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Hysterectomy with uterosacral suspension or Uphold™ hysteropexy in women with apical prolapse: a parallel cohort study

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Abstract

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. Secondary outcomes included a composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes were based on quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score).

Results

We recruited 50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016. Participants were followed up for a median of 25 months (23–96). Five women from the VH (10%) and 7 from the HP (14%) group were lost to follow-up. Combined anatomical and symptomatic outcomes were available for 41 (82%) VH and 39 (76%) in the HP group. There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50). We found no difference in the composite cure rate (78% VH vs 85% HP, 0.45) between the groups. There was no significant difference in surgical complications (p = 0.33), assessed using Clavien–Dindo classification. There was a 2% surgery rate for mesh exposure in the HP group.

Conclusions

Uphold™ uterine suspension and VH appear to have similar objective and subjective cure at 25 months, with no significant difference in surgical complications.

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Authors’ participation

M. Kulkarni: follow-up, database, manuscript preparation; N. Young: study design, recruitment, follow-up, database, manuscript preparation; J. Lee: study design, recruitment, follow-up, database, manuscript preparation; A. Rosamilia: study design, recruitment, follow-up, database, manuscript preparation.

Funding

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.

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Authors and Affiliations

  1. Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia

    Mugdha Kulkarni, Natharnia Young & Anna Rosamilia

  2. St. Vincents Clinic, UNSW Sydney Australia, Sydney, Australia

    Joseph Lee

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  1. Mugdha Kulkarni
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Corresponding author

Correspondence to Mugdha Kulkarni.

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Conflicts of interest

M. Kulkarni: none; N. Young: none; J. Lee: this study was an investigator-initiated and -led study with financial support by Boston Scientific. These funds were transferred to Monash University fund at arm’s length from the investigators and used to fund research nurse salary and other costs related to the study; A. Rosamilia: this study was an investigator-initiated and -led study with financial support by Boston Scientific. These funds were transferred to Monash University fund at arm’s length from the investigators and used to fund research nurse salary and other costs related to the study.

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Kulkarni, M., Young, N., Lee, J. et al. Hysterectomy with uterosacral suspension or Uphold™ hysteropexy in women with apical prolapse: a parallel cohort study. Int Urogynecol J 31, 2137–2146 (2020). https://doi.org/10.1007/s00192-020-04328-y

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