CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 184 target
Drug / intervention
EM Chair +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06589869
NCT06589869N/ARecruitingMonitorUpdated 21mo ago · Completion was 4mo ago
Slow Enrollment
Long Recruiting
Monitor

To Investigate the Effect 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

Chinese University of Hong Kong·interventional·Posted Sep 19, 2024·Updated Sep 19, 2024

In Brief

A clinical study evaluating EM Chair and Standard of care for Urinary Incontinence , Stress and Prostatectomy. Currently recruiting, targeting 184 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong
Collaborators--

Timeline

N/ARecruitingOverdue
2023202420252026
First PostedSep 19, 2024
Enrollment StartJul 29, 2022
Primary CompletionMar 1, 2026
Study CompletionJun 1, 2026
TodayJul 1, 2026
Enrollment to primary: 3.6 yearsPosted 1.8 years ago

Interventions

EM Chairdevice

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.

Standard of careother

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