The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patients
NCT ID: NCT06218927
Last Updated: 2024-01-23
Study Results
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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RECRUITING
40 participants
OBSERVATIONAL
2023-11-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Autologous hematopoietic stem cell transplantation (AHSCT)
Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT).
QoL monitoring
QoL questionnaire
Disease-modifying therapy
Patients who undergo disease-modifying therapy - standard treatment.
QoL monitoring
QoL questionnaire
Interventions
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QoL monitoring
QoL questionnaire
Eligibility Criteria
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Inclusion Criteria
* Subjects with signed informed consent
* Subjects able to undergo examination according to the protocol
* Patients indicated by neurologists to perform AHSCT or treated with the closest similar disease-modifying therapy (control group)
Exclusion Criteria
* Subjects after previous pelvic radiotherapy
* Subjects with evidence of microscopic or macroscopic hematuria
* Subjects with a history of bladder reconstruction (augmentation cystoplasty, catheterizable stoma), subjects after cystectomy
* Treatment with botulinum toxin injection into the bladder wall in the last 12 months
* Patients in whom the pharmacological treatment of the lower urinary tract has not been stable in the last 3 months and is being adjusted
* Patients whose lower urinary tract symptoms are not stable for at least 3 months
* Patients with a permanent catheter
* Patients with recurrent symptomatic lower urinary tract infections - 3 or more episodes of infection in the last 12 months
* Subjects with tubal urine screening-proven bacteriuria
* Patients with acute lower urinary tract inflammation at baseline
* Subjects with painful bladder syndrome
* Patients after sacral neuromodulation
* Patients with severe pelvic organ prolapse
* Patients after radical pelvic surgery
* Patients with a life expectancy of less than 5 years at the time of inclusion in the study
* Lactating women, pregnant women, women trying to get pregnant, or sexually active women without a tendency to use safe contraception (hormonal-based oral contraceptives, injectable contraception, hormonally active implants, sexual abstinence, vasectomy in a partner)
* Subjects who participated in another study in the previous 90 days
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Radek Paus Sýkora, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Jan Krhut, prof.,MD,PhD
Role: STUDY_DIRECTOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FNO-URO-RS-2023
Identifier Type: -
Identifier Source: org_study_id
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