Impact of a vaginal pessary on the quality of life in women with pelvic organ prolapse

We conducted this observational study from January 2011 to December 2011. The study protocol was approved by the Institutional Ethical Committee and Review Board of Faculty of Medicine Ramathibodi Hospital, Mahidol University (approval No. 2553/567). Forty women with pelvic organ prolapse attending the Urogynecology Clinic willing to use a vaginal pessary and were recruited into this study. All women provided their written informed consent to participate. Their anonymity was protected. Participant’s age, number of vaginal deliveries, body mass index, and menopausal status were collected as demographic data. Their history of medical comorbidities, reconstructive pelvic surgery, and other treatments for pelvic organ prolapse were recorded. Women who could not complete the questionnaire or assume a lithotomy position and women who were lost to follow-up at 3 and 6 months were excluded from this study.

The participants and their relatives were educated in how to take care of pessaries according to a standard protocol. The pessaries were inserted participants who had appointments scheduled for 1 week later to recheck the pessaries. Then, they had follow up appointments scheduled at 3 and 6 months. Vaginal estrogen cream was prescribed if there was evidence of vaginal atrophy.

All participants were asked to complete a Thai version of the International Consultation on Incontinence Modular Questionnaire or ICIQ -Vaginal Symptoms (ICIQ-VS) [13] at visit 1 (baseline), visit 2 (month 3), and visit 3 (month 6). The ICIQ-VS is composed of 14 questions divided into 3 parts, each with an independent score. The first part contains 8 items related to vaginal symptoms; the vaginal symptom score (VSS), and has a possible minimum of 0 and maximum of 53 items. The second part contained 3 items related to sexual matters; the sexual matters score (SMS), and has a possible minimum of 0 and a maximum of 58. The third part contained 1 item related to quality of life; the quality of life score (QoLS), and has a possible minimum of 0 and maximum of 10. The score increases with the severity of symptoms. A decrease in QoLS indicates improvement in the quality of life. The Thai version of ICIQ-VS questionnaire was successfully validated for Thai women and was used in this study.

Satisfaction was evaluated by using a visual analog satisfaction scale (VASS) [14] at the initial visit, visit 2 (month 3) and visit 3 (month 6). It was composed of a 100 mm vertical line with most satisfied at the top of the line and least satisfied at the bottom. Participants were asked to mark the level of their satisfaction on the scale.

Pelvic organ prolapse severