Browsing by Subject "Pelvic Organ Prolapse"
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Item Open Access A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery.(Obstetrics and gynecology, 2014-02) Jelovsek, J Eric; Chagin, Kevin; Brubaker, Linda; Rogers, Rebecca G; Richter, Holly E; Arya, Lily; Barber, Matthew D; Shepherd, Jonathan P; Nolen, Tracy L; Norton, Peggy; Sung, Vivian; Menefee, Shawn; Siddiqui, Nazema; Meikle, Susan F; Kattan, Michael W; Pelvic Floor Disorders NetworkTo construct and validate a prediction model for estimating the risk of de novo stress urinary incontinence (SUI) after vaginal pelvic organ prolapse (POP) surgery and compare it with predictions using preoperative urinary stress testing and expert surgeons' predictions.Using the data set (n=457) from the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial, a model using 12 clinical preoperative predictors of de novo SUI was constructed. De novo SUI was determined by Pelvic Floor Distress Inventory responses through 12 months postoperatively. After fitting the multivariable logistic regression model using the best predictors, the model was internally validated with 1,000 bootstrap samples to obtain bias-corrected accuracy using a concordance index. The model's predictions were also externally validated by comparing findings against actual outcomes using Colpopexy and Urinary Reduction Efforts trial patients (n=316). The final model's performance was compared with experts using a test data set of 32 randomly chosen Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial patients through comparison of the model's area under the curve against: 1) 22 experts' predictions; and 2) preoperative prolapse reduction stress testing.A model containing seven predictors discriminated between de novo SUI status (concordance index 0.73, 95% confidence interval [CI] 0.65-0.80) in Outcomes Following Vaginal Prolapse Repair and Midurethral Sling participants and outperformed expert clinicians (area under the curve 0.72 compared with 0.62, P<.001) and preoperative urinary stress testing (area under the curve 0.72 compared with 0.54, P<.001). The concordance index for Colpopexy and Urinary Reduction Efforts trial participants was 0.62 (95% CI 0.56-0.69).This individualized prediction model for de novo SUI after vaginal POP surgery is valid and outperforms preoperative stress testing, prediction by experts, and preoperative reduction cough stress testing. An online calculator is provided for clinical use.III.Item Open Access Development and Validation of a Model for Predicting Surgical Site Infection After Pelvic Organ Prolapse Surgery.(Urogynecology (Hagerstown, Md.), 2022-10) Sheyn, David; Gregory, W Thomas; Osazuwa-Peters, Oyomoare; Jelovsek, J EricImportance
Surgical site infection (SSI) is a common and costly complication. Targeted interventions in high-risk patients may lead to a reduction in SSI; at present, there is no method to consistently identify patients at increased risk of SSI.Objective
The aim of this study was to develop and validate a model for predicting risk of SSI after pelvic organ prolapse surgery.Study design
Women undergoing surgery between 2011 and 2017 were identified using Current Procedural Terminology codes from the Centers for Medicare and Medicaid Services 5% Limited Data Set. Surgical site infection ≤90 days of surgery was the primary outcome, with 41 candidate predictors identified, including demographics, comorbidities, and perioperative variables. Generalized linear regression was used to fit a full specified model, including all predictors and a reduced penalized model approximating the full model. Model performance was measured using the c-statistic, Brier score, and calibration curves. Accuracy measures were internally validated using bootstrapping to correct for bias and overfitting. Decision curves were used to determine the net benefit of using the model.Results
Of 12,334 women, 4.7% experienced SSI. The approximated model included 10 predictors. Model accuracy was acceptable (bias-corrected c-statistic [95% confidence interval], 0.603 [0.578-0.624]; Brier score, 0.045). The model was moderately calibrated when predicting up to 5-6 times the average risk of SSI between 0 and 25-30%. There was a net benefit for clinical use when risk thresholds for intervention were between 3% and 12%.Conclusions
