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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-29

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Urinary Incontinence , Stress Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type 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

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.

Group Type EXPERIMENTAL

EM Chair

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No