Lower Urinary Tract Symptoms, Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Lower Urinary Tract Symptoms, Autologous Hematopoietic Stem Cell Transplantation, Disease-Modifying Therapy, Quality of Life
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).
Interventions
OTHERQoL monitoring
QoL questionnaire
Sponsors
University Hospital Ostrava
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoL changes associated with MS treatment | 30 months | The overall score from the baseline to the end of follow-up will be calculated, using the Qualiveen questionnaire. The 30-item Qualiveen is a specific health-related quality-of-life questionnaire for urinary disorders in patients with neurological conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurogenic Bladder Symptom Score (NBSS) | 30 months | The change in lower urinary tract symptoms will be measured by the NBSS score, from baseline to the end of follow-up. The Neurogenic Bladder Symptom Score (NBSS) (24-item) is a freely available, self-administered, questionnaire that assesses urinary symptoms and bladder-related consequences in patients with acquired or congenital neurogenic bladder dysfunction as a result of spinal cord injury, multiple sclerosis, and spinal bifida. |
| Patient satisfaction (PGI-I) | 30 months | Patient satisfaction associated with the treatment of multiple sclerosis will be monitored using the PGI-I tool (Patient Global Impression of Improvement) from baseline to the end of follow-up. The PGI-I is a global index that may be used to rate the response of a condition to a therapy (transition scale). |
Countries
Czechia
Outcome results
None listed