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

June 5, 2014 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study population consists of women with pelvic organ prolapse and occult stress urinary incontinence. They are randomised within two groups : one group with pelvic organ prolapse surgery alone and one group with implantation of TOT together with prolapse surgery for prevention of stress urinary incontinence.TOT implantation is performed as described previously, while the pelvic organ prolapse surgery could either be of abdominal (open or laparoscopic) or vaginal approach. Eighty eight (88) patients will be enrolled at 3 sites centers.

This study is a prospective, multicenter, randomised, active-control arm trial. The study population consists of women with pelvic organ prolapse and occult stress urinary incontinence. They are randomised within two groups : one group with pelvic organ prolapse surgery alone and one group with implantation of TOT together with prolapse surgery for prevention of stress urinary incontinence.TOT implantation is performed as described previously, while the pelvic organ prolapse surgery could either be of abdominal (open or laparoscopic) or vaginal approach. Eighty eight (88) patients will be enrolled at 3 sites centers.

Visit I (J-2 months +/- 1 month) :

During this visit the following will be performed :

  • Collection of general medical, obstetric and surgical history of the patients

  • Collection of incontinence, prolapse and sexual history with the following questionnaires :

    • Standard Questionnaire
    • PFIQ-7 : Pelvic Floor Impact Questionnaire
    • PFDI-20 : Pelvic Floor Distress Inventory-short version Questionnaire
    • PISQ-12 : Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire

  • Clinical examination that includes :

    • a stress test in lithotomy position before and after reduction of prolapse with bladder filled with 250 cc of water. The reduction of prolapse will be performed manually and using a vaginal speculum. The results after both types of reduction will be recorded separately
    • a Vaginal examination establishing the oestrogen status of patient's vagina and classification of prolapse using Baden Walker halfway method and modified ICS POP-Q system
    • Urodynamic test that includes Uroflowmetry as follows :
    • urethral pressure profile, maximum urethral closure pressure (MUCP) and Valsalva leak point pressure (VLPP) determination before and after reduction of prolapse manually
    • Filling cystometry without reduction of prolapse Post void residual volume of urine will be recorded
    • Explanation of the research protocol
    • Evaluation criteria for inclusion and exclusion
    • Information and signed informed consent of the patient
    • Randomization

Hospitalization (J0 at J 6days +/- 2 days) :

During the stay in the hospital the following will be recorded:

  • Type and duration of each procedure
  • Total number of days of hospitalization
  • Immediate complications (e.g perioperative hemorrhage requiring transfusion or not, urine retention requiring catheterisation)
  • Postvoid residual volume of urine for all the patients by bladder scan

Visit II (J 45 days +/- 15 days) :

During this visit the following will be performed :

  • Objective and subjective evaluation of POP treatment and TOT placement

  • Filling out questionnaires :

    • PFIQ-7 : Pelvic Floor Impact Questionnaire
    • PFDI-20 : Pelvic Floor Distress Inventory-short version Questionnaire

  • Clinical examination including :

    • Stress test in lithotomy position as of visit I
    • Vaginal examination
    • In case of prolapse, the modified ICS POP-Q and Baden Walker halfway method for quantification

Visit III (J 6 months +/- 1 month) :

During this visit the following will be performed :

  • Filling out questionnaires :

    • PFIQ-7 : Pelvic Floor Impact Questionnaire
    • PFDI-20 : Pelvic Floor Distress Inventory-short version Questionnaire
    • PISQ-12 : Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
    • PGI-I : Patient Global Impression of Improvement
    • Degree of satisfaction by the operation (visual 0-10 scale)

  • Clinical examination including :

    • Stress test in lithotomy position as of visit I
    • Vaginal examination
    • In case of prolapse, the modified ICS POP-Q and Baden Walker halfway method for quantification
  • Uroflowmetry
  • Short time pad test
  • Full urodynamic test in case of incontinence or obstruction

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75012
        • Diaconesses Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To compare the severity of postoperative stress urinary incontinence between the two groups
Time Frame: 6 month
6 month
To compare the prevalence of new onset overactive bladder postoperatively between the two groups
Time Frame: 6 month
6 month
To compare the severity of new onset overactive bladder between the two groups
Time Frame: 6 month
6 month
To compare the prevalence of postoperative dyspareunia at 6 months between the two groups
Time Frame: 6 month
6 month
To compare the prevalence of postoperative urinary retention between the two groups
Time Frame: 6 month
6 month
To compare the severity of postoperative dyspareunia at 6 months between the two groups
Time Frame: 6 month
6 month
To compare the prevalence of dyschesia and constipation at 6 months between the two groups
Time Frame: 6 month
6 month
To compare pre- and postoperative urodynamic test of patients when they are incontinent at 6 months
Time Frame: 6 month
6 month
To compare the postoperative Patient Global Impression of Improvement and degree of satisfaction at 6 months between the 2 groups
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ariane Cortesse, MD, Department of Urology, Saint Louis Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P090304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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