Pessary treatment for pelvic organ prolapse and health-related quality of life: a review

We searched Medline (1966 to December 2010) using the Mesh term ‘pessary’ and limits ‘female’ AND ‘human’. This resulted in 726 articles. An additional search on Embase using the term ‘pessary’ and limits ‘human’ resulted in 633 articles. After screening of both title and abstract, we were left with 159 articles related to pelvic organ prolapse and pessary. This review focused solely on pessary treatment in pelvic organ prolapse. Therefore, articles regarding pessary treatment in urinary incontinence or other conditions were excluded. Guidelines on how to fit a pessary, case reports describing rare complications without any literature review and experts’ letters were excluded. From the remaining 41 articles which were considered useful, 13 articles were a review [2, 5, 8‐18], and 28 articles were original research articles [3, 4, 6, 7, 19‐43]. Only 10 articles [6, 19‐21, 25, 27, 32, 34, 35, 41] met the exact criteria of the reviewers’ aim to assess the health-related quality of life in women with pelvic organ prolapse. Although the other articles did not meet these pre-specified criteria, they were considered useful in additional analyses, such as for example which women are most suitable for pessary treatment, successful fitting, dropout rates and management of pessary treatment. Table 1 shows a description of papers included in this review. This review was originally set up as a systematic review. After reviewing the articles, there was inconsistency in definitions such as successful fitting and dropout rates, sample sizes, and follow-up periods, and there was shortage of studies that met the exact criteria. Therefore, the goal of a systematic review could unfortunately not be achieved, but the available (or lack of) research articles did, to our opinion, justify the present review.

Which patients are considered suitable for pessary treatment remains unclear from the literature. Patients themselves may have preconceived ideas, and both beliefs and attitudes regarding the aetiology and success of pessary treatment may influence their choice of treatment [3, 22, 31, 33].

Some factors contributing to patient’s choices appear to be independently associated with treatment choices of patients in a fairly predictable way. The probability of choosing pessary treatment over surgery increases as patients’ age rises and respectively decreases as stage of POP increases [31]. Women who already have undergone prior POP surgery are more eager to choose POP surgery again [31]. Women preferring surgery to pessary treatment for POP reported more bothersome symptoms related to POP and felt more affected by POP in their general well-being [33]. Furthermore, the majority of patients who were sexually active tended to prefer surgery above conservative treatment [33].

Most papers reported that there are certain groups of patients that drop out. There are patients who initially do not comfortably retain a pessary (mostly at their first visit). There is an additional group of patients who abandon pessary treatment after some weeks because of discomfort or repeated expulsions [30]. There is no agreement in the literature on what is considered successful pessary fitting. Some authors considered fitting successful if a pessary was perceived comfortable by a patient when retained during Valsalva and voiding, at the initial patient visit, while others considered fitting successful if a patient continued to use the pessary until the following doctor’s appointment [40]. Therefore, the rate of unsuccessful fitting and dropout ranges widely. Table 2 offers an overview of successful fitting and dropout rates of studies included in this review. In this review, we considered fitting to be successful if a patient comfortably retained a pessary at their first visit. A patient was considered to drop out if they abandoned pessary use at the following doctors’ appointment.

Most studies reported successful fitting rates to be over 85%. Risk factors that are reported to be responsible for unsuccessful pessary fitting are short vaginal length, a large genital hiatus, prior history of hysterectomy and prior surgical repairs of POP [37, 39].

The compartment and stage of POP have not been reported to have any influence on successful pessary fitting and should therefore not be a factor of patient selection for pessary treatment [39]. Continuation rates on the short-term range from 50% to 80% after 3 or 4 months. After 1 year of use, the continuation rates remain unchanged: 50–80%. Only two studies reported long-term continuation of pessary use over more than 1 year. One study reported a continued pessary use in 48% of patients for an average duration of 5.4 years [23]. A more recent study on the long term reported a 14% continued pessary use with a mean duration of 7 years [43].

An independent factor associated with the continued use of a pessary is age above 65 years. Sexually active women were more likely to continue wearing a pessary for a longer period of time [22, 26, 28].

POP causes symptoms that have impact on patients’ daily activities and quality of life. Women with POP seem to have a negative body image compared to women without POP [44]. Women who seek medical advice perceive these symptoms bothersome enough to opt for treatment and strive to improve their perceived quality of life [44].

