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Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder

NCT06283498 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-03-18

No results posted yet for this study

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

DEVICE

Device Morpheus8V

Assigned to be treated using the modified Morpheus8V

Sponsors & Collaborators

  • InMode MD Ltd.

    lead INDUSTRY

Principal Investigators

  • Mickey Karram, MD · Not Affiliated

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2025-11-10
Completion
2027-11-10
FDA Device
Yes

Countries

  • United States
  • Colombia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283498 on ClinicalTrials.gov