Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury
NCT07008157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2025-06-06
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.
Conditions
- Spinal Cord Injury
Interventions
- OTHER
-
1. IFC
IFC therapy was applied while the patient lay in a supine position with the knees slightly apart. Each treatment session involved four electrodes enclosed in lint cloth covers. Two electrodes were positioned bilaterally on the lower abdomen, just below the anterior superior iliac spines (ASIS), while the remaining two were placed on the inner surfaces of both thighs. To maintain hygienic standards, the cloth covers were replaced for each participant at every session. The intervention was administered three times weekly over an eight-week period. A frequency range of 0-10 Hz was used, and the current intensity was carefully adjusted based on each patient's comfort and tolerance. Each IFC session lasted 15 minutes, with the aim of modulating pelvic region activity to support improved bladder function. This protocol was implemented three times per week over an eight-week period
- OTHER
-
2. Timed voiding.
The approach involved instructing participants to follow a fixed, scheduled voiding routine, typically every 3 hours, irrespective of the sensation to urinate. Additionally, patients were advised to adjust their toileting posture by sitting and leaning forward at an angle of approximately 45 degrees, allowing adequate time for complete bladder emptying. The technique also included practicing double voiding, where the individual would stand up and sit down again after the initial void to help ensure maximum bladder evacuation
- OTHER
-
motor imagery training
Prior to initiating MIT, participants watched a 10-minute instructional video in a quiet treatment space, illustrating proper PFM contractions through both visual and auditory cues. The therapist provided a detailed explanation, using a simple analogy of the bladder as a balloon filled with urine, connected by a tube (the urethra) to the outside, and controlled by the PFM. It was explained that contracting these muscles tightens the balloon, holding back urine, whereas weak or relaxed muscles may lead to leakage. Patients were then guided to mentally visualize contracting and holding these muscles until they reached a suitable time and place (the toilet), without physically performing the action. Following this explanation, patients were asked to sit comfortably with their eyes closed and spend 10 minutes visualizing the movement and control of their PFM while remaining physically relaxed. Throughout the session, the therapist used open-ended prompts to help maintain the patient's focu
- OTHER
-
pelvic floor muscles training
Before beginning each treatment session, participants were instructed to empty their bladders to promote comfort and relaxation during the exercises. All patients were taught a structured PFMT routine, to be performed daily in multiple positions such as lying, sitting, and standing. The program consisted of contracting the PFM for 10 seconds, followed by a 10-second relaxation period, with this sequence repeated 15 times in each session. To gradually enhance the endurance of the slow-twitch muscle fibers, both contraction and relaxation times were increased by one second each week. In addition, to activate and strengthen the fast-twitch muscle fibers, patients were directed to perform 20 quick, repetitive contractions and relaxations of the levator ani muscles - simulating the act of stopping urine flow, followed by a 10-second rest. This rapid contraction sequence was repeated for 2 to 4 sets in each session. This protocol was implemented three times per week over an eight-week period
Sponsors & Collaborators
-
Cairo University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-01
- Primary Completion
- 2025-04-16
- Completion
- 2025-04-16
Countries
- Egypt
Study Locations
More Related Trials
-
Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury
NCT04879862 ·Status: RECRUITING ·Phase: NA
-
Quantitative and Qualitative Changes in Neural Efferent Receptors
NCT00472784 ·Status: WITHDRAWN
-
Neuromodulation After Spinal Cord Injury to Improve Limb Function
NCT06815601 ·Status: RECRUITING ·Phase: NA
-
Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
NCT04193709 ·Status: COMPLETED ·Phase: NA
-
Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (SCI)
NCT01920243 ·Status: COMPLETED ·Phase: NA
-
Urodynamic Evaluation in Patients After Spinal Cord Injury
NCT04231474 ·Status: UNKNOWN
-
Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
NCT01891110 ·Status: COMPLETED ·Phase: NA
-
Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients
NCT01043848 ·Status: WITHDRAWN ·Phase: NA
-
Cell Transplant in Spinal Cord Injury Patients
NCT00816803 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury
NCT00286520 ·Status: COMPLETED ·Phase: PHASE4
-
Wheelchair Mobility Assessment of Individuals With Spinal Cord Injury
NCT01204047 ·Status: COMPLETED
-
Two Devices for Reflex Voiding Following Spinal Cord Injury
NCT00662207 ·Status: COMPLETED ·Phase: PHASE1
-
Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury
NCT07306052 ·Status: RECRUITING ·Phase: NA
-
Internet Self-Management for People With Intermittent Urinary Catheters
NCT02168465 ·Status: COMPLETED ·Phase: NA
-
Urodynamics of Suprasacral Spinal Cord Injury Patients
NCT04642170 ·Status: COMPLETED
-
Epidural Electrical Stimulation to Restore Standing and Walking in Patients With Chronic Paralysis Due to Spinal Cord Injury: A Study on Motor Recovery, Spasticity Reduction, and Quality of Life Improvement Through Neuromodulation and Intensive Rehabilitation
NCT06847295 ·Status: RECRUITING ·Phase: NA
-
A Wheelchair Propulsion Training Program
NCT04009187 ·Status: COMPLETED ·Phase: NA
-
The Impact of ESP on Neurophysiological Monitoring in Scoliotic Patients
NCT05632016 ·Status: UNKNOWN ·Phase: NA
-
Rehabilitation Combining Spatiotemporal Spinal Cord Stimulation and Real-time Triggering Exoskeleton After Spinal Cord Injury
NCT06881134 ·Status: COMPLETED ·Phase: NA
-
Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
NCT01807728 ·Status: COMPLETED ·Phase: NA
-
Improving Bladder Function in SCI by Neuromodulation
NCT02331979 ·Status: RECRUITING ·Phase: NA
-
Epidural Stimulation and Resistance Training After SCI
NCT04782947 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury
NCT06845904 ·Status: RECRUITING ·Phase: NA
-
Pediatric Locomotor Training Bladder Study
NCT03559036 ·Status: ACTIVE_NOT_RECRUITING
-
Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury
NCT05267951 ·Status: RECRUITING ·Phase: NA