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

BMC Urology

Study Protocol

Amitabh Jha¹  Jeffrey Rosenbluth¹  John T. Stoffel²  Sean P. Elliott³  Sara M. Lenherr⁴  Jeremy B. Myers⁴  Darshan P. Patel⁴  Angela P. Presson⁵  Blayne Welk⁶ 

[1] Department of Physical Medicine and Rehabilitation, University of Utah Health Care, Salt Lake City, Utah, USA;Department of Urology, University of Michigan, Ann Arbor, Michigan, USA;Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA;Division of Urology, Department of Surgery, University of Utah Health Care, 30 North 1900 East, Room #3B420, 84132, Salt Lake City, UT, USA;Divsion of Epidemiology, Department of Internal Medicine, University of Utah Health Care, Salt Lake City, Utah, USA;Divsion of Urology, University of Western Ontario, London, Ontario, Canada;

关键词: Urinary bladder;    Spinal cord injury;    Patient reported outcomes;    Quality of life;    Incontinence;    Bladder management;   

DOI  :  10.1186/s12894-017-0286-3

 received in 2017-08-10, accepted in 2017-10-02,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe majority of spinal cord injury (SCI) patients have urinary issues, such as incontinence, retention, and frequency. These problems place a significant burden on patients’ physical health and quality of life (QoL). There are a wide variety of bladder management strategies available to patients with no clear guidelines on appropriate selection. Inappropriate bladder management can cause hospitalizations and serious complications, such as urosepsis and renal failure. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder-management strategy but little is known about patient’s QoL with different bladder managements. Our study’s aim is to assess patient reported QoL measures with various bladder managements after SCI. This manuscript describes the approach, study design and common data elements for our central study.MethodsThis is a multi-institutional prospective cohort study comparing three different bladder-management strategies (clean intermittent catheterization, indwelling catheters, and surgery). Information collected from participants includes demographics, past medical and surgical history, injury characteristics, current and past bladder management, and SCI /bladder-related complications. Patient reported outcomes and QoL questionnaires were administered at enrollment and every 3 months for 1 year. Aims of this study protocol are: (1) to assess baseline QoL differences between the three different bladder-management strategies; (2) determine QoL impact when those using either form of catheter management undergo a surgery over the 1 year of follow-up among patients eligible for surgery; (3) assess the effects of changes in bladder management and complications on QoL over a 1-year longitudinal follow-up.DiscussionBy providing information about patient-reported outcomes associated with different bladder management strategies after SCI, and the impact of bladder management changes and complications on QoL, this study will provide essential information for shared decision-making and guide future investigation.Trial registrationTrial registration number: www.clinicaltrials.gov: Identifier: NCT0261608; U.S. National Library of Medicine, wwwcf.nlm.nih.gov: Identifier: HSRP20153564.

【 授权许可】

CC BY   
© The Author(s). 2017