Status:
RECRUITING
The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patients
Lead Sponsor:
University Hospital Ostrava
Conditions:
Multiple Sclerosis
Lower Urinary Tract Symptoms
Eligibility:
All Genders
18+ years
Brief Summary
Academic research project monitoring the effect of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) on multiple sclerosis-associated lower urinary tract symptoms.
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06218927
Start Date
November 1 2023
End Date
December 1 2026
Last Update
January 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852