Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
MALE
Healthy Volunteers
NCT05680168

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

Led by Hamad General Hospital · Updated on 2023-01-13

60

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult male patients 18 years of age and older
  • Diagnosed with localized low or intermediate risk prostate cancer
  • Chose radical prostatectomy (open or robotic-assisted) as first treatment
  • Surgery performed under care of Hamad General Hospital urology department
Not Eligible

You will not qualify if you...

  • Patients with high risk, locally advanced, or metastatic prostate cancer at diagnosis
  • Patients who received chemotherapy or radiotherapy before salvage surgery
  • Patients with urinary incontinence or overactive bladder before prostatectomy
  • Patients with complicated surgery causing anastomotic leak or prolonged catheter use over 3 weeks
  • Patients who refuse to participate in the clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ambulatory Care Center

Doha, Qatar

Actively Recruiting

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Research Team

A

Ahmed Albakr

CONTACT

A

Ardalan Ghafouri

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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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 | DecenTrialz