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Procedure

Nerve Ablation 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

Must not have

Current hydronephrosis or hydroureter

Active pelvic organ malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am between 21 and 80 years old.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have swelling in my kidney or ureter due to urine buildup.

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I have an active cancer in my pelvic area.

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I currently have a urinary tract or vaginal infection.

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I have no active skin conditions like sores or eczema in the treatment area.

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I have severe difficulty moving or thinking clearly.

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I do not have conditions like severe pelvic organ prolapse that would prevent device use.

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I have problems emptying my bladder or need a catheter for a long time.

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I do not speak English.

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I have a blockage in my urethra.

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I have difficulty urinating due to a blockage.

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I have a permanent implant or have received an injection in the treatment area.

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My diabetes or thyroid condition is not well-managed.

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I had surgery for pelvic organ prolapse or incontinence in the last 6 months.

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I am experiencing issues from past surgery for incontinence.

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I have or had cancer, or have premalignant moles.

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I do not have severe heart, nerve, epilepsy, uncontrolled high blood pressure, or liver/kidney diseases.

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My immune system is weakened due to a condition like AIDS or medication.

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I have a severe neurological condition like MS or Parkinson's.

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I have had interstitial cystitis, bladder cancer, or chronic pelvic pain before.

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I have had radiation treatment to my pelvis.

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I have a urinary tract infection that hasn't been treated yet.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in urgency incontinence episodes after 3 month

Secondary study objectives

Analysis to assess the urinary frequency

Analysis to assess the urinary frequency.

Analysis to assess urinary frequency

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 24Eligibility criteria met

Find a Location

Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor

24 Previous Clinical Trials

1,370 Total Patients Enrolled

Mickey Karram, MDPrincipal InvestigatorNot Affiliated

1 Previous Clinical Trials

17 Total Patients Enrolled

~9 spots leftby Nov 2025

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