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

NCT06589869 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Urinary Incontinence , Stress
  • Prostatectomy

Interventions

DEVICE

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.

OTHER

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Chi Fai NG, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06589869 on ClinicalTrials.gov