Clinical trial NCT06218927: The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patients
Official title: The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related Quality of Life in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lower Urinary Tract Symptoms
Keywords: Multiple Sclerosis
Lower Urinary Tract Symptoms
Autologous Hematopoietic Stem Cell Transplantation
Disease-Modifying Therapy
Quality of Life
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple sclerosis referred for HSCT or referred for other DMT.

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 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).

Eligibility 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

Primary outcomes:
measure: QoL changes associated with MS treatment
timeFrame: 30 months
Secondary outcomes:
measure: Neurogenic Bladder Symptom Score (NBSS)
timeFrame: 30 months
measure: Patient satisfaction (PGI-I)
timeFrame: 30 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Radek Paus Sýkora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ostrava
name: Jan Krhut, prof.,MD,PhD
role: STUDY_DIRECTOR
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