Reported outcomes and outcome measures in RCTs of laparoscopic and robotic interventions for pelvic organ prolapse in women: a systematic review.

BACKGROUND

Considerable variations exist in the selection and reporting of outcomes and outcome measures across randomized controlled trials (RCTs) evaluating surgical treatments for pelvic organ prolapse (POP). These variations hinder the ability to conduct comprehensive analyses and limit the comparability of results regarding safety and efficacy.

OBJECTIVE

To create an inventory of selected and reported outcomes and outcome measures in published RCTs evaluating laparoscopic and robotic surgical treatments for POP and to assess their variations. Additionally, we aimed to investigate methodological parameters and quality of outcome reporting in these studies.

METHODS

A comprehensive search was conducted across EMBASE, the Cochrane Central Register of Controlled Trials, and PubMed from inception to May 2025 to identify relevant RCTs. Data on study characteristics and reported outcomes were extracted and compiled. Outcomes were organized into overarching domains and sub-categorized into specific themes. We considered all RCTs on adult women in English language.

RESULTS

Forty-five RCTs involving a total of 4566 female participants were included. Across these studies, 83 outcomes and 59 different outcome measures were identified. The most reported outcomes were duration of operation (65%), postoperative pain (45%), quality of life (45%), intraoperative blood loss (40%), and anatomical correction (40%). Twelve outcome domains were recognized, with "intraoperative technical aspects and observations" being the most comprehensive, containing 11 unique outcomes. Less frequently reported outcomes included financial cost (20%), sexual function (10%), and the cosmetic appearance of surgical wounds (5%). Outcome measures were grouped into six domains, with quality of life representing the most diverse, encompassing 24 different measures. The Pelvic Organ Prolapse Quantification (POP-Q) system emerged as the most consistently utilized outcome measure.