Outcomes of patients who declined randomization to MiniMo trial

Natharnia Young, Joseph Lee, Anna Rosamilia

Research output: Contribution to journalArticleResearchpeer-review

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Abstract

To evaluate lower urinary tract outcomes of eligible women who declined randomization to MiniArc? versus Monarc? (MiniMo) RCT. To explore reasons why eligible women declined participation. STUDY DESIGN:The medical records of 44 women who declined randomization to MiniMo were reviewed. Women had a phone questionnaire at a mean of 2.4 years after surgery (range 1.3-3.9) and asked to document their symptoms at 6 and 12 months after operation, if they had not attended previously. Objective cure was defined as a negative cough stress test. Subjective cure was defined as patient reporting no leak on cough, sneeze or exercise. Outcomes of patients who declined were compared with those who participated in the MiniMo RCT. Women were asked to outline their reasons for declining participation in the MiniMo RCT. RESULTS:Baseline characteristics were similar except for BMI, which was higher in the declined group compared to the randomized group. Subjective cure at 6 months (79 vs. 94 , p=0.01) and 12 months was significantly lower in the declined group (58 vs. 93 , p
Original languageEnglish
Pages (from-to)117 - 121
Number of pages5
JournalEuropean Journal of Obstetrics & Gynecology and Reproductive Biology
Volume195
DOIs
Publication statusPublished - 2015

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