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

NCT ID: NCT04635709

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2020-04-01

Brief Summary

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

Detailed Description

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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

Conditions

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Bladder Dysfunction on Patients With Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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behavioral therapy

applying biofeedback training on the pelvic floor muscles

Group Type EXPERIMENTAL

biofeedback training and interferential therapy

Intervention Type DEVICE

compare the effect of applying both types of devices on the pelvic floor muscles

interferential therapy (IF)

Interferential current was applied to the body using four surface electrodes placed on the lower abdomen and lower buttocks.

Group Type EXPERIMENTAL

biofeedback training and interferential therapy

Intervention Type DEVICE

compare the effect of applying both types of devices on the pelvic floor muscles

Interventions

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biofeedback training and interferential therapy

compare the effect of applying both types of devices on the pelvic floor muscles

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Taibah University

OTHER

Sponsor Role lead

Responsible Party

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walaa M Ragab

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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walaa M Ragab, PHD

Role: PRINCIPAL_INVESTIGATOR

Taibah University ,saidi arab

Locations

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Taibah University

Madinah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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taibahu

Identifier Type: -

Identifier Source: org_study_id