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TLDR of the most impactful studies. In the clurb, we all fam.

BENIGN GYNECOLOGY LANDMARK TRIALS

*** coming soon…

UROGYNECOLOGY LANDMARK TRIALS

Inspired by Dr. Jocelyn Fitzgerald’s Landmark Urogyn Trials List.

  • ABC Trial (Visco et al. NEJM 2013): Anticholinergic vs Botox for UUI.

    • Both botox and anticholinergics reduced UUI episodes equally. Botox had higher cure rates but more UTIs and urinary retention. Anticholinergics had more dry mouth.

  • ATLAS Trial (Richter et al. Obstet Gynecol 2010): Pessary vs PFMT vs Combined for SUI.

    • At 3 months, behavioral therapy provides more relief from bothersome symptoms and higher satisfaction than pessary, but by 12 months all three non-surgical strategies perform similarly if patients remain on therapy. Combined therapy is not superior to either alone, so starting with a single modality is reasonable.

  • BOOST Trial (Richter et al. FPMRS 2016): FI and AI after OASI.

    • At 24 wks, fecal incontinence (liquid/solid stool/mucus) occurred in 9% and anal incontinence (stool/gas) in 24%, with no significant difference between 3rd and 4th degree tears. Caucasian race and shorter second stage were independently associated with higher odds of anal incontinence.

  • CAPABLe Trial (Jelovsek et al. Lancet GI 2019): Loperamide & Biofeedback for FI.

    • At 24 wks, loperamide and biofeedback did not provide a clinically important or statistically significant improvement in FI severity vs placebo or education, and combination therapy produced only small additional benefits while increasing constipation.

  • CARE Trial (Brubaker et al. NEJM 2006): Abd SCP +/- Burch vs Abd SCP alone to prevent postop SUI.

    • In stress continent pts undergoing abdominal SCP for stage 2-4 prolapse, adding a Burch colposuspension roughly halves postop SUI at 3 months without increasing urge symptoms or urinary retention.

  • eCARE Trial (Nygaard et al. JAMA 2013): 7 yr f/u of CARE: Abd SCP +/- Burch to prevent postop SUI.

    • By 7 years after abdominal SCP, anatomic and symptomatic POP failures accumulate, but few pts undergo repeat POP surgery. Adding a Burch reduces long term de novo SUI.

  • ESTEEM Trial (Sung et al. JAMA 2019): Sling +/- perioperative PFMT for MUI.

    • For MUI, adding structured behavioral therapy and PFMT to MUS yields a small additional improvement in symptom scores and fewer subsequent LUTS treatments, but the between-group difference does not reach clinical importance.

  • MOAD Trial (Handa et al. Obstet Gynecol 2011): Examined pelvic floor disorders 5-10 years after CD vs VD.

    • 5-10 years after first delivery, spontaneous vaginal birth and especially operative vaginal birth are associated with substantially higher odds of SUI and POP compared with cesarean delivery without labor.

  • OPTIMAL Trial (Culligan et al. JAMA 2014): USLS vs SSLF +/- PFMT for apical prolapse.

  • eOPTIMAL Trial (NIDDK PFDN, JAMA 2018): 5y f/u of long‑term failure rates of apical prolapse repairs.

  • OPUS Trial (Ward et al. Obstet Gynecol 2012): Vaginal prolapse repair +/- ppx tension‑free vaginal tape to prevent postop SUI.

  • ORBIT Trial (Peters et al. J Urol 2009): PTNS vs tolterodine for OAB.

  • PESSRI Trial (Yoon et al. Obstet Gynecol 2007): Ring vs Gellhorn pessary for POP.

  • ROSETTA Trial (Gingell et al. JAMA 2016): Botox vs SNM for refractory UUI.

  • SISTeR Trial (Richter et al., NEJM 2007): Autologous rectus fascial sling vs Burch for SUI.

  • SuMIT Trial (Peters et al., J Urol 2010): PTNS vs sham therapy for OAB.

  • STEP Trial (Peters et al. J Urol 2013): Extension of SuMIT assessing long‑term maintenance of PTNS.

  • SUPeR Trial (Ghetti et al. Obstet Gynecol 2019): Transvaginal mesh hysteropexy vs hysterectomy with USLS for uterovaginal prolapse.

  • eSUPeR Trial (Ghetti et al., AJOG 2021): 10y f/u evaluating long‑term efficacy and safety of mesh vs native tissue hysteropexy.

  • TOMUS Trial (Richter et al. NEJM 2010): Retropubic vs transobturator MUS for SUI.

  • VALUE Trial (Nager et al. NEJM 2012): Preop urodynamic testing vs office evaluation alone for uncomplicated SUI.

GYNECOLOGY ONCOLOGY LANDMARK TRIALS

List determined by the SGO Education Committee. It is not meant to be comprehensive or an official study guide. Last updated: 2025.