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Figure 1 | BMC Women's Health

Figure 1

From: Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

Figure 1

Trial profile. Women who consent to participate in the study may be determined ineligible prior to randomization: (1) at the time of surgery if the surgeon determines that the fistula is 'not simple': (2) at the end of surgery if the fistula is not closed based on dye test results; and (3) 7 days after surgery if the fistula is not closed based on dye test results. Seven days after surgery, women with a closed fistula will be randomized to catheter removal on that day (i.e. the 7-day removal group) or to have the catheter kept in place for an additional 7 days (i.e. the 14-day removal group). Women will remain at the study site for an additional 7 days after catheter removal. On days 1, 3 and 7 after catheter removal, urine retention will be assessed and intermittent catheterization employed as needed. Women with a positive urinary dye test at 7 days following catheter removal will be classified as having experienced a repair breakdown and their participation in the study will be completed. Remaining women will be asked to return for a follow-up visit 3 months after the date of surgery.

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