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Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery

NCT02231099 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2015-02-06

No results posted yet for this study

Summary

Pelvic organ prolapse is highly prevalent in the female population. The recurrence rate of pelvic organ prolapse after surgical treatment is high. This emphasizes the clinical need for improvement of the surgical techniques currently used. Placement of a mesh aims at reducing the recurrence rate.

In this study the investigators compare the effectiveness of the Tension free Vaginal mesh + Monocryl with standard vaginal prolapse surgery without mesh.

Conditions

  • Pelvic Organ Prolapse
  • Cystocele
  • Rectocele
  • Uterine Prolapse

Interventions

PROCEDURE

Prolift + M

prolapse surgery with mesh

PROCEDURE

conventional vaginal prolapse surgery

conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Mariella IJ Withagen, MD, PhD · Radboud Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02231099 on ClinicalTrials.gov