Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
JOGO Health Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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/m (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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. 3.Durability of improvement assessed at 6-month follow-up.Timepoint: Baseline and End of Therapy (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). 3.Usability: Mean System Usability Scale (SUS) score reported by therapists. 4.Patient Comfort: Percentage of participants rating comfort/ease of use more than or equal to 4 on a 5-point Likert scale. 5.Device Performance: Percentage of sessions with usable EMG signal and successful Bluetooth connectivity. 6.Adverse Events: Frequency and nature of device-related or procedure-related AEs. 7.Adherence: Proportion of prescribed sessions completed per patient.Timepoint: Baseline and End of Therapy (6 months);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.Timepoint: Baseline and End of Therapy (6 months) | — |
Countries
India
Contacts
Public ContactPravinkumar Pal
JOGO Health Private Limited
Outcome results
None listed