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NCT Number: NCT05680168

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatory Care Center

Doha, Qatar

Location status: Recruiting

Location contact

Ahmed Albakr

CONTACT

33757500 ext. 00974

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal electromagnetic stimulation

Device

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

pelvic floor exercises

Behavioral

Pelvic floor muscle training in serial training sessions with our therapist

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. International Consultation on Incontinence Questionnaire quality of life score

    Time frame: 18 months from the start of intervention

    Questionnaire administered at 6 points of follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Albakr

CONTACT

[email protected]

33757500 ext. 974

Ardalan Ghafouri

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hamad General Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jan 11, 2023
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.