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Associate Professor, Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Washington University School of Medicine, St. Louis
Dr. Ghetti reports no financial relationships relevant to this field of study.
SYNOPSIS: Prediction models can provide helpful information regarding the risk of recurrence after prolapse surgery.
SOURCE: Jelovsek JE, Chagin K, Lukacz ES, et al; NICHD Pelvic Floor Disorders Network. Models for predicting recurrence, complications, and health status in women after pelvic organ prolapse surgery. Obstet Gynecol 2018;132:298-309.
The objective of this study was to develop statistical models to predict recurrent pelvic organ prolapse, surgical complications, and change in health status one year after apical prolapse surgery. Jelovsek et al used combined data from five studies conducted by the Pelvic Floor Disorders Network — three randomized trials and two prospective cohort studies, which together included data from 1,301 participants. The five studies had very different objectives. They were designed to determine the following: the rates of de novo stress incontinence after sacral colpopexy, the rates of de novo stress urinary incontinence after vaginal prolapse surgery with either retropubic midurethral sling or sham procedure, surgical outcomes following vaginal surgery for apical prolapse, the effect of standardized preoperative behavioral and pelvic floor muscle training compared to usual care, and colpocleisis postoperative outcomes.
Jelovsek et al created prediction models using logistic regression with prospective one-year outcome data from the five studies. Recurrent prolapse was defined by a composite definition including prolapse beyond the hymen, the presence of bothersome bulge symptoms, or prolapse reoperation or retreatment within 12 months after surgery. The authors identified 32 risk factors commonly used to counsel women about the risk of recurrence of prolapse or complication through consensus of 10 experienced surgeons within the Pelvic Floor Disorders Network. These 32 factors were considered for each model. Four models were explored for prediction of recurrence. Overall, 20% of subjects had recurrence. The factors that increased the risk of recurrent prolapse included vaginal apical suspension procedure compared with abdominal sacral colpopexy and larger POP-Q examination points Ba and GH, corresponding to the most distal anterior vaginal wall and size of genital hiatus. Two complication models were explored. Seventeen percent of subjects experienced any serious adverse event and 11% experienced one or more Clavien-Dindo grade III or higher complications. A Clavien-Dindo grade III complication is any surgical complication requiring surgical, endoscopic, or radiologic intervention. A grade IV complication is life-threatening, requiring management in an intensive care unit, and a grade V complication is death. Calibration curves demonstrated the models provide accurate estimates along a range of clinically relevant probabilities.
Patients come into my office every day and emphatically state that they do not want a pessary and they want to fix their prolapse once and for all. I frequently find myself reframing their expectations. I often tell patients that even after the most durable surgery available, 17% of women will need retreatment for pelvic floor disorders within seven years. These were the results of the extended follow-up study of the CARE trial.1 The prediction models developed by Jelovsek et al go beyond this basic estimate to provide a more thorough and accurate way to approximate an individual woman’s risk of recurrence and complication 12 months after surgery. The model is available at: http://riskcalc.org/PRECISE_Models/. The results are quite sobering. For a very healthy 63-year-old woman who had two prior births and is undergoing hysterectomy for stage 3 anterior predominant prolapse (anterior vagina descends to 2 cm beyond the hymen) and with the cervix at 5 cm within the introitus and average genital hiatus of 3 cm, the risk of recurrence based on the composite definition following a vaginal native tissue apical support procedure with hysterectomy (without anterior and posterior colporrhaphy) is 29%. When performed in conjunction with anterior and posterior colporrhaphies, the risk of recurrence decreases to 14%. The risk following abdominal sacral colpopexy alone is 4% vs. 2% for sacral colpopexy and concomitant colporrhaphies. Certainly, not all patients are candidates for a sacral colpopexy.
There are a variety of considerations in reviewing management options for prolapse. Conservative therapy is the first-line management for pelvic organ prolapse. Surgery is not indicated in women with asymptomatic pelvic organ prolapse. When reviewing primary surgical options, clinicians should consider a variety of factors: Does the patient desire reconstructive or obliterative surgery? Obliterative procedures (e.g., colpocleisis) are an option for women who do not plan to have future vaginal intercourse. Will a concomitant hysterectomy be performed? What is the optimal surgical route, abdominal vs. vaginal? Should a concomitant anti-incontinence surgery be performed? Will the repair involve native tissue only or the use of surgical mesh? The prediction models developed by Jelovsek et al augment the surgical decision-making algorithm by incorporating individual women’s risk factors. The models are an excellent resource for perioperative counseling.
I leave you with a question to ponder: What risks would you be willing to take for surgery with a 29% failure rate or greater? Extensive preoperative counseling is essential for women of all ages undergoing elective surgery for repair of prolapse.
Financial Disclosure: OB/GYN Clinical Alert’s Editor Jeffrey T. Jensen, MD, MPH, reports that he is a consultant for and receives grant/research support from ObstetRx, Bayer, Merck, and Sebela; he receives grant/research support from Abbvie, Mithra, and Daré Bioscience; and he is a consultant for CooperSurgical and the Population Council. Peer Reviewer Catherine Leclair, MD; Nurse Planners Marci Messerle Forbes, RN, FNP, and Andrea O’Donnell, FNP; Editorial Group Manager Terrey L. Hatcher; Executive Editor Leslie Coplin; Editor Jonathan Springston; and Accreditations Manager Amy M. Johnson, MSN, RN, CPN report no financial relationships relevant to this field of study.