Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy

Not Applicable

Recruiting

• Conditions: Urinary Incontinence , Stress; Prostatectomy
• Interventions: Other: Standard of care; Device: EM Chair

• Registration Number: NCT06589869
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy.

Detailed Description

This is a prospective randomised control trial of consecutive patients with prostatectomy to have either standard of care versus HIFEM assisted pelvic floor exercise. Randomization will be performed for patients when the subject has completed the informed consent for study participation. Randomization will be performed in 1:1 ratio into 2 arms: HIFEM assisted (BTL EMsella) pelvic floor muscle training (Arm A) plus Standard of care or Standard of care (Arm B).

Study Timeline

• Study Start: 2022-07-29
• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Submitted: 2024-09-10
• Last Update Posted: 2024-09-13
• Primary Completion: 2026-03
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 184

Inclusion Criteria

• Undergone robotic radical prostatectomy
• Able to carry out 1-hour pad test
• Voluntary participation and signing of the informed consent form

Read More

Exclusion Criteria

• Pre-existing stress urinary incontinence
• Post-void residual urine greater than 200ml
• Active urinary tract infection
• Urethral or bladder fistula
• History of pelvic irradiation
• Neurological condition (Spinal cord problems, stroke with poor neurological recovery, epilepsy, Parkinson disease, multiple sclerosis)
• Previous surgery for SUI
• Concurrent medication with diuretics, serotonin-norepinephrine reuptake inhibitors or any other medication known to worsen incontinence
• Condition contraindicated for electromagnetic therapy i.e. Arrhythmia, on a pacemaker or implanted metallic device; Coagulopathy or on anticoagulant

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of care	Standard of care. Perioperative education for information related to prostatectomy and pelvic floor exercise training. Patient were advice to perform pelvic floor exercise at least 30 times per day
EM Chair	EM Chair	Patients who randomised to intervention group (Arm A) will receive HIFEM assisted (BTL EMsella) pelvic floor muscle training for total 6 sessions (2 session per week, 30 minutes per session with modulated intensity) plus standard of care. The intervention will be started within 2 weeks after Foley Catheter removed. Patients will attend follow up for training and at 1, 3 and 6 month post-operatively.

Primary Outcome Measures

Name	Time	Method
Weight of 1-hour pad test	Baseline, Month 1, Month 3 and Month 6	Weight of 1-hour pad test

Secondary Outcome Measures

Name	Time	Method
Severity of Incontinence.	Baseline, Month 1, Month 3 and Month 6	It is evaluated by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short FormInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The ICIQ score with a range from 0-21; the higher the score the worse of incontinence
Sexual Function	Baseline, Month 1, Month 3 and Month 6	It is evaluated by International Index of Erectile Function Score (IIEF-5). The IIEF-5 score is the sum of the ordinal response to the 5 items. The lowest the score, the more severe of erectile dysfunction
Severity of Incontinence	Baseline, Month 1, Month 3 and Month 6	The number of pads used
Complications	Month 1, Month 3 and Month 6	It is evaluated by CTCAE Grade 5

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong