Hypothesis / aims of study
The outcome of this study was to evaluate the efficacy and safety of ring pessaries under continuous use during more than 2 years.
Our starting hypothesis was that, without periodic removal, cleaning or replacement, during 24 to 48 months after insertion is safe and effective.
Study design, materials and methods
We performed this prospective observational and descriptive study in a tertiary obstetrics and gynecology department between January 2013 and January 2020.
A total of 123 consecutive women who presented with symptomatic POP (stages III and IV) at the time of enrollment were recruited. As inclusion criteria, they agreed to use the vaginal ring pessary as a treatment. As exclusion criteria, no previous treatment regarding this problem could have been performed before the consultation.
All women were monitored for 24 months after the start of their pessary use.
One hundred one women who successfully completed the 24 first months of continuous use of a ring pessary, were monitored for another 24 months. The objectives were to establish the percentage of patients maintaining its use 48 months after insertion, the reasons for discontinuation and the adverse events. Another purpose of this study was to determine the timing of replacement of the vaginal pessary in long-term users.
Results
The fitting was successful for 115 patients (93.5%).
Four patients died of non-pessary-related causes during the study and, one patient dropped out the follow-up so that finally, 110 patients were included in the efficacy analysis.
At 24 months the pessary use was maintained by 91.8% of the women. The adverse events rate was low (27.0%). The two main factors of interruption in the pessary use were: age (OR 0.93; 95% CI 0.87–0.99) and history of urinary urge incontinence (OR 0.33; 95% CI 0.11–0.96]). Continuing the follow up 92.1% (93/101) had successful pessary use, and it was discontinued by three patients (2.9%, 3/101).
To the end of the study 76.2% (77/101) of the women continued pessary use and for 16 (15.8%, 16/101) patients, after pessary removal, the prolapse disappeared and did not recur. Forty-five women (48.4%, 45/93) presented some adverse events that required temporary pessary removal. The most common one was an increase in vaginal discharge (73.3%, 33/45). In four women (8.9%, 4/45), the ring pessary was detected embedded in the vaginal epithelium.
Interpretation of results
A problem with pessary use is the long-term continuation rate: if we included all periods of follow-up after initial recruitment, the efficacy at 48 months of follow-up was 80.9% (93/115), or 88.6% (93/105) if we exclude patients who died from non-pessary-related
causes and drop-out women.
Self-care is usually recommended for patients to manage the pessary to prevent complications.
Continuous use of a pessary for long periods has the benefits of convenience and comfort. These reasons may have contributed to our high success rate and elevated continuation rates.
To wear a ring pessary for 2 to 4 years, without periodic removal or replacement, could be an excellent option for asymptomatic women.
Neglected vaginal pessaries can cause major complications (hydronephrosis, fistula, fecal impaction, bowel incarceration and urosepsis).
In the first 24 months of follow-up, embedded pessaries were not observed. We detected the first three cases in hysterectomized women (3/13) at 30 months of pessary use. In all cases, the epithelial bridge originated on the vaginal vault.
Only one woman with an intact uterus (1/80) developed an embedded pessary on the left lateral side of the vagina at 48 months of follow-up.It is essential, therefore, to instruct the patients about the importance of regular medical controls of the pessary, especially in long-term continuous use.
This finding moves us to consider changing or removing the pessary 24 months after continuous use as a recommendable strategy, specifically in hysterectomized patients with POP, to prevent this complication. Conversely, in hysterectomized patients, we propose the pessary change or removal at 24 months of continuous use to prevent embedded pessary cases