This model provides estimates of probability of SSI within 90 days after pelvic organ prolapse surgery and demonstrates net benefit when considering prevention strategies to reduce SSI.Item Open Access Incidence of adverse events after uterosacral colpopexy for uterovaginal and posthysterectomy vault prolapse.(Am J Obstet Gynecol, 2015-05) Unger, Cecile A; Walters, Mark D; Ridgeway, Beri; Jelovsek, J Eric; Barber, Matthew D; Paraiso, Marie Fidela ROBJECTIVE: We sought to describe perioperative and postoperative adverse events associated with uterosacral colpopexy, to describe the rate of recurrent pelvic organ prolapse (POP) associated with uterosacral colpopexy, and to determine whether surgeon technique and suture choice are associated with these rates. STUDY DESIGN: This was a retrospective chart review of women who underwent uterosacral colpopexy for POP from January 2006 through December 2011 at a single tertiary care center. The electronic medical record was queried for demographic, intraoperative, and postoperative data. Strict definitions were used for all clinically relevant adverse events. Recurrent POP was defined as the following: symptomatic vaginal bulge, prolapse to or beyond the hymen, or any retreatment for POP. RESULTS: In all, 983 subjects met study inclusion criteria. The overall adverse event rate was 31.2% (95% confidence interval [CI], 29.2-38.6), which included 20.3% (95% CI, 17.9-23.6) of subjects with postoperative urinary tract infections. Of all adverse events, 3.4% were attributed to a preexisting medical condition, while all other events were ascribed to the surgical intervention. Vaginal hysterectomy, age, and operative time were not significantly associated with any adverse event. The intraoperative bladder injury rate was 1% (95% CI, 0.6-1.9) and there were no intraoperative ureteral injuries; 4.5% (95% CI, 3.4-6.0) of cases were complicated by ureteral kinking requiring suture removal. The rates of pulmonary and cardiac complications were 2.3% (95% CI, 1.6-3.5) and 0.8% (95% CI, 0.4-1.6); and the rates of postoperative ileus and small bowel obstruction were 0.1% (95% CI, 0.02-0.6) and 0.8% (95% CI, 0.4-1.6). The composite recurrent POP rate was 14.4% (95% CI, 12.4-16.8): 10.6% (95% CI, 8.8-12.7) of patients experienced vaginal bulge symptoms, 11% (95% CI, 9.2-13.1) presented with prolapse to or beyond the hymen, and 3.4% (95% CI, 2.4-4.7) required retreatment. Number and type of suture used were not associated with a higher rate of recurrence. Of the subjects who required unilateral removal of sutures to resolve ureteral kinking, 63.6% did not undergo suture replacement; this was not associated with a higher rate of POP recurrence. CONCLUSION: Perioperative and postoperative complication rates associated with severe morbidity after uterosacral colpopexy appear to be low. Uterosacral colpopexy remains a safe option for the treatment of vaginal vault prolapse.Item Open Access Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery.(Obstetrics and gynecology, 2018-08) Jelovsek, J Eric; Chagin, Kevin; Lukacz, Emily S; Nolen, Tracy L; Shepherd, Jonathan P; Barber, Matthew D; Sung, Vivian; Brubaker, Linda; Norton, Peggy A; Rahn, David D; Smith, Ariana L; Ballard, Alicia; Jeppson, Peter; Meikle, Susan F; Kattan, Michael W; NICHD Pelvic Floor Disorders NetworkOBJECTIVE:To develop statistical models predicting recurrent pelvic organ prolapse, surgical complications, and change in health status 12 months after apical prolapse surgery. METHODS:Logistic regression models were developed using a combined cohort from three randomized trials and two prospective cohort studies from 1,301 participants enrolled in surgical studies conducted by the Pelvic Floor Disorders Network. Composite recurrent prolapse was defined as prolapse beyond the hymen; the presence of bothersome bulge symptoms; or prolapse reoperation or retreatment within 12 months after surgery. Complications were defined as any serious adverse event or Dindo grade III complication within 12 months of surgery. Significant change in health status was defined as a minimum important change of SF-6D utility score (±0.035 points) from baseline. Thirty-two candidate risk factors were considered for each model and model accuracy was measured using concordance indices. All indices were internally validated using 1,000 bootstrap resamples to correct for bias. RESULTS:The models accurately predicted composite recurrent prolapse (concordance index=0.72, 95% CI 0.69-0.76), bothersome vaginal bulge (concordance index=0.73, 95% CI 0.68-0.77), prolapse beyond the hymen (concordance index=0.74, 95% CI 0.70-0.77), serious adverse event (concordance index=0.60, 95% CI 0.56-0.64), Dindo grade III or greater complication (concordance index=0.62, 95% CI 0.58-0.66), and health status improvement (concordance index=0.64, 95% CI 0.62-0.67) or worsening (concordance index=0.63, 95% CI 0.60-0.67). Calibration curves demonstrated all models were accurate through clinically useful predicted probabilities. CONCLUSION:These prediction models are able to provide accurate and discriminating estimates of prolapse recurrence, complications, and health status 12 months after prolapse surgery.Item Open Access Natural history of lower urinary tract symptoms in treatment-seeking women with pelvic organ prolapse; the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).