Clinical trial NCT03174600: Impact of Lower Urinary Tract Dysfunction on Clinical Manifestation in Patients With Stroke
Official title: The Course of Post-stroke Bladder Problems and Their Relation With Functional, Mental Status and Quality of Life: A Six-month Prospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Keywords: Stroke
Lower urinary tract dysfunction
Functional status
Mini mental test
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients

Brief summary: The course of post-stroke bladder problems and their relation with functional, mental status and quality of life: A six-month prospective, multicenter study

Detailed description: Lower urinary tract symptoms is a broad term of subjective urinary symptoms such as nocturia, urgency, urinary incontinence, and frequency of voiding, defined by the International Continence Society. Several disorders and conditions affecting the nervous system that controls the lower urinary system can result in neurogenic lower urinary tract dysfunction (LUTD). Stroke is one of these conditions. The literature review reveals that there is insufficient data regarding the course of LUTD symptoms other than urinary incontinence in stroke patients, and their relation with functional and mental status. The aim of this prospective, multi-center study was to determine the frequency and course of post-stroke LUTD from early term up to a period of six months, and to investigate the relation of LUTD with functional and mental status and quality of life in stroke patients.

This study was designed as a prospective study and included 70 stroke patients enrolled by the Neurogenic Bladder Study Group from five different centers across Turkey.

The demographic (age, sex, education, marital status and occupation) and clinical characteristics (side of the stroke, cause of the stroke, stroke localization and anticholinergic medication use) of the patients were obtained from the patient files and through face-to-face interviews. In addition, patients were questioned on the post-stroke 1st, 3rd, and 6th months in terms of bladder drainage methods (normal spontaneous urination, use of adjunct maneuvers such as crede, valsalva and tapping, presence of overflow, clean intermittent catheterization use, permanent catheter use) after stroke.

The patients were questioned using the Danish Prostatic Symptom Score (DAN-PSS), and evaluated using the Brunnstrom motor staging (hand, upper and lower extremities), modified Barthel index, incontinence quality of life questionnaire (I-QOL), and the Mini-Mental Test (MMT) on the 1st, 3rd and 6th months.

Eligibility criteria: Inclusion criteria were as follows: 1) a recent (one month) stroke in medically stable patients and 2) being older than 18 years.

Exclusion criteria were as follows:eria: 1) presence of a history of a prior cerebrovascular disease, 2) presence of a concurrent neurological disorder, 3) presence of an acute systemic disorder or a concomitant disease that could affect urination problems, 4) history of urinary system problems before stroke, and 5) patients incapable of answering questions due to any reason.

Primary outcomes:
measure: Change from baseline modified Barthel index at 3rd and 6th months
timeFrame: Up to 6 th months
measure: Change from baseline mini mental test score at 3rd and 6th months
timeFrame: Up to 6 th months
measure: Change from baseline incontinence quality of life questionnaire score at 3rd and 6th months
timeFrame: Up to 6 th months
Secondary outcomes:
measure: Change from baseline Danish Prostatic Symptom Score at 3rd and 6th months
timeFrame: Up to 6 th months
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Hilal Yesil
state: Eyalet/Yerleşke
Study officials:
References: