PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation (PTNM) System in Patients With OAB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 21
- 主要终点
- Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline
研究概览
简要总结
To evaluate the NURO system for the treatment of OAB in drug naïve patients.
详细描述
The purpose of this prospective, multicenter, single arm study is to evaluate the NURO system for the treatment of OAB in drug naïve patients. The study will assess change from baseline through 12 PTNM therapy sessions in UUI (urge urinary incontinence) episodes, voiding episodes, and patient reported outcomes. The study is expected to last approximately 14 weeks per subject following the enrollment visit. Subjects will be exited from the study after the final study visit is complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Diagnosis of OAB and associated symptoms of UUI and qualify with at least 3 episodes of mild, moderate, or severe urgency demonstrated on a 3-day urinary voiding diary
- •Experiencing UUI symptoms for at least 3 months
- •No prior treatment with anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB
- •Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol
- •Willing and able to provide signed and dated informed consent
排除标准
- •Have received anticholinergics/antimuscarinics or beta 3-agonists medications to treat OAB or advanced therapy treatment options for OAB (botulinum toxin injections, sacral neuromodulation, or percutaneous tibial nerve stimulation/neuromodulation)
- •Primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- •Have implantable pacemakers or implantable defibrillators
- •Use of transcutaneous electrical nerve stimulation (TENS) in pelvic region, back or legs
- •Women who are pregnant or planning to become pregnant during the course of the study
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol
- •Nerve damage that could impact either tibial nerve or pelvic floor function.
- •Subjects prone to excessive bleeding
- •Inadequate skin integrity in the area of PTNM needle placement
- •History of diabetes unless the diabetes is well-controlled through diet and/or medications
- •Have symptomatic urinary tract infection (UTI)
- •Participation in any research study involving or impacting gynecologic, urinary or renal function within the 4-week period prior to or plans to participate during study enrollment
研究组 & 干预措施
NURO System PTNM Therapy
Subjects will undergo 12 PTNM therapy sessions, administered weekly, utilizing the NURO system.
干预措施: NURO System PTNM Therapy (Device)
结局指标
主要结局
Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline
时间窗: 12 Weeks
Number of UUI episodes were collected at baseline and following the 12th PTNM therapy session. For each subject in the analysis, change in UUI episodes per day was calculated as UUI episodes per day after 12th PTNM session minus baseline. A negative change indicates the improvement in UUI symptom.
次要结局
- Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects(12 Weeks)
- Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline(12 Weeks)