Abstract
Introduction and hypothesis
Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III–IV) and stress urinary incontinence.
Methods
This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.
Results
Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5–1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6–2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3–0.9]), with no retreatment in stage II.
Conclusions
Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.
ClinicalTrials.gov Identifier: NCT01166373.
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Acknowledgements
In addition to the authors, the following members of the Pelvic Floor Disorders Network participated in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial:
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Financial support
Supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1 HD054241, UG1 HD041261, UG1 HD054214, UG1 HD041267, UG1 HD069010, UG1 HD069006, UG1 HD069013, U24 HD069031) and the National Institutes of Health Office of Research on Women’s Health.
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I Meyer, RE Whitworth, AL Smith, VW Sung, MF Ackenbom, C Wai: No conflict of interest.
ES Lukacz: Research Support: Boston Scientific, Uroplasty/Cogentix, Pfizer; Consultant: Axonics.
AG Visco: Stock ownership: NinoMed.
D Mazloomdoost: Research Grant: Boston Scientific.
MG Gantz: Research Grant: Boston Scientific.
HE Richter: Research Grant: Renovia, Allergan;
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Meyer, I., Whitworth, R.E., Lukacz, E.S. et al. Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence. Int Urogynecol J 31, 2155–2164 (2020). https://doi.org/10.1007/s00192-020-04271-y
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DOI: https://doi.org/10.1007/s00192-020-04271-y