The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patients

NCT06218927 | Recruiting

• 1 other identifier: FNO-URO-RS-2023
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Academic research project monitoring the effect of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) on multiple sclerosis-associated lower urinary tract symptoms.

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Keywords

Multiple Sclerosis; Lower Urinary Tract Symptoms; Autologous Hematopoietic Stem Cell Transplantation; Disease-Modifying Therapy; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Neurogenic Bladder Symptom Score (NBSS)

  30 months

• Patient satisfaction (PGI-I)

  30 months

Study Arms (2)

Autologous hematopoietic stem cell transplantation (AHSCT)

Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT).

Other: QoL monitoring

Disease-modifying therapy

Patients who undergo disease-modifying therapy - standard treatment.

Other: QoL monitoring

Interventions

QoL monitoring OTHER

QoL questionnaire

Autologous hematopoietic stem cell transplantation (AHSCT); Disease-modifying therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple sclerosis referred for HSCT or referred for other DMT.

You may qualify if:

• Subjects (male and female) aged 18 and over
• 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)

You may not qualify if:

• Subjects with a history of bladder cancer
• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (15)

• 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.

  PMID: 8482974 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.

  PMID: 8780061 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.

  PMID: 27956442 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.

  PMID: 16966832 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.

  PMID: 17881401 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.

  PMID: 31099113 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.

  PMID: 33065745 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.

  PMID: 21781094 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.

  PMID: 29623108 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.

  PMID: 19449014 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.

  PMID: 19818081 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.

  PMID: 11948720 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.

  PMID: 15906795 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.

  PMID: 18394545 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.

  PMID: 24518764 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Radek Paus Sýkora, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

• Jan Krhut, prof.,MD,PhD

  University Hospital Ostrava

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)