Multiple SclerosisMUSANCT05075642
Multicenter Observational Study for the Evaluation in Clinical Practice of Urinary Disorders in Multiple Sclerosis
An observational study of Multiple Sclerosis and Urinary Bladder, Neurogenic, run by ASP 7 Ragusa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Urinary Bladder, Neurogenic
- What is being tested?
- Initial management of the urinary disorder/s identified during the screening phase
- How many people
- 214 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2021to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Multiple Sclerosis Center of ASP 7 Ragusa
Vittoria, Ragusa, 97019
Carmela Leone, MD, 003932030477748, carmela.leone@asp.rg.it
Angela Vicenzino, Nurse, 00390932999145, angela.vicenzino@asp.rg.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Urinary Bladder, Neurogenic
- Being tested
- Initial management of the urinary disorder/s identified during the screening phase
- Keywords
- Patient global impression of improvement, management, treatment, low urinary tract symptoms, diagnostic tools, prevalence
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial management of the urinary disorder/s identified during the screening phaseOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: at visit 0 and Visit 2 (weeks 12-16 from Visit 1, that is the management start-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASP 7 Ragusa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmela Leone, ASP 7 Ragusa
- Investigators
- Carmela Leone, MD, Principal investigator, Multiple Sclerosis Center of ASP7 RagusaAntonello Giordano, MD, Study director, Multiple Sclerosis Center of ASP7 Ragusa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075642
- Sponsor's protocol ID
- E - 0027793
- Acronym
- MUSA
- Status last verified
- Sep 2021
- First submitted
- 19 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17881401Panicker 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.
PubMed 26067125Khalaf 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.
PubMed 25327401Musco 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.
PubMed 29392753Groen 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.
PubMed 26304502Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57.
PubMed 10022678Grasso 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.
PubMed 1743544Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008 Jun;9(6):453-66. doi: 10.1038/nrn2401.
PubMed 18490916Griffiths 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.
PubMed 18092336Ghezzi 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.
PubMed 21948057De 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.
PubMed 23880016Medina-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.
PubMed 31943361Bates 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.
PubMed 23837535Burks 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.
PubMed 24453782Denys 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.
PubMed 24958444
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Observational Study for the Evaluation in Clinical Practice of the Initial Diagnostic-therapeutic Path of Urinary Disorders in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05075642
- Acronym / sponsor ID
- MUSA / E - 0027793
- Conditions
- Multiple Sclerosis, Urinary Bladder, Neurogenic
- Keywords
- Patient global impression of improvement, management, treatment, low urinary tract symptoms, diagnostic tools, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- ASP 7 RagusaUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- analphabetism;
- severe cognitive impairment;
- severe psychiatric pathologies;
- EDSS> 7;
- clinical relapse of MS within the previous 30 days;
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 |
|---|---|---|
| Initial management of the urinary disorder/s identified during the screening phaseIntervention 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. | Other | – |
Primary outcome
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".
3 secondary outcomes
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Results publication: PubMed 17881401de 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.
- Results publication: PubMed 26067125Panicker 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.
- Results publication: PubMed 25327401Khalaf 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.
- Results publication: PubMed 29392753Musco 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.
- Results publication: PubMed 26304502Groen 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.
- Results publication: PubMed 10022678Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57.
- Results publication: PubMed 1743544Grasso 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.
- Results publication: PubMed 18490916Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nat Rev Neurosci. 2008 Jun;9(6):453-66. doi: 10.1038/nrn2401.
- Results publication: PubMed 18092336Griffiths 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.
- Results publication: PubMed 21948057Ghezzi 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.
- Results publication: PubMed 23880016De 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.
- Results publication: PubMed 31943361Medina-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.
- Individual participant dataSharing planned: No
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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.
Carmela Leone, MD principal investigator
Multiple Sclerosis Center of ASP7 Ragusa
Antonello Giordano, MD study director
Multiple Sclerosis Center of ASP7 Ragusa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Urinary Bladder, Neurogenic, run by ASP 7 Ragusa at 1 site in Italy.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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 Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmela Leone, MD (00393203047748, carmela.leone@asp.rg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT05075642, which also lists 32 linked publications.
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 13 Oct 2021.