An observational study in Multiple Sclerosis and Lower Urinary Tract Symptoms, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by University Hospital Ostrava · Observational
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with multiple sclerosis referred for HSCT or referred for other DMT.
Exclusion Criteria:
Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT).
Other: QoL monitoring
Patients who undergo disease-modifying therapy - standard treatment.
Other: QoL monitoring
QoL questionnaire
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.
Time frame: 30 months
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.
Time frame: 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).
Time frame: 30 months
Plan to share: No — There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University Hospital Ostrava