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

NCT07008157 | Completed DMC

• 1 other identifier: PT.BU.EC.18
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Rehabilitation Program; Bladder Control; Incomplete Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• 1. Urodynamic assessments

  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

  at three time points: baseline, after 8 weeks of treatment, and at an 8-week follow-up

• Body Mass Index

  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).

  baseline, after 8 weeks of treatment, and at an 8-week follow-up.

Secondary Outcomes (1)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

received IFC, PFMT, motor MIT, and timed voiding (TV)1. IFC interferential current, pelvic floor muscles training, timed voiding, and motor imagery training

Other: 1. IFC; Other: 2. Timed voiding.; Other: motor imagery training; Other: pelvic floor muscles training

control group

ACTIVE COMPARATOR

participants received interferential current therapy, timed voiding, and pelvic floor muscles training

Other: 1. IFC; Other: 2. Timed voiding.; Other: pelvic floor muscles training

Interventions

1. IFC OTHER

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

control group; experimental group

2. Timed voiding. OTHER

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

control group; experimental group

motor imagery training OTHER

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

experimental group

pelvic floor muscles training OTHER

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

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo University

Cairo, Cairo Governorate, P.O.Box 11432, Egypt

Location

Related Publications (1)

• 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. 2025 Jun;24(2):376-382. doi: 10.1177/15347346221093860. Epub 2022 Apr 14.

  PMID: 35422171 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: both participants and outcome assessors blinded to group assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: prospective, randomized, double-blind clinical trial

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 6, 2025
• Study Start: October 1, 2024
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)