Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT07008157
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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

1. Urodynamic assessments

2. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)

3. PFM strength Treatment procedures

1. IFC therapy 2. Timed voiding. 3. Motor imagery Training 4. PFMT

Study Timeline

• Study Start: 2024-10-01
• Primary Completion: 2025-04-16
• Study Completion: 2025-04-16
• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

Inclusion Criteria

• 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

Exclusion Criteria

• complete spinal cord injury
• current urinary tract infections
• a history of pelvic malignancy
• prior bladder or pelvic surgeries
• significant cognitive or psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1. Urodynamic assessments	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	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).

Secondary Outcome Measures

Name	Time	Method
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	ICIQ-UI SF is a widely recognized, validated, and reliable tool designed to assess the severity of urinary incontinence and its effect on QOL. It has demonstrated strong validity and reliability, producing consistent, reproducible results across diverse clinical and research populations (Avery et al., 2004). In the present study, the ICIQ-UI SF was administered at three time points: baseline, after 8 weeks of intervention, and at an 8-week follow-up, in accordance with the study's schedule for evaluating changes in urinary symptoms and related QOL

Trial Locations

Locations (1)

faculty of physical therapy, Cairo University; 🇪🇬 Cairo, Egypt