We found only few articles in which validated urogynaecological questionnaires were used to asses treatment effects on health-related quality of life [6, 19, 21, 27, 32, 34, 35, 41]. Two articles did not use validated questionnaires but measured improvement of POP symptoms and satisfaction in pessary users with questionnaires that were not validated [20, 25]. Other questionnaires that were used were the Female Sexual Function Index Questionnaire (FSFI), the Pelvic Floor Distress Inventory (PFDI), the Pelvic Floor Impact Questionnaire (PFIQ), the Body Image Scale, the Sheffield Pelvic Organ Prolapse Symptom Questionnaire and the King’s Health Questionnaire. The PFDI and PFIQ have been validated for use in women with POP [41]. The body image scale evaluates a woman’s self-perception of her physical appearance, attractiveness, and satisfaction with her body. This questionnaire has been used in research on women with cancer and was considered valid and reliable for that group of patients, but is not yet validated for use in women with POP [45]. The FSFI is a validated questionnaire that refers to the domains of desire, arousal, lubrication, orgasm and satisfaction in sexual functioning [46]. The Sheffield prolapse questionnaire relates to the severity of POP specific symptoms, while the King’s Health Questionnaire evaluates domains of health-related quality of life [35]. The results of 10 available studies are shown in Table 3. Consistent in most papers is the improvement gained in both bulge and irritative bladder symptoms following pessary treatment. Two studies reported de novo stress urinary incontinence [25, 35]. Women who were sexually active and wore a pessary reported a significant increase in both frequency and satisfaction of sexual activity [19, 27]. There were significant improvements in desire, lubrification and sexual satisfaction after treatment of POP with a pessary [35]. These findings may have resulted of improvements in general well-being which may have altered patients’ self-esteem. These data are suggestive that a vaginal pessary does not negatively interfere with sexual activity and may even improve sexual functioning as a whole.

Patients’ satisfaction rates with medium-term pessary use are high (70–92%) [20, 25]. Pessary treatment for 3 months not only reduced POP-related bother symptoms but also caused improvement in quality of life and women’s perception of their body image [41].

A recently published study compared the effectiveness of pessaries with surgery in women with symptomatic POP [19]. The authors reported similar improvements in urinary, bowel, sexual function and quality of life parameters in both treatment arms. That suggests that pessary treatment in POP might be as effective as surgery in improving health-related quality of life.

There may be a decrease in the size of the genital hiatus with continued pessary use. This decrease is detected even after 2 weeks of continuous pessary wearing [32]. There may also be an improvement in POP stage after 1 year of pessary treatment [29]. Such improvements may have been due to a transient effect of pessary use [29, 38]. Limitations of these papers are the small sample sizes. Whether this reduction in POP stage sustains at the long term and whether it is clinically relevant need further research.

Evidence is lacking on the type of pessary that is chosen, or who should be responsible for cleaning and changing pessaries and how often this should be performed [14, 30]. Ideally, the physician can teach a patient how to remove and replace the pessary herself. This increases patients’ autonomy, allowing her to use it and clean it when needed [5, 18]. In such a setting, follow-up could be on an annual basis [18]. Patients who are not willing or able to manage pessary care themselves require more frequent doctors (or nurse practitioner) visits. There is a lack of evidence on whether a pessary should be used in combination with hormone replacement therapy or pelvic floor exercises [3]. If HRT is prescribed, local HRT seems to be more beneficial in reducing side effects than systemic HRT or a combination of both [30]. HRT is particularly used to prevent vaginal irritation and ulceration due to pressure of the pessary in an older and atrophic vagina [17]. There is some evidence that local HRT plays a significant role in the initial success of fitting [30].

The most common side effects of pessary use are a foul smell, vaginal discharge, bleeding, pain and constipation [43]. A recent study reported that 56% of women wearing a pessary reported one of these side effects [43]. Changing a pessary at frequent intervals could prevent this vaginal irritation. Therefore, it is helpful if the patient is willing and able to remove, clean and replace the pessary herself [18].

Rarely, pessaries cause major urinary, rectal and genital complications such as fistula, faecal impaction, hydronephrosis and urosepsis [1]. These rare complications are almost exclusively related to a long period of use and negligence of care. With regular follow-up, the majority of pessary complications can be avoided and kept to a minimum [9].