Exploring the Benefits of Pelvic Floor Muscle Training on Bladder, Bowel, and Sexual Function in People With Spinal Cord Injury

Официальное название

Exploring the Feasibility and Urogenital Benefits of Pelvic Floor Muscle Training in Individuals With Motor-incomplete Spinal Cord Injury

Обзор

The goal of this trial is to learn about the feasibility and benefits of delivering a pelvic floor muscle training program to people with motor-incomplete spinal cord injury. The main questions it aims to answer are: 1. To evaluate the feasibility of delivering a pelvic floor muscle training program to people with spinal cord injury. The investigators will examine recruitment rate, compliance and adherence to the intervention and other study protocols, adverse events, and participant perspectives of the study protocols. 2. To explore the potential effectiveness of pelvic floor muscle training on pelvic floor, bladder, bowel, and sexual function. Participants will be asked to complete a pelvic floor muscle training program for 3 months. At the beginning, middle, and end of the program, researchers will conduct a series of tests to determine the feasibility and potential effectiveness of this program.

Вмешательства

• Поведенческое Pelvic Floor Muscle Training
  Pelvic floor muscle training 5x/week for 12-weeks

Первичные конечные точки

• Feasibility - Recruitment Rate [Срок оценки: Through study completion, up to 12 weeks]
• Feasibility - Compliance [Срок оценки: Through study completion, up to 12 weeks]
• Feasibility - Adverse Events [Срок оценки: Through study completion, up to 12 weeks]
• Feasibility - Acceptability [Срок оценки: Through study completion, up to 12 weeks]

Вторичные конечные точки (12)

• Incontinence Quality of Life Questionnaire (I-QoL) [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Neurogenic Bladder Symptoms Score (NBSS) [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• 3-Day Bladder Diary [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Timed Bowel Movement [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Neurogenic Bowel Dysfunction Score (NBDS) [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• International Index of Erectile Function (IIEF) Questionnaire (Males only) [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Female Sexual Function Index (FSFI) Questionnaire (Females Only) [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Sexual Quality of Life Questionnaire - Male/Female [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Pelvic Floor Electromyography [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Effectiveness of Cueing [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Transcranial Magnetic Stimulation (TMS) Assessment [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]
• Pudendal Somatosensory Evoked Potential (SEP) Assessment [Срок оценки: From enrollment to within 2 weeks of completing the study intervention]

Критерии участия

Критерии включения

• Are at least 19 years of age.
• Have a non-progressive, motor-incomplete spinal cord injury that is at or above the T12 neurological level at least 12 months ago.
• Have symptoms of bladder, bowel, and/or sexual dysfunction that are caused by your spinal cord injury.
• Have stable management of spinal cord related secondary health concerns (e.g., spasticity, neuropathic pain).
• Are able to speak and understand English.

Критерии исключения

• Are currently pregnant, have been pregnant within the past 6 months, or are planning to become pregnant in the next 6 months.
• Have had urogenital surgery within the past 12 months.
• Have received Botox bladder injections within the past 4 weeks, or anticipate receiving an injection in the next 6 months.
• Have presence of severe medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to pressure sores, cardiovascular disease, and unmanaged diabetes.
• Have any permanent metal fixtures in their head (excluding dental fillings), or pacemakers, stimulators, or implanted medication pumps.
• Have a history of seizures, are taking medications that lower the seizure threshold, or experience recurring headaches.
• Have a condition for which exercise is contraindicated.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Blusson Spinal Cord Centre — Vancouver

Идентификаторы

NCT: NCT06705790 · H21-02281 · PTJ-166040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