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. 2013 Feb 28;2013(2):CD004010. doi: 10.1002/14651858.CD004010.pub3
Outcome Units I II III
A. Patients' observations        
perceived alleviation of prolapse symptoms        
acceptability/ satisfaction with outcome of treatment        
B. Objective measures        
grade of prolapse with device in situ judged on clinical examination e.g. (which system?? ‐ ICS POP‐Q system (Bump 1996)        
Site‐specific grading of prolapse judged on clinical examination e.g. ICS POP‐Q system (Bump 1996)        
C. Quality of Life        
prolapse‐specific quality of life questionnaire e.g. P‐QoL (Bump 1996)        
generic quality of life or health status measures e.g. SF‐36 (Ware 1992)        
psychological outcome measures e.g. Hospital Anxiety and Depression Score (Zigmond 1983)        
 
D. Measures of Associated Symptoms
       
bladder problems (including UI, occult UI, relief of voiding difficulty)        
bowel problems (including relief of obstructed defaecation)        
sexual function (including acceptability to both partners)        
E. Complications        
associated with pessary use: fistula formation, ulceration, bleeding, discharge etc. [record all complications]        
Reasons for device removal        
F. Socio‐economic evaluations        
cost comparisons