Neurogenic Bladder and Quality of Life in Patients With Stroke
27. august 2019 oppdatert av: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
71
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Istanbul, Tyrkia, 34186
- Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 88 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Stroke patients who were hospitalised to Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Case group
Case group reported urinary complaints
|
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.
|
Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Short Form-36 (SF-36)
Tidsramme: 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.
|
15 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Beck Depression Inventory
Tidsramme: 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.
|
15 minutes
|
|
Mini Mental Test (MMT)
Tidsramme: 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.
|
15 minutes
|
|
Brunnstrom scale
Tidsramme: 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.
|
15 minute
|
|
Functional Ambulation Category
Tidsramme: 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.
|
15 minute
|
|
Barthel Index (BI)
Tidsramme: 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.
|
15 minute
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Kadriye Önes, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. januar 2015
Primær fullføring (Faktiske)
15. desember 2015
Studiet fullført (Faktiske)
15. desember 2015
Datoer for studieregistrering
Først innsendt
23. august 2019
Først innsendt som oppfylte QC-kriteriene
27. august 2019
Først lagt ut (Faktiske)
28. august 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TURKEYPMR
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .