Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

Обзор

The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.

Подробное описание

A double-blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm will be conducted; followed by an open label trial at 3 months for any sham treatment arm participants who do not meet treatment success.

The primary goal is to compare the subjective success rates for the resolution of stress urinary incontinence (SUI) for the magnetic stimulation treatment at 3 months. Secondary aims include an assessment of complications, resolution of SUI symptoms, patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 158 patients. At the 3-month post treatment evaluation, the treatment allocation will be unmasked. Patients will be followed post treatment up to 2 years.

Вмешательства

• Устройство Magnetic stimulation
  The magnetic stimulation to the pelvic floor muscle will be provided by the Emsella® chair: which will be activated for 28 minutes at each treatment session. The treatment arm will receive up to 100% intensity at each treatment session.
• Устройство Sham Magnetic stimulation
  The sham arm will receive up to 5% intensity at each treatment session

Первичные конечные точки

• ICIQ-SF (standardized, validated questionnaire) [Срок оценки: 3 months post treatment]

Вторичные конечные точки (6)

• UDI-6 [Срок оценки: 3, 6, 12 and 24 months post treatment]
• IIQ-7 [Срок оценки: 3, 6, 12 and 24 months post treatment]
• ICIQ-LUTS-qol [Срок оценки: 3, 6, 12 and 24 months post treatment]
• PGI-I [Срок оценки: 3, 6, 12 and 24 months post treatment]
• PISQ-12 [Срок оценки: 3, 6, 12 and 24 months post treatment]
• 24 hour pad test [Срок оценки: 3 and 12 months]

Критерии участия

Критерии включения

1\) Non-pregnant adult female, not planning pregnancy during the duration of the study 2) Stress urinary incontinence (SUI), as confirmed by history, focused evaluation for ≥3 months 3) objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc 4) Bladder capacity ≥200cc 5) Post void residual ≤100cc with Stage I or lower pelvic organ prolapse 6) No concurrent or new planned treatment for SUI during the treatment period and the 3 months following it 7) No known body metal from umbilicus to knees 8) Willing and able to comply with the protocol.

Критерии исключения

1\) Patient is pregnant, lactating, or plans to become pregnant during the Study; or Patient is <12 months post partum 2) Patient has other predominant type of UI (e.g. Urgency UI, overflow UI, fistula) 3) Current chemo/radiotherapy; history of pelvic radiation; or pelvic surgery < 3 months 4) Systemic diseases known to affect bladder function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury) 5) Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms 6) Current evaluation or treatment for chronic pelvic pain 7) Participation in another treatment intervention that might interfere with the results of this trial 8) Patient has a medical condition or disorder that may cause non-compliance with the protocol (e.g. unable to perform self-evaluations and/or accurately report medical history, and/or data). 9) Patient has ambulatory 24-hour pad test, where the increased pad weight is < 3 grams. 10) Patient is non-ambulatory (ambulatory with assistive devices allowed) or unable to sit in a chair independently 12) Known body metal located from umbilicus to knees, or cardiac pacemaker 13) Previous magnetic stimulation therapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Sunnybrook Health Sciences Centre — Toronto

Идентификаторы

NCT: NCT05952258 · 5819

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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