Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

Conditions

• Idiopathic Overactive Bladder
• Idiopathic Overactive Bladder With Urinary Incontinence
• Mixed Urinary Incontinence
• Mixed Urinary Incontinence (Urge-Predominant)
• Overactive Bladder
• Overactive Bladder (OAB)
• Urge Urinary Incontinence

Eligibility Criteria

Sex

FEMALE

Age

22 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Detrusor nerve radiofrequency ablation — DEVICE
  A single, vaginal radiofrequency (RF) treatment. The procedure is performed with a bipolar RF applicator and requires no anesthesia. Delivered in a single session in an outpatient setting.
• Simulated (sham) detrusor nerve radiofrequency ablation — DEVICE
  A simulated (sham) radiofrequency (RF) treatment, but with no energy delivered. The procedure mimics the appearance, duration, and positioning of the active device, without therapeutic effect.

Study Details

The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. The main questions it aims to answer are: Does the MORPHEUSV device lower the number of daily episodes of accidental urine leakage caused by urgency? Does it work better than a sham (placebo) treatment? Researchers will compare the MORPHEUSV device to a sham treatment to see how well it reduces symptoms of overactive bladder. Participants will: 1) Receive one session of either the MORPHEUSV or sham treatment. 2) Track their symptoms using a diary and questionnaires 3) Return for three to six follow-up visits over 12 months. This study is being conducted at multiple clinics in the United States.

Key Dates

Start date

Nov 25, 2025

Status verified

Aug 2025

Primary completion

Jun 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

202 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: MORPHEUSV Treatment Arm
  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.
• Sham Comparator: Sham Control Arm
  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.

Primary Outcome Measure

Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes [ Time Frame: 6 months post-treatment ]

Central Contacts

• FFHA Study Manager
  573-300-9185
  [email protected]

Locations (9)

Find similar trials in Palo Alto, CA

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