Effect of Behavioral Therapy Versus Interferential Current on Bladder Dysfunction in Patients With Multiple Sclerosis (MS)

• ClinicalTrials.gov Identifier: NCT04635709
• Recruitment Status: Completed
• First Posted: November 19, 2020
• Last Update Posted: November 19, 2020
• Sponsor: Taibah University
• Information provided by (Responsible Party): walaa M Ragab, Taibah University

Study Description

Brief Summary:

study the effect of behavioral therapy and interferential current on management of bladder dysfunction in patients with multiple sclerosis

Condition or disease	Intervention/treatment	Phase
Bladder Dysfunction on Patients With Multiple Sclerosis	Device: biofeedback training and interferential therapy	Phase 1

Detailed Description:

Fifty patients with multiple sclerosis (MS) (secondary progressive type SPMS) suffering from bladder dysfunction were divided equally into two groups randomly; Group A received biofeedback training (behavioral therapy) while group B received interferential training. Both groups were assessed by urodynamics for detrusor pressure and maximum flow rate before and after eight weeks of behavioral therapy and interferential training.

Data analysis was managed using SPSS for windows, version 22 (SPSS, Inc., Chicago, IL). The current test involved two independent variables. The first one was the (tested group); between subject factors which had two levels (group A received behavioral therapy and group B who received IF ) .The second one was the (measuring periods); within subject factor which had two levels (pre, post). In addition, this test involved two tested dependent variables (detrusor pressure and maximum flow rate ) .T independent and dependent tests were used to compare between and within groups respectively. Data was considered statistically significant when P < .05

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Behavioral Therapy Versus Interferential Current on Bladder Dysfunction in Patients With Multiple Sclerosis
• Actual Study Start Date: February 15, 2019
• Actual Primary Completion Date: April 1, 2020
• Actual Study Completion Date: April 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: behavioral therapy; applying biofeedback training on the pelvic floor muscles	Device: biofeedback training and interferential therapy; compare the effect of applying both types of devices on the pelvic floor muscles
Experimental: interferential therapy (IF); Interferential current was applied to the body using four surface electrodes placed on the lower abdomen and lower buttocks.	Device: biofeedback training and interferential therapy; compare the effect of applying both types of devices on the pelvic floor muscles

Outcome Measures

Primary Outcome Measures :

1. Detruser pressure between and within groups [ Time Frame: eight weeks ]
   test it by urodynamic test before and after management
2. Maximum flow rate between and within groups [ Time Frame: eight weeks ]
   test it by urodynamic test before and after management

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 35 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: male patients with multiple sclerosis complaining of bladder dysfunctions
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• All the patients were referred by a neurologist and the diagnosis was confirmed by the Magnetic Resonance Image (MRI).The duration of being diagnosed as SPMS for both groups were between one to two years. All the selected patients had normal mental examination according to mini mental scale .Also, all the selected patients were medically stable.

Exclusion Criteria:

• Patients with any other neurological deficits or orthopedics abnormalities or with auditory dysfunction were excluded from this study. Patients with history of bladder dysfunctions before the diagnosis of MS or attaining any attack during the treatment period were also excluded.

Contacts and Locations

Locations

Saudi Arabia

Taibah University

Medina, Saudi Arabia, 42353

Sponsors and Collaborators

Taibah University

Investigators

• Principal Investigator: walaa M Ragab, PHD; Taibah University ,saidi arab

More Information

• Responsible Party: walaa M Ragab, DR, Taibah University
• ClinicalTrials.gov Identifier: NCT04635709
• Other Study ID Numbers: taibahu
• First Posted: November 19, 2020
• Last Update Posted: November 19, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases