trial Phase
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Recruiting NCT03664986 - Pudendal Block Using Liposomal Bupivacaine vs. Standard Treatment During Sacrospinous Ligament Fixation Phase 4
Completed NCT00388947 - Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products N/A
Not yet recruiting NCT04078802 - 0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse N/A
Recruiting NCT00918099 - The Use of Avaulta for Anterior Repair N/A
Completed NCT00769054 - Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study Phase 4
Completed NCT03187574 - Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse N/A
Completed NCT00679276 - Treatment Outcomes of Vaginal Prolapse Repair N/A
Completed NCT03338400 - Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role? Phase 2
Completed NCT00153231 - Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair Phase 4
Completed NCT01409902 - Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue N/A
Completed NCT00557882 - Efficacy Study of Vaginal Mesh for Anterior Prolapse Phase 4
Completed NCT00196495 - Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse Phase 4
Not yet recruiting NCT06234449 - The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
Active, not recruiting NCT03658395 - Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms N/A
Recruiting NCT05449054 - Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy N/A
Completed NCT00475540 - Efficacy Study of Vaginal Mesh for Prolapse N/A
Enrolling by invitation NCT00571350 - Anterior Vaginal Wall Reconstruction Phase 1/Phase 2
Not yet recruiting NCT03333811 - Sexual Function After Vaginal Repair With Perineorrhaphy N/A
Completed NCT02431897 - Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen Phase 4