The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patients
Recruiting · NCT06218927 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital Ostrava
View the official record on ClinicalTrials.gov →Interventions studied
QoL monitoring
What this trial is about
Academic research project monitoring the effect of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) on multiple sclerosis-associated lower urinary tract symptoms.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- University Hospital Ostrava - Ostrava, Moravian-Silesian Region, Czechia