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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01095692
First received: March 29, 2010
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Pelvic Organ Prolapse
Procedure: Pelvic Organ Prolapse and Suburethral TOT implantation
Procedure: Pelvic Organ Prolapse intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • To compare the postoperative prevalence of stress incontinence in patients with or without TOT implant during a pelvic organ prolapse surgery [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the severity of postoperative stress urinary incontinence between the two groups [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To compare the prevalence of new onset overactive bladder postoperatively between the two groups [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To compare the severity of new onset overactive bladder between the two groups [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To compare the prevalence of postoperative dyspareunia at 6 months between the two groups [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To compare the prevalence of postoperative urinary retention between the two groups [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To compare the severity of postoperative dyspareunia at 6 months between the two groups [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To compare the prevalence of dyschesia and constipation at 6 months between the two groups [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To compare pre- and postoperative urodynamic test of patients when they are incontinent at 6 months [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To compare the postoperative Patient Global Impression of Improvement and degree of satisfaction at 6 months between the 2 groups [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: July 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: only surgery Procedure: Pelvic Organ Prolapse intervention
Procedure/Surgery: Pelvic Organ Prolapse intervention
Other Names:
  • -Laparoscopic sacrocolpopexy
  • -Vaginal surgery for prolapse using autologous tissue
  • -Vaginal surgery for prolapse using synthetic mesh
Experimental: surgery + TOT Procedure: Pelvic Organ Prolapse and Suburethral TOT implantation
Procedure/Surgery: Pelvic Organ Prolapse intervention and Suburethral TOT implantation
Other Names:
  • Laparoscopic sacrocolpopexy
  • Vaginal surgery for prolapse using autologous tissue
  • Vaginal surgery for prolapse using synthetic mesh

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Symptoms of stress urinary incontinence preoperatively
  • Patients not having social security
  • Pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095692

Locations
France
Diaconesses Hospital
Paris, Ile De France, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Ariane Cortesse, MD Department of Urology, Saint Louis Hospital
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01095692     History of Changes
Other Study ID Numbers: P090304
Study First Received: March 29, 2010
Last Updated: June 5, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Occult stress Incontinence,
Pelvic Organ Prolapse,
Prevention of stress urinary incontinence,
Postoperative incontinence,
Sub-urethral tape

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence
Urinary Incontinence, Stress
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014