Detrusor Nerve Radiofrequency Ablation for Overactive Bladder

(DENARA Trial)

Not yet recruiting at 10 trial locations

Overseen By FFHA Study Manager

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: InMode MD Ltd.

Must not be taking: Anticholinergics, Beta-3 agonists

Disqualifiers: Neurologic conditions, UTI, Bladder cancer, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a vaginal radiofrequency device, MORPHEUSV, to determine its effectiveness in reducing daily episodes of accidental urine leakage in women with overactive bladder (OAB). Researchers compare the device to a sham treatment to assess both its effectiveness and safety. Women with OAB symptoms for at least 6 months and frequent urge-related leaks may qualify for this trial. Participants will attend follow-up visits and track their symptoms over a year. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatment options for OAB.

Do I have to stop taking my current medications for the trial?

Yes, if you are currently taking medications for overactive bladder, you will need to stop them at least 2 weeks before the baseline treatment visit.

What prior data suggests that the MORPHEUSV device is safe for treating overactive bladder in women?

Research has shown that the MORPHEUSV device, which uses radio waves, was generally well-tolerated in earlier studies for treating overactive bladder (OAB). Previous trials reported no negative side effects, suggesting the procedure is safe for participants. The device targets specific nerves to help manage bladder control without anesthesia. According to existing research, this non-invasive method has shown promising results in reducing OAB symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Detrusor Nerve Radiofrequency Ablation for overactive bladder because it offers a non-invasive treatment option that doesn't require anesthesia. Unlike typical treatments such as medications that work by relaxing the bladder muscles, this technique uses radiofrequency energy delivered vaginally to target and modify nerve activity in the bladder wall, potentially reducing symptoms more directly. Its unique delivery method via the MORPHEUSV device is designed to be quick, safe, and painless, with the potential to provide long-lasting relief from overactive bladder symptoms. Plus, the treatment's effectiveness is being closely monitored over a 12-month period, which could demonstrate its long-term benefits compared to current therapies.

What evidence suggests that the MORPHEUSV device is effective for treating overactive bladder?

Research has shown that detrusor nerve radiofrequency ablation, a treatment available to participants in this trial, can reduce symptoms of overactive bladder (OAB). Some studies reported that 60% to 70% of patients experienced symptom relief. The procedure calms the nerves in the bladder, helping to prevent accidental leaks. While symptoms might return over time, many patients initially see promising results. This treatment has effectively reduced the number of urgent incontinence episodes. Participants in the sham control arm will undergo a procedure that mimics the active treatment but without RF energy delivery. ^{1 2 3 4 6}

Who Is on the Research Team?

Mickey Karram, MD

Principal Investigator

Foundation for Female Health Awareness (FFHA)

Are You a Good Fit for This Trial?

This trial is for women aged 22 to 80 who have been experiencing overactive bladder symptoms for at least six months. Participants will be randomly assigned to receive either the MORPHEUSV device treatment or a sham procedure and will track their symptoms over a year.

Inclusion Criteria

I am a woman aged between 22 and 80.

I have more episodes of urge incontinence than stress incontinence.

Willing and able to complete the 3-day bladder diary

Exclusion Criteria

Currently pregnant, breastfeeding, or planning pregnancy during the study

I haven't used incontinence treatments like bulking agents, Botox, or surgery in the last year.

My pelvic organ prolapse is severe, extending beyond the hymen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single session of either the MORPHEUSV or sham treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 to 6 visits (in-person)

Crossover (optional)

Sham participants may opt to receive the active RF treatment after 6-month follow-up

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Detrusor Nerve Radiofrequency Ablation
• Simulated (sham) Detrusor Nerve Radiofrequency Ablation

Trial Overview The study tests if the MORPHEUSV, a vaginal radiofrequency device, can reduce daily episodes of accidental urine leakage due to urgency in women with OAB better than a placebo treatment. It involves one session of treatment followed by multiple follow-ups.

How Is the Trial Designed?

Group I: MORPHEUSV Treatment Arm Active Control 1 Intervention

Participants in this arm will receive a single session of radiofrequency (RF) treatment using the MORPHEUSV device. The treatment is delivered vaginally using a bipolar RF applicator at a therapeutic energy setting. No anesthesia is required. Participants will be followed for 12 months to evaluate safety and effectiveness.

Group II: Sham Control Arm Placebo Group 1 Intervention

Participants in this arm will undergo a procedure using a visually identical MORPHEUSV applicator, but without RF energy delivery (sham). The procedure mimics the appearance and duration of the active treatment. Participants will be followed for 12 months. After completing the 6-month follow-up, they may elect to cross over and receive a single session of the active RF treatment.

Who Is Running the Clinical Trial?

InMode MD Ltd.

Lead Sponsor

Trials

26

Recruited

1,500+

Foundation for Female Health Awareness

Collaborator

Trials

3

Recruited

630+

Citations

1. 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) ...

2. 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 ...

3. 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 ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003214.05

MP03-05 DETRUSOR NERVE RADIOFREQUENCY ... CONCLUSIONS: This study shows that DENERA device can cause sub trigonal perivesical nerve denervation, with some rebound at 12 weeks. The ease ...

5. urologytimes.com urologytimes.com/view/dr-ghoniem-on-detrusor-nerve-radiofrequency-ablation-research

Dr. Ghoniem on detrusor nerve radiofrequency ablation ... The results were decent; a 60% to 70% success rate. However, the longevity outcome goes out by time.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06283498

Transvaginal Detrusor Nerve Radiofrequency Ablation for ... The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive ...