Clinical trial NCT05075642: Multicenter Observational Study for the Evaluation in Clinical Practice of Urinary Disorders in Multiple Sclerosis
Official title: A Multicentre Observational Study for the Evaluation in Clinical Practice of the Initial Diagnostic-therapeutic Path of Urinary Disorders in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Urinary Bladder, Neurogenic
Keywords: Patient global impression of improvement
management
treatment
low urinary tract symptoms
diagnostic tools
prevalence
Lead sponsor: ASP 7 Ragusa
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient global impression of Improvement (PGI-I) questionnaire
timeFrame: 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 outcomes:
measure: Qualiveen-Short Form (SF) questionnaire
timeFrame: 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)
measure: Post-void residual volume (PVR) assessment
timeFrame: at visit 0 and Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)
measure: Micturitions' frequency and episodes of urgency/incontinence at three days frequency/volume chart
timeFrame: at visit 0 and Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)
Other outcomes:
measure: Prevalence of LUTS
timeFrame: at Visit 0 (screening visit)
measure: Demographic, Clinical and instrumental characteristics
timeFrame: at visit 0 (screening visit)
measure: 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
timeFrame: at visit 0 (screening visit) and visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)
Locations:
city: Vittoria
country: Italy
facility: Multiple Sclerosis Center of ASP 7 Ragusa
state: Ragusa
Study officials:
affiliation: Multiple Sclerosis Center of ASP7 Ragusa
name: Carmela Leone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Multiple Sclerosis Center of ASP7 Ragusa
name: Antonello Giordano, MD
role: STUDY_DIRECTOR
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