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

Primary Purpose

Bladder Dysfunction on Patients With Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

Saudi Arabia

Study Type

Interventional

Intervention

biofeedback training and interferential therapy

About this trial

This is an interventional treatment trial for Bladder Dysfunction on Patients With Multiple Sclerosis

Eligibility Criteria

25 Years - 35 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Taibah University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

behavioral therapy

interferential therapy (IF)

Arm Description

applying biofeedback training on the pelvic floor muscles

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

Outcomes

Primary Outcome Measures

Detruser pressure between and within groups

test it by urodynamic test before and after management

Maximum flow rate between and within groups

test it by urodynamic test before and after management

Secondary Outcome Measures

Full Information

NCT ID

NCT04635709

First Posted

November 14, 2020

Last Updated

November 14, 2020

Sponsor

Taibah University

1. Study Identification

Unique Protocol Identification Number

NCT04635709

Brief Title

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

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

February 15, 2019 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taibah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Dysfunction on Patients With Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

behavioral therapy

Arm Type

Experimental

Arm Description

applying biofeedback training on the pelvic floor muscles

Arm Title

interferential therapy (IF)

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

biofeedback training and interferential therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Detruser pressure between and within groups

Description

test it by urodynamic test before and after management

Time Frame

eight weeks

Title

Maximum flow rate between and within groups

Description

test it by urodynamic test before and after management

Time Frame

eight weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

male patients with multiple sclerosis complaining of bladder dysfunctions

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

walaa M Ragab, PHD

Organizational Affiliation

Taibah University ,saidi arab

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taibah University

City

Medina

ZIP/Postal Code

42353

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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