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Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms

Overactive Bladder Clinical Trial

Official title:
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms

Clinical Trial Summary

To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04758247
Study type Interventional
Source Theranova, L.L.C.
Contact
Status Completed
Phase N/A
Start date October 28, 2021
Completion date December 8, 2023
View Details
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