Hysterectomy with uterosacral suspension or Uphold (TM) hysteropexy in women with apical prolapse: a parallel cohort study
Mugdha Kulkarni, Natharnia Young, Joseph Lee, Anna Rosamilia
INTERNATIONAL UROGYNECOLOGY JOURNAL | SPRINGER LONDON LTD | Published : 2020
INTRODUCTION AND HYPOTHESIS: The aim was to compare objective and subjective cure rates between Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension. METHODS: A sample size of 49 in each arm would be required to detect a clinical difference of 20% between the groups. Owing to delayed recruitment, this originally planned randomised controlled trial was changed to a patient preference study after randomising initial 6 participants. Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included. Routine follow-up was scheduled at 6 weeks, 6 months, 12 months, and annually thereafter. Primary outcome was absence of stage ≥2 apical prolapse..View full abstract
This study was an investigator-initiated and -led study with financial support from Boston Scientific. These funds were transferred to Monash University fund at arm's length from the investigators and used to fund a research nurse salary and other costs related to the study.