Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extracorporeal electromagnetic stimulation, Pelvic floor exercises.
- Who it may be relevant to
- Registry conditions: Post Radical Prostatectomy Urinary Incontinence. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Qatar
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence: A Randomized Controlled Trial
Overview
Urinary incontinence is one of the most common complications of radical prostatectomy. Multiple prevention and treatment modalities have been proposed in the management of post prostatectomy urinary incontinence. This is a randomized controlled comparative study to evaluate the efficacy of extracorporeal magnetic stimulation alone and combined with pelvic floor muscle exercise versus pelvic floor muscle exercise alone in the management of post radical prostatectomy urinary incontinence. This study is expected to be performed over 7 years. The study population will be all male patients who are prepared for radical prostatectomy under urology department in HMC and were referred to voiding dysfunction for preoperative counselling and postoperative rehabilitation. Patients will be randomized into one of three treatment groups. The first group will receive sessions of extracorporeal magnetic field stimulation only. The second group will receive extracorporeal magnetic stimulation in addition to pelvic floor muscle exercise. The third group will receive pelvic floor muscle exercise only. The recruitment phase will take 3 years. Patients will be followed for 18 months for the course of urinary incontinence symptoms, severity of urinary incontinence on 1-hour pad test, urodynamic leak point pressure and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and the ICIQ quality of life (QOL) score. This study is proposed to reveal strong evidence on the efficacy of extracorporeal magnetic stimulation on the management of post radical prostatectomy urinary incontinence.
Interventions
- Device Extracorporeal electromagnetic stimulation
Electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia). - Behavioral Pelvic floor exercises
Pelvic floor muscle training in serial training sessions with our therapist
Primary outcome measures
- One hour pad test [Time frame: 18 months from the start of intervention]
- the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) [Time frame: 18 months from the start of intervention]
- Urodynamic leak point pressure. [Time frame: 1 day (Once) after 6 weeks of the start of rehabilitation process]
Secondary outcome measures (1)
- International Consultation on Incontinence Questionnaire quality of life score [Time frame: 18 months from the start of intervention]
Eligibility criteria
Inclusion criteria
- The study population will include all adult male patients 18 years of age and above, with localized prostate cancer of low or intermediate risk disease who chose definitive treatment with radical prostatectomy either through open radical retropubic prostatectomy (RRP) or through robotic assissted laparoscopic radical prostatectomy (RALP) as first line for treatment and had the surgery under Hamad General Hospital urology department care.
Exclusion criteria
- Patients with high risk , locally advanced or metastatic prostate cancer at time of diagnosis
- Patients with low to intermediate risk prostate cancer who received chemo or radiotherapy then had salvage surgery
- Patients with urinary incontinence or diagnosed overactive bladder before radical prostatectomy.
- Patients with complicated surgery resulting in anastomotic leak, prolonged catheterisation more than 3 weeks, reinsertion of catheter due to retention of urine.
- Patients who refuse to participate in the clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Qatar · 1 center
- Ambulatory Care Center — Doha
Identifiers
NCT: NCT05680168 · MRC0122185