NCT04547920

FREEOAB Study for Overactive Bladder

Completed NA Results posted Last updated 26 February 2025

What this trial tests

NA trial testing Wearable Bladder Modulation System in Overactive Bladder in 96 participants. Completed in 15 June 2023.

Timeline

11 January 2021

Primary endpoint
8 October 2021

15 June 2023

Quick facts

Lead sponsor	Avation Medical, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	11 January 2021
Primary completion	8 October 2021
Estimated completion	15 June 2023
Sites	9 locations across United States

Drugs / interventions tested

• Wearable Bladder Modulation System

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →
• Urinary Frequency — all drugs for Urinary Frequency →
• Urinary Incontinence, Urge — all drugs for Urinary Incontinence, Urge →
• Urinary Urgency — all drugs for Urinary Urgency →

Sponsor

Avation Medical, Inc.

Who can join

18 and older, any sex, with Overactive Bladder or Urinary Frequency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Responders in Voiding (Urinary Frequency) Events Primary · 12 Weeks

The percentage of responders in voiding (urinary frequency) events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total voids per day relative to an upper normal limit of 8 voids per day, or returns to normal (8 or fewer voids per day) at Week 12.

Group	Value	95% CI
12 Weeks Followed by Optional 12 Month Continuation	55

Percentage of Responders in Incontinence (Leak) Events (IE) Secondary · 12 Weeks

Percentage of Responders in Incontinence (Leak) Events (IE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total incontinence events per day, or returns to normal (0 events per day), at Week 12.

Group	Value	95% CI
12 Weeks Followed by Optional 12 Month Continuation	47

Percentage of Responders in Urgency Events (UE) Secondary · 12 Weeks

Percentage of Responders in Urgency Events (UE), where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 5), in total urgency events per day, or returns to normal (0 events per day) at Week 12.

Group	Value	95% CI
12 Weeks Followed by Optional 12 Month Continuation	41

Overall Responder Rate at 12 Weeks Secondary · 12 Weeks

Overall Responder Rate at 12 Weeks, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at Week 12.

Group	Value	95% CI
12 Weeks Followed by Optional 12 Month Continuation	74

Overall Responder Rate at 12 Months Secondary · 12 Months

Overall Responder Rate at 12 Months, where responder is defined as any subject with a 50% or greater improvement, or return to normal, in the total number of voids per day, or the total number of urgency events/day, or the total number of leaks per day from baseline at 6 months.

Group	Value	95% CI
12 Weeks Followed by Optional 12 Month Continuation	30

Adverse events — posted to ClinicalTrials.gov

Time frame: Length of Study (12 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

12 Weeks Followed by Optional 12 Month Continuation

Serious: 0/96 (0%)

Deaths: 0/96

Other adverse events (9 terms — click to expand)

Reaction	System	12 Weeks Followed by Optio…
Pollakiuria (Frequent Urination)	Renal and urinary disorders	—
Foot Pain / Intense Stimulation	Musculoskeletal and connective tissue disorders	—
Muscle Spasm (Foot Cramping)	Musculoskeletal and connective tissue disorders	—
Paraesthesia (Tingling Sensation)	Nervous system disorders	—
Urinary Incontinence	Renal and urinary disorders	—
Foot Contusion	Skin and subcutaneous tissue disorders	—
Thermal Burn	Skin and subcutaneous tissue disorders	—
Skin Irritation	Skin and subcutaneous tissue disorders	—
Varicose Veins	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04547920 adverse events section.

Sponsor's own description

This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.