Exploring the Feasibility and Urogenital Benefits of Pelvic Floor Muscle Training in Individuals With Motor-incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility - Recruitment Rate
研究概览
简要总结
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pelvic Floor Muscle Training Group
干预措施: Pelvic Floor Muscle Training (Behavioral)
结局指标
主要结局
Feasibility - Recruitment Rate
时间窗: Through study completion, up to 12 weeks
Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.
Feasibility - Compliance
时间窗: Through study completion, up to 12 weeks
Compliance will be tracked by the adherence of participants to the prescribed exercise program, with reasons for missed sessions or drop-outs noted.
Feasibility - Adverse Events
时间窗: Through study completion, up to 12 weeks
Any adverse events to study protocols will be recorded.
Feasibility - Acceptability
时间窗: Through study completion, up to 12 weeks
The acceptability of the intervention will be evaluated using a 7-point Likert scale to rate participants' enjoyment of the exercise program and whether they felt the program was beneficial for improving their bladder, bowel, and/or sexual function.
次要结局
- Incontinence Quality of Life Questionnaire (I-QoL)(From enrollment to within 2 weeks of completing the study intervention)
- Neurogenic Bladder Symptoms Score (NBSS)(From enrollment to within 2 weeks of completing the study intervention)
- 3-Day Bladder Diary(From enrollment to within 2 weeks of completing the study intervention)
- Timed Bowel Movement(From enrollment to within 2 weeks of completing the study intervention)
- Neurogenic Bowel Dysfunction Score (NBDS)(From enrollment to within 2 weeks of completing the study intervention)
- International Index of Erectile Function (IIEF) Questionnaire (Males only)(From enrollment to within 2 weeks of completing the study intervention)
- Female Sexual Function Index (FSFI) Questionnaire (Females Only)(From enrollment to within 2 weeks of completing the study intervention)
- Sexual Quality of Life Questionnaire - Male/Female(From enrollment to within 2 weeks of completing the study intervention)
- Pelvic Floor Electromyography(From enrollment to within 2 weeks of completing the study intervention)
- Effectiveness of Cueing(From enrollment to within 2 weeks of completing the study intervention)
- Transcranial Magnetic Stimulation (TMS) Assessment(From enrollment to within 2 weeks of completing the study intervention)
- Pudendal Somatosensory Evoked Potential (SEP) Assessment(From enrollment to within 2 weeks of completing the study intervention)
- Transperineal Ultrasound(From enrollment to within 2 weeks of completing the study intervention)
研究者
Tania Lam
Principal Investigator
University of British Columbia