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

Description

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.