A prospective study to assess the efficacy and safety of the BlueWind RENOVA iStim* System for the treatment of patients diagnosed with overactive bladder (OASIS - OverActive bladder StImulation System study)

Recruiting

• Conditions: Overactive bladder; 10004994; frequent need to urinate

• Registration Number: NL-OMON55598
• Lead Sponsor: BlueWind Medical Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

• 2 - Female aged 18 or greater (21 or greater in the US), with no plans to
become pregnant
during the trial; if of bearing potential, negative pregnancy test and
if sexually active, using
acceptable contraception.
• 4 - Diagnosis of UUI demonstrated on a 7-consecutive days voiding diary
defined as
a minimum of nine (9) leaking episodes associated with urgency with at
least one episode per
day for 5 days.
• 5 - More than or equal to 6 months history of UUI diagnosis
• 6 - Patient with inadequate response to any of the following conservative
treatments (i.e.
dietary restriction, fluid restriction, bladder training, behavioral
modification, pelvic muscle
training, biofeedback, etc.) and pharmacologic treatment.

Exclusion Criteria

• 1 - Previous participation in another study with any investigational drug or
device
within the past 90 days
• 5 - Any significant medical condition that is likely to interfere with study
procedures,
device operation, or likely to confound evaluation of study endpoints
• 19 - More than minimal level of stress incontinence or mixed incontinence
with stress
component likely to confound study outcome, based on a 7-day voiding
diary or medical history,or when stress incontinence score in the MESA
incontinence questionnaire is higher than the urgency incontinence score
• 28 - Have a life expectancy of less than 1 year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy<br /><br>• Proportion of responders at 6 months post system activation as demonstrated<br /><br>by >=50% improvement in average number of urgency related<br /><br>incontinence episodes, as measured by 7-day Patient Voiding Diary.<br /><br>Overall study success criteria is defined as a lower 97.5%<br /><br>confidence bound for a single binomial proportion of >50% patient success at 6<br /><br>months.<br /><br><br /><br>Safety<br /><br>• Incidence of adverse events from implantation to 12-months post-activation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Proportion of subjects with >=10 points (MID) improvement in HRQL (based on<br /><br>OAB-q) at 6 months post system activation<br /><br>• Proportion of responders at 12 months post system activation as demonstrated<br /><br>by >=50% improvement in either average number of urgency<br /><br>related incontinence episodes or average number of severe/large urgency<br /><br>related incontinence episodes, as measured by 7-day Patient Voiding Diary.<br /><br>• Proportion of responders at 6 months post system activation as demonstrated<br /><br>by >=50% improvement in the average number of moderate-severe urgency epsiodes<br /><br>PPIUS degree 3,4 or <8 voids/day </p><br>