Multicenter Observational Study for the Evaluation in Clinical Practice of Urinary Disorders in Multiple Sclerosis
NCT ID: NCT05075642
Last Updated: 2021-10-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
214 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-11-30
Study Completion Date
2023-07-31
Brief Summary
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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
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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.
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.
Conditions
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Multiple Sclerosis
Urinary Bladder, Neurogenic
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Interventions
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Initial management of the urinary disorder/s identified during the screening phase
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.
Intervention Type
OTHER
Eligibility Criteria
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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.
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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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ASP 7 Ragusa
OTHER
Sponsor Role
lead
Responsible Party
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Carmela Leone
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Carmela Leone, MD
Role: PRINCIPAL_INVESTIGATOR
Multiple Sclerosis Center of ASP7 Ragusa
Antonello Giordano, MD
Role: STUDY_DIRECTOR
Multiple Sclerosis Center of ASP7 Ragusa
Locations
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Multiple Sclerosis Center of ASP 7 Ragusa
Vittoria, Ragusa, Italy
Site Status
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008 Jun;9(6):453-66. doi: 10.1038/nrn2401.
Reference Type
RESULT
Griffiths D, Tadic SD. Bladder control, urgency, and urge incontinence: evidence from functional brain imaging. Neurourol Urodyn. 2008;27(6):466-74. doi: 10.1002/nau.20549.
Reference Type
RESULT
Ghezzi A, Carone R, Del Popolo G, Amato MP, Bertolotto A, Comola M, Del Carro U, Di Benedetto P, Giannantoni A, Lopes de Carvalho ML, Montanari E, Patti F, Protti A, Rasia S, Salonia A, Scandellari C, Sperli F, Spinelli M, Solaro C, Uccelli A, Zaffaroni M, Zipoli V; Multiple Sclerosis Study Group, Italian Society of Neurology. Recommendations for the management of urinary disorders in multiple sclerosis: a consensus of the Italian Multiple Sclerosis Study Group. Neurol Sci. 2011 Dec;32(6):1223-31. doi: 10.1007/s10072-011-0794-y.
Reference Type
RESULT
de Seze M, Ruffion A, Denys P, Joseph PA, Perrouin-Verbe B; GENULF. The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines. Mult Scler. 2007 Aug;13(7):915-28. doi: 10.1177/1352458506075651. Epub 2007 Mar 15.
Reference Type
RESULT
Panicker JN, Fowler CJ, Kessler TM. Lower urinary tract dysfunction in the neurological patient: clinical assessment and management. Lancet Neurol. 2015 Jul;14(7):720-32. doi: 10.1016/S1474-4422(15)00070-8.
Reference Type
RESULT
Khalaf KM, Coyne KS, Globe DR, Malone DC, Armstrong EP, Patel V, Burks J. The impact of lower urinary tract symptoms on health-related quality of life among patients with multiple sclerosis. Neurourol Urodyn. 2016 Jan;35(1):48-54. doi: 10.1002/nau.22670. Epub 2014 Oct 18.
Reference Type
RESULT
Musco S, Padilla-Fernandez B, Del Popolo G, Bonifazi M, Blok BFM, Groen J, 't Hoen L, Pannek J, Bonzon J, Kessler TM, Schneider MP, Gross T, Karsenty G, Phe V, Hamid R, Ecclestone H, Castro-Diaz D. Value of urodynamic findings in predicting upper urinary tract damage in neuro-urological patients: A systematic review. Neurourol Urodyn. 2018 Jun;37(5):1522-1540. doi: 10.1002/nau.23501. Epub 2018 Feb 2.
Reference Type
RESULT
Groen J, Pannek J, Castro Diaz D, Del Popolo G, Gross T, Hamid R, Karsenty G, Kessler TM, Schneider M, 't Hoen L, Blok B. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2016 Feb;69(2):324-33. doi: 10.1016/j.eururo.2015.07.071. Epub 2015 Aug 22.
Reference Type
RESULT
Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57.
Reference Type
RESULT
Grasso MG, Pozzilli C, Anzini A, Salvetti M, Bastianello S, Fieschi C. Relationship between bladder dysfunction and brain MRI in multiple sclerosis. Funct Neurol. 1991 Jul-Sep;6(3):289-92.
