OBJECTIVE: To compare effects on activity between two catheter management systems after failed voiding trial after pelvic reconstructive surgery. METHODS: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. RESULTS: 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=.202). CONCLUSION: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, NCT03071211.
RCT Entities:
OBJECTIVE: To compare effects on activity between two catheter management systems after failed voiding trial after pelvic reconstructive surgery. METHODS: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. RESULTS: 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=.202). CONCLUSION: 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, NCT03071211.
Authors: Wenjin Cheng; Emily English; Whitney Horner; Carolyn W Swenson; Luyun Chen; Fernanda Pipitone; James A Ashton-Miller; John O L DeLancey Journal: Int Urogynecol J Date: 2022-09-21 Impact factor: 1.932