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

January 12, 2024 updated by: University Hospital Ostrava

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Radek Paus Sýkora, MD
        • Sub-Investigator:
          • Jan Krhut, prof.,MD,PhD
        • Sub-Investigator:
          • Tomáš Rychlý, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with multiple sclerosis referred for HSCT or referred for other DMT.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Autologous hematopoietic stem cell transplantation (AHSCT)
Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT).
Other: QoL monitoring
QoL questionnaire
Disease-modifying therapy
Patients who undergo disease-modifying therapy - standard treatment.
Other: QoL monitoring
QoL questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL changes associated with MS treatment
Time Frame: 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.
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurogenic Bladder Symptom Score (NBSS)
Time Frame: 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.
30 months
Patient satisfaction (PGI-I)
Time Frame: 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).
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Radek Paus Sýkora, MD, University Hospital Ostrava
  • Study Director: Jan Krhut, prof.,MD,PhD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-URO-RS-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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