Pelvic organ prolapse (POP) is a condition that is seen in up to 50% of women by examination in the United States.1 While it is a benign condition, it has been shown to greatly affect quality of life with common symptoms of vaginal bulge and pelvic pressure.1 Nonsurgical treatments include physical therapy and vaginal pessary. Several studies have shown improvement in POP symptoms, quality of life, bowel symptoms, and body image perception with vaginal pessary use.2–5
Severity of POP with pessary use in the short term has been evaluated previously in 2 studies.6,7 Handa and Jones6 evaluated women with symptomatic POP managed with pessary use over a 1-year period and found a significant improvement in the stage of disease, but no significant improvement in specific POP quantification (POPQ) points on examination. Jones et al7 similarly evaluated women with symptomatic POP over a 3-month period of pessary use and found a significant decrease in the genital hiatus (GH) measurement. Both studies showed promising short-term outcomes in women undergoing conservative management of symptomatic POP with vaginal pessary.
This study evaluates the effectiveness of long-term pessary use on the severity of POP over time. Specifically, we investigated whether a change in POPQ point GH occurs with increased duration of pessary use. We hypothesized that long-term pessary use in women with symptomatic POP is associated with a difference in POPQ point GH from baseline evaluation.
MATERIALS AND METHODS
This was a Hartford HealthCare IRB-approved (HHC-2017-0079) cohort study of women with symptomatic POP managed with pessary who underwent office-based care at a single pelvic reconstructive surgery practice from January 2014 to April 2017. This was a secondary analysis of a previously published randomized controlled trial of pessary use in women undergoing office management for POP and/or incontinence by Propst et al.8
Women 18 years or older with documented POPQ examination performed during the specified timeframe were included in the cohort. The baseline POPQ and characteristics were recorded from the earliest recorded outpatient evaluation within the institution’s electronic medical records (EMR) system before initial pessary placement. The patient’s examination from their last study visit was used as the endpoint for comparison. Exclusion criteria were patients younger than 18 years, those without POPQ examination documented at least once since January 2014, and those who performed self-maintenance of the pessary. The primary outcome studied was change in POPQ point GH. Secondary outcomes included changes in POP stage, pessary size, and type of pessary used. Demographic information, Pelvic Floor Distress Inventory (PFDI), Urinary Distress Inventory, Short Form (UDI-6), and Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) scores from their earliest recorded outpatient evaluation, history of prior incontinence or POP procedures, complications of pessary use (eg, epithelial erosions, fistula formation, pessary incarceration, and granulation tissue), and risk factors for complications (eg, diabetes mellitus, anticoagulation medication, and history of tobacco use) were also abstracted and recorded.
Descriptive statistics were calculated for demographic characteristics. Continuous variables (eg, age, BMI) were summarized with means and standard deviations. Parity was summarized with a median and interquartile range (IQR). Relationships between pessary use and time were evaluated with Pearson correlation or Spearman rank correlation coefficient as appropriate. The mean PFDI-20, UDI-6, and POPDI-6 scores according to most recent category of pessary were analyzed using Student t test. The mean Colorectal-Anal Distress Inventory-8 scores according to most recent category of pessary were analyzed using Mann-Whitney U test. All results yielding P less than 0.05 were deemed statistically significant. SPSS v. 21 (IBM Corp., Armonk, NY 2013) and MedCalc v. 16 and higher (MedCalc Software, 2016) were used for all analyses.
One hundred thirty-two women were included in the analysis and all completed follow-up. The mean age of the cohort was 80.6 ± 7.2 years, with median parity of 3 (IQR, 2–4). Median duration of pessary use was 39.5 months (IQR, 17–64.5 months). Table 1 shows demographic and baseline characteristics of the study cohort.
TABLE 1 -
Demographics and Baseline Characteristics (n = 132)
| Underweight <18.5
| Normal 18.5–24.9
| Overweight 25–29.9
| Obese ≥30
| Non-Hispanic White
| Non-Hispanic Black
|Prior prolapse repair
|Prior incontinence surgery
| Urethral bulking
|Other incontinence procedures
| Unknown bladder surgery
|Indication for pessary
| Prolapse and incontinence
| Stage 0
| Stage 1
| Stage 2
| Stage 3
| Stage 4
TOT, transobturator tape; TVT, transvaginal tape; PTNS, percutaneous tibial nerve stimulation.
There was a significant relationship between POPQ point GH and duration of pessary use (r = −0.215, P = 0.014). The mean change in GH for the cohort was −0.47 cm (range, −5 to 2; SD, 1.02). The changes in anterior, posterior, and apical POPQ stages were similar (P = 0.591, Table 2). There was also a significant relationship between POPQ stage and duration of pessary use (ρ = −0.276, P = 0.001, Fig. 1). Women with baseline POPQ stages of 3 or 4 had significantly greater decreases in GH compared with women with less severe baseline prolapse (mean, 0.67 ± 1.05 cm vs mean, 0.01 ± 0.77 cm; P < 0.001). Patients with baseline GH more than 3 cm had a significantly greater decrease in GH than those with baseline GH less than or equal to 3 cm (mean, 0.76 ± 1.03 cm vs mean, 0.18 ± 0.61 cm, P < 0.001). However, this difference was not significantly correlated with duration of pessary use (r = −0.175, P = 0.103 vs r = −0.132, P = 0.410).
