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Multiple SclerosisNCT06218927

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

An observational study of Multiple Sclerosis and Lower Urinary Tract Symptoms, run by University Hospital Ostrava at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
QoL monitoring
How many people
40 participants
Where
1 siteCzechia
Study dates
1 Nov 2023to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with multiple sclerosis referred for HSCT or referred for other DMT.

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Czechia1 site, 1 recruiting

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

    Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz

    Radek Paus Sýkora, MD

    Recruiting

Other trials in Czechia

About this study

Official title: The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related Quality of Life in Multiple Sclerosis Patients

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

Read the detailed description

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).

Being tested
QoL monitoring
Keywords
Multiple Sclerosis, Lower Urinary Tract Symptoms, Autologous Hematopoietic Stem Cell Transplantation, Disease-Modifying Therapy, Quality of Life
Medical subject headings
Multiple Sclerosis, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QoL monitoringOther

    QoL questionnaire

Study groups in NCT06218927
Study groupRoleWhat they receive
Autologous hematopoietic stem cell transplantation (AHSCT)Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT).
Receives: Other: QoL monitoring
Disease-modifying therapyPatients who undergo disease-modifying therapy - standard treatment.
Receives: Other: QoL monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 months

Secondary outcomes (2)

  1. 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.

    Measured: 30 months

  2. 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).

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start1 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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-control
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06218927
Sponsor's protocol ID
FNO-URO-RS-2023
Status last verified
Jan 2024
First submitted
12 Jan 2024
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Publications

  • 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.

    PubMed 8482974

  • 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.

    PubMed 8780061

  • 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.

    PubMed 27956442

  • 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.

    PubMed 16966832

  • 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 17881401

  • 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.

    PubMed 31099113

  • 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.

    PubMed 33065745

  • 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.

    PubMed 21781094

  • 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.

    PubMed 29623108

  • 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.

    PubMed 19449014

  • 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.

    PubMed 19818081

  • 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.

    PubMed 11948720

  • 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.

    PubMed 15906795

  • 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.

    PubMed 18394545

  • 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.

    PubMed 24518764

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Lower Urinary Tract Symptoms, run by University Hospital Ostrava at 1 site in Czechia.

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 4 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 23 Jan 2024. 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 Czechia. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QoL changes associated with MS treatment (time frame: 30 months). 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 NCT06218927, which also lists 15 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 23 Jan 2024.

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