A Multicenter, Prospective, Observational, Non-Interventional, Post Marketing Study to assess the Real-World Effectiveness, Usability, and Comfort of the JOGO Digital sEMG Biofeedback therapy in the treatment of Male Patients with Post-Prostatectomy Urinary Incontinence in India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- 1.Change in International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) total score from Baseline to End of Therapy (after completion of therapist-defined session series).
研究概览
简要总结
This post-marketing, multicenter, observational study is designed to generate real-world evidence on the clinical effectiveness, usability, and safety of the Digital surface electromyography (sEMG) biofeedback therapy using JOGO device when used by qualified pelvic floor therapists in male patients with post-prostatectomy urinary incontinence (PPI). The study aims to evaluate improvement in urinary continence, pelvic floor muscle strength, and quality of life achieved through pelvic floor muscle training (PFMT) augmented with EMG biofeedback under routine clinical practice conditions. In addition, the study will assess patient comfort, device usability, adherence, and adverse events to support the continued safe and effective use of JOGO therapy in the post-marketing setting in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male patients aged equal to or more than 40 years at the time of enrollment.
- •2.Documented history of prostatectomy (radical or simple) performed for benign prostatic hyperplasia or prostate malignancy.
- •3.Presence of persistent urinary incontinence (of any type: stress, urge, or mixed) for more than or equal to 3 months following prostatectomy, confirmed by clinical evaluation.
- •4.Diagnosis of stress, urge, or mixed urinary incontinence established based on clinical history, physical examination, and/or urodynamic assessment, where available.
- •5.Ability and willingness to provide written informed consent prior to participation.
- •6.Sufficient physical and cognitive capacity to participate in a minimum of 10 JOGO therapy sessions, including one introductory session, and to complete scheduled follow-up assessments.
排除标准
- •1.History of pelvic or prostate bed radiotherapy within the preceding 6 months.
- •2.Presence of urethral stricture, artificial urinary sphincter, or recent bulking agent therapy for incontinence.
- •3.Morbid obesity -Body Mass Index (BMI) more than 35 kg/m² (morbid obesity) that may interfere with pelvic floor rehabilitation.
- •4.Evidence of ongoing or untreated urinary tract infection at screening.
- •5.Presence of severe cardiovascular, renal, hepatic, or neurological disorders that could interfere with study participation or data interpretation.
- •6.Any major surgical intervention unrelated to prostatectomy performed within the past 3 months.
- •7.Known or suspected recurrence of bladder or prostate malignancy.
- •8.Patients who are unable to understand, follow, or comply with the therapy protocol or study requirements, as determined by the investigator.
结局指标
主要结局
1.Change in International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) total score from Baseline to End of Therapy (after completion of therapist-defined session series).
时间窗: Baseline and End of Therapy (6 months)
2.Change in Modified Oxford Scale score and sEMG-derived activity metrics (mean contraction amplitude, peak amplitude, relaxation response) from Baseline to End of Therapy.
时间窗: Baseline and End of Therapy (6 months)
3.Durability of improvement assessed at 6-month follow-up.
时间窗: Baseline and End of Therapy (6 months)
次要结局
- 1.Change in IIQ-7 total score from Baseline to End of Therapy and at 6-month follow-up.(2.Change in bladder-diary parameters (voiding frequency, leakage episodes, pad usage).)
- 1.Relationship between change in sEMG amplitude and improvement in functional scales (Modified Oxford Scale, ICIQ-UI SF).(2.Therapist satisfaction and feedback on clinical workflow integration.)
研究者
Sachin Pawar
CLINICA Research Solutions LLP