Reference Type
RESULT
De Ridder D, Van Der Aa F, Debruyne J, D'hooghe MB, Dubois B, Guillaume D, Heerings M, Ilsbroukx S, Medaer R, Nagels G, Seeldrayers P, Van Landegem W, Willekens B, Zicot AF. Consensus guidelines on the neurologist's role in the management of neurogenic lower urinary tract dysfunction in multiple sclerosis. Clin Neurol Neurosurg. 2013 Oct;115(10):2033-40. doi: 10.1016/j.clineuro.2013.06.018. Epub 2013 Jul 20.
Reference Type
RESULT
Medina-Polo J, Adot JM, Allue M, Arlandis S, Blasco P, Casanova B, Matias-Guiu J, Madurga B, Meza-Murillo ER, Muller-Arteaga C, Rodriguez-Acevedo B, Vara J, Zubiaur MC, Lopez-Fando L. Consensus document on the multidisciplinary management of neurogenic lower urinary tract dysfunction in patients with multiple sclerosis. Neurourol Urodyn. 2020 Feb;39(2):762-770. doi: 10.1002/nau.24276. Epub 2020 Jan 15.
Reference Type
RESULT
Bates D, Burks J, Globe D, Signori M, Hudgens S, Denys P, Macdiarmid S, Nitti V, Odderson I, Ross AP, Chancellor M. Development of a short form and scoring algorithm from the validated actionable bladder symptom screening tool. BMC Neurol. 2013 Jul 9;13:78. doi: 10.1186/1471-2377-13-78.
Reference Type
RESULT
Burks J, Chancellor M, Bates D, Denys P, Macdiarmid S, Nitti V, Globe D, Signori M, Hudgens S, Odderson I, Panicker J, Ross AP. Development and validation of the actionable bladder symptom screening tool for multiple sclerosis patients. Int J MS Care. 2013 Winter;15(4):182-92. doi: 10.7224/1537-2073.2012-049.
Reference Type
RESULT
Denys P, Phe V, Even A, Chartier-Kastler E. Therapeutic strategies of urinary disorders in MS. Practice and algorithms. Ann Phys Rehabil Med. 2014 Jul;57(5):297-301. doi: 10.1016/j.rehab.2014.05.003. Epub 2014 Jun 4.
Reference Type
RESULT
Tsang B, Stothers L, Macnab A, Lazare D, Nigro M. A systematic review and comparison of questionnaires in the management of spinal cord injury, multiple sclerosis and the neurogenic bladder. Neurourol Urodyn. 2016 Mar;35(3):354-64. doi: 10.1002/nau.22720. Epub 2015 Jan 25.
Reference Type
RESULT
Welk B, Morrow S, Madarasz W, Baverstock R, Macnab J, Sequeira K. The validity and reliability of the neurogenic bladder symptom score. J Urol. 2014 Aug;192(2):452-7. doi: 10.1016/j.juro.2014.01.027. Epub 2014 Feb 8.
Reference Type
RESULT
Al Dandan HB, Coote S, McClurg D. Prevalence of Lower Urinary Tract Symptoms in People with Multiple Sclerosis: A Systematic Review and Meta-analysis. Int J MS Care. 2020 Mar-Apr;22(2):91-99. doi: 10.7224/1537-2073.2019-030.
Reference Type
RESULT
Amarenco G, Chartier-Kastler E, Denys P, Jean JL, de Seze M, Lubetzski C. First-line urological evaluation in multiple sclerosis: validation of a specific decision-making algorithm. Mult Scler. 2013 Dec;19(14):1931-7. doi: 10.1177/1352458513489758. Epub 2013 May 22.
Reference Type
RESULT
Bonniaud V, Bryant D, Parratte B, Guyatt G. Qualiveen, a urinary-disorder specific instrument: 0.5 corresponds to the minimal important difference. J Clin Epidemiol. 2008 May;61(5):505-10. doi: 10.1016/j.jclinepi.2007.06.008. Epub 2008 Jan 7.
Reference Type
RESULT
Bonniaud V, Bryant D, Parratte B, Guyatt G. Development and validation of the short form of a urinary quality of life questionnaire: SF-Qualiveen. J Urol. 2008 Dec;180(6):2592-8. doi: 10.1016/j.juro.2008.08.016. Epub 2008 Oct 31.
Reference Type
RESULT
Domurath B, Kurze I, Kirschner-Hermanns R, Kaufmann A, Feneberg W, Schmidt P, Henze T, Flachenecker P, Brandt A, Vance WN, Beck J, Vonthien M, Ratering K; MS Consensus Group. Neurourological assessment in people with multiple sclerosis (MS): a new evaluated algorithm. Mult Scler Relat Disord. 2020 Sep;44:102248. doi: 10.1016/j.msard.2020.102248. Epub 2020 May 30.
Reference Type
RESULT
Li V, Panicker JN, Haslam C, Chataway J. Use of a symptom-based questionnaire to screen for the presence of significant voiding dysfunction in patients with multiple sclerosis and lower urinary tract symptoms: a pilot study. J Neurol. 2020 Dec;267(12):3683-3688. doi: 10.1007/s00415-020-10068-2. Epub 2020 Jul 16.
Reference Type
RESULT
Ghezzi A, Mutta E, Bianchi F, Bonavita S, Buttari F, Caramma A, Cavarretta R, Centonze D, Coghe GC, Coniglio G, Del Carro U, Ferro MT, Marrosu MG, Patti F, Rovaris M, Sparaco M, Simone I, Tortorella C, Bergamaschi R. Diagnostic tools for assessment of urinary dysfunction in MS patients without urinary disturbances. Neurol Sci. 2016 Mar;37(3):437-42. doi: 10.1007/s10072-015-2415-7. Epub 2015 Nov 27.
Reference Type
RESULT
Monti Bragadin M, Motta R, Messmer Uccelli M, Tacchino A, Ponzio M, Podda J, Konrad G, Rinaldi S, Della Cava M, Battaglia MA, Brichetto G. Lower urinary tract dysfunction in patients with multiple sclerosis: A post-void residual analysis of 501 cases. Mult Scler Relat Disord. 2020 Oct;45:102378. doi: 10.1016/j.msard.2020.102378. Epub 2020 Jul 5.
Reference Type
RESULT
Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
Reference Type
RESULT
Bjelic-Radisic V, Ulrich D, Hinterholzer S, Reinstadler E, Geiss I, Aigmueller T, Tamussino K, Greimel E, Trutnovsky G; Austrian Urogynecology Working Group. Psychometric properties and validation of two global impression questionnaires (PGI-S, PGI-I) for stress incontinence in a German-speaking female population. Neurourol Urodyn. 2018 Apr;37(4):1365-1371. doi: 10.1002/nau.23447. Epub 2017 Nov 11.
Reference Type
RESULT
Viktrup L, Hayes RP, Wang P, Shen W. Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. BMC Urol. 2012 Nov 7;12:30. doi: 10.1186/1471-2490-12-30.
Reference Type
RESULT
Twiss CO, Fischer MC, Nitti VW. Comparison between reduction in 24-hour pad weight, International Consultation on Incontinence-Short Form (ICIQ-SF) score, International Prostate Symptom Score (IPSS), and Post-Operative Patient Global Impression of Improvement (PGI-I) score in patient evaluation after male perineal sling. Neurourol Urodyn. 2007;26(1):8-13. doi: 10.1002/nau.20333.
Reference Type
RESULT
McDonald WI, Compston A, Edan G, Goodkin D, Hartung HP, Lublin FD, McFarland HF, Paty DW, Polman CH, Reingold SC, Sandberg-Wollheim M, Sibley W, Thompson A, van den Noort S, Weinshenker BY, Wolinsky JS. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001 Jul;50(1):121-7. doi: 10.1002/ana.1032.
Reference Type
RESULT
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
Reference Type
RESULT
Bates P, Bradley WE, Glen E, Melchior H, Rowan D, Sterling A, Hald T. The standardization of terminology of lower urinary tract function. Eur Urol. 1976;2(6):274-6. doi: 10.1159/000472029.
Reference Type
RESULT
Other Identifiers
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E - 0027793
Identifier Type: -
Identifier Source: org_study_id