Impact of Lower Urinary Tract Dysfunction on Clinical Manifestation in Patients With Stroke

NCT ID: NCT03174600

Last Updated: 2017-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-01

Study Completion Date

2017-02-01

Brief Summary

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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

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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.

Conditions

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Lower Urinary Tract Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke patients

Stroke patients were questioned using the Danish Prostatic Symptom Score (DAN-PSS), and evaluated using modified Barthel index, incontinence quality of life questionnaire (I-QOL), and the Mini-Mental Test (MMT) on the 1st, 3rd and 6th months

Questionnaire

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hilal Yeşil

OTHER

Sponsor Role lead

Responsible Party

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Hilal Yeşil

Assist. Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hilal Yesil

Afyonkarahisar, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2017-YAHY

Identifier Type: -

Identifier Source: org_study_id

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