(American journal of obstetrics and gynecology, 2022-12) Kowalski, Joseph T; Wiseman, Jonathan B; Smith, Abigail R; Helmuth, Margaret E; Cameron, Anne; DeLancey, John OL; Hendrickson, Whitney K; Jelovsek, J Eric; Kirby, Anna; Kreder, Karl; Lai, H Henry; Mueller, Margaret; Siddiqui, Nazema; Bradley, Catherine SBackground
The association of pelvic organ prolapse with overactive bladder and other lower urinary tract symptoms, and the natural history of those symptoms are not well characterized. Previous cross-sectional studies demonstrated conflicting relationships between prolapse and lower urinary tract symptoms.Objective
This study primarily aimed to determine the baseline association between lower urinary tract symptoms and prolapse and to assess longitudinal differences in symptoms over 12 months in women with and without prolapse. Secondary aims were to explore associations between lower urinary tract symptoms and prolapse treatment. We hypothesized that: (1) prolapse is associated with the presence of lower urinary tract symptoms, (2) lower urinary tract symptoms are stable over time in patients with and without prolapse, and (3) prolapse treatment is associated with lower urinary tract symptom improvement.Study design
Women enrolled in the Symptoms of Lower Urinary Tract Dysfunction Research Network Observational Cohort Study with adequate 12-month follow-up data were included. Prolapse and lower urinary tract symptom treatment during follow-up was guided by standard of care. Outcome measures included the Lower Urinary Tract Symptoms Tool total severity score (in addition to overactive bladder, obstructive, and stress urinary incontinence subscales) and Urogenital Distress Inventory-6 Short Form. Prolapse (yes or no) was defined primarily when Pelvic Organ Prolapse Quantification System points Ba, C or Bp were >0 (beyond the hymen). Mixed-effects models with random effects for patient slopes and intercepts were fitted for each lower urinary tract symptom outcome and prolapse predictor, adjusted for other covariates. The study had >90% power to detect differences as small as 0.4 standard deviation for less prevalent group comparisons (eg, prolapse vs not).Results
A total of 371 women were analyzed, including 313 (84%) with no prolapse and 58 (16%) with prolapse. Women with prolapse were older (64.6±8.8 vs 55.3±14.1 years; P<.001) and more likely to have prolapse surgery (28% vs 1%; P<.001) and pessary treatment (26% vs 4%; P<.001) during the study. Average baseline Lower Urinary Tract Symptoms Tool total severity scores were lower (fewer symptoms) for participants with prolapse compared with those without (38.9±14.0 vs 43.2±14.0; P=.036), but there were no differences in average scores between prolapse groups for other scales. For all urinary outcomes, average scores were significantly lower (improved) at 3 and 12 months compared with baseline (all P<.05). In mixed-effects models, there were no statistically significant interactions between pelvic organ prolapse measurement and visit and time-dependent prolapse treatment groups (P>.05 for all regression interaction coefficients). The Lower Urinary Tract Symptoms Tool obstructive severity score had a statistically significant positive association with Pelvic Organ Prolapse Quantification System Ba, Bp, and point of maximum vaginal descent. The Lower Urinary Tract Symptoms Tool total severity scale had a statistically significant negative association with Pelvic Organ Prolapse Quantification System Ba and point of maximum vaginal descent. No other associations between prolapse and lower urinary tract symptoms were significant (P>.05 for all regression coefficients). Symptom differences between prolapse groups were small: all regression coefficients (interpretable as additive percentage change in each score) were between -5 and 5 (standard deviation of outcomes ranged from 14.0-32.4).Conclusion
Among treatment-seeking women with urinary symptoms, obstructive symptoms were positively associated with prolapse, and overall lower urinary tract symptom severity was negatively associated with prolapse. Lower Urinary Tract Symptoms Tool scores improved over 12 months regardless of prolapse status, including in those with treated prolapse, untreated prolapse, and without prolapse.