NCT00442247

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

February 28, 2007

Last Update Submit

February 28, 2007

Conditions

Vaginal Prolapse

Keywords

anterior vaginal wall prolapse, Pelvicol, biomeshAnterior vaginal wall prolapse

Outcome Measures

Primary Outcomes (1)

  • Difference in POP-Q measurements for vaginal prolapse

Secondary Outcomes (1)

  • Affect on bladder function after surgery for anterior vaginal wall prolapse

Interventions

PelvicolDEVICE

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Recurrent vaginal prolapse, wault prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Obstetrics and Gynecology

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ulla Hviid, MD

    Roskilde County Hospital, Dept. of Obstetrics and Gynecology, Roskilde University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

September 1, 2004

Study Completion

December 1, 2008

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

DK(1)