ABSTRACT
Introduction: We previously reported a 6.1% rate of mesh/permanent suture exposure at 1 year after minimally-invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a light-weight polypropylene mesh. Vaginal mesh exposures may increase over time. Objective: The goal of this extension study was to evaluate total and incident mesh/permanent suture exposure rates at least 2 years after surgery. Our secondary aims were to evaluate surgical success and late adverse events. Methods: This extension study included women previously enrolled in the multicenter randomized trial of permanent (2-0 GoreTex) vs delayed-absorbable (2-0 PDS) suture with Upsylon™ mesh during TLH + SCP for > stage II prolapse (POP), for follow-up at least 24 months after surgery. Due to COVID-19, women were given the option of an in-person (symptoms + exam) or telephone visit (symptoms only). The primary outcome was total and incident permanent suture or mesh exposure, or symptoms suggestive of mesh exposure in women without a pelvic examination (vaginal bleeding, bothersome discharge, partner feeling mesh). Women who did not enter the extension trial but were confirmed to have mesh exposure at 1 year were carried forward as a mesh exposure. Secondary outcomes were: 1) Surgical success, which was defined as no subjective bulge on PFDI questionnaire, no prolapse beyond the hymen, and no POP retreatment and 2) Adverse events, which were classified according to Dindo grading scale. Results: 182/200 previously randomized participants were eligible for inclusion, of which 106 (58%) women (78 in-person and 28 via questionnaire only) agreed to the extension study. Demographic characteristics are presented in Table 1. At a mean of 3.9 years post-surgery, the rate of mesh/suture exposure was 7.7% (14/182): 5 in-person,1 in the questionnaire only group and 8 cases carried forward from 1-year follow-up. Only 2 were incident cases reported after 1-year follow-up. There were 2 cases of suture exposure in the original cohort at 1 year, and 0 suture exposures in the current group, for a carry forward rate of 1.1% (2/182). There was no significant difference in mean age or follow-up time for women with and without an exam. None reported vaginal bleeding/discharge, dyspareunia, or penile dyspareunia. Mesh/suture exposures were managed as follows: 4 (66.7%) vaginal estrogen, 2 (33.3%) office trimming and 1 (16.7%) vaginal mesh excision surgery. For women without a study visit, there was one reported mesh exposure which was treated with office removal. Surgical success was 93/ 106 (87.7%): 13/94 (13.8%) failed by bulge symptoms, 2/78 (2.6%) by prolapse beyond hymen, 1/85 (1.2%) by retreatment with pessary, and 0 retreatment with surgery. There were 34 (32%) subjects who reported an adverse event. The most common were vaginal atrophy (16), pelvic or vaginal pain (7), dyspareunia (5), UTI (3), vaginal bleeding (3), and vaginal discharge (3). There were no serious adverse events. Conclusions: The rate of incident mesh exposure between 1 and 3.9 years postsurgery was low, success rates remained high, and there were no delayed serious adverse events after TLH + SCP with lightweight polypropylene mesh (Table Presented).
ABSTRACT
Introduction: Telehealth has emerged as an increasingly useful tool to provide care amidst the COVID-19 pandemic. The acceptability and safety of telehealth has been previously reported in Urogynecology for preoperative counseling and postoperative care but not for new patient evaluation. Objective: To determine if new patient telehealth encounters are non-inferior to inperson office encounters for women presenting to a Urogynecology clinic using a patient satisfaction questionnaire. Secondary objectives were to assess number of follow up visits, phone calls, and travel distance and time. Methods: This was a randomized controlled trial of women presenting to a Urogynecology clinic for a new patient visit. Participants were randomized after appointment scheduling to either telehealth or in-person visits. Telehealth visits were scheduled for 15 minutes and conducted over a video platform by the attending physician. Pelvic exams were not performed over telehealth and patients were counseled and scheduled for follow-up including procedures and treatments. In-person visits included trainees and a pelvic exam. Patients completed the validated Patient Satisfaction Questionnaire-18 (PSQ-18) after their visit. The primary outcome was composite patient satisfaction on the PSQ-18 questionnaire. Demographics and health care utilization data were ed from chart review. Using a non-inferiority margin of 5 points on the PSQ-18 composite score, 25 patients per arm were required with a power of 80% and an alpha of 0.05. Results: From March to September 2021, 133 women were screened for eligibility, 71 were randomized, and 58 were included in the final analysis (30 in telehealth group and 28 in in-person group). Demographic characteristics were similar between groups. Patients overall had a high education level, with 60% having a college degree or higher. Patient satisfaction, as measured on the PSQ-18 questionnaire (maximum score 90), was high for both groups but higher for in-person visits vs telehealth visits (75.68 ± 8.55 vs 66.60 ± 11.80, P = 0.001, difference -9.08, 90% confidence interval -4.57 to -13.6) and our results were inconclusive with respect to determining non-inferiority. Patients ≥60 years reported higher rates of satisfaction overall compared to those younger than 60 years (P = 0.009). Women in the in-person group were more likely to perceive that they had enough time with the provider (P = 0.003) and their visit was timely and efficient (P = 0.016) despite having less attending physician face time. Women in the telehealth group expressed uncertainty regarding the format and the perceived benefits of telehealth. There were no differences in the number of follow up visits (P = 0.81), patient-initiated (P = 0.52) or staff-initiated phone calls (P = 0.07), distance from home to office (P = 0.87), or travel time from home to office (P = 0.94) between groups. There were no differences in treatments (surgical vs non-surgical) chosen based on PSQ-18 scores. Conclusions: Women seen by urogynecologic providers either in person or via telehealth demonstrated high satisfaction with their first visit. Although the results are inconclusive with respect to non-inferiority, telehealth is safe and does not impact conversion to surgical or procedural treatments. As telehealth use continues to demonstrate safety, efficacy, and tolerability by patients, we must educate providers and patients on the utility of this platform.