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JAMA Aug 2023In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse.... (Comparative Study)
Comparative Study Randomized Controlled Trial
IMPORTANCE
In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure.
OBJECTIVE
To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent.
DESIGN, SETTING, AND PARTICIPANTS
Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen.
INTERVENTIONS
Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).
MAIN OUTCOMES AND MEASURES
The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications.
RESULTS
Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of -9% for the lower limit of the CI (risk difference, -10.3%; 95% CI, -17.8% to -2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups.
CONCLUSIONS
Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure.
TRIAL REGISTRATION
TrialRegister.nl Identifier: NTR 6978.
Topics: Female; Humans; Middle Aged; Gynecologic Surgical Procedures; Pelvic Organ Prolapse; Treatment Outcome; Uterine Prolapse; Uterus; Aged
PubMed: 37581670
DOI: 10.1001/jama.2023.13140 -
Cureus Jul 2023The coronavirus disease 2019 (COVID-19) infection commonly presents with symptoms of fever, cough, and anosmia. However, there have been case reports of unusual symptoms...
The coronavirus disease 2019 (COVID-19) infection commonly presents with symptoms of fever, cough, and anosmia. However, there have been case reports of unusual symptoms associated with COVID-19. We encountered one such case where a 55-year-old male who tested positive for COVID-19 was noted to have, along with cough and vomiting, a new onset of left eyelid ptosis. COVID-19 infection and ptosis association is seldom seen and very few similar studies are reported.
PubMed: 37554604
DOI: 10.7759/cureus.41574 -
JAMA Aug 2023Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a... (Comparative Study)
Comparative Study Randomized Controlled Trial
IMPORTANCE
Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain.
OBJECTIVE
To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair.
DESIGN, SETTING, AND PARTICIPANTS
This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020.
INTERVENTIONS
The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation).
MAIN OUTCOMES AND MEASURES
The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events.
RESULTS
Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen.
CONCLUSIONS AND RELEVANCE
Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02431897.
Topics: Aged; Female; Humans; Middle Aged; Administration, Intravaginal; Estrogens, Conjugated (USP); Gynecologic Surgical Procedures; Hysterectomy; Hysterectomy, Vaginal; Pelvic Organ Prolapse; Secondary Prevention; Treatment Outcome; Uterine Prolapse; Vagina; Vaginal Creams, Foams, and Jellies
PubMed: 37581673
DOI: 10.1001/jama.2023.12317