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NCT Number: NCT06589869

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

EM Chair

Device

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 care

Other

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

Primary outcomes

  1. Weight of 1-hour pad test

    Time frame: Baseline, Month 1, Month 3 and Month 6

    Weight of 1-hour pad test

Secondary outcomes

  1. Severity of Incontinence.

    Time frame: 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

  2. Sexual Function

    Time frame: 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

  3. Severity of Incontinence

    Time frame: Baseline, Month 1, Month 3 and Month 6

    The number of pads used

  4. Complications

    Time frame: Month 1, Month 3 and Month 6

    It is evaluated by CTCAE Grade 5

Study contacts

Contact information is provided by the study sponsor or research team.

Chi Fai NG, MD

CONTACT

[email protected]

35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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