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.
Female, aged 22 to 80 years inclusive at the time of consent.
History of idiopathic overactive bladder (OAB) symptoms for ≥6 months.
At least 7 episodes of urge urinary incontinence (UUI) over 3 days, as recorded in a 3-day bladder diary during screening.
Urge-predominant incontinence, defined as greater number of UUI episodes than stress urinary incontinence (SUI) episodes during screening.
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
Parallel
Detrusor nerve radiofrequency ablation
DeviceA 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
DeviceA 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.
Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes
The percentage of participants who achieve at least a 50% reduction from baseline in the number of UUI episodes per week, as recorded in a 7-day bladder diary. This is the primary efficacy endpoint used to evaluate the effectiveness of the MORPHEUSV device compared to sham.
Change from baseline in mean number of UUI episodes per week
Mean change in UUI episodes per week from baseline, based on 7-day bladder diary.
Change from baseline in mean number of urgency episodes per week
Mean change in urgency episodes per week from baseline, based on bladder diary.
Change from baseline in mean number of micturitions per 24 hours
Change in average number of daily voids as measured via bladder diary.
Change from baseline in Incontinence Quality of Life (I-QOL) total score
Mean change from baseline in total score on the Incontinence Quality of Life Questionnaire (I-QOL), a validated 22-item patient-reported outcome measure assessing the impact of urinary incontinence on quality of life. Total scores range from 0 to 100, with higher scores indicating better quality of life.
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InMode MD Ltd.
Lead sponsor
Foundation for Female Health Awareness
Collaborator
