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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Extracorporeal electromagnetic stimulation
  Electromagnetic stimulation using Magneto STYM device, (Iskra medical d.o.o, Slovenia).
• Поведенческое Pelvic floor exercises
  Pelvic floor muscle training in serial training sessions with our therapist

Первичные конечные точки

• One hour pad test [Срок оценки: 18 months from the start of intervention]
• the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) [Срок оценки: 18 months from the start of intervention]
• Urodynamic leak point pressure. [Срок оценки: 1 day (Once) after 6 weeks of the start of rehabilitation process]

Вторичные конечные точки (1)

• International Consultation on Incontinence Questionnaire quality of life score [Срок оценки: 18 months from the start of intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Катар · 1 центр

• Ambulatory Care Center — Doha

Идентификаторы

NCT: NCT05680168 · MRC0122185

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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