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NCT00771225 Clinical Trial

National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift

Genital Prolapse Clinical Trial

Official title:
A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00771225
Other study ID # 300-07-002
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received October 10, 2008
Last updated February 2, 2010
Start date November 2008
Est. completion date November 2013

Study information
Verified date October 2008
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.

Description:

180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.Are eligible women aged between 50 and 80 years old.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 180
Est. completion date November 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Between 50 and 80 yrs

Exclusion Criteria:

- Less than 50 and more than 80 yrs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• fascial repair
surgery to treat genital prolapse with fascia repair
• mesh repair
surgery to genital prolapse with mesh

Locations
Country Name City State
Brazil Simone Brandao Sao Paulo

Sponsors (5)
Lead Sponsor Collaborator
University of Sao Paulo Feculdade de Medicina da Universidade de Sao Paulo - Brasil, Federal University of São Paulo, Irmandade da Santa Casa de Misericordia de Sao Paulo, University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correction of genital prolapse 8 years No
See also
  Status Clinical Trial Phase
Terminated NCT00784602 - Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes N/A
Recruiting NCT02050568 - Mechanism of Incontinence Before and After Genital Prolapse Surgery N/A
Completed NCT02585544 - Ambulatory Prolapse Surgery N/A
Recruiting NCT06296316 - Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair
Not yet recruiting NCT02906111 - Vaginal Estriol Before and Vaginal Surgery for Prolapse Phase 4
Completed NCT00551551 - Prenatal Pelvic Floor Prevention (3PN) Phase 3
Completed NCT06338852 - Awareness of Gynaecologists About Role of Physical Therapy in Genital Prolapse
Withdrawn NCT00554944 - Intraoperative Goal-directed Fluid Management N/A
Recruiting NCT03615872 - Pessary Satisfaction Criteria for Urogenital Prolapse
Completed NCT04856709 - Abdominal Pectopexy Versus Abdominal Sacral Hysteropexy. N/A
Completed NCT00747370 - Dynamic MRI of the Behaviour of Female Pelvic Floor Phase 0
Not yet recruiting NCT05691543 - Modified Technique in Sacrospinous Fixation for Treatment of Apical Genital Prolapse
Completed NCT03901586 - Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008 N/A