(167) Penile Plication is Well Tolerated Under Conscious Sedation: A Prospective Comparison of Deep Intravenous Vs. Nursing Administered Conscious Sedation

Abstract

Abstract Introduction Penile plication is a common and effective surgical treatment for Peyronie's Disease. Although generally performed under general or spinal anesthesia, patient tolerability of penile plication under conscious sedation (CS) has several advantages: reduced anesthetic risk, health care cost savings, decrease wait times, and the ability conduct in outpatient facilities. While CS would provide significant potential benefit, there have been no evaluations of patient-reported tolerability to penile plication completed under conscious sedation nor comparisons with varying administrations. Objective To evaluate and compare patient-reported tolerability of penile plication performed under two CS sedation approaches: (1) deep intravenous conscious sedation (IVCS) administered by anesthesiologists and (2) nursing administered conscious sedation (NACS). Methods We evaluated procedure tolerability in a prospective cohort of 40 adult patients (23 IVCS; 17 NACS) undergoing primary penile plication between August 2022 and May 2023. Revision surgeries, and those with hourglass or hinge deformities were excluded. IVCS patients were administered midazolam (5mg) and ketamine (20mg) along with a continuous infusion of propofol (25-50 mcg/kg/min) and remifentanil (0.05 mcg/kg/min). NACS sedation protocol consisted of midazolam (1-2 mg) and fentanyl (50-100 ug). Patient baseline characteristics, procedure information, pain assessments (Likert scale; 0 [no pain]-10[most pain]) made by the patient and surgeon before during and after the procedure were collected. Following a post-surgical healing period, patients were contacted and administered an evaluated standardized patient tolerability questionnaire. Overall patient tolerability, pain assessments, and complication rates were compared descriptively, and using Wilcoxon sign-rank tests and McNemar tests. Results Baseline characteristics were similar between IVSC and NACS groups. Median pre-operative curvature of the IVCS cohort was 55 degrees (IQR=43.75-76.25) whereas the NACS curvature was 45 degrees (IQR=45-60). There was a 100% procedural success rate with no intra-operative concerns leading to the abortion of the procedure or conversion to general anesthetic. At six-week post-operative follow up, all patients had functional curvature. 100% of patients in the IVCS and NACS cohorts reported that they would recommend CS to others. Additionally, 95% (19/20; CI95=75.3%-99.0%) of those undergoing IVCS and 93.3% (14/15; CI95=70.2-98.8%) of the NACS cohort would choose CS over general anesthetic if they had to undergo the same surgery again. Sedation choice did not differ between CS groups (p=1.0). Most patients reported no pain pre-operatively (IVCS:[18/20]; NACS:[13/15]; p=1.0), peri-operatively (IVCS:[16/20]; NACS:[13/15]; p=0.68), or immediately post-operatively (IVCS:[14/20]; NACS:[14/15]; p=0.20). Two-hour post-operative pain did not differ between groups (p=0.89). Median two-hour post-operative IVCS pain was 2.5 (IQR=0-5.0) whereas median NACS pain was 3.0 (IQR=1.5-3.0). Conclusions Penile plication is exceptionally well tolerated when completed under either anesthesiologist administered intravenous conscious sedation or nursing administered conscious sedation. Most patients would choose conscious sedation over general anesthetic for the procedure in the future and all would recommend conscious sedation to others. Self-reported pain did not differ between groups and most patients reported no pain pre-, peri-, or immediately post-operatively. These results suggest that penile plication surgery can be completed in an outpatient setting under conscious sedation administered by trained nursing staff, which is expected to decrease costs, risks and wait-times of the procedure. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.