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

University Hospital Ostrava

Status

Enrolling

Conditions

Lower Urinary Tract Symptoms

Multiple Sclerosis

Treatments

Other: QoL monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT06218927

FNO-URO-RS-2023

Details and patient eligibility

About

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

Full 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 symptoms occurrence. The main goal is to observe the influence of this treatment modality on changes in the quality of life. Secondary endpoints are the changes in the urodynamic parameters and lower urinary tract occurrence. The investigators assume the inclusion of a minimum of 20 patients with AHSCT and 20 patients in the control group with other disease-modifying therapy (DMT).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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