Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 2:10 PM
Study NCT ID:
NCT01095692
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2010-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENA
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: