NCT00420225

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 11, 2007

Status Verified

January 1, 2007

First QC Date

January 9, 2007

Last Update Submit

January 9, 2007

Conditions

Anterior Vaginal Wall Prolapse

Keywords

Cystocelesurgerymeshgenital prolapse

Outcome Measures

Primary Outcomes (1)

  • Recurrence of anterior vaginal wall prolapse

Secondary Outcomes (3)

  • Postvoidal residual urine

  • Symptom resolution

  • Complications

Interventions

Low-weight prolypropylene meshDEVICE

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital, Department of Obstetrics and Gynaecology

Tampere, 33521, Finland

Location

Related Publications (1)

  • 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.

    PMID: 18716704DERIVED

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kari Nieminen

    Tampere University Hospital, Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

April 1, 2003

Study Completion

May 1, 2008

Last Updated

January 11, 2007

Record last verified: 2007-01

Locations

FI(1)