Nerve Ablation for Overactive Bladder

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: InMode MD Ltd.

Must not be taking: Antimuscarinics, Beta3 agonists, Immunosuppressants, Anticoagulants

Disqualifiers: Cancer, Cardiac disorders, Neurologic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking anti-muscarinic or beta3 agonist therapy, and there must be at least a 2-week period without these medications before starting the trial.

What data supports the effectiveness of the treatment Transvaginal Detrusor Nerve Radiofrequency Ablation for Overactive Bladder?

Research shows that nerve stimulation treatments, like tibial nerve stimulation, can help manage overactive bladder symptoms. These studies suggest that targeting nerves related to bladder control can be effective, which may support the potential of nerve ablation treatments. ^{1 2 3 4 5}

Is nerve ablation for overactive bladder safe for humans?

Research on similar nerve treatments for overactive bladder, like sacral nerve modulation and tibial nerve stimulation, shows they are generally safe with no life-threatening side effects. These treatments have been effective and well-tolerated in studies, suggesting nerve ablation may also be safe. ^{6 7 8 9 10}

How does the treatment Transvaginal Detrusor Nerve Radiofrequency Ablation for Overactive Bladder differ from other treatments?

Transvaginal Detrusor Nerve Radiofrequency Ablation is unique because it uses radiofrequency energy to target and disrupt specific nerves involved in bladder control, potentially offering a novel approach for managing overactive bladder symptoms compared to traditional medications or behavioral therapies. ^{11 12 13 14 15}

Research Team

Mickey Karram, MD

Principal Investigator

Not Affiliated

Eligibility Criteria

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.

Inclusion Criteria

I am between 21 and 80 years old.

1 UUI episode on a 3-day bladder diary

Post-void residual (PVR) ≤ 100 ml

Exclusion Criteria

History of vaginal disorders, keloids, abnormal wound healing

Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body

Less than 12 months post-partum or currently pregnant or plan to become pregnant in the following 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one treatment session and are reassessed at 4 weeks post-treatment. Additional sessions may occur at 4-week intervals if needed.

3 months

1-3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment at 3, 6, and 12 months.

12 months

3 visits (in-person)

Treatment Details

Interventions

• Transvaginal Detrusor Nerve Radiofrequency Ablation

Trial Overview 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.

Participant Groups

Group I: Device Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

InMode MD Ltd.

Lead Sponsor

Trials

26

Recruited

1,500+

Findings from Research

Transcutaneous tibial nerve stimulation (TTNS) is as effective as percutaneous tibial nerve stimulation (PTNS) in treating overactive bladder, based on a systematic review of 4 trials involving 142 patients.

TTNS showed a total complication rate of only 2.1% with no adverse events reported, indicating a potentially safer option compared to PTNS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation. Yang, DY., Zhao, LN., Qiu, MX.[2023]

Sacral nerve modulation (SNM) and percutaneous tibial nerve stimulation (PTNS) are both effective treatments for overactive bladder (OAB) symptoms, with therapeutic success rates of 61% to 90% for SNM and 54% to 79% for PTNS based on a review of randomized trials involving at least 20 adult patients.

Both treatments are considered safe, with no life-threatening adverse effects reported, and PTNS is noted for being less invasive and providing quicker results with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is New in Neuromodulation for Overactive Bladder? Tutolo, M., Ammirati, E., Van der Aa, F.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous tibial nerve electrical stimulation versus vaginal electrical stimulation in women with overactive bladder syndrome: Is there a role for short-term interventions? [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for refractory daytime urinary urge incontinence. [2009]

4. England pubmed.ncbi.nlm.nih.gov

Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the effects of electrical stimulation and posterior tibial nerve stimulation in the treatment of overactive bladder syndrome. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and adverse events of sacral nerve stimulation for overactive bladder: A systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Six-Month Results of Selective Bladder Denervation in Women with Refractory Overactive Bladder. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

What Is New in Neuromodulation for Overactive Bladder? [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Tibial Nerve Stimulation in the Management of Overactive Bladder: A Scoping Review. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

International expert consensus statement: Percutaneous transluminal renal denervation for the treatment of resistant hypertension. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Intravascular Ultrasound Can Be Used to Locate Nerves, but not Confirm Ablation, During Renal Sympathetic Denervation. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Effect of percutaneous renal sympathetic nerve radiofrequency ablation in patients with severe heart failure. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Procedural and Anatomical Determinants of Multielectrode Renal Denervation Efficacy. [2020]

15. United States pubmed.ncbi.nlm.nih.gov

Catheter-based renal nerve ablation and centrally generated sympathetic activity in difficult-to-control hypertensive patients: prospective case series. [2021]