E-PACTII: Extension trial of Permanent vs delayed-Absorbable suture at the time of TLH & SCP

Objectives: Our primary objective was to determine long-term mesh complications ( >36 months) after minimally-invasive total hysterectomy and sacrocolpopexy (TLH+SCP) with a light-weight polypropylene mesh. Our secondary aims were to evaluate surgical success and late adverse events.

Methods: This second 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™ lightweight mesh during TLH + SCP for > stage II prolapse (POP), for follow-up > 36 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. Women who did not enter the extension trial but were confirmed to have mesh exposure at any follow up visit were carried forward as a mesh exposure. Secondary outcomes were: 1) surgical success, which was a composite outcome, defined as no subjective bulge on PFDI questionnaire, no prolapse beyond the hymen, or no retreatment for POP with either pessary or surgery; and 2) adverse events.

Results: Of the 106/200 randomized participants from the original study who participated in the first extension study, 82 women participated in this second extension study: 56 in-person and 26 via questionnaire only. Of these women, 46 were in the permanent suture group and 36 in the delayed absorbable group. Demographic characteristics are presented in Table 1. At a mean of 5.3 years post-surgery, cumulative mesh or suture exposure was 9.9% (18 out of 182) with 18 mesh exposures and 3 permanent suture exposures. Of those cases, 4 (3 mesh and 1 suture exposures) were incident cases since >2 year follow up. Table 2 describes surgical and adverse outcomes. Surgical success was 95.1%: 2 failed by bulge symptoms, 2 by prolapse beyond hymen, 1 by retreatment with pessary, and no retreatment with surgery. Few women reported minor complications, such as vaginal bleeding (4/80, 5%), granulation tissue (1/76, 1.3%), or vaginal discharge (1/76, 1.3%). The majority of patients (92.7%) reported “Very much better”, “Much better” or “A little better” on the PGII questionnaire. There were no serious adverse events including no cases of mesh erosion into bladder or bowel. The most commonly reported adverse events were: vaginal pain (n=3); vaginal bleeding (n=3), dyspareunia (n=6), and stress urinary incontinence (n=2). No significant differences across suture type were noted in any patient characteristic, surgical failure or adverse outcomes.

Conclusions: The prevalence of mesh exposure following TLH + SCP with a lightweight mesh rises slowly over time and approaches 10% > 5 years post-surgery. Success rates remained high and there were no delayed serious adverse events.