Multiple SclerosisPhase 4NCT01930799

Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns

A Phase 4 study testing Systematic Screening and Education Regimen in people with Multiple Sclerosis and Urinary Bladder Diseases, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will assess the impact of a systematic bladder health screening and disease education regimen as well as the implementation of a referral process on the quality of life of multiple sclerosis patients with bladder dysfunction. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Sclerosis, Urinary Bladder Diseases
What is being tested?: Systematic Screening and Education Regimen
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Mar 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of relapsing-remitting multiple sclerosis and currently being treated by study doctor

Who cannot join

Diagnosis of primary-progressive, secondary-progressive, or progressive-relapsing multiple sclerosis

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Fresno, California

Other trials in United States

About this study

Conditions: Multiple Sclerosis, Urinary Bladder Diseases
Being tested: Systematic Screening and Education Regimen
Medical subject headings: Multiple Sclerosis, Urinary Bladder Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Systematic Screening and Education RegimenBehavioural
Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.

Study groups in NCT01930799
Study group	Role	What they receive
All Enrolled Patients	Other	Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals. Receives: Behavioral: Systematic Screening and Education Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.
Measured: Baseline, Month 6

Secondary outcomes (1)

Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
The Patient Post-Video Questionnaire was based on 5 individual questions assessing the patient's perception of the utility of the video in helping them 1) understand how MS can affect the bladder, 2) how to recognize bladder symptoms, 3) understand various treatment options, 4) understand self-help strategies, and 5) better manage their bladder problems. Percentages represent the proportion of patients who "agree/completely agree" with each question. Patients viewed the video at the Baseline visit, then completed the Patient Post-Video Questionnaire immediately after viewing the video at the Baseline visit.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Mar 2015

First posted29 Aug 2013 (estimated)
Study startAug 2013
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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 4
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01930799
Sponsor's protocol ID: GMA-NDO-112
Status last verified: Apr 2016
First submitted: 26 Aug 2013
Last updated: 27 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
ClinicalTrials.gov ID: NCT01930799
Acronym / sponsor ID: GMA-NDO-112
Conditions: Multiple Sclerosis, Urinary Bladder Diseases
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 29 Aug 2013 (estimated)
Results: Posted 27 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All Enrolled Patients	Other	Behavioral: Systematic Screening and Education RegimenSite will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosis of relapsing-remitting multiple sclerosis and currently being treated by study doctor

Key exclusion criteria (1 listed)

Diagnosis of primary-progressive, secondary-progressive, or progressive-relapsing multiple sclerosis

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
Systematic Screening and Education RegimenSite will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.	Behavioural	All Enrolled Patients

Primary outcome

Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
Time frame: Baseline, Month 6
The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.

1 secondary outcome

Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
Time frame: Baseline

Results and safety

Results posted to the registry on 27 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Patients	120	112

Primary outcome: Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	All Enrolled Patients n = 112
Baseline (BL)-General Health Perception	39.7 (23.1)
Chng from BL at M6-General Health Percept (N=111)	2.5 (22.3)
BL-Incontinence Impact	60.7 (23.8)
Chng from BL at M6-Incontinence Impact (N=111)	1.2 (24.2)
BL-Role Limitations (N=111)	43.8 (29.6)
Chng from BL at M6-Role Limitations (N=111)	-6.9 (27.5)
BL-Physical Limitations (N=111)	45.3 (28.0)
Chng from BL at M6-Physical Limitations (N=111)	-9.8 (26.3)

Population analysed: Eligible and enrolled subjects who completed the Month 6 visit

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Patients	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Multiple Sclerosis

RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingPhase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder

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.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Systematic Screening and Education Regimen in people with Multiple Sclerosis and Urinary Bladder Diseases, run by Allergan at 1 site in United States.

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 27 May 2016. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01930799.

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 27 May 2016.