NCT04635709

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

November 14, 2020

Last Update Submit

November 14, 2020

Conditions

Bladder Dysfunction on Patients With Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Detruser pressure between and within groups

    test it by urodynamic test before and after management

    eight weeks

  • Maximum flow rate between and within groups

    test it by urodynamic test before and after management

    eight weeks

Study Arms (2)

behavioral therapy

EXPERIMENTAL

applying biofeedback training on the pelvic floor muscles

Device: biofeedback training and interferential therapy

interferential therapy (IF)

EXPERIMENTAL

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

Device: biofeedback training and interferential therapy

Interventions

biofeedback training and interferential therapyDEVICE

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

behavioral therapyinterferential therapy (IF)

Eligibility Criteria

Age25 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale patients with multiple sclerosis complaining of bladder dysfunctions
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taibah University

Madinah, 42353, Saudi Arabia

Location

Study Officials

  • walaa M Ragab, PHD

    Taibah University ,saidi arab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

November 14, 2020

First Posted

November 19, 2020

Study Start

February 15, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

SA(1)