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ENROLLING BY INVITATION
NCT06283498
NA

Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

Sponsor: InMode MD Ltd.

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2023-11-10

Completion Date

2027-11-10

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

DEVICE

Device Morpheus8V

Assigned to be treated using the modified Morpheus8V

Locations (3)

Mickey Karram MD

Corona del Mar, California, United States

Institute for Female Pelvic Medicine

Knoxville, Tennessee, United States

The Hospital Infantil Universitario de San José (University Children's Hospital of San José)

Bogotá, Colombia