The influence of health status and age for outcomes after pelvic organ prolapse surgery – a nationwide register study

Larsudd-Kåverud J1, Gyhagen J2, Åkervall S1, Molin M3, Milsom I1, Gyhagen M1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 132
Best Urogynaecology & Female Pelvic Floor Dysfunctions
Scientific Podium Session 13
Thursday 24th October 2024
11:45 - 12:00
Hall N105
Surgery Pelvic Organ Prolapse Prolapse Symptoms
1. Institute of Clinical Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden, 2. Department of Geriatrics, Dalens Hospital, Stockholm, Sweden, 3. Statistical Consultancy Group, Gothenburg, Sweden
Presenter
Links

Abstract

Hypothesis / aims of study
We aimed to explore the influence of health status, according to the American Society of Anesthesiologists (ASA) physical status classification system and chronological age, on the results 1 year after surgery for pelvic organ prolapse (POP) in terms of cure, improvement, satisfaction, de novo symptoms, and adverse events.
Study design, materials and methods
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).
Results
16,027 women completed the questionnaires: Cohort 1, 55-64 years, n=6249; Cohort 2, 65-74 years, n=6696; Cohort 3, 75-96 years, n=3082. The distribution of ASA-class 3-4 was 1.5%, 1.3%, and 8.6% in cohorts 1–3, respectively. Women aged <75 years were more likely to be smokers (trend p <.0001) and having a BMI ≥30 (trend p <0.0009). Conversely, prior hysterectomy, cardiovascular disease, diabetes, lower urinary tract symptoms (LUTS), and estrogen treatments increased with age. There were no significant differences in cure and satisfaction rates with increasing age, with adjusted odds ratio per 10 years cure: aOR10y 0.99, (95%CI 0.94–1.05, trend p=0.79) (Figure 1); satisfied: aOR10y 0.96 (95%CI 0.91–1.01, trend p=0.13). The overall improvement rates decreased with increasing age, aOR10y, 0.85 (95%CI 0.80–0.9, trend p <0.0001) (Figure 1A). The age-related probability of cure was similar across ages for ASA-class 1-2, aOR10y, 0.99 (95%CI, 0.94–1.05) and ASA-class 3-4, aOR10y 1.01 (95%CI, 0.78–1.32) (Figure 1B). Approximately every second woman reported “Improvement” postoperatively for nocturia, urgency, bladder emptying difficulties, and urinary incontinence (Table 1). De novo symptoms occurred in 5-15%. The effect of age was most pronounced for nocturia, aOR10y, 1.88 (95%CI 1.70–2.08, trend p <0.0001), but did not change significantly for de novo bladder emptying difficulties (trend p=0.70).  The rate of ureteric, urethra injuries, and fistulas were comparable between age groups. Readmission was <2%, and the 30-day mortality rate was zero.
Interpretation of results
Regardless of age and ASA class, the vast majority of women expressed satisfaction with the result of POP surgery. The procedures used in this study appear to be highly effective and safe, even for older women and those with health issues.
Concluding message
A large national register dataset coupled with long-term follow-up allows for comprehensive analyses of healthcare results and provides valuable insights for patient-centered healthcare equality, quality improvement, and policy decision-making.
Figure 1
Figure 2
References
  1. https://www.kvalitetsregister.se/en/kvalitetsregister/hittaregister/registerarkiv/gynekologiskaoperationer.44199.html. Accessed Mars 29, 2024.
  2. https://skr.se/en/kvalitetsregister/omnationellakvalitetsregister.52218.html. In English. Accessed Mars 29, 2024.
  3. Tegerstedt G, Miedel A, Maehle-Schmidt M, Nyren O, Hammarström M. A short-form questionnaire identified genital organ prolapse. J Clin Epidemiol. 2005 Jan;58(1):41-6. doi: 10.1016/j.jclinepi.2004.06.008. PMID: 15649669.
Disclosures
Funding The study was financed by grants from the Swedish state under the agreement between the Swedish Government and the county councils, the ALF-agreement (No. ALFGBG-966115), Hjalmar Svenssons Fund (No. HJSV2021017). Clinical Trial No Subjects Human Ethics Committee Ethical approvals for this study were obtained from the Regional Ethical Review Board in Gothenburg (reference no. 345-17; June 15, 2017) and Swedish Ethical Review Authority (reference no. 2020-01359; May 6, 2020). The study used an anonymized dataset, and all women gave their written consent to participate. All women planned for surgery received written information about GynOp and were informed about the possibility of declining participation or opt-out at any time. Helsinki Yes Informed Consent Yes
Citation

Continence 12S (2024) 101474
DOI: 10.1016/j.cont.2024.101474

10/11/2024 17:53:53