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
Aims: Vaginal atrophy (VA) in post-menopausal women with breast cancer (BC) is common and often exacerbated by endocrine therapies. Fractional CO2 intra-vaginal laser is a non-hormonal therapy designed to treat VA by improving microcirculation and collagen formation. We evaluated the feasibility of CO2 laser in women with BC on aromatase inhibitors (AI). Methods : In this single-arm pilot study, post-menopausal BC patients receiving adjuvant AI with symptomatic VA had 3 laser treatments scheduled 4 weeks apart. Clinician assessment, vaginal cytology, biopsy and questionnaires were undertaken at baseline and 12-weeks post treatment. The primary endpoint was improvement in the Urogenital Atrophy Questionnaire (UAQ) and Vaginal Health Index Scores (VHIS). Secondary end points were improvement in epithelial cytology and vaginal atrophy by central review and the Female Sexual Function Index (FSFI). Results : Between May 2017 and July 2020, 33 patients were enrolled. Slow recruitment and COVID-19 restrictions lead to premature study closure. Participants: median age 52 years (range 32-76), bilateral oophorectomy (n = 15, 45%), prior chemotherapy (n = 24, 73%) and bilateral mastectomy (n = 9, 27%). 27 patients completed all 3 pre-planned treatments and post-treatment assessment (T1 n = 30;T2 n = 30;T3 n = 28;post-Rx n = 27) and were eligible for final analysis. patient-reported vaginal dryness (100 vs 48%), irritation/itch (56 vs 19%), pain (63 vs 11%) and dyspareunia (89 vs 78%) all reduced in frequency at 12-weeks post treatment. VHIS score improved by a median of 5-points, predominantly due to an increase in epithelial integrity score. Reported vaginal dryness for most/all the time on UAQ reduced from n = 21/27 (78% to n = 8/27 (30%). No clinically meaningful improvement in sexual function domains was detected on UAQ and FSFI questionnaires. Cytology and histological findings will be presented. Conclusions : Pilot work suggests CO2 laser may be a feasible non-hormonal option for management of vaginal dryness and clinician-assessed VA, with little impact on sexual dysfunction.