Neurogenic Bladder and Quality of Life in Patients With Stroke

NCT04072796 | Completed

• 1 other identifier: TURKEYPMR
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Complication; Neurogenic Bladder

Keywords

urinary bladder, neurogenic; quality of life; socioeconomic factors; stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Beck Depression Inventory

  15 minutes

• Mini Mental Test (MMT)

  15 minutes

• Brunnstrom scale

  15 minute

• Functional Ambulation Category

  15 minute

• Barthel Index (BI)

  15 minute

Study Arms (2)

Case group

Case group reported urinary complaints

Behavioral: Questionnaires

Control group

Control group did not have any urinary complaints.

Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

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

Case group; Control group

Eligibility Criteria

• Age: 30 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 22748867 BACKGROUND

• 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.

  PMID: 28716321 BACKGROUND

• 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.

  PMID: 25642097 BACKGROUND

• 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.

  PMID: 27734771 BACKGROUND

MeSH Terms

Conditions

Stroke; Urinary Bladder, Neurogenic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 Officials

• Kadriye Önes, Prof

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: January 15, 2015
• Primary Completion: December 15, 2015
• Study Completion: December 15, 2015
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)