← Back to Search

Procedure

Device Treatment for Overactive Bladder

N/A

Waitlist Available

Led By Mickey Karram, MD

Research Sponsored by InMode MD Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-80 years old, inclusive

Urinary incontinence, predominant urgency incontinence for at least one episode on a 3-days diary

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

"This trial aims to study the safety and effectiveness of a procedure called transvaginal Detrusor Nerve Ablation for treating overactive bladder symptoms, including those that have not responded to other

Who is the study for?

This trial is for individuals with overactive bladder, particularly those who haven't responded well to other treatments. Participants will undergo a procedure using the Morpheus8V device and may receive up to three sessions based on their improvement. They'll be monitored for up to a year after the last treatment.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of transvaginal detrusor nerve radiofrequency ablation using Morpheus8V in reducing urgency incontinence episodes. Progress is measured from baseline through follow-ups at 3, 6, and 12 months post-treatment.See study design

What are the potential side effects?

Potential side effects are not specified here but could include discomfort or pain related to the procedure, temporary urinary issues, or tissue reactions at the treatment site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 80 years old.

Select...

I have had at least one episode of sudden need to urinate in the past 3 days.

Select...

I use the bathroom more than 8 times and feel a strong urge to go more than 3 times a day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in urgency incontinence episodes after 3 month

Secondary outcome measures

Analysis to assess the urinary frequency

Analysis to assess the urinary frequency.

Analysis to assess urinary frequency

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device TreatmentExperimental Treatment1 Intervention

20 female patients with overactive bladder symptoms, aged 21 to 80 years old, inclusive from two sites.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor

23 Previous Clinical Trials

1,345 Total Patients Enrolled

Mickey Karram, MDPrincipal InvestigatorNot Affiliated

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be the ideal candidate to participate in this medical study?

"Individuals aged between 21 and 80 with a confirmed diagnosis of overactive bladder are eligible for this trial, which has availability for up to 20 participants."

Answered by AI

Are individuals who are older than 35 years eligible to participate in this medical study?

"As specified in the study's admission requirements, eligible participants must be at least 21 years old and no more than 80 years of age."

Answered by AI

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"As per the information provided on clinicaltrials.gov, patient recruitment is not ongoing for this trial. The trial was initially listed on 11/10/2023 and last modified on 2/21/2024. Although this specific trial is inactive in terms of patient recruitment presently, it's notable that there are currently 73 other trials actively seeking participants at this time."

Answered by AI