To compare effects on activity between two catheter management systems after failed voiding trial after pelvic reconstructive surgery.
Women with a failed postoperative voiding trial after reconstructive pelvic surgeries were randomized to plug–unplug or continuous drainage catheters. The primary outcome was a mean activity assessment scale score. Secondary outcomes included urinary tract infection (UTI), time to passing outpatient voiding trial, and patient satisfaction. Enrollees who passed the voiding trial were assigned to a “Reference” arm. Ninety participants (30 per arm) provided more than 80% power to detect an effect size of 0.33 in the primary outcome, using a two-sided alpha of 0.05.
Sixty-three patients were randomized (32 plug–unplug, 31 continuous drainage). The first 30 participants discharged without a catheter comprised the reference arm. There was no difference in postoperative activity assessment scale scores (total: plug–unplug 70.3, continuous drainage 67.7, reference arm 79.4; P
=.090) between arms. Women in the continuous drainage arm noted more difficulty compared with the plug–unplug arm when managing the catheter “during the day” (P
=.043) and “all the time” (P
=.049) and felt the catheter impeded activities (P
=.012) and wearing clothes (P
=.005). The catheter arms had significantly higher rates of culture-positive UTI compared with the reference arm (58.7% vs 6.7%, P
<.001). However, rate of UTI did not differ between catheter arms (plug–unplug, 68.8% vs continuous drainage, 48.4%, P
=.625). The majority of patients passed their outpatient voiding trials at the initial postoperative visit (plug–unplug 71.9%, continuous drainage 58.1%, P
=.250). There was no difference in patient satisfaction, with the majority reporting they were “very satisfied” (plug–unplug 78.1%, continuous drainage 80.0%, reference 66.7%, P
Postoperative activity does not differ in patients discharged with plug–unplug or continuous drainage catheters, but those with plug–unplug perceive easier management and ability to complete activities of daily living. The plug–unplug method is an acceptable alternative to traditional catheterization after pelvic reconstructive surgery.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov