Outcomes of patients who declined randomization to MiniMo trial.

OBJECTIVE

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<0.001). The commonest reason for declining participation in this study was the requirement for additional follow up.

CONCLUSIONS

Results of RCTs may be overstated compared to standard clinical care as seen in this study.