Neurogenic Bladder and Quality of Life in Patients With Stroke

The Effects of Stroke Related Neurogenic Bladder on The Quality of Life: A Study of Turkish Population

This study investigated effects of the neurogenic bladder on the quality of life in stroke survivors. Patients were divided into two groups: the First group consisted of patients with neurogenic bladder and the Second group consisted of patients without neurogenic bladder.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bladder; Stroke, Complication
• Intervention / Treatment: Behavioral: Questionnaires

Detailed Description

Neurogenic bladder after stroke is a commonly encountered medical condition which slows down the recovery process and exacerbates the functional status of the patient. The neurogenic bladder may possibly affect the quality of life of patients with stroke.

Objectives: The aim of this study is to investigate the relationship between the quality of life and the neurogenic bladder in Turkish stroke survivors.

Methods: 71 patients with stroke were included in the study. Patients were divided into two groups: the First group consisted of patients with neurogenic bladder and the Second group consisted of patients without neurogenic bladder. Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires were applied to both groups for clinical evaluations.

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34186
    • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stroke patients who were hospitalised to Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.

Description

Inclusion Criteria:

• Hemorrhagic or ischemic stroke
• No previous stroke history
• Disease duration > 6 months

Exclusion Criteria:

• Patients with different stroke etiologies other than cerebrovascular events (such as traumatic and tumoral pathologies)
• Previous multiple stroke history
• Pre-stroke urinary complaints
• Previous urogenital surgery history
• Spinal Cord Injury (SCI)
• Prostate volume of > 35ml documented with urinary ultrasonography
• Bladder outlet obstruction
• Poorly controlled Diabetes Mellitus (DM)
• Concomitant neurological diseases such as Multiple Sclerosis and Parkinson's Disease
• Anticholinergic, alpha agonist-antagonist drug use
• Sensory and global aphasia
• Severe communication impairment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; Case group reported urinary complaints	Behavioral: Questionnaires; Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires
Control group; Control group did not have any urinary complaints.	Behavioral: Questionnaires; Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36 (SF-36)	Short Form-36 (SF-36) was used to evaluate the quality of life of the patients. The form consists of 36 items, which measure 8 dimensions. These include (1) Physical function, (2) Social function, (3) Pain, (4) Energy/vitality, (5) Role limitation due to emotional problems , (6) Role limitation due to physical health problems, (7) Mental health and (8) General perception of health. Each subscale is evaluated between 0-100 points. A higher score indicates the better health.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	Beck Depression Inventory was used to assess depressive signs. The scale consists of 21 items and the items are ordered from mild to severe. Evaluation is performed in a range of 0-63 points. The lower score indicates the better psychological profile.	15 minutes
Mini Mental Test (MMT)	Mini Mental Test (MMT) was used to evaluate the extent of cognitive impairment. MMT is divided into 5 main categories: orientation (10 points), memory (3 points), attention and calculation (5 points), recalling (3 points) and language (9 points). Total points is 30. Total score between 0-9 points is considered as severe cognitive impairment. Total score between 10-19 points is considered as moderate cognitive impairment. Total score between 20-23 points is considered as mild cognitive impairment. Total score between 24-30 points is considered as normal.	15 minutes
Brunnstrom scale	Brunnstrom scale is used to evaluate separately upper extremity, lower extremity or hand functions. Six stages are defined. Stage 1: No active movement, Stage 2: Mild spasticity, weak flexor-extensor synergy patterns, Stage 3: Marked spasticity, synergy patterns are evident, Stage 4: Some isolated movements other than synergy patterns can be seen, Stage 5: Decreased spasticity, most muscle activities are isolated, Stage 6: Phasic and well-coordinated isolated movements are performed. A higher point indicates the better status.	15 minute
Functional Ambulation Category	Functional Ambulation Category (FAC) was used to evaluate the functional status. FAC assesses human support for ambulation rather than assistive devices. FAC 0: nonfunctional ambulation, FAC 1: Ambulator- dependent for physical assistance level II FAC 2: Ambulator- dependent for physical assistance level I, FAC 3: Ambulator-dependent for supervision FAC 4: Ambulator-independent level surfaces only FAC 5: Ambulator-independent. A higher score indicates the better status.	15 minute
Barthel Index (BI)	Barthel Index (BI) evaluates functional independence in term of daily living activity. Total score is 100 points. A higher point indicates better functional status.	15 minute

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Study Chair: Kadriye Önes, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

General Publications

• Milsom I, Kaplan SA, Coyne KS, Sexton CC, Kopp ZS. Effect of bothersome overactive bladder symptoms on health-related quality of life, anxiety, depression, and treatment seeking in the United States: results from EpiLUTS. Urology. 2012 Jul;80(1):90-6. doi: 10.1016/j.urology.2012.04.004.
• Panfili Z, Metcalf M, Griebling TL. Contemporary Evaluation and Treatment of Poststroke Lower Urinary Tract Dysfunction. Urol Clin North Am. 2017 Aug;44(3):403-414. doi: 10.1016/j.ucl.2017.04.007.
• Kim KJ, Heo M, Chun IA, Jun HJ; PhDc; Lee JS, Jegal H, Yang YS. The relationship between stroke and quality of life in Korean adults: based on the 2010 Korean community health survey. J Phys Ther Sci. 2015 Jan;27(1):309-12. doi: 10.1589/jpts.27.309. Epub 2015 Jan 9.
• Best KL, Ethans K, Craven BC, Noreau L, Hitzig SL. Identifying and classifying quality of life tools for neurogenic bladder function after spinal cord injury: A systematic review. J Spinal Cord Med. 2017 Sep;40(5):505-529. doi: 10.1080/10790268.2016.1226700. Epub 2016 Oct 13.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2015
• Primary Completion (Actual): December 15, 2015
• Study Completion (Actual): December 15, 2015

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; stroke rehabilitation; socioeconomic factors; urinary bladder, neurogenic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Stroke; Urinary Bladder, Neurogenic
• Other Study ID Numbers: TURKEYPMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No