Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury

BMC Urology, 2017 · DOI: 10.1186/s12894-017-0286-3 · Published: October 2, 2017

Spinal Cord Injury Urology Participation

Simple Explanation

Spinal cord injury (SCI) patients often experience urinary issues that significantly affect their quality of life. This study aims to evaluate patient-reported quality of life measures across different bladder management strategies after SCI. The study will compare clean intermittent catheterization (CIC), indwelling catheters (IDC), and surgical interventions. It will gather data on patient demographics, medical history, injury details, bladder management approaches, and SCI-related complications using questionnaires administered every 3 months for a year. The goal is to provide essential information for shared decision-making between patients and healthcare providers and to guide future research by understanding how different bladder management strategies, changes in management, and complications impact patient-reported outcomes.

Study Duration

1 year

Participants

900-1300 adult patients with acquired SCI

Evidence Level

Level 2: Prospective cohort study

Key Findings

1
The primary aim of the study is to determine baseline patient-reported QoL with three different bladder management strategies (CIC, IDC, and surgery) in SCI.
2
A secondary aim is to assess the comparative effectiveness of CIC/IDC versus surgery in terms of QoL over a 1-year follow-up among patients eligible for surgery.
3
The tertiary aim is to determine how changes in bladder management and urinary tract complications affect patient-reported outcomes and QoL during longitudinal follow-up.

Research Summary

This multi-institutional prospective cohort study aims to compare patient-reported outcomes related to different bladder management methods (CIC, IDC, and reconstructive surgery) in adult patients with acquired SCI. The study will collect data using questionnaires administered at enrollment and every three months for one year to assess QoL, bladder management changes, and urologic complications. The results of the study are expected to provide valuable insights into patient-centered care and shared decision-making for bladder management after SCI.

Practical Implications

Informed Decision Making

The study will provide essential information for shared decision-making between patients and healthcare providers when selecting bladder management strategies.

Improved Patient Care

Understanding patient-reported outcomes and quality of life associated with different bladder management approaches can help healthcare providers tailor treatment plans to better meet individual patient needs.

Future Research Guidance

The study's findings can guide future investigations focused on patient-centered outcomes and quality of life in individuals with SCI and neurogenic bladder.

Study Limitations

1
Descriptive approach for assessing the effects of changes in bladder management strategy and complications on QoL due to potentially limited sample size.
2
Potential for loss to follow-up, which could affect the study's power and generalizability.
3
Reliance on patient-reported outcomes, which may be subject to recall bias or subjective interpretation.

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