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

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

• Другое QoL monitoring
  QoL questionnaire

Первичные конечные точки

• QoL changes associated with MS treatment [Срок оценки: 30 months]

Вторичные конечные точки (2)

• Neurogenic Bladder Symptom Score (NBSS) [Срок оценки: 30 months]
• Patient satisfaction (PGI-I) [Срок оценки: 30 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Чехия · 1 центр

• University Hospital Ostrava — Ostrava

Публикации

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• Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology. 1996 Apr;46(4):907-11. doi: 10.1212/wnl.46.4.907. PMID 8780061
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• Henze T, Rieckmann P, Toyka KV; Multiple Sclerosis Therapy Consensus Group of the German Multiple Sclerosis Society. Symptomatic treatment of multiple sclerosis. Multiple Sclerosis Therapy Consensus Group (MSTCG) of the German Multiple Sclerosis Society. Eur Neurol. 2006;56(2):78-105. doi: 10.1159/000095699. Epub 2006 Sep 8. PMID 16966832
• de Seze M, Ruffion A, Denys P, Joseph PA, Perrouin-Verbe B; GENULF. The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines. Mult Scler. 2007 Aug;13(7):915-28. doi: 10.1177/1352458506075651. Epub 2007 Mar 15. PMID 17881401
• Schneider MP, Tornic J, Sykora R, Abo Youssef N, Mordasini L, Krhut J, Chartier-Kastler E, Davies M, Gajewski J, Schurch B, Bachmann LM, Kessler TM. Alpha-blockers for treating neurogenic lower urinary tract dysfunction in patients with multiple sclerosis: A systematic review and meta-analysis. A report from the Neuro-Urology Promotion Committee of the International Continence Society (ICS). Neuro PMID 31099113
• Panicker JN. Neurogenic Bladder: Epidemiology, Diagnosis, and Management. Semin Neurol. 2020 Oct;40(5):569-579. doi: 10.1055/s-0040-1713876. Epub 2020 Oct 16. PMID 33065745
• Alsaid B, Moszkowicz D, Peschaud F, Bessede T, Zaitouna M, Karam I, Droupy S, Benoit G. Autonomic-somatic communications in the human pelvis: computer-assisted anatomic dissection in male and female fetuses. J Anat. 2011 Nov;219(5):565-73. doi: 10.1111/j.1469-7580.2011.01416.x. Epub 2011 Jul 22. PMID 21781094

Идентификаторы

NCT: NCT06218927 · FNO-URO-RS-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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