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 AND HYPOTHESIS: While 2017 guidelines from The American College of Obstetricians & Gynecologists called for pessary replacement every 3 to 4 months, a recent study in Obstetrics and Gynecology suggested that uninterrupted pessary use up to 6 months is not an independent risk factor for development of pessary-related complications. METHODS: Our recent experience throughout the Covid-19 pandemic highlights the potential ramifications of delayed clinical follow-up. RESULTS: During the Covid-19 pandemic, 3 of our patients developed rectovaginal fistulae secondary to Gellhorn pessary erosion in the context of delayed clinical follow-up. Our patients had previously attended routine appointments every 3 months without complications until missed appointments secondary to the pandemic led to fistulae formation. CONCLUSION: We believe that delayed clinical follow-up of pessary management beyond 3 months due to the Covid-19 pandemic may lead to fistula complications in elderly women with Gellhorn pessaries.
Subject(s)
COVID-19 , Pelvic Organ Prolapse , Aged , Female , Follow-Up Studies , Humans , Pandemics , Pelvic Organ Prolapse/therapy , Pessaries , SARS-CoV-2ABSTRACT
INTRODUCTION AND HYPOTHESIS: This study aimed to evaluate the efficacy and safety of ring pessaries under continuous use for > 2 years. Our starting hypothesis was that their use without periodic removal, cleaning or replacement for between 24 to 48 months after insertion is safe and effective. METHODS: This was a prospective observational and descriptive study. One hundred one women who successfully completed the 24 first months of continuous use of a ring pessary were included and monitored for another 24 months. The objectives were to establish the percentage of patients maintaining its use 48 months after insertion, the reasons for discontinuation and the adverse events. Another purpose of this study was to determine the timing of replacement of the vaginal pessary in long-term users. RESULTS: Of the women, 92.1% (93/101) had successful pessary use, and it was discontinued by three patients (2.9%, 3/101); 76.2% (77/101) of the women continued pessary use after the end of the study, and in 16 (15.8%, 16/101) patients, after pessary removal, the prolapse disappeared and did not recur. Forty-five women (48.4%, 45/93) presented some adverse events that required temporary pessary removal. The most common one was an increase in vaginal discharge (73.3%, 33/45). In four women (8.9%, 4/45), the ring pessary was detected embedded in the vaginal epithelium. CONCLUSIONS: Continuous use of a ring pessary can be recommended for 2 years in hysterectomized women and for 4 years in non-hysterectomized women if there are no complications.