Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair (Investigation to Minimize Prolapse Recurrence of the Vagina using Estrogen: IMPROVE).

ABSTRACT:

Objectives

To provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair.

Methods

Study population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal len

SUBMITTER: Rahn DD 

PROVIDER: S-EPMC7769931 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature