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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04635709
Other study ID # taibahu
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 15, 2019
Est. completion date April 1, 2020

Study information

Verified date November 2020
Source Taibah University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender Male
Age group 25 Years to 35 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
biofeedback training and interferential therapy
compare the effect of applying both types of devices on the pelvic floor muscles

Locations

Country Name City State
Saudi Arabia Taibah University Medina

Sponsors (1)

Lead Sponsor Collaborator
Taibah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detruser pressure between and within groups test it by urodynamic test before and after management eight weeks
Primary Maximum flow rate between and within groups test it by urodynamic test before and after management eight weeks