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Completed

NCT Number: NCT04635709

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

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

Completed

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Key information

Age range

25 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taibah University

Madinah, 42353, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biofeedback training and interferential therapy

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Taibah University

Other

Registry information

Acronym: MS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.