TABLE 2 -
Change in GH and POPQ Stages by Compartment From Baseline Examination to Final Follow-Up Examination
||−0.47 ± 1.02
|Anterior compartment stage
||−0.47 ± 0.76
|Posterior compartment stage
||−0.47 ± 1.02
|Apical compartment stage
||−0.32 ± 1.33
POPQ, POP quantification.
Table 3 shows baseline mean PFDI-20 scores and their relation to category of pessary. There was no difference in scores when comparing women with space-filling pessaries to women with support pessaries (Table 2).
TABLE 3 -
Baseline Mean PFDI Scores by Pessary Type
||86.29 ± 49.57
||80.72 ± 45.62
||89.24 ± 51.90
||34.15 ± 22.69
||30.38 ± 21.90
||36.05 ± 22.47
||20.87 ± 18.28
||19.42 ± 17.75
||21.2 ± 17.93
||31.01 ± 21.60
||30.92 ± 22.05
||31.47 ± 21.34
* Student t test.
†Mann-Whitney U test.
CRADI-8, colorectal-anal distress inventory-8.
As duration of pessary use increased, the number of changes in pessary type also increased and this relationship was significant (r = 0.492, P < 0.001). However, subgroup analysis of women initially using space-filling pessaries compared to support pessaries showed no difference in number of pessary changes over time (mean, 1.98 ± 1.73 vs mean, 1.79 ± 2.12, P = 0.245). There was also no significant difference in the change in pessary size over time (P = 0.191).
This study is the first to evaluate objective changes in prolapse in women using pessaries greater than 1 year. Women in our cohort had a median duration of pessary use of almost 40 months. Both GH and POPQ stage decrease as duration of pessary use increases. The change in GH is greater in women with POPQ stage ≥3, as well as those with a baseline GH more than 3 cm. We found that providers changed the type of pessary significantly more as duration of pessary use increased; however, the size of the pessary was not changed. Our data add to previously published short-term analyses of prolapse with pessary use in women with incontinence and pelvic organ prolapse.6,7 The results suggest that there is remodeling of vaginal anatomy in women who use pessaries. Therefore, this may provide opportunities for decreasing the size of the pessary or even discontinuing its use over time. Importantly, we found no incidence of worsening prolapse in women choosing conservative management with vaginal pessaries, a finding also seen in prior objective evaluations of prolapse severity.6,7 Given these findings, patients should be counseled regarding these possibilities at the time of pessary placement and reassured that active management with a pessary in lieu of surgery is not associated with worsening prolapse.
Strengths of the study include the objective measurement of prolapse severity using the POPQ, a validated and reproducible assessment tool for pelvic organ prolapse. Although the cohort is small, it was a clearly defined population of patients as it was drawn from a previously conducted randomized controlled trial. Additionally, the cohort had excellent follow-up and compliance with the pessary, as management was strictly office-based.
A limitation of the study is the reliance on EMR for baseline POPQ measurements. Although the cohort was drawn from a prior prospective study and most recent examinations were reliable, the baseline examination was from the earliest recorded EMR visit at the institution. As some patients included in the cohort may have had initial pessary placements at an outside institution, our data may not reflect true baseline objective severity. That being said, this likely means baseline severity may be underreported and change in POPQ stage and GH may be even greater than what our data have shown. All women within the cohort did have a baseline PFDI-20 score on evaluation within our institution and scores were similar regardless of type of pessary used at initial evaluation. Timing of the POPQ examination in relation to pessary removal is also a potential limitation. All patients underwent POPQ examinations immediately following pessary removal and it is unclear if the extent of prolapse severity is seen at this time point. There is paucity of data on timing of pessary removal and accuracy of POPQ examination; therefore, the actual risk of discrepancy compared with performing the examination after longer duration without pessary in place is uncertain.
Our study shows that the vaginal pessary is a safe and effective management option for symptomatic pelvic organ prolapse. Prior studies have shown that women fit successfully with pessaries have high satisfaction rates and symptomatic improvement.3,4,6,7,9 Our findings support the theory that vaginal anatomy changes with long-term pessary use. Importantly, active management with pessary is not associated with a worsening in prolapse stage or severity. Patients who chose a pessary to manage their pelvic organ prolapse should be reassured it is an effective long-term treatment option.
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. Obstet Gynecol
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3. Patel MS, Mellen C, O’Sullivan DM, et al. Pessary use and impact on quality of life and body image. Female Pelvic Med Reconstr Surg
4. Brazell HD, Patel M, O’Sullivan DM, et al. The impact of pessary use on bowel symptoms: one-year outcomes. Female Pelvic Med Reconstr Surg
5. Ding J, Chen C, Song XC, et al. Changes in prolapse and urinary symptoms after successful fitting of a ring pessary with support in women with advanced pelvic organ prolapse
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?Int Urogynecol J Pelvic Floor Dysfunct
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. Obstet Gynecol
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9. Clemons J, Aguilar V, Tillinghast T, et al. Patient satisfaction and changes in prolapse and urinary symptoms in women who were fitted successfully with a pessary for pelvic organ prolapse
. Am J Obstet Gynecol