Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women: A Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-13

Study Completion Date

2027-11-30

Brief Summary

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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.

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Detailed Description

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Overactive bladder (OAB) is a common condition that significantly impacts the quality of life in women, especially those with urge urinary incontinence (UUI) or mixed incontinence with a predominant urgency component. Current treatments for OAB, including behavioral therapy and pharmacologic agents, often have limited long-term efficacy, tolerability issues, or low adherence rates. There is a significant need for alternative, non-invasive therapies that can provide symptom relief with fewer side effects. The MORPHEUSV system is a vaginally delivered radiofrequency (RF) energy device designed to remodel submucosal tissue through controlled thermal stimulation. This technology is currently being investigated for its ability to improve bladder control by targeting pelvic tissue support and neuromodulation pathways. The device is investigational for this indication and is being studied under an FDA-approved Investigational Device Exemption (IDE G250071). This is a prospective, randomized, multicenter, double-blind, sham-controlled clinical trial designed to evaluate the safety and efficacy of the MORPHEUSV RF device in women aged 22 to 80 with idiopathic OAB and at least 7 episodes of UUI per week. The study will enroll approximately 202 participants at up to 12 sites across the United States. Participants will be randomized 2:1 to either a single session of active RF treatment or a sham (placebo) treatment. The primary outcome is the proportion of participants achieving a ≥50% reduction in UUI episodes from baseline at 6 months. Secondary and exploratory outcomes include symptom reduction across urgency, frequency, nocturia, and quality of life metrics, as well as device-related adverse events. Blinding will be maintained through the use of an identical sham applicator with no RF energy delivery. A crossover option is available for sham subjects who complete the 6-month follow-up, allowing them to receive the active treatment. All participants will be followed for 12 months after their initial intervention to evaluate durability of response and long-term safety. An internal data review committee will periodically evaluate cumulative safety data. The study is conducted under Good Clinical Practice (GCP) guidelines and will be overseen by Sterling IRB.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized in a 2:1 ratio to receive either a single session of the MORPHEUS V radiofrequency (RF) treatment or a sham procedure. The study uses a parallel assignment model in which participants remain in their assigned group through the 6-month primary endpoint. After completing the 6-month visit, participants in the sham group may elect to cross over and receive the active treatment. All participants will be followed for 12 months from the time of their initial intervention to assess safety and durability of treatment effects.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Detrusor nerve radiofrequency ablation

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Simulated (sham) detrusor nerve radiofrequency ablation

* Predominant stress urinary incontinence (SUI) based on bladder diary
* Currently pregnant, breastfeeding, or planning pregnancy during the study
* History of neurologic conditions affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease)
* Active urinary tract infection (UTI) at screening
* History of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain
* Prior or current bladder cancer, pelvic malignancy, or pelvic radiation
* Pelvic organ prolapse beyond the hymen (POP-Q stage \> II)
* Implanted neuromodulation device or prior sacral nerve stimulation
* Use of bulking agents, Botox, or surgical treatment for incontinence within 12 months
* Prior pelvic floor RF treatment or laser vaginal rejuvenation
* Significant pelvic anatomical abnormalities that interfere with treatment
* Use of investigational drug or device within 30 days before screening
* Any condition that, in the investigator's opinion, would interfere with safe study participation or data integrity
* Uncontrolled systemic disease (e.g., uncontrolled diabetes, cardiovascular disease)
* Inability or unwillingness to comply with study requirements or follow-up

Minimum Eligible Age

22 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No