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

NCT05075642 | Unknown DMC FDA Drug

• 1 other identifier: E - 0027793
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Urinary Bladder, Neurogenic

Keywords

Patient global impression of improvement; management; treatment; low urinary tract symptoms; diagnostic tools; prevalence

Outcome Measures

Primary Outcomes (1)

• Patient global impression of Improvement (PGI-I) questionnaire

  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 Outcomes (3)

• Qualiveen-Short Form (SF) questionnaire

  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

  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

  at visit 0 and Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)

Other Outcomes (3)

• Prevalence of LUTS

  at Visit 0 (screening visit)

• Demographic, Clinical and instrumental characteristics

  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

  at visit 0 (screening visit) and visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)

Interventions

Initial management of the urinary disorder/s identified during the screening phase OTHER

Intervention can be defined as the initial management of the LUTS identified during the screening phase; management lasts at least three months. As observation of routine clinical practice, no specific intervention is included, but any counseling/drug/rehabilitation included as first line management.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ASP 7 Ragusa: lead

Study Sites (1)

Multiple Sclerosis Center of ASP 7 Ragusa

Vittoria, Ragusa, 97019, Italy

Location

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MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmela Leone, MD

  Multiple Sclerosis Center of ASP7 Ragusa

  PRINCIPAL INVESTIGATOR

• Antonello Giordano, MD

  Multiple Sclerosis Center of ASP7 Ragusa

  STUDY DIRECTOR

Central Study Contacts

Carmela Leone, MD

CONTACT

00393203047748; carmela.leone@asp.rg.it

Antonello Giordano, MD

CONTACT

00393333344471; antonello.giordano@asp.rg.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 13, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)