Nerve Ablation for Overactive Bladder

Enrolling by invitation at 4 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with overactive bladder, aiming to reduce sudden urges to urinate and accidents. The treatment uses nerve ablation, which applies radiofrequency energy to specific nerves to improve bladder control. This procedure is called Transvaginal Detrusor Nerve Radiofrequency Ablation. Ideal participants are women who frequently and urgently need to urinate, such as more than eight times a day, and feel a strong urge to go. Participants must not be on certain bladder medications and should be willing to follow study requirements, like keeping a bladder diary and attending follow-up visits. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in bladder control treatments.

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 prior data suggests that this nerve ablation technique is safe for treating overactive bladder?

Research has shown that transvaginal detrusor nerve radiofrequency ablation, a treatment for overactive bladder, is generally well-tolerated. Studies have found that this method can significantly reduce sudden urges to urinate. Importantly, it appears to lower the risk of urinary tract infections (UTIs) by using short needles that do not penetrate deeply.

Although some discomfort may occur during the procedure, most patients manage it well. Early results from previous studies have been encouraging, with noticeable improvements in symptoms observed one and three months after treatment. It is important to discuss potential risks and benefits with a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for overactive bladder, such as medications and behavioral therapies, Transvaginal Detrusor Nerve Radiofrequency Ablation offers a novel approach by directly targeting the nerves that control bladder function. This method uses radiofrequency energy to ablate or disrupt nerve signals, potentially reducing overactive bladder symptoms more effectively and with fewer side effects. Researchers are excited because this technique promises a minimally invasive solution that could provide long-lasting relief for patients who have not responded well to other treatments.

What evidence suggests that transvaginal detrusor nerve ablation is effective for overactive bladder?

Research has shown that transvaginal detrusor nerve radiofrequency ablation, the treatment participants in this trial will receive, can reduce symptoms of an overactive bladder. In earlier studies, patients experienced fewer sudden urges to urinate, reducing the risk of accidents. These studies indicate that the treatment can lead to noticeable improvements within a few months. Some research even found a decrease in nerve density in key bladder areas, aiding in the control of bladder overactivity. Overall, this method has shown promising results in managing overactive bladder symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Mickey Karram, MD

Principal Investigator

Not Affiliated

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40179038/

Transvaginal Detrusor Nerve Radiofrequency Ablation for ... The primary outcome was the change in urge incontinence episodes on a 3-day voiding diary at 3 months after procedure. Secondary outcomes were ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07209397

Detrusor Nerve Radiofrequency Ablation for Overactive ... The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) ...

3. semanticscholar.org semanticscholar.org/paper/Transvaginal-Detrusor-Nerve-Radiofrequency-Ablation-Ghoniem-Karram/730a3e390fb2ded993a19133cb92535304845214

Transvaginal Detrusor Nerve Radiofrequency Ablation for ... ... outcome metrics, the transvaginal detrusor nerve radiofrequency ablation for treatment of overactive bladder showed statistically significant improvements.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25367

Detrusor nerve radiofrequency ablation (DENERA) ... A transurethral radiofrequency ablation approach has successfully denervated this region to alleviate overactive bladder symptoms, with some ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429519308027

Initial Evaluation of a Novel Modulated Radiofrequency- ... In the porcine model, modulated RFA delivered by our novel device reduced nerve density in the bladder neck and trigone by 88.6% and 88.9% at 12 weeks without ...

6. pfdweek24.eventscribe.net pfdweek24.eventscribe.net/ajaxcalls/PresentationInfo.asp?efp=SEJFVkpKU1kxOTE3MQ&PresentationID=1450651&rnd=0.151657

Transvaginal Detrusor Nerve Radiofrequency Ablation for ... Preliminary results have been very encouraging. All 8 outcomes metrics, were highly statistically significant post-treatment at both one-month and three-month ...