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Tracks bladder symptoms and quality of life after stem cell transplant in multiple sclerosis

Follows adults with multiple sclerosis who have urinary symptoms after stem cell transplantation.

Plain-language title generated from the registry record
Registry title: The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patients

Key facts

Where
Ostrava, CzechiaSee the site

Where in Czechia

  • University Hospital OstravaOstrava, CzechiaTaking people

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Trial details

Who runs it
University Hospital Ostrava
Trial code
NCT06218927
Record updated
23 January 2024
Original description
Academic research project monitoring the effect of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) on multiple sclerosis-associated lower urinary tract symptoms.Read full original descriptionShow less

The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related Quality of Life in Multiple Sclerosis Patients

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

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 after previous pelvic radiotherapy; Treatment with botulinum toxin injection into the bladder wall in the last 12 months; Patients after radical pelvic surgery; 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; Subjects with a history of bladder cancer; Subjects with a history of bladder reconstruction (augmentation cystoplasty, catheterizable stoma), subjects after cystectomy; Patients with recurrent symptomatic lower urinary tract infections - 3 or more episodes of infection in the last 12 months; Subjects with painful bladder syndrome; Subjects with evidence of microscopic or macroscopic hematuria; 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; Subjects with tubal urine screening-proven bacteriuria; Patients with acute lower urinary tract inflammation at baseline; Patients after sacral neuromodulation; Patients with severe pelvic organ prolapse; Patients with a life expectancy of less than 5 years at the time of inclusion in the study.

ClinicalTrials.gov NCT06218927