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

NCT ID: NCT05680168

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2029-12-31

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.

Conditions

Post Radical Prostatectomy Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Extracorporeal electromagnetic stimulation

Intervention Type: DEVICE

Electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia).

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.

Group Type: ACTIVE_COMPARATOR

Extracorporeal electromagnetic stimulation

Intervention Type: DEVICE

Electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia).

Pelvic floor exercises

Intervention Type: BEHAVIORAL

Pelvic floor muscle training in serial training sessions with our therapist

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.

Group Type: ACTIVE_COMPARATOR

Pelvic floor exercises

Intervention Type: BEHAVIORAL

Pelvic floor muscle training in serial training sessions with our therapist

Interventions

Extracorporeal electromagnetic stimulation

Electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia).

Intervention Type: DEVICE

Pelvic floor exercises

Pelvic floor muscle training in serial training sessions with our therapist

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hamad General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmed Albakr

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ambulatory Care Center

Doha, , Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Ahmed Albakr

Role: CONTACT

aalbakr3@hamad.qa

33757500 ext. 974

Ardalan Ghafouri

Role: CONTACT

aghafouri@hamad.qa

Facility Contacts

Ahmed Albakr

Role: primary

33757500 ext. 00974

Other Identifiers

MRC0122185

Identifier Type: -

Identifier Source: org_study_id