About this trial
Academic research project monitoring the effect of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) on multiple sclerosis-associated lower urinary tract symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients with multiple sclerosis referred for HSCT or referred for other DMT.
Trial design
Case-control
Prospective
Treatments tested in this trial
QoL monitoring
Other interventionQoL questionnaire
Treatment groups
Trial outcomes
Primary outcomes
QoL changes associated with MS treatment
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 outcomes
Neurogenic Bladder Symptom Score (NBSS)
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)
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).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.