Abstract
The aim of this prospective randomized, double-masked, placebo-controlled, multicenter study was to analyze the surgeon’s individual assessment of tissue quality during pelvic floor surgery in postmenopausal women pre-treated with local estrogen therapy (LET) or placebo cream. Secondary outcomes included intraoperative and early postoperative course of the two study groups. Surgeons, blinded to patient’s preoperative treatment, completed an 8-item questionnaire after each prolapse surgery to assess tissue quality as well as surgical conditions. Our hypothesis was that there is no significant difference in individual surgical assessment of tissue quality between local estrogen or placebo pre-treatment. Multivariate logistic regression analysis was performed to identify independent risk factors for intra- or early postoperative complications. Out of 120 randomized women, 103 (86%) remained for final analysis. Surgeons assessed the tissue quality similarity in cases with or without LET, representing no statistically significant differences concerning tissue perfusion, tissue atrophy, tissue consistency, difficulty of dissection and regular pelvic anatomy. Regarding pre-treatment, the rating of the surgeon correlated significantly with LET (r = 0.043), meaning a correct assumption of the surgeon. Operative time, intraoperative blood loss, occurrence of intraoperative complications, total length of stay, frequent use of analgesics and rate of readmission did not significantly differ between LET and placebo pre-treatment. The rate of defined postoperative complications and use of antibiotics was significantly more frequent in patients without LET (p = 0.045 and p = 0.003). Tissue quality was similarly assessed in cases with or without local estrogen pre-treatment, but it seems that LET prior to prolapse surgery may improve vaginal health as well as tissue-healing processes, protecting these patients from early postoperative complications.
Highlights
Since estradiol receptors α and β (ESR1/2) were found in the squamous epithelium of the bladder, urethra, vagina and anal canal [1] as well as in the paraurethral tissues such as urethral sphincter, uterosacral ligaments and pelvic floor muscles [2], it is clear that the pelvic organs and their surrounding muscular and connective tissue support are estrogen-responsive.For some time, local estrogen therapy (LET) has become the focus of interest in the treatment of pelvic floor disorders
Majority of the baseline characteristics were comparable between the two groups (p > 0.05), except for uterus preserving surgery, which was significantly more frequently performed within the placebo group (34.6% vs. 21.6%; p = 0.043)
Ninety-six (93.2%) surgeries were performed by vaginal route, and 7 (6.8%) cases were operated by a laparoscopic route
Summary
Local estrogen therapy (LET) has become the focus of interest in the treatment of pelvic floor disorders. Little research with different results has been carried out on determining the effect of preoperative locally applied estrogen on the tissue quality as well as on the intraoperative and early postoperative course in postmenopausal patients undergoing surgical prolapse repair. In one study, evaluating the role of locally applied estrogen prior to POP surgery, no statistically significant increase in the thickness of the vagina in the treatment group compared to the placebo group could be observed [6]. Pre-treatment with vaginally applied estradiol has shown easier tissue handling and significant cervical ripening in postmenopausal women prior to operative hysteroscopy [7]. The authors concluded that this might be an improvement of the substrate for suture placement at the time of surgical repair [5]
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