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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • QoL monitoring

    Other intervention

    QoL questionnaire

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Autologous hematopoietic stem cell transplantation (AHSCT)1 intervention
Group B: Disease-modifying therapy1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 months

Secondary outcomes

1

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.

Time frame
30 months
2

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).

Time frame
30 months

Other outcomes

Sponsors and contacts

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