Clinical Trials in Czechia / NCT06218927
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Ostrava | Ostrava | Moravian-Silesian Region | Recruiting |
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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