Status:
TERMINATED
Periurethral Pro-ACTTM Balloons vs Retrourethral AdvanceXP(TM) Male Sling for Post-prostatectomy Incontinence
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Stress Urinary Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical p...
Detailed Description
Background: Stress urinary incontinence (SUI) is a common adverse event of radical prostatectomy (RP) for localized prostate cancer and can dramatically impact quality of life. Management of SUI after...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01500603
Start Date
March 1 2013
End Date
June 1 2014
Last Update
October 8 2014
Active Locations (1)
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1
Service d'urologie, Hôpital Tenon
Paris, France, 75020