Prostatectomy, Urinary Incontinence , Stress
Conditions
Keywords
stress urinary incontinence, prostatectomy
Brief 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.
Detailed 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).
Interventions
DEVICEEM 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.
OTHERStandard 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
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight of 1-hour pad test | Baseline, Month 1, Month 3 and Month 6 | Weight of 1-hour pad test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Incontinence. | 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 |
| Sexual Function | 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 |
| Severity of Incontinence | Baseline, Month 1, Month 3 and Month 6 | The number of pads used |
| Complications | Month 1, Month 3 and Month 6 | It is evaluated by CTCAE Grade 5 |
Countries
Hong Kong
Contacts
Primary ContactChi Fai NG, MD
Outcome results
None listed