作者
Amy L. Askew,Samantha L. Margulies,Ijeoma Agu,Katie M. LeCroy,Elizabeth J. Geller,Jennifer M. Wu
摘要
To compare postoperative urinary retention rates in the early postoperative period between home and office catheter removal. Secondary outcomes included pain, difficulty, satisfaction, likelihood to use again, and health care utilization.We conducted a nonblinded, randomized controlled, noninferiority trial of women undergoing surgery for stress incontinence and prolapse from March 2021 to June 2022. Exclusion criteria were preoperative voiding dysfunction (need for self-catheterization or postvoid residual [PVR] greater than 150 mL), urethral bulking, and need for prolonged postoperative catheterization. Participants discharged with indwelling catheters because of an initial failed void trial were randomized 1:1 to home compared with office removal on postoperative day 3-4. For home removal, participants were instructed to remove the catheter at 7 am and to drink two glasses of water. If they had difficulty voiding 5 hours after catheter removal, they came to the office for a void trial. For office removal, participants returned for a backfill void trial with PVR assessment. Our primary outcome was rate of early postoperative urinary retention , defined as confirmed retention (PVR greater than half the voided volume) after catheter removal. Secondary outcomes were assessed at a 2-week call. Health care utilization (telephone calls and office visits) related to catheter issues was also assessed. At 80% power and α=0.05, we needed 100 participants (50/group) to detect a noninferiority margin of 11%.Among 117 participants, the home (n=59) and office (n=58) removal groups were similar in mean age (60 years vs 61 years), mean body mass index (29 vs 30), pelvic organ prolapse quantification system stage 3 or 4, and proportion who underwent hysterectomy or apical suspension. Sling procedures were more common in the office group (45.8% vs 77.6%). For our primary outcome, the rate of early postoperative retention was 11.9% in the home group and 22.4% in the office group ( P =.13). Our predetermined noninferiority margin was greater than the upper bound of our 95% CI; thus, we conclude noninferiority of home removal. For secondary outcomes, the home removal group was more likely to report "no pain" ( P =.02) and "very likely" to use this method again ( P =.004). There were no differences in difficulty or satisfaction between groups. Number of nursing calls was not different ( P =.66); however, number of office visits was higher in the office group (median 0 [interquartile range 0-1] vs 1 [1-1], P <.001).Postoperative urinary catheter removal by the patient at home was noninferior to office removal when early urinary retention rates were compared. Participants in the home removal group had fewer office visits and reported low pain, low difficulty, and high satisfaction.ClinicalTrials.gov , NCT04783012.