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

NCT03174600 | Completed

• 1 other identifier: 2017-YAHY
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Lower Urinary Tract Symptoms

Keywords

Stroke; Lower urinary tract dysfunction; Functional status; Mini mental test

Outcome Measures

Primary Outcomes (3)

• Change from baseline modified Barthel index at 3rd and 6th months

  Modified Barthel Index; is used to measure the disability experienced by the patient in performing activities of daily living. It comprises 10 items regarding activities of daily living and mobility and assesses feeding, transfer from wheelchair to bed and back, self-care, bathing, walking, climbing stairs, dressing, and bladder and bowel continence. Scoring is based on whether the patient requires help or not in performing any of the above mentioned activities.

  Up to 6 th months

• Change from baseline mini mental test score at 3rd and 6th months

  Mini mental test measures cognitive functions such as sense of direction, memory, attention, linguistic function, and visual-spatial abilities, as well as the ability to count, recall things, repeat, and carry out orders.\[19\] The possible score ranges from 0 to 30, with lower scores indicating more severe cognitive function disorders.

  Up to 6 th months

• Change from baseline incontinence quality of life questionnaire score at 3rd and 6th months

  Incontinence quality of life questionnaire assessed differences in disease-specific health related quality of life between urinary symptom subgroups. It is comprised of 22 statements designed to elicit subjective evaluations of urinary incontinence (UI)- related effects and concerns.

  Up to 6 th months

Secondary Outcomes (1)

• Change from baseline Danish Prostatic Symptom Score at 3rd and 6th months

  Up to 6 th months

Study Arms (1)

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

Other: Questionnaire

Interventions

Questionnaire 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.

Stroke patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients

Sponsors & Collaborators

• Hilal Yeşil: lead

Study Sites (1)

Hilal Yesil

Afyonkarahisar, Eyalet/Yerleşke, 0300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: June 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)