Neurogenic Bladder and Quality of Life in Patients With Stroke

Completed

• Conditions: Neurogenic Bladder; Stroke, Complication
• Interventions: Behavioral: Questionnaires

• Registration Number: NCT04072796
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2015-01-15
• Primary Completion: 2015-12-15
• Study Completion: 2015-12-15
• Status Verified: 2019-08
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-27
• Last Update Submitted: 2019-08-27
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Questionnaires	Control group did not have any urinary complaints.
Case group	Questionnaires	Case group reported urinary complaints

Primary Outcome Measures

Name	Time	Method
Short Form-36 (SF-36)	15 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Functional Ambulation Category	15 minute	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.
Brunnstrom scale	15 minute	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.
Beck Depression Inventory	15 minutes	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.
Mini Mental Test (MMT)	15 minutes	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.
Barthel Index (BI)	15 minute	Barthel Index (BI) evaluates functional independence in term of daily living activity. Total score is 100 points. A higher point indicates better functional status.

Trial Locations

Locations (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Turkey