A Randomized, Prospective, Multicenter, Double-Blind, Sham-Controlled Study to Assess the MORPHEUSV Radiofrequency (RF) Device in the Treatment of Female Patients With Idiopathic Overactive Bladder (OAB) With Urge Incontinence and/or Urge-Predominant Mixed Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 9
- 主要终点
- Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Willing and able to complete the 3-day bladder diary.
- •Willing to discontinue OAB medications (e.g., anticholinergics, beta-3 agonists) at least 2 weeks prior to baseline treatment visit, if currently taking such medications.
- •Willing to use a reliable method of contraception during the study period, if of childbearing potential and sexually active.
- •Negative pregnancy test at screening (if applicable).
- •Willing and able to provide written informed consent and comply with study procedures and follow-up schedule.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Detrusor nerve radiofrequency ablation (Device)
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.
干预措施: Simulated (sham) detrusor nerve radiofrequency ablation (Device)
结局指标
主要结局
Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes
时间窗: 6 months post-treatment
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.
次要结局
- Change from baseline in mean number of UUI episodes per week(6 months)
- Change from baseline in mean number of urgency episodes per week(6 months)
- Change from baseline in mean number of micturitions per 24 hours(6 Months)
- Incidence and severity of adverse events(12 Months)
- Change from baseline in Incontinence Quality of Life (I-QOL) total score(6 Months)
- Change from baseline in Urgency Perception Scale (UPS) score(6 Months)