Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT01500603
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Patient presenting mild to moderate stress urinary incontinence (20g \< 72 hours pad-test \< 300g) following radical prostatectomy more than 1 year ago.
* Patient capable of roaming, independent and capable of using toilet without any trouble.
* Patients able to answer to questionnaire and communicate in French
* Informed consent
* Patients with social security
Exclusion Criteria:
* Uncontrolled prostatic adenocarcinoma or PSA \> 1 ng/ml
* Maximum urinary flow rate \< 15 ml/sec
* Postvoid residual volume \> 150 ml
* Urinated volume in 24h \> 3000 ml
* Uninhibited detrusor contractions associated with leakage during the preoperative urodynamic assessment (realized under anticholinergic if the patient is usually under this medication)
* Severe incontinence (Pad test \> 300g/24h)
* History of artificial urinary sphincter
* Known neurologic bladder dysfunction
* History of neurological disease which can interfere with the urinary symptoms
* Presence of a urethral stenosis or of an anastomotic stricture during the preoperative endoscopy.
* Previous treatment with pelvic radiation therapy in 6 months before inclusion
* Uncontrolled urinary tract infection
* Patients affected by an infiltrative bladder tumour
* Patients with bladder stones
* Severe constitutional hemorrhagic disease or haemophilia
* Deep depression of immune system
* Severe renal impairment or obstructive pathology of the upper urinary tract with severe renal impairment
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01500603
Study Brief:
Protocol Section:
NCT01500603