Effect of stem cell transplantation on urinary function in MS patients
The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related Quality of Life in Multiple Sclerosis Patients
This study looks at whether stem cell transplantation can improve urinary problems and quality of life for people with multiple sclerosis compared to those receiving other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT06218927 on ClinicalTrials.gov |
What this trial studies
This observational study monitors the impact of autologous hematopoietic stem cell transplantation (AHSCT) on lower urinary tract symptoms in patients with multiple sclerosis (MS). The primary goal is to assess how this treatment affects the quality of life of participants. Additionally, the study will evaluate changes in urodynamic parameters and the occurrence of urinary tract symptoms. A minimum of 20 patients receiving AHSCT will be compared to 20 patients undergoing other disease-modifying therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with multiple sclerosis who are indicated for AHSCT or similar disease-modifying therapies.
Not a fit: Patients with a history of bladder cancer, previous pelvic radiotherapy, or unstable lower urinary tract symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for MS patients experiencing lower urinary tract symptoms.
How similar studies have performed: While there is limited data on AHSCT specifically for urinary symptoms in MS, similar approaches in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ostrava, Moravian-Silesian Region
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (Recruiting)
Study contacts
- Principal investigator: Radek Paus Sýkora, MD — University Hospital Ostrava
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.