Multicenter Observational Study for the Evaluation in Clinical Practice of Urinary Disorders in Multiple Sclerosis (MUSA)

September 29, 2021 updated by: Carmela Leone, ASP 7 Ragusa

A Multicentre Observational Study for the Evaluation in Clinical Practice of the Initial Diagnostic-therapeutic Path of Urinary Disorders in Multiple Sclerosis

The major part of people with multiple sclerosis (pwMS) experiences Low Urinary Tract Symptoms (LUTS) secondary to neurogenic Low Urinary Tract Dysfunctions (n-LUTDs) during the course of MS, reaching almost 100% after about 10 years. N-LUTDs represent an important issue for pwMS, especially for their negative impact on Quality of Life (QoL), as they are mainly youngs in the prime of their life. Moreover n-LUTDs can lead to serious complications on the urinary tract as infections or renal failure. Therefore, the neurologist in daily clinical practice must intercept the possible presence of LUTS as soon as possible so that he can promptly initiate optimal management. To do this, it is essential to provide neurologists with validated, reproducible and sensitive tools that are, above all, easy to use in an outpatient setting. Our clinical research seeks, for the first time, to show whether pwMS get any improvement after the initial LUTS management, whether this improvement, if any, is related to the professional figure takes care about LUTS (neurologist vs urologist) and if there is an objective improvement of voiding performances on standardized measures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a multicenter observational no-profit study to investigate the impact of Low Urinary Tract Symptoms (LUTS) management on subjective measure of patient global impression of improvement.

Initial management of LUTS in MS should address both voiding and storage deficiency symptoms and is determined by the severity of symptoms and the risk of developing upper urinary tract damage. First-line treatments include behavioral / physical ones, such as rehabilitation of the pelvic floor, and pharmacological ones (antimuscarinics, alpha-lytics, beta3 agonists); second-line treatments are represented by intradetrusorial (or intrasphinteric) injection of botulinum toxin and by non-invasive (percutaneous and transcutaneous tibial nerve stimulation) and invasive (sacral neuromodulation) neuromodulation techniques; third-line treatments consist of surgical approaches. According to the various consensus and recommendations available for MS, the initial approach in most cases should be the prerogative of the neurologist, while the neurourologist should intervene when the initial treatment has been ineffective or there are pathologies of the urinary tract that require a non-postponable specialist evaluation.

As regards the effectiveness of any initial management of LUTS in pcSM, there are, to the best of our knowledge, no studies in the literature that have analyzed the phenomenon, both in terms of subjective perception of clinical improvement and in objective terms of objective improved "voiding performance".

This study was developed with the primary intention of measuring, through the observation of real clinical practice, the presence and extent of improvement (through the PGI-I scale) of the subject with LUTS after at least three months of any type of initial management. A subgroup analysis will help us to assess whether the neurologist's management of LUTS is different from that of the urologist in terms of perceived improvement.

A patient reported outcome assessing quality of life (Qualiveen-SF), a three-day frequency / volume chart, and post-voiding residual volume (PVR) will be used as secondary outcomes to reveal the effectiveness of the two approaches on quality of life and data objective measures of urinary disorders.

The study also aims to 1) evaluate the prevalence of LUTS through a new diagnostic algorithm that consists of two questionnaires (the Urinary Bothersome Questionnaire-MS and the Actionable Bladder Symptoms Screening Tool-ABSST) and an objective measure of voiding dysfunction-the PVR and 2) analyze the influence of the more common risk factors on the presence of LUTS as thus diagnosed.

Study Type

Observational

Enrollment (Anticipated)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Ragusa
      • Vittoria, Ragusa, Italy, 97019
        • Multiple Sclerosis Center of ASP 7 Ragusa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carmela Leone, MD
        • Sub-Investigator:
          • Salvatore Maria Cavalli, MD
        • Sub-Investigator:
          • Giuseppe Zelante, MD
        • Sub-Investigator:
          • Francesco Savoca, MD
        • Sub-Investigator:
          • Angela Vicenzino, Nurse
        • Sub-Investigator:
          • Marta Biondo, Nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

For this study, a total of 214 persons with MS will be recruited. They will be recruited from the patients consecutively will attend the clinic or will be admitted to the participating Multiple Sclerosis Center, after approval of the study by the respective ethics committee

Description

Inclusion Criteria:

  • People with MS (relapsing-remitting, secondary progressive, primary progressive phenotype) or clinically isolated demyelinating disease syndrome-CIS) according to McDonald's 2001 criteria, consecutively afferent to the outpatient clinic or hospitalized after study approval by the ethics committee.

They:

  • have never been previously evaluated and/or treated for LUTS secondary to MS;
  • are between 18 and 80 years old;
  • have given written consent to study part.

