Clinical trial NCT05680168: Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Radical Prostatectomy Urinary Incontinence
Keywords: Radical prostatectomy
Magnetic stimulation
pelvic floor exercises
Lead sponsor: Hamad General Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-11
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: One hour pad test
timeFrame: 18 months from the start of intervention
measure: the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: 18 months from the start of intervention
measure: Urodynamic leak point pressure.
timeFrame: 1 day (Once) after 6 weeks of the start of rehabilitation process
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire quality of life score
timeFrame: 18 months from the start of intervention
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Ambulatory Care Center
Study officials:
References: