Efficacy of a Multimodal Conservative Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- 1. Urodynamic assessments
研究概览
简要总结
This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Participants were recruited between October 2024 and April 2025 from the National Institute of Urology and Nephrology in Mataria, as well as the Department of Urology and Nephrology at Kasr Alaini Hospital. All diagnoses were verified by a consultant urologist. The study received ethical approval from the Institutional Review Board of the Faculty of Physical Therapy, Benha University, Egypt, and written informed consent was obtained from each participant prior to enrollment.
Participants Individuals between 18 and 65 years of age presenting with OAB symptoms, confirmed through urodynamic testing, and diagnosed with ISCI classified as AIS C or D above the L1 spinal level, were considered eligible for inclusion in this study. Participants were required to be medically stable, able to follow study protocols, and willing to provide informed consent. Exclusion criteria included those with complete spinal cord injury (AIS A), current urinary tract infections, a history of pelvic malignancy, prior bladder or pelvic surgeries, or significant cognitive or psychiatric disorders.
详细描述
This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Participants were recruited between October 2024 and April 2025 from the National Institute of Urology and Nephrology in Mataria, as well as the Department of Urology and Nephrology at Kasr Alaini Hospital. All diagnoses were verified by a consultant urologist. The study received ethical approval from the Institutional Review Board of the Faculty of Physical Therapy, Benha University, Egypt, and written informed consent was obtained from each participant prior to enrollment.
Participants Individuals between 18 and 65 years of age presenting with OAB symptoms, confirmed through urodynamic testing, and diagnosed with ISCI classified as AIS C or D above the L1 spinal level, were considered eligible for inclusion in this study. Participants were required to be medically stable, able to follow study protocols, and willing to provide informed consent. Exclusion criteria included those with complete spinal cord injury (AIS A), current urinary tract infections, a history of pelvic malignancy, prior bladder or pelvic surgeries, or significant cognitive or psychiatric disorders. Simple randomization was applied to allocate participants into one of two groups: the EG, which received IFC, PFMT, motor MIT, and timed voiding (TV); and the CG, which received IFC, PFMT, and TV. The randomization process involved a computer-generated sequence created using dedicated software to ensure an equal number of participants in each group. Allocation concealment was maintained by placing group assignments in sealed, opaque envelopes, which were opened sequentially as participants were enrolled in the study.
Outcome Measures
-
Urodynamic assessments
-
The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)
-
PFM strength Treatment procedures
-
IFC therapy 2. Timed voiding. 3. Motor imagery Training 4. PFMT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
both participants and outcome assessors blinded to group assignments
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Individuals between 18 and 65 years of age
- •presenting with OAB symptoms
- •diagnosed with ISCI classified as AIS C or D above the L1 spinal level
排除标准
- •complete spinal cord injury
- •current urinary tract infections
- •a history of pelvic malignancy
- •prior bladder or pelvic surgeries
- •significant cognitive or psychiatric disorders
研究组 & 干预措施
experimental group
received IFC, PFMT, motor MIT, and timed voiding (TV)1. IFC interferential current, pelvic floor muscles training, timed voiding, and motor imagery training
干预措施: 1. IFC (Other)
experimental group
received IFC, PFMT, motor MIT, and timed voiding (TV)1. IFC interferential current, pelvic floor muscles training, timed voiding, and motor imagery training
干预措施: 2. Timed voiding. (Other)
experimental group
received IFC, PFMT, motor MIT, and timed voiding (TV)1. IFC interferential current, pelvic floor muscles training, timed voiding, and motor imagery training
干预措施: motor imagery training (Other)
experimental group
received IFC, PFMT, motor MIT, and timed voiding (TV)1. IFC interferential current, pelvic floor muscles training, timed voiding, and motor imagery training
干预措施: pelvic floor muscles training (Other)
control group
participants received interferential current therapy, timed voiding, and pelvic floor muscles training
干预措施: 1. IFC (Other)
control group
participants received interferential current therapy, timed voiding, and pelvic floor muscles training
干预措施: 2. Timed voiding. (Other)
control group
participants received interferential current therapy, timed voiding, and pelvic floor muscles training
干预措施: pelvic floor muscles training (Other)
结局指标
主要结局
1. Urodynamic assessments
时间窗: at three time points: baseline, after 8 weeks of treatment, and at an 8-week follow-up
These evaluations were carried out by experienced clinicians to maintain consistency and accuracy, providing real-time measurements of bladder function in a controlled environment. The procedure involved positioning the patient either supine or seated, followed by the insertion of a sterile catheter through the urethra into the bladder for fluid instillation and pressure monitoring. During cystometric testing, the bladder was gradually filled with sterile saline at a steady rate, while intravesical and abdominal pressures were continuously recorded. Key parameters measured included MCC, LPP, and the bladder volume at the first sensation of the urge to void
Body Mass Index
时间窗: baseline, after 8 weeks of treatment, and at an 8-week follow-up.
In this study, Body Mass Index (BMI) was used as an anthropometric measure to assess the weight status of patients with incomplete spinal cord injuries. BMI was calculated using the formula: BMI = weight (kg) / height² (m²). The classification of BMI values followed the guidelines established by the World Health Organization, where individuals with a BMI less than 18.5 kg/m² were considered underweight, those between 18.5-24.9 kg/m² were classified as having a normal weight, values from 25.0-29.9 kg/m² indicated overweight, and a BMI of 30.0 kg/m² or higher was categorized as obesity (World Health Organization, 2000).
次要结局
- 2. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)(at three time points: baseline, after 8 weeks of intervention, and at an 8-week follow-up)
研究者
Hany Mohamed Ibrahim Elgohary
Professor
Cairo University