Clinical trial NCT04072796: Neurogenic Bladder and Quality of Life in Patients With Stroke
Official title: The Effects of Stroke Related Neurogenic Bladder on The Quality of Life: A Study of Turkish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Complication
Neurogenic Bladder
Keywords: urinary bladder, neurogenic
quality of life
socioeconomic factors
stroke rehabilitation
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-08-28
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients who were hospitalised to Istanbul Physical Medicine and 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Form-36 (SF-36)
timeFrame: 15 minutes
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 15 minutes
measure: Mini Mental Test (MMT)
timeFrame: 15 minutes
measure: Brunnstrom scale
timeFrame: 15 minute
measure: Functional Ambulation Category
timeFrame: 15 minute
measure: Barthel Index (BI)
timeFrame: 15 minute
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Kadriye Önes, Prof
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.