INJECTABLE BULKING AGENT FOR MALE URINARY INCONTINENCE TREATMENT: A MULTI-CENTRE EFFECTIVENESS AND SAFETY PILOT STUDY

Phase 4

Completed

Conditions: incontinence
urine loss
10046447

Registration Number: NL-OMON43352

Lead Sponsor: Ziekenhuisgroep Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

* 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>* Two 24 h Pad Weight Test (PWT)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondairy endpoints:<br /><br>* 48 h voiding diary to record micturition episodes<br /><br>* Complete Urinalysis with Urine culture<br /><br>* Urodynamic evaluation:<br /><br>o Uroflowmetry<br /><br>o Urethral pressure (leak point pressure measurement before and after<br /><br>surgery)<br /><br>o Cystometric test<br /><br>o Post Void Residual Measurement<br /><br>* International Consultation on Incontinence Questionnaire * Short Form<br /><br>(ICIQ-UI-SF)<br /><br>* Incontinence Impact Questionnaire * Short Form (IIQ-7)<br /><br>* Patient Global Impression of Improvement (PGI-I)<br /><br>* Urogenital Distress Inventory * Short Form (UDI-6)</p><br>