NCT06283498

Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: InMode MD Ltd. · Industry
• Sex: Female
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DEVICE	Device Morpheus8V	Assigned to be treated using the modified Morpheus8V

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-11-10
• Completion: 2027-11-10
• First posted: 2024-02-28
• Last updated: 2025-03-18

Locations

3 sites across 2 countries: United States, Colombia

Regulatory

• FDA-regulated device study