| 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 | ||||