Exclusion Criteria:

  • analphabetism;
  • severe cognitive impairment;
  • severe psychiatric pathologies;
  • EDSS> 7;
  • clinical relapse of MS within the previous 30 days;
  • history of urinary fevers > 2 in the last 6 months or > 3 in the last year;
  • indwelling catheter;
  • renal failure (creatinine> 1.2 mg / dL);
  • presence of hydronephrosis, mono or bilateral vesicoureteral reflux;
  • presence of urinary stones;
  • history of urological surgery, neoplasms of the urogenital system and / or pelvic radiotherapy;
  • therapy/treatment for LUTS secondary to MS or other diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient global impression of Improvement (PGI-I) questionnaire
Time Frame: at the end-of-study visit named Visit 2, corresponding at week 12-16 from Visit 1, that is the management start-up visit
In participants with recorded LUTS, it will be measured the subjective impression of improvement after at least three months of stable urinary disorder management, by means of the PGI-I questionnaire. The PGI-I is a 1-item questionnaire designed to assess the patient's impression of change with values ranging from 1 to 7; higher scores mean a worse outcome. Patient is required to "Check the one number that best describes how you feel now" by entering his answer on a 7-point scale scored as: (1) "very much better," (2) "much better," (3) "a little better," (4) "no change," (5) "a little worse," (6) "much worse," or (7) "very much worse." For this study, investigators will evaluated as primary outcome measure "the percentage of patient gave a response to PGI-I equal to or less than 2".
at the end-of-study visit named Visit 2, corresponding at week 12-16 from Visit 1, that is the management start-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualiveen-Short Form (SF) questionnaire
Time Frame: at the end of screening period named Visit 0, and at Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)

In participants with recorded LUTS, it will be measured the patient reported urinary-related quality of life by means of the Qualiveen-Short Form (SF) questionnaire. It's a specific health related quality of life (HRQOL) with questionnaire for urinary disorders in patients with neurological conditions, such as Multiple Sclerosis.

The Qualiveen-SF is an 8-items questionnaire. Response options are framed as 5-point Likert-type scales with 0 indicating no impact of urinary problems on HRQOL and 4 indicating a high adverse impact of urinary difficulty on HRQOL. Qualiveen domain scores are calculated as an average of the scores on items in that domain and, thus, the range is 0 to 4 with an overall score representing the mean of the 4 domains, which also ranges from 0 to 4. Higher scores mean worse outcome.

For this study investigators will evaluated whether three-months (max 4 months) of urinary disorder stable management may change HRQOL in terms of Qualiveen-SF scores.
at the end of screening period named Visit 0, and at Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)
Post-void residual volume (PVR) assessment
Time Frame: at visit 0 and Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)

The post-void residual volume (PVR) measured in ml is the urine volume remaining in bladder after a physiological micturition. It will be measured by ultrasound scans and calculated by the radiologist subtracting post-void bladder volume from pre-void bladder volume.

For this study, the investigators will evaluate whether three months (max 4 months) of urinary disorder stable management may change the amount of PVR.

Lower volume values mean better outcome.
at visit 0 and Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)
Micturitions' frequency and episodes of urgency/incontinence at three days frequency/volume chart
Time Frame: at visit 0 and Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)

In participants with recorded LUTS, it will be measured the number of daily micturitions and episodes of urgency or incontinence signed on a three days frequency/volume chart. Frequency/volume chart is a brief diary where patients are asked to record for three days how many times they urinate and the volume of each micturition; they are also asked to record each episode of urinary urgency and incontinence. Higher numbers mean worse outcome.

As secondary outcome, it will be evaluated whether three months (max 4 months) of urinary disorder stable management may change the numbers of micturitions and numbers of urinary urgency and/or incontinence.
at visit 0 and Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of LUTS
Time Frame: at Visit 0 (screening visit)
Considering all participants underwent screening visit, it will be estimated the prevalence of Low Urinary Tract Symptoms (LUTS); a new diagnostic screening model consisting of the Urinary Bothersome Questionnaire for Multiple Sclerosis (UBQ-MS), the Actionable Bladder Symptoms Screening Tool (ABSST) questionnaire and the PVR volume is used; LUTS is defined by the presence of at least one diagnostic tool with abnormal finding: UBQ-MS score at least 1, ABSST at least 3, PVR at least 100 ml or more than 30% of pre-void assessed volume.
at Visit 0 (screening visit)
Demographic, Clinical and instrumental characteristics
Time Frame: at visit 0 (screening visit)
Evaluating the presence of demographic (age, sex, BMI), clinical (disease duration, phenotype, Expanded Disease Status Scale, spinal lesions and their location, therapy, comorbidities) and instrumental factors (urinalysis with urine culture, radiological imaging, number of urinations and urgency-frequency episodes with frequency / volume chart) predictive of the type of urinary disorders reported.
at visit 0 (screening visit)
Patient global impression of Improvement (PGI-I) questionnaire, Qualiveen-Short Form questionnaire, Post-void residual volume (PVR) amount, Micturitions' frequency and episodes of urgency/incontinence at three days frequency/volume chart
Time Frame: at visit 0 (screening visit) and visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)

Finally, by means of a subgroup analysis, the investigators will evaluate whether enrolled participants managed by neurologists or by urologists show any difference in scores of Patient global impression of Improvement (PGI-I) questionnaire, Qualiveen-Short Form questionnaire, Post-void residual volume (PVR) assessment, Micturitions' frequency and episodes of urgency/incontinence at three days frequency/volume chart.

According to the specific MS center clinical practice, patients with MS may be managed by the neurologist or by the urologist by the urologist to whom they will be referred.
at visit 0 (screening visit) and visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASP 7 Ragusa

Investigators

  • Principal Investigator: Carmela Leone, MD, Multiple Sclerosis Center of ASP7 Ragusa
  • Study Director: Antonello Giordano, MD, Multiple Sclerosis Center of ASP7 Ragusa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E - 0027793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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