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Recruiting Observational

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

NCT06218927 · tracked via the Priya Life Science Czechia tracker
Phase
Observational
Started
2023-11-01
Last updated
2024-01-23

Condition(s) studied

Multiple SclerosisLower Urinary Tract Symptoms

Investigational drug(s) / intervention(s)

QoL monitoring

QoL monitoring: QoL questionnaire

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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

Primary outcome measure(s)

  • QoL changes associated with MS treatment — 30 months
    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.

Trial sites (1)

FacilityCityRegionStatus
University Hospital Ostrava Ostrava Moravian-Silesian Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06218927 on ClinicalTrials.gov ↗ ← All trials in Czechia