Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence

NCT01095692 | Completed

• 1 other identifier: P090304
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays the clinical significance of an occult stress urinary incontinence and its optimal treatment is not known.Regarding treatment, there are 2 main approaches : either the systematic preventive treatment of the occult stress urinary incontinence by means of a tension free vaginal tape (TOT) together with the treatment of prolapse or the treatment of prolapse in the first place and treatment of stress incontinence in a second time when and if it appears.This study is expected to provide objective evidence concerning the efficacy and security of TOT implantation for the prevention treatment of occult stress urinary incontinence in women with pelvic organ prolapse and occult urinary incontinence.The perspective is to improve the management of these patients by providing evidence based recommendation for their treatment.

Conditions

Stress Urinary Incontinence; Pelvic Organ Prolapse

Keywords

Occult stress Incontinence,; Pelvic Organ Prolapse,; Prevention of stress urinary incontinence,; Postoperative incontinence,; Sub-urethral tape

Outcome Measures

Primary Outcomes (1)

• To compare the postoperative prevalence of stress incontinence in patients with or without TOT implant during a pelvic organ prolapse surgery

  6 month

Secondary Outcomes (9)

• To compare the severity of postoperative stress urinary incontinence between the two groups

  6 month

• To compare the prevalence of new onset overactive bladder postoperatively between the two groups

  6 month

• To compare the severity of new onset overactive bladder between the two groups

  6 month

• To compare the prevalence of postoperative dyspareunia at 6 months between the two groups

  6 month

• To compare the prevalence of postoperative urinary retention between the two groups

  6 month

Study Arms (2)

only surgery

ACTIVE COMPARATOR

Procedure: Pelvic Organ Prolapse intervention

surgery + TOT

EXPERIMENTAL

Procedure: Pelvic Organ Prolapse and Suburethral TOT implantation

Interventions

Pelvic Organ Prolapse and Suburethral TOT implantation PROCEDURE

Procedure/Surgery: Pelvic Organ Prolapse intervention and Suburethral TOT implantation

Also known as: Laparoscopic sacrocolpopexy, Vaginal surgery for prolapse using autologous tissue, Vaginal surgery for prolapse using synthetic mesh

surgery + TOT

Pelvic Organ Prolapse intervention PROCEDURE

Procedure/Surgery: Pelvic Organ Prolapse intervention

Also known as: -Laparoscopic sacrocolpopexy, -Vaginal surgery for prolapse using autologous tissue, -Vaginal surgery for prolapse using synthetic mesh

only surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients, at least 18 years of age
• Having a pelvic organ prolapse and occult stress urinary incontinence
• Patient non opposed to the exploitation of data in research
• Agree to comply with all protocol-specified procedures, including protocol mandated follow up visits

You may not qualify if:

• Symptoms of stress urinary incontinence preoperatively
• Patients not having social security
• Pregnancy or lactation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Diaconesses Hospital

Paris, Île-de-France Region, 75012, France

Location

Related Publications (3)

• Cortesse A, Jacquetin B, Grise P, Le Normand L, Richard F, Haab F. Prospective multicenter clinical trial of Uretex Sup for surgical treatment of stress urinary incontinence. Int J Urol. 2007 Jul;14(7):611-5. doi: 10.1111/j.1442-2042.2007.01542.x.

  PMID: 17645604 RESULT

• Yeung E, Baessler K, Christmann-Schmid C, Haya N, Chen Z, Wallace SA, Mowat A, Maher C. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2024 Mar 13;3(3):CD012079. doi: 10.1002/14651858.CD012079.pub2.

  PMID: 38477494 DERIVED

• Maher C, Yeung E, Haya N, Christmann-Schmid C, Mowat A, Chen Z, Baessler K. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD012376. doi: 10.1002/14651858.CD012376.pub2.

  PMID: 37493538 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Ariane Cortesse, MD

  Department of Urology, Saint Louis Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 6, 2014

Record last verified: 2014-06

Locations

FR (1)