Clinical trial NCT07008157: Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury
Official title: Efficacy of a Multimodal Conservative Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Rehabilitation Program
Bladder Control
Incomplete Spinal Cord Injury
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, double-blind clinical trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 1. Urodynamic assessments
timeFrame: at three time points: baseline, after 8 weeks of treatment, and at an 8-week follow-up
measure: Body Mass Index
timeFrame: baseline, after 8 weeks of treatment, and at an 8-week follow-up.
Secondary outcomes:
measure: 2. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)
timeFrame: at three time points: baseline, after 8 weeks of intervention, and at an 8-week follow-up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of physical therapy, Cairo University
Study officials:
References:
citation: Elfahl AM, Abd El Baky AM, Yousef MT, Elgohary HM. High Versus Low Frequency Transcutaneous Electric Nerve Stimulation On Chronic Venous Lower Limb Ulceration Randomized Controlled Trial. Int J Low Extrem Wounds. 2022 Apr 14:15347346221093860. doi: 10.1177/15347346221093860. Online ahead of print.