Five Year Prevalence of Pelvic Organ Prolapse After Vaginal Hysterectomy with Prophylactic Apical Support

Introduction

Pelvic organ prolapse (POP) is a condition that affects quality of life of millions of women worldwide and can affect physical, sexual, and emotional health. ¹ Hysterectomy is an important risk factor for POP and subsequent surgery.^2,3 During hysterectomy, apical uterovaginal support could be compromised, which may predispose women to developing subsequent prolapse.^3,4 This risk appears to be highest within five years of surgery (high risk [HR]: 6.0; 95% confidence interval [CI] 4.4–8.1).^3,4 The prevalence of posthysterectomy apical prolapse is typically between 6% and 8% of patients.^1,5,6

An apical support procedure that has been used conventionally to treat POP is McCall's culdeplasty. ⁷ The goal of this culdeplasty is to recreate the support provided by the cardinal and uterosacral ligament complexes in order to support the vaginal apex.^1,8 Current research suggests prophylactically reestablishing apical support at the time of vaginal hysterectomy can modify future risk of developing subsequent POP.^1,4,9 The characteristics of women who do and do not develop POP after hysterectomy with simultaneous McCall's culdeplasty are not well-described in the literature. Furthermore, there are few data on the prevalence of symptomatic POP posthysterectomy for benign indications, excluding women with prior histories of prolapses.

The aim of this study was to assess and describe the 5-year prevalence and the population of women who developed symptomatic POP after total vaginal hysterectomies (TVHs) with prophylactic McCall's culdeplasty. It was hypothesized that prophylactic support of the vaginal apex at the time of hysterectomy for benign indications (excluding baseline POP) would be associated with a low prevalence of subsequent POP rates.

Materials and Methods

All study procedures were approved and deemed to be exempt by the Mayo Clinic's institutional review board (IRB: 18-004614). A retrospective case-control study was performed including all women who underwent TVH with McCall's culdeplasty within the Mayo Clinic, including the Phoenix and Rochester locations. Selection of these cases began from May 1, 2000, when the electronic medical record (EMR) system was globally instituted at this institution, and ended on May 1, 2013, to facilitate a full 5-year follow-up as data collection occurred between July 2018 and July 2019. Patients were identified using Current Procedural Terminology codes 58260 (uterus <250 g) and 58290 (uterus >250 g) for vaginal hysterectomy.

Five years posthysterectomy was determined as the highest risk for developing prolapse based on data suggesting that the majority of posthysterectomy prolapses present by five years postoperatively. ³ Considering that increasing age is associated with an increased risk of developing prolapse and/or undergoing surgery for symptomatic prolapse, only women older than 45 were included in the analysis.^2,3,10

Patients' records were excluded from the study for histories of POP at time of their TVHs, known neoplasms at the time of the TVHs, deaths before 5-year follow-up, or losses to follow-up after surgery. To determine if women's records met inclusion criteria, gynecologic surgery consultation notes and operative reports were reviewed. Prolapse was defined as vaginal vault prolapse, enterocele, rectocele, or cystocele as determined by physical examination. Symptomatic prolapse was identified by evaluating notes from yearly gynecologic visits or annual examinations conducted by primary-care providers (PCPs). Physical examination was not required to determine presence or absence of prolapse in accordance with U.S. task force and the American College of Obstetricians and Gynecologists recommendations that women with no gynecologic complaints do not require pelvic examinations.^11,12 Asymptomatic women with no documented pelvic examinations performed within 5 years were classified as having no symptomatic prolapse.

All de-identified information was stored in a Health Insurance Portability and Accountability Act–compliant REDcap database and accessed only by study personnel.

Results

A total of 1289 vaginal hysterectomies were performed by minimally invasive gynecologic surgeons. Of these, 916 were excluded from analysis for the following one or more reasons: 669 (73.0%) had POP at the time of TVH; 115 (12.6%) had no prophylactic McCall's procedure; 91 (9.9%) had known neoplasms; 29 (3.2%) had missing operative reports; 9 (1.0%) died before 5 years; 5 (0.5%) were lost to follow-up, and 4 (0.4%) abdominal conversions were made from vaginal attempts. For 110 women, there were no documentation of pelvic examinations during any provider appointments prior to surgery and no descriptions of vaginal supports in the operative reports prior to hysterectomy. As prior or concurrent prolapse could not be excluded reasonably prior to hysterectomy, these records were excluded from the analysis.

Inclusion criteria were met by 263 patients (Fig. 1). These women were 93.5% non-Hispanic and 88.9% white, with an average age at TVH of 49.9 years (range: 45–77 years). The median parity was 2 deliveries (range: 0–9 deliveries). For women who had at least one delivery, 89.4% had at least one vaginal delivery. Demographic characteristics are reported in Table 1.

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FIG. 1.

Inclusion and exclusion criteria for women in the analysis. Flowchart shows the number of women excluded and included in the analysis. POP, pelvic organ prolapse; r/o, ruled out.

Of 263 women, 146 had at least one speculum examination—performed by a gynecologic surgeon, internist, family medicine provider, or midlevel provider within the 5-year postoperative time—documenting no symptomatic prolapse. A consistent method of documenting prolapse was not used across providers of different medical specialties; however, descriptions of gynecologic examinations were assessed qualitatively by researchers to determine the presence or absence of prolapse.

The remaining 117 of the 263 included patients who did not have any speculum examinations performed by a gynecologic surgeons or primary care providers within the 5-year study duration. Within these provider notes, the most–frequently cited reason for deferral of the pelvic examination was prior hysterectomy. However, all 117 women had external genitalia inspection and bimanual examinations performed, which showed no POP at the level of the vaginal introitus. In addition, all 117 patients answered that they did not have any genitourinary complaints or gynecologic symptoms when asked by their providers. These 117 women, therefore, were classified as having no symptomatic prolapse.

Of the total 263 patients, 9 women developed POP, resulting in a 5-year incidence of 3.4%. No statistically significant differences in age, race, body mass index, number of deliveries, or history of smoking were found between women who did and did not develop POP. Due to the low event threshold, no variables within the univariate or multivariate model were associated with statistical significance. Of the 263 women, 11 had stress urinary incontinence at the time of hysterectomy, and 6 of these women had a sling procedure performed during the TVH. None of these 11 women later developed POP within 5 years.

For women who did develop prolapse, 2 women had grade 1 rectoceles; 4 women had grade 1 cystoceles; 1 woman had both a grade 1 cystocele and a grade 1 rectocele; 1 woman had grade 1 apical prolapse with a mild rectocele; and 1 woman had a grade 1 cystocele, a grade 1–2 rectocele, and a grade 2 apical prolapse. For treatment for their prolapses, 4 women were managed expectantly (50%), 3 women received physical therapy (30%), 1 woman had a pessary placed (10%), and 1 woman was lost to follow-up (10%).

Discussion

For a sample of primarily white, multiparous women of average body habitus, receiving McCall's culdeplasty at the time of hysterectomy for benign indications was associated with a 3.4% rate of subsequent POP. In addition, there were no observed statistically significant differences between patients who did and did not develop POP.

These results suggest that patients who undergo prophylactic McCall's culdeplasty have a low rate of subsequent POP at 5 years' postsurgery. However, the true prevalence of POP posthysterectomy is difficult to describe. Women can be asymptomatic, unaware they have prolapse, or might choose not to seek care for their symptoms.^1,2 One survey of 65 hospitals in Austria reported a modified frequency of 6.52% for vault prolapse within 10 years. ⁵ There are additional studies that suggest prior hysterectomy increases the risk of surgery for POP or pelvic floor repair.^3,5,6,13 These studies, however, intentionally capture women with prolapse severe or symptomatic enough to warrant surgery. The studies do not provide information on the prevalence of mild-to-moderate prolapse in symptomatic women who choose to manage their prolapse by other methods (such as the 9 women in the current study's sample).

McCall's culdeplasty was first described in 1957, ⁷ and its benefits were demonstrated further in a randomized controlled trial performed by Cruikshank and Kovac in 1999 to prevent the development of POP. ¹⁴ Since 1999, however, apical procedures do not appear to have been adopted widely. An institutional study of hysterectomies performed from 2000 to 2010 for a diagnosis other than prolapse revealed that only 172 of 2145 (8.0%) vaginal hysterectomies included an apical support procedure. ⁶ This study was repeated in 2017 with a publicly available national database (National Inpatient Sample) from 2004 to 2013. Only 3.1% of inpatient hysterectomies performed for benign indications (excluding prolapse) used an apical support procedure. ⁴ Guidelines from the American Association of Gynecologic Laparoscopists in 2014, and the British Society of Urogynaecology and the Royal College of Obstetricians and Gynaecologists in 2015, have formally recommended that McCall's culdeplasty be used as an apical support procedure during vaginal hysterectomy to reduce the risk of postoperative apical prolapse.^1,15

There are several established risk factors for developing POP, such as white race, non-Hispanic ethnicity, obesity, parity, and vaginal delivery.^3,16,17 In the current sample of women, who all received McCall's culdeplasty, there were no differences between women who did and did not develop POP. This persisted despite the sample being primarily non-Hispanic white, overweight, and with histories of vaginal deliveries. This conclusion was limited, however, by the low event rate of prolapse within the study sample. Furthermore, 117 women in this sample had pelvic examinations without speculum examinations performed. Although these women had no visible prolapses and were not symptomatic, this excludes the possibility that the women had undocumented mild or asymptomatic prolapse such as grade 1 or possibly grade 2.

In addition, as previously stated, women might be hesitant to admit to having genitourinary symptoms even when asked directly. A larger population of women would need to be evaluated with apical support. A prospective study with standardized speculum examinations and prolapse-screening questions would capture the true posthysterectomy prolapse rate better.

This study was designed with a follow-up period of 5 years based on the results from prior research, which found rates of prolapse surgery dropped significantly after 5 years. ³ Future research could expand this follow-up period to evaluate the prevalence of prolapse posthysterectomy further, and trend the yearly intervals at which women are most at risk for developing prolapse.

Major limitations of this research included incomplete medical records, patients lost to follow-up, and inconsistency in staging and grading of prolapses. Women might have had additional visits and pelvic examinations performed at gynecologists' offices outside of the study institution, which would not have been captured in this data. In addition, women might have denied having symptoms of prolapse due to embarrassment. Determination of prolapse was limited to patient notes and documented physical examinations, which were often performed by nongynecologic surgeons. This increased the risk of provider documentation error or errors in data abstraction. Finally, this research did not compare cohorts of women who received McCall's culdeplasty to those who did not. Comparing these cohorts of women would require a large sample size of women over a long time period to evaluate if POP develops or not.

The strength of this study was in its novelty. All women who underwent vaginal hysterectomy with simultaneous McCall's culdeplasty were evaluated. In addition, 91.1% of all women who underwent hysterectomy received a McCall's culdeplasty which provided a robust sample for analysis.

Conclusions

An apical support procedure, such as McCall's culdeplasty, at the time of vaginal hysterectomy for benign indications could be associated with low rates of symptomatic POP within 5 years, regardless of prolapse-specific risk factors.