The primary hypothesis of this study is that Opsys will improve mild incontinence based on urine loss per 24 h measured by 24 h pad weight test (PWT). Primary Objective The primary objective of this study is to test the effectiveness of Opsys in…
ID
Bron
Verkorte titel
Aandoening
mannelijk incontinentie
bulking stof
male incontinence
bulking agent
Ondersteuning
performer ZGT and Jeroen Bosch Ziekenhuis
self financing research: fund = initiator=
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study endpoint is whether treatment was successful, based on the two 24 h pad weight test (PWT) before and after treatment. The success rate of the procedure will be assessed according to the following criteria presented in Table 2.
<br><br>
Table 2. Criteria for defining treatment success, improvement and failure.<br>
Result Criteria<br>
Endpoint Actual value Endpoint Actual value
SUCCESS 24-h PWT 0 -3 g OR Voiding diary
(Count pads) 0 pads<br>
IMPROVEMENT 24-h PWT ¡Ý 50% reduction OR Voiding diary <br>
(Count pads) ¡Ý 50% less usage of pads<br>
FAILURE Unable to meet the previous criteria
Doel van het onderzoek
The primary hypothesis of this study is that Opsys will improve mild incontinence based on urine loss per 24 h measured by 24 h pad weight test (PWT).
Primary Objective
The primary objective of this study is to test the effectiveness of Opsys in a controlled group of selected subjects with mild (less than 30 g per day urine loss on 24 h pad weight test) post-radical prostatectomy SUI, based on urine loss per 24 h measured by 24 h pad weight test.
Onderzoeksopzet
All visits
Pre-operative
(1 mo)
(3 mo)
(6 mo)
(12 mo)
(24 mo)
(36 mo)
(60 mo)
Onderzoeksproduct en/of interventie
Opsys will be implanted in urethra using a video endoscope with a transurethral injection needle. All the procedures will be recorded on CD-Rom.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Subject remains dry at night.
• Ability to voluntarily stop micturition.
• Stress Urinary Incontinence caused by Intrinsic sphincter deficiency ISD secondary to a post RP, refractory to conservative treatment with a post-operative of at least 12 months.
• Urinary incontinence classified as mild incontinence level by a 24 h pad weight test mentioned in the clinical data (less than 30 g per day urine loss on 24 h pad weight test), and quality of life has deteriorated so as to require surgery as a method of treatment.
• Consent informed signed.
Subjects will be physical and urodynamically examined to confirm RP SUI. The degree of urine leakage will be quantified using two 24 h pad weight test
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Post-prostatectomy radiotherapy or brachytherapy.
• Subject radiated as treatment of Prostate Cancer, being this interstitial or external, neo-adjuvant, therapeutic or adjuvant.
• Bladder neck sclerosis or urethral stricture.
• Urge Incontinence
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5846 |
| NTR-old | NTR6001 |
| Ander register | : abr NL5705404416 |