Post Radical Prostatectomy Urinary IncontinenceNCT05680168
Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence
A study testing Extracorporeal electromagnetic stimulation and Pelvic floor exercises in people with Post Radical Prostatectomy Urinary Incontinence, run by Hamad General Hospital at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post Radical Prostatectomy Urinary Incontinence
- What is being tested?
- Extracorporeal electromagnetic stimulation and Pelvic floor exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteQatar
- Study dates
- 1 Jan 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ardalan Ghafouri contact
Qatar1 site, 1 recruiting
- Recruiting
Ambulatory Care Center
Doha
Ahmed Albakr, 33757500 ext. 00974
About this study
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
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.
- Being tested
- Extracorporeal electromagnetic stimulation, Pelvic floor exercises
- Keywords
- Radical prostatectomy, Magnetic stimulation, pelvic floor exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal electromagnetic stimulationDevice
Electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia).
Pelvic floor exercisesBehavioural
Pelvic floor muscle training in serial training sessions with our therapist
| Study group | Role | What they receive |
|---|---|---|
| Group A: Extracorporeal Magnetic stimulation | Active comparator | 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. Receives: Device: Extracorporeal electromagnetic stimulation |
| Group B: Extracorporeal Magnetic stimulation and pelvic floor exercises | Active comparator | 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. Receives: Device: Extracorporeal electromagnetic stimulation; Behavioral: Pelvic floor exercises |
| Group C: Pelvic floor exercises | Active comparator | 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. Receives: Behavioral: Pelvic floor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 day (Once) after 6 weeks of the start of rehabilitation process
Secondary outcomes (1)
International Consultation on Incontinence Questionnaire quality of life score
Questionnaire administered at 6 points of follow up
Measured: 18 months from the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2023
- Primary completion1 Feb 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Radical Prostatectomy Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Albakr, Hamad General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680168
- Sponsor's protocol ID
- MRC0122185
- Status last verified
- Jan 2023
- First submitted
- 15 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05680168
- Acronym / sponsor ID
- MRC0122185
- Keywords
- Radical prostatectomy, Magnetic stimulation, pelvic floor exercises
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hamad General HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Extracorporeal Magnetic stimulation | Active comparator | Device: Extracorporeal electromagnetic stimulationGroup (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: Extracorporeal Magnetic stimulation and pelvic floor exercises | Active comparator | Device: Extracorporeal electromagnetic stimulation, Behavioral: Pelvic floor exercisesGroup (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: Pelvic floor exercises | Active comparator | Behavioral: Pelvic floor exercisesGroup (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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal electromagnetic stimulationElectromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia). | Device | Group A: Extracorporeal Magnetic stimulation, Group B: Extracorporeal Magnetic stimulation and pelvic floor exercises |
| Pelvic floor exercisesPelvic floor muscle training in serial training sessions with our therapist | Behavioural | Group B: Extracorporeal Magnetic stimulation and pelvic floor exercises, Group C: Pelvic floor exercises |
Primary outcome
One hour pad test
Time frame: 18 months from the start of intervention
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)
Time frame: 18 months from the start of intervention
Questionnaire administered at 6 points of follow up
Urodynamic leak point pressure.
Time frame: 1 day (Once) after 6 weeks of the start of rehabilitation process
Urodynamic study to evaluate the bladder dynamics and its response to radical prostatectomy and its response to rehabilitation
1 secondary outcome
International Consultation on Incontinence Questionnaire quality of life score
Time frame: 18 months from the start of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ardalan Ghafouri contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal electromagnetic stimulation and Pelvic floor exercises in people with Post Radical Prostatectomy Urinary Incontinence, run by Hamad General Hospital at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Albakr (33757500 ext. 974, aalbakr3@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One hour pad test (time frame: 18 months from the start of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.