No registrations found.
ID
Source
Brief title
Health condition
mannelijk incontinentie
bulking stof
male incontinence
bulking agent
Sponsors and support
performer ZGT and Jeroen Bosch Ziekenhuis
self financing research: fund = initiator=
Intervention
Outcome measures
Primary outcome
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.
Table 2. Criteria for defining treatment success, improvement and failure.
Result Criteria
Endpoint Actual value Endpoint Actual value
SUCCESS 24-h PWT 0 -3 g OR Voiding diary
(Count pads) 0 pads
IMPROVEMENT 24-h PWT ¡Ý 50% reduction OR Voiding diary
(Count pads) ¡Ý 50% less usage of pads
FAILURE Unable to meet the previous criteria
Secondary outcome
Secondary endpoints are:
• 48 h voiding diary to record micturition episodes
• Complete Urinalysis with Urine culture
• Urodynamic evaluation:
o Uroflowmetry
o Urethral pressure (leak point pressure measurement before and after surgery)
o Cystometric test
o Post Void Residual Measurement
• International Consultation on Incontinence Questionnaire ¨C Short Form (ICIQ-UI-SF)
• Incontinence Impact Questionnaire ¨C Short Form (IIQ-7)
• Patient Global Impression of Improvement (PGI-I)
• Urogenital Distress Inventory (UDI-6)
Safety endpoints are:
• Record of intraoperative complications (including device and surgical instrument (needle) complications and procedure related problems).
• Record of postoperative complications (e.g. urinary retention, voiding pain, etc.).
• Visual Analogue Scale for assessment of pain (pre- and postoperative).
• Any other adverse events regarding safety issues will be recorded and followed-up after their appearance.
Study objective
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.
Study design
All visits
Pre-operative
(1 mo)
(3 mo)
(6 mo)
(12 mo)
(24 mo)
(36 mo)
(60 mo)
Intervention
Opsys will be implanted in urethra using a video endoscope with a transurethral injection needle. All the procedures will be recorded on CD-Rom.
Inclusion criteria
• 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
Exclusion criteria
• 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5846 |
| NTR-old | NTR6001 |
| Other | : abr NL5705404416 |