Study of the MORPHEUSV Vaginal Radiofrequency Device for Treating Overactive Bladder in Women Aged 22 to 80

What this Trial Is About

Researchers are evaluating the MORPHEUSV vaginal radiofrequency RF device to treat overactive bladder OAB in women aged 22 to 80 with symptoms lasting at least 6 months. This clinical trial aims to determine if the device reduces episodes of accidental urine leakage caused by urgency better than a sham treatment, while also assessing its safety. The study includes women with idiopathic OAB and at least 7 urge urinary incontinence episodes per week, comparing active treatment to placebo in a randomized, double-blind design. Participants will be randomly assigned in a 21 ratio to receive either a single session of vaginal RF treatment using the MORPHEUSV device or a sham procedure that looks identical but delivers no energy. No anesthesia is needed. Those in the sham group who complete 6 months of follow-up can opt to receive the active treatment. All participants will be followed for 12 months to evaluate long-term safety and effectiveness. The study is conducted at multiple sites in the United States under Good Clinical Practice guidelines. During the study, participants will track their symptoms using bladder diaries and questionnaires, with follow-up visits scheduled three to six times over 12 months. Researchers will monitor the proportion of participants achieving at least a 50% reduction in weekly urge urinary incontinence episodes at 6 months, along with changes in urgency, frequency, quality of life, and any adverse events. Safety data will be reviewed periodically by an internal committee to ensure participant well-being throughout the trial.

Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women