Bladder Dysfunction on Patients With Multiple SclerosisPhase 1MSNCT04635709
Effect of Behavioral Therapy Versus Interferential Current on Bladder Dysfunction in Patients With Multiple Sclerosis
A Phase 1 study testing biofeedback training and interferential therapy in people with Bladder Dysfunction on Patients With Multiple Sclerosis, run by Taibah University at 1 site in Saudi Arabia.
Trial summary
study the effect of behavioral therapy and interferential current on management of bladder dysfunction in patients with multiple sclerosis Read more about this study
- Who is it for?
- Ages 25 to 35 years, men only
- Conditions the study is for
- Bladder Dysfunction on Patients With Multiple Sclerosis
- What is being tested?
- biofeedback training and interferential therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Feb 2019to 1 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
study the effect of behavioral therapy and interferential current on management of bladder dysfunction in patients with multiple sclerosis
Read the 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
- Being tested
- biofeedback training and interferential therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedback training and interferential therapyDevice
compare the effect of applying both types of devices on the pelvic floor muscles
| Study group | Role | What they receive |
|---|---|---|
| behavioral therapy | Experimental | applying biofeedback training on the pelvic floor muscles Receives: 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. Receives: Device: biofeedback training and interferential therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detruser pressure between and within groups
test it by urodynamic test before and after management
Measured: eight weeks
Maximum flow rate between and within groups
test it by urodynamic test before and after management
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start15 Feb 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Dysfunction on Patients With Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa M Ragab, Taibah University
- Investigators
- walaa M Ragab, PHD, Principal investigator, Taibah University ,saidi arab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635709
- Sponsor's protocol ID
- taibahu
- Acronym
- MS
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Behavioral Therapy Versus Interferential Current on Bladder Dysfunction in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04635709
- Acronym / sponsor ID
- MS / taibahu
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioral therapy | Experimental | Device: biofeedback training and interferential therapyapplying biofeedback training on the pelvic floor muscles |
| interferential therapy (IF) | Experimental | Device: biofeedback training and interferential therapyInterferential current was applied to the body using four surface electrodes placed on the lower abdomen and lower buttocks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biofeedback training and interferential therapycompare the effect of applying both types of devices on the pelvic floor muscles | Device | behavioral therapy, interferential therapy (IF) |
Primary outcome
Detruser pressure between and within groups
Time frame: eight weeks
test it by urodynamic test before and after management
Maximum flow rate between and within groups
Time frame: eight weeks
test it by urodynamic test before and after management
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
walaa M Ragab, PHD principal investigator
Taibah University ,saidi arab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing biofeedback training and interferential therapy in people with Bladder Dysfunction on Patients With Multiple Sclerosis, run by Taibah University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detruser pressure between and within groups (time frame: eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.