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Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

Overactive Bladder Syndrome Clinical Trial

Official title:
Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

Clinical Trial Summary

The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder The main questions it aims to answer are: •Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. [Time Frame: 3 months] Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis. Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06283498
Study type Interventional
Source InMode MD Ltd.
Contact
Status Enrolling by invitation
Phase N/A
Start date November 10, 2023
Completion date July 2026
View Details
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