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 |
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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 | ||||