Stress Urinary IncontinenceATHENANCT01095692
Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence
A study testing Pelvic Organ Prolapse and Suburethral TOT implantation and Pelvic Organ Prolapse intervention in people with Stress Urinary Incontinence and Pelvic Organ Prolapse, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Pelvic Organ Prolapse
- What is being tested?
- Pelvic Organ Prolapse and Suburethral TOT implantation and Pelvic Organ Prolapse intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2010to 24 Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Symptoms of stress urinary incontinence preoperatively
- Patients not having social security
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Stress Urinary Incontinence, Pelvic Organ Prolapse
- Being tested
- Pelvic Organ Prolapse and Suburethral TOT implantation, Pelvic Organ Prolapse intervention
- Keywords
- Occult stress Incontinence,, Pelvic Organ Prolapse,, Prevention of stress urinary incontinence,, Postoperative incontinence,, Sub-urethral tape
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Organ Prolapse and Suburethral TOT implantationProcedure or surgery
Also called Laparoscopic sacrocolpopexy, Vaginal surgery for prolapse using autologous tissue, Vaginal surgery for prolapse using synthetic mesh
Procedure/Surgery: Pelvic Organ Prolapse intervention and Suburethral TOT implantation
Pelvic Organ Prolapse interventionProcedure or surgery
Also called -Laparoscopic sacrocolpopexy, -Vaginal surgery for prolapse using autologous tissue, -Vaginal surgery for prolapse using synthetic mesh
Procedure/Surgery: Pelvic Organ Prolapse intervention
| Study group | Role | What they receive |
|---|---|---|
| only surgery | Active comparator | Not described Receives: Procedure: Pelvic Organ Prolapse intervention |
| surgery + TOT | Experimental | Not described Receives: Procedure: Pelvic Organ Prolapse and Suburethral TOT implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the postoperative prevalence of stress incontinence in patients with or without TOT implant during a pelvic organ prolapse surgery
Measured: 6 month
Secondary outcomes (9)
To compare the severity of postoperative stress urinary incontinence between the two groups
Measured: 6 month
To compare the prevalence of new onset overactive bladder postoperatively between the two groups
Measured: 6 month
To compare the severity of new onset overactive bladder between the two groups
Measured: 6 month
To compare the prevalence of postoperative dyspareunia at 6 months between the two groups
Measured: 6 month
To compare the prevalence of postoperative urinary retention between the two groups
Measured: 6 month
To compare the severity of postoperative dyspareunia at 6 months between the two groups
Measured: 6 month
To compare the prevalence of dyschesia and constipation at 6 months between the two groups
Measured: 6 month
To compare pre- and postoperative urodynamic test of patients when they are incontinent at 6 months
Measured: 6 month
To compare the postoperative Patient Global Impression of Improvement and degree of satisfaction at 6 months between the 2 groups
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study start22 Jul 2010
- Primary completion24 Oct 2013
- Study completion24 Oct 2013
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariane Cortesse, MD, Principal investigator, Department of Urology, Saint Louis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095692
- Sponsor's protocol ID
- P090304
- Acronym
- ATHENA
- Status last verified
- Jun 2014
- First submitted
- 29 Mar 2010
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17645604Yeung 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.
PubMed 38477494Maher 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.
PubMed 37493538
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01095692
- Acronym / sponsor ID
- ATHENA / P090304
- Conditions
- Stress Urinary Incontinence, Pelvic Organ Prolapse
- Keywords
- Occult stress Incontinence,, Pelvic Organ Prolapse,, Prevention of stress urinary incontinence,, Postoperative incontinence,, Sub-urethral tape
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Jul 2010 (actual)
- Primary completion
- 24 Oct 2013 (actual)
- Study completion
- 24 Oct 2013 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| only surgery | Active comparator | Procedure: Pelvic Organ Prolapse intervention |
| surgery + TOT | Experimental | Procedure: Pelvic Organ Prolapse and Suburethral TOT implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Symptoms of stress urinary incontinence preoperatively
- Patients not having social security
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Organ Prolapse and Suburethral TOT implantationAlso: Laparoscopic sacrocolpopexy, Vaginal surgery for prolapse using autologous tissue, Vaginal surgery for prolapse using synthetic meshProcedure/Surgery: Pelvic Organ Prolapse intervention and Suburethral TOT implantation | Procedure or surgery | surgery + TOT |
| Pelvic Organ Prolapse interventionAlso: -Laparoscopic sacrocolpopexy, -Vaginal surgery for prolapse using autologous tissue, -Vaginal surgery for prolapse using synthetic meshProcedure/Surgery: Pelvic Organ Prolapse intervention | Procedure or surgery | only surgery |
Primary outcome
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
9 secondary outcomes
To compare the severity of postoperative stress urinary incontinence between the two groups
Time frame: 6 month
To compare the prevalence of new onset overactive bladder postoperatively between the two groups
Time frame: 6 month
To compare the severity of new onset overactive bladder between the two groups
Time frame: 6 month
To compare the prevalence of postoperative dyspareunia at 6 months between the two groups
Time frame: 6 month
To compare the prevalence of postoperative urinary retention between the two groups
Time frame: 6 month
To compare the severity of postoperative dyspareunia at 6 months between the two groups
Time frame: 6 month
To compare the prevalence of dyschesia and constipation at 6 months between the two groups
Time frame: 6 month
To compare pre- and postoperative urodynamic test of patients when they are incontinent at 6 months
Time frame: 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
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Results publication: PubMed 17645604Cortesse 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.
- Derived from this study: PubMed 38477494Yeung 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.
- Derived from this study: PubMed 37493538Maher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariane Cortesse, MD principal investigator
Department of Urology, Saint Louis Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Organ Prolapse and Suburethral TOT implantation and Pelvic Organ Prolapse intervention in people with Stress Urinary Incontinence and Pelvic Organ Prolapse, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01095692, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.