search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Opsys bulking agent bij mannelijke incontinentie


- candidate number24685
- NTR NumberNTR6001
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jul-2016
- Secondary IDsabr NL5705404416 
- Public TitleOpsys bulking agent bij mannelijke incontinentie
- Scientific TitleINJECTABLE BULKING AGENT FOR MALE URINARY INCONTINENCE TREATMENT: A MULTI-CENTRE PILOT SAFETY AND EFFICACY STUDY
- ACRONYMOPSYS
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedIncontinence
- 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 receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate1-jan-2022
- Target number of participants0
- InterventionsOpsys will be implanted in urethra using a video endoscope with a transurethral injection needle. All the procedures will be recorded on CD-Rom.
- Primary outcomeThe 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 50% reduction OR Voiding diary
(Count pads) 50% less usage of pads
FAILURE Unable to meet the previous criteria
- Secondary outcomeSecondary 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.
- TimepointsAll visits

Pre-operative
(1 mo)
(3 mo)
(6 mo)
(12 mo)
(24 mo)
(36 mo)
(60 mo)
- Trial web sitenot yet: information by e.cornel@zgt.nl
- statusstopped
- CONTACT FOR PUBLIC QUERIESDr E.B. Cornel
- CONTACT for SCIENTIFIC QUERIESDr E.B. Cornel
- Sponsor/Initiator ZGT Hospital, Jeroen Bosch Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZGT Hospital
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-jul-2016 - 26-aug-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl