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

Phase 1

Completed

• Conditions: Bladder Dysfunction on Patients With Multiple Sclerosis
• Interventions: Device: biofeedback training and interferential therapy

• Registration Number: NCT04635709
• Lead Sponsor: Taibah University

Brief Summary

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

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 Timeline

• Study Start: 2019-02-15
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-14
• Last Update Submitted: 2020-11-14
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
behavioral therapy	biofeedback training and interferential therapy	applying biofeedback training on the pelvic floor muscles
interferential therapy (IF)	biofeedback training and interferential therapy	Interferential current was applied to the body using four surface electrodes placed on the lower abdomen and lower buttocks.

Primary Outcome Measures

Name	Time	Method
Detruser pressure between and within groups	eight weeks	test it by urodynamic test before and after management
Maximum flow rate between and within groups	eight weeks	test it by urodynamic test before and after management

Trial Locations

Locations (1)

Taibah University; 🇸🇦 Medina, Saudi Arabia