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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Prostatectomy; Urinary Incontinence , Stress

Treatments: Device: EM Chair; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT06589869

CRE-2021.506-T

Details and patient eligibility

About

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.

Full 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).

Enrollment: 184 estimated patients

Sex: Male

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Standard of care

EM Chair

Experimental group

Description:

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.

Treatment:

Device: EM Chair