Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Radical Prostatectomy Urinary Incontinence
• Intervention / Treatment: Device: Extracorporeal electromagnetic stimulation; Behavioral: Pelvic floor exercises

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Albakr; Phone Number: 974 33757500; Email: aalbakr3@hamad.qa
• Study Contact Backup: Name: Ardalan Ghafouri; Email: aghafouri@hamad.qa

Study Locations

• Qatar
  • Doha, Qatar
    • Recruiting
    • Ambulatory Care Center
    • Contact: Ahmed Albakr; Phone Number: 00974 33757500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Extracorporeal Magnetic stimulation; Group (A): will receive rehabilitation program with exposure to ExMS, Patients will receive regular sessions of electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia). Each session will last for 20 minutes. Patients will receive three weekly sessions for total of 20 sessions starting one month after catheter removal.	Device: Extracorporeal electromagnetic stimulation; Electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia).
Active Comparator: Group B: Extracorporeal Magnetic stimulation and pelvic floor exercises; Group (B): This group will receive a rehabilitation program depending ExMS with the protocol described above. In addition, this group will be advised for pelvic floor muscle training in serial training sessions with our therapist for PME.	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
Active Comparator: Group C: Pelvic floor exercises; Group (C): This will be the control group. This group will be advised to do PME only. The pelvic floor exercises will consist of advice to the patients to contract the anal sphincter muscles in successive way as if holding flatus. The pelvic floor muscle training schedule and therapist in group B and group C will be the same.	Behavioral: Pelvic floor exercises; Pelvic floor muscle training in serial training sessions with our therapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One hour pad test	Measuring the weight of an incontinence pad used for one hour to detect the volume of urinary leakage in one hour assessed at 6 points of follow up	18 months from the start of intervention
the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)	Questionnaire administered at 6 points of follow up	18 months from the start of intervention
Urodynamic leak point pressure.	Urodynamic study to evaluate the bladder dynamics and its response to radical prostatectomy and its response to rehabilitation	1 day (Once) after 6 weeks of the start of rehabilitation process

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire quality of life score	Questionnaire administered at 6 points of follow up	18 months from the start of intervention

Collaborators and Investigators

• Sponsor: Hamad General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): February 1, 2029
• Study Completion (Anticipated): December 31, 2029

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Radical prostatectomy; pelvic floor exercises; Magnetic stimulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: MRC0122185

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No