Periurethral Pro-ACTTM Balloons vs Retrourethral AdvanceXP(TM) Male Sling for Post-prostatectomy Incontinence (BALLANCE)
Stress Urinary Incontinence
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring post-radical prostatectomy, stress urinary incontinence, periurethral Pro-ACT balloons, AdvanceXP retrourethral male sling
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
Sites / Locations
- Service d'urologie, Hôpital Tenon
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental
Active comparator
Patients will receive AdvanceXP retrourethral male sling implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route
Patients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms.