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Academic research project monitoring the effect of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) on multiple sclerosis-associated lower urinary tract symptoms.
An observational study (academic research project) monitoring the effect of autologous hematopoietic stem cell transplantation (AHSCT) in patients with multiple sclerosis (MS) on lower urinary tract symptoms occurrence. The main goal is to observe the influence of this treatment modality on changes in the quality of life. Secondary endpoints are the changes in the urodynamic parameters and lower urinary tract occurrence. The investigators assume the inclusion of a minimum of 20 patients with AHSCT and 20 patients in the control group with other disease-modifying therapy (DMT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous hematopoietic stem cell transplantation (AHSCT) | Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT). |
| |
| Disease-modifying therapy | Patients who undergo disease-modifying therapy - standard treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QoL monitoring | Other | QoL questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| QoL changes associated with MS treatment | The overall score from the baseline to the end of follow-up will be calculated, using the Qualiveen questionnaire. The 30-item Qualiveen is a specific health-related quality-of-life questionnaire for urinary disorders in patients with neurological conditions. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurogenic Bladder Symptom Score (NBSS) | The change in lower urinary tract symptoms will be measured by the NBSS score, from baseline to the end of follow-up. The Neurogenic Bladder Symptom Score (NBSS) (24-item) is a freely available, self-administered, questionnaire that assesses urinary symptoms and bladder-related consequences in patients with acquired or congenital neurogenic bladder dysfunction as a result of spinal cord injury, multiple sclerosis, and spinal bifida. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with multiple sclerosis referred for HSCT or referred for other DMT.
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| Name | Affiliation | Role |
|---|---|---|
| Radek Paus Sýkora, MD | University Hospital Ostrava | Principal Investigator |
| Jan Krhut, prof.,MD,PhD | University Hospital Ostrava | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8482974 | Background | Cohen RA, Kessler HR, Fischer M. The Extended Disability Status Scale (EDSS) as a predictor of impairments of functional activities of daily living in multiple sclerosis. J Neurol Sci. 1993 Apr;115(2):132-5. doi: 10.1016/0022-510x(93)90215-k. | |
| 8780061 | Background | Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology. 1996 Apr;46(4):907-11. doi: 10.1212/wnl.46.4.907. |
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There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 30 months |
| Patient satisfaction (PGI-I) | Patient satisfaction associated with the treatment of multiple sclerosis will be monitored using the PGI-I tool (Patient Global Impression of Improvement) from baseline to the end of follow-up. The PGI-I is a global index that may be used to rate the response of a condition to a therapy (transition scale). | 30 months |
| 27956442 | Background | Doshi A, Chataway J. Multiple sclerosis, a treatable disease. Clin Med (Lond). 2016 Dec;16(Suppl 6):s53-s59. doi: 10.7861/clinmedicine.16-6-s53. |
| 16966832 | Background | Henze T, Rieckmann P, Toyka KV; Multiple Sclerosis Therapy Consensus Group of the German Multiple Sclerosis Society. Symptomatic treatment of multiple sclerosis. Multiple Sclerosis Therapy Consensus Group (MSTCG) of the German Multiple Sclerosis Society. Eur Neurol. 2006;56(2):78-105. doi: 10.1159/000095699. Epub 2006 Sep 8. |
| 17881401 | Background | 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. |
| 31099113 | Background | Schneider MP, Tornic J, Sykora R, Abo Youssef N, Mordasini L, Krhut J, Chartier-Kastler E, Davies M, Gajewski J, Schurch B, Bachmann LM, Kessler TM. Alpha-blockers for treating neurogenic lower urinary tract dysfunction in patients with multiple sclerosis: A systematic review and meta-analysis. A report from the Neuro-Urology Promotion Committee of the International Continence Society (ICS). Neurourol Urodyn. 2019 Aug;38(6):1482-1491. doi: 10.1002/nau.24039. Epub 2019 May 16. |
| 33065745 | Background | Panicker JN. Neurogenic Bladder: Epidemiology, Diagnosis, and Management. Semin Neurol. 2020 Oct;40(5):569-579. doi: 10.1055/s-0040-1713876. Epub 2020 Oct 16. |
| 21781094 | Background | Alsaid B, Moszkowicz D, Peschaud F, Bessede T, Zaitouna M, Karam I, Droupy S, Benoit G. Autonomic-somatic communications in the human pelvis: computer-assisted anatomic dissection in male and female fetuses. J Anat. 2011 Nov;219(5):565-73. doi: 10.1111/j.1469-7580.2011.01416.x. Epub 2011 Jul 22. |
| 29623108 | Background | Abello A, Das AK. Electrical neuromodulation in the management of lower urinary tract dysfunction: evidence, experience and future prospects. Ther Adv Urol. 2018 Feb 22;10(5):165-173. doi: 10.1177/1756287218756082. eCollection 2018 May. |
| 19449014 | Background | Michel MC, Sand C. Effect of pre-contraction on beta-adrenoceptor-mediated relaxation of rat urinary bladder. World J Urol. 2009 Dec;27(6):711-5. doi: 10.1007/s00345-009-0416-y. |
| 19818081 | Background | Cartwright R, Panayi D, Cardozo L, Khullar V. Reliability and normal ranges for the Patient's Perception of Intensity of Urgency Scale in asymptomatic women. BJU Int. 2010 Mar;105(6):832-6. doi: 10.1111/j.1464-410X.2009.08846.x. Epub 2009 Oct 10. |
| 11948720 | Background | Schafer W, Abrams P, Liao L, Mattiasson A, Pesce F, Spangberg A, Sterling AM, Zinner NR, van Kerrebroeck P; International Continence Society. Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn. 2002;21(3):261-74. doi: 10.1002/nau.10066. |
| 15906795 | Background | Dicuio M, Pomara G, Menchini Fabris F, Ales V, Dahlstrand C, Morelli G. Measurements of urinary bladder volume: comparison of five ultrasound calculation methods in volunteers. Arch Ital Urol Androl. 2005 Mar;77(1):60-2. |
| 18394545 | Background | 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. |
| 24518764 | Background | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |