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NCT Number: NCT04072796

Neurogenic Bladder and Quality of Life in Patients With Stroke

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Behavioral

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

Primary outcomes

  1. Short Form-36 (SF-36)

    Time frame: 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 outcomes

  1. Beck Depression Inventory

    Time frame: 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.

  2. Mini Mental Test (MMT)

    Time frame: 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.

  3. Brunnstrom scale

    Time frame: 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.

  4. Functional Ambulation Category

    Time frame: 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.

  5. Barthel Index (BI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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