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CTRI Number  CTRI/2026/04/107524 [Registered on: 02/04/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Real World Registry 
Study Design  Other 
Public Title of Study   Study to evaluate how effective and comfortable the JOGO digital biofeedback therapy is in improving urinary leakage in men after prostate surgery in India. 
Scientific Title of Study   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. 
Trial Acronym  PRECISION Registry 
Secondary IDs if Any  
Secondary ID  Identifier 
CRS/25/005 Version 1.0, Original, Dated 31 December 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sachin Pawar 
Designation  Director- Operations 
Affiliation  CLINICA Research Solutions LLP 
Address  Office No.706 & 706-A, 7th Floor, Gauri Commercial Complex, Plot No. 19, Sector 11, CBD Belapur, Navi Mumbai

Thane
MAHARASHTRA
400614
India 
Phone  02249705627  
Fax    
Email  Sachin.P@Clinicaresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Shah 
Designation  Senior Medical Advisor 
Affiliation  JOGO Health Private Limited 
Address  1/2,11th Cross st., Shastri Nagar, Adyar, Chennai

Chennai
TAMIL NADU
600020
India 
Phone  9730901654  
Fax    
Email  dr.ruchishah@jogohealth.com  
 
Details of Contact Person
Public Query  
Name  Pravinkumar Pal 
Designation  Associate Director - Clinical Operations 
Affiliation  CLINICA Research Solutions LLP 
Address  Office No.706 & 706-A, 7th Floor, Gauri Commercial Complex, Plot No. 19, Sector 11, CBD Belapur, Navi Mumbai

Thane
MAHARASHTRA
400614
India 
Phone  02249705627  
Fax    
Email  Pravinkumar.Pal@Clinicaresearch.com  
 
Source of Monetary or Material Support  
JOGO Health Private Limited 1/2,11th Cross st., Shastri Nagar, Adyar, Chennai-600020, Tamil Nadu  
 
Primary Sponsor  
Name  JOGO Health Private Limited 
Address  1/2,11th Cross st., Shastri Nagar, Adyar, Chennai-600020, Tamil Nadu  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vamsi Krishna  CARE Hospital  Road No.1, Banjara Hills, Hyderabad- 500034,
Hyderabad
TELANGANA 		 9490190102

vamsiurologist@gmail.com 
Dr Ashish Saini  Excel Advance Urology  C-48A ground floor Greater Kailash part 1, hansraj Gupta Marg kailash colony, New Delhi-110048
New Delhi
DELHI 		 9868732531

drsaini.ak@gmail.com 
Dr Sanjay Pandey  Kokilaben Dhirubhai Ambani Hospital (KDAH)  Rao Saheb Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai – 400053
Mumbai
MAHARASHTRA 		 9324718283

sanjaypdr@gmail.com 
Dr Rohit Kaushal  Max Super Speciality Hospital  1&2, Press Enclave marg, saket Institutional Area, New Delhi- 110017
New Delhi
DELHI 		 9873752329

rohit_kaushal184@yahoo.com 
Dr Tarun Jawali  Ramaiah Memorial Hospital  New BEL Road, M S Ramaiah Nagar, MSRIT Post, Bengaluru – 560054,
Bangalore
KARNATAKA 		 7760944947

tarunjavali@gmail.com 
Dr Gaurang Shah  Saifee Hospital  Maharshi karve road, Opp. Charni Road, Opera House, Girgaon, Mumbi-400004
Mumbai
MAHARASHTRA 		 9821019432

drgrshah@gmail.com 
Dr Ganesh Gopalakrishnan  Vedanayagan Hospital  No. 52, East Bashyakaralu Road, R.S. Puram, Coimbatore – 641002,
Coimbatore
TAMIL NADU 		 9843123423

gopalakrishnanganesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee M S Ramaiah Medical College And Hospitals  Submittted/Under Review 
Care Hospital, Institutional Ethics Committee  Submittted/Under Review 
Good Society for Ethical Research  Approved 
Institutional Ethics Committee   Submittted/Under Review 
Institutional Ethics Committee Kokilaben Dhirubhai Ambani Hospital (KDAH)  Submittted/Under Review 
Institutional Ethics Committee Kovai Diabetes speciality Centre & Hospital  Approved 
Saifee Hospital Institutional Review Board  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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. 		 Baseline and End of Therapy (6 months) 
 
Secondary Outcome  
Outcome  TimePoints 
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. 		 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. 		 Baseline and End of Therapy (6 months) 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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