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

Primary Purpose

Post Radical Prostatectomy Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Extracorporeal electromagnetic stimulation
Pelvic floor exercises
Sponsored by
Hamad General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Radical Prostatectomy Urinary Incontinence focused on measuring Radical prostatectomy, Magnetic stimulation, pelvic floor exercises

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ambulatory Care CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A: Extracorporeal Magnetic stimulation

Group B: Extracorporeal Magnetic stimulation and pelvic floor exercises

Group C: Pelvic floor exercises

Arm Description

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 (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 (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.

Outcomes

Primary Outcome Measures

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
the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Questionnaire administered at 6 points of follow up
Urodynamic leak point pressure.
Urodynamic study to evaluate the bladder dynamics and its response to radical prostatectomy and its response to rehabilitation

Secondary Outcome Measures

International Consultation on Incontinence Questionnaire quality of life score
Questionnaire administered at 6 points of follow up

Full Information

First Posted
December 15, 2022
Last Updated
January 11, 2023
Sponsor
Hamad General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05680168
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 1, 2029 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Radical Prostatectomy Urinary Incontinence
Keywords
Radical prostatectomy, Magnetic stimulation, pelvic floor exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Extracorporeal Magnetic stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B: Extracorporeal Magnetic stimulation and pelvic floor exercises
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group C: Pelvic floor exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal electromagnetic stimulation
Intervention Description
Electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia).
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor exercises
Intervention Description
Pelvic floor muscle training in serial training sessions with our therapist
Primary Outcome Measure Information:
Title
One hour pad test
Description
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
Time Frame
18 months from the start of intervention
Title
the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Description
Questionnaire administered at 6 points of follow up
Time Frame
18 months from the start of intervention
Title
Urodynamic leak point pressure.
Description
Urodynamic study to evaluate the bladder dynamics and its response to radical prostatectomy and its response to rehabilitation
Time Frame
1 day (Once) after 6 weeks of the start of rehabilitation process
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire quality of life score
Description
Questionnaire administered at 6 points of follow up
Time Frame
18 months from the start of intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Albakr
Phone
33757500
Ext
974
Email
aalbakr3@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Ardalan Ghafouri
Email
aghafouri@hamad.qa
Facility Information:
Facility Name
Ambulatory Care Center
City
Doha
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Albakr
Phone
33757500
Ext
00974

12. IPD Sharing Statement

Learn more about this trial

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

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