RecruitingNCT06218927

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


Sponsor

University Hospital Ostrava

Enrollment

40 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria18

  • 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

Interventions

OTHERQoL monitoring

QoL questionnaire


Locations(1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

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NCT06218927


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