Neurogenic Bladder and Quality of Life in Patients With Stroke

Neurogenic Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072796
• Other study ID #: TURKEYPMR
• Status: Completed
• Start date: January 15, 2015
• Est. completion date: December 15, 2015

Study information

• Verified date: August 2019
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 15, 2015
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Bladder
• Stroke
• Stroke, Complication
• Urinary Bladder, Neurogenic

Intervention

Behavioral:
• Questionnaires
Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine and Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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