This cohort study used data from the Swedish National Quality Register of Gynecological Surgery (GynOp), which was started in 1997 (1). In 2016, almost 6,500 prolapse surgeries were reported (coverage >93%) from 58 clinics. Data was prospectively and consecutively collected throughout the health care process, based on a preoperative evaluation (with postal- and web-based questionnaires), hospital records at admission, surgery, and discharge, and postoperative questionnaires. The Swedish Association of Local Authorities and Regions has reviewed and certified GynOp at the highest level (1) (2).
Study population
23,624 women aged 55 to 96 years who had their primary prolapse procedure in 2007–2017 were included. The following procedures were included, either as a single or a combined procedure: anterior and posterior colporraphy, perineorrhaphy, and colpocleisis. Patients with concomitant mesh surgery for urinary incontinence (UI) and apical surgery were excluded. The participants were allocated to three age cohorts: 55-64, 65-74, and 75-96 years and categorized according to ASA class 1–2 (healthy or mild systemic disease) and those with ASA class 3–4 (severe systemic disease with and without a constant threat to life). The anesthesiologist conducted the classification preoperatively. The procedures were performed as a day or inpatient case under local, regional, or general anesthesia.
The questionnaires
The preoperative questionnaire contained questions about height, weight, parity, prior surgery, smoking, estrogen usage, physical performance, and co-morbidities.
A validated question regarding symptoms of POP was used (3). 1-year postoperatively, symptomatic POP was present by affirming, “Do you have a feeling that something is bulging out from the vagina?” followed by the options “Never,” “Almost never,” and “1-3 times per month” (no POP), “1-3 times per week,” and “Daily” (POP). Nocturia was defined as usually urinating ≥2 times/night. Bladder emptying difficulties were affirmed when occurring “1-3 times per week or more often.” Body mass index (BMI, kg/m2) was calculated using information from the preoperative questionnaire.
Urinary urgency was present by affirming, “Have you had problems with a sudden onset of a strong need to urinate?” and deemed positive by the answers “1–3 times/week” or more often.” “Cure” meant that symptoms of POP occurred “Never,” “Almost never,” or “1-3 times per month.” “Improvement” was defined by being “greatly improved” and “improved” versus “unchanged” or “worse.”
“Satisfaction with the procedure” was evaluated by the answers “Very satisfied” and “Satisfied” (satisfied), and “Neither satisfied nor dissatisfied” and “Very dissatisfied” (not satisfied).
De novo nocturia denoted a preoperative frequency of <2 times per night and ≥2 times per night postoperatively. De novo symptoms of UI, urgency, and bladder emptying difficulties were defined as a frequency of ≥1 time per week postoperatively. Postoperative death or severe adverse events, which included readmission within 30 days of surgery or by answering in the affirmative about an affected or injured organ (ureter, urethra, or intestine) was recorded.
Statistics
Continuous variables were presented as mean and standard deviation, median, and interquartile range (Q1-Q3), and categorical data as number, percent, and 95% confidence interval (CI). For comparison between groups, the Mantel-Haenszel Chi-Square test was used for ordered categorical variables, and the Chi-Square test was used for non-ordered variables. The Kruskal-Wallis test was used for continuous variables. Logistic regression with adjustment for BMI was used to calculate the estimated age-related probability per 10 years of cure, improvement, satisfaction, and ASA class. Missing data were accounted for and excluded. The statistical testing was two-sided, and a significance level of p <.05 was used. Given the size of the study cohorts, an alfa level of .05, and a power value of 80%, the minimum significant difference in the prevalence of outcomes was 5% in pairwise comparisons between groups using Fisher’s exact test for the analysis. Analyses were performed using SAS, version 9.4 (SAS Institute, Inc., Cary, NC).