Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse

There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.

There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.

There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.