|- candidate number||24685|
|- NTR Number||NTR6001|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-jul-2016|
|- Secondary IDs||abr NL5705404416 |
|- Public Title||Opsys bulking agent bij mannelijke incontinentie|
|- Scientific Title||INJECTABLE BULKING AGENT FOR MALE URINARY INCONTINENCE TREATMENT:
A MULTI-CENTRE PILOT SAFETY AND EFFICACY STUDY
|- hypothesis||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).
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.
|- Healt Condition(s) or Problem(s) studied||Incontinence|
|- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jun-2016|
|- planned closingdate||1-jan-2022|
|- Target number of participants||0|
|- Interventions||Opsys will be implanted in urethra using a video endoscope with a transurethral injection needle. All the procedures will be recorded on CD-Rom. |
|- 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.
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 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.
|- Timepoints||All visits
|- Trial web site||not yet: information by firstname.lastname@example.org|
|- CONTACT FOR PUBLIC QUERIES||Dr E.B. Cornel|
|- CONTACT for SCIENTIFIC QUERIES||Dr E.B. Cornel|
|- Sponsor/Initiator ||ZGT Hospital, Jeroen Bosch Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||25-jul-2016 - 26-aug-2017|