incontinence urine loss
Conditions
Interventions
Opsys will be implanted using a video endoscope with a transurethral injection
needle.
Sponsors
Ziekenhuisgroep Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: * Male, aged between 18 and 85 years old. * 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 minimal to 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.
Exclusion criteria
Exclusion criteria: 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. * Detrusor hyperactivity. * Lower Urinary Tract Infections * Urge Incontinence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: * Two 24 h Pad Weight Test (PWT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondairy endpoints: * 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 * Short Form (ICIQ-UI-SF) * Incontinence Impact Questionnaire * Short Form (IIQ-7) * Patient Global Impression of Improvement (PGI-I) * Urogenital Distress Inventory * Short Form (UDI-6) | — |
Countries
Netherlands
Outcome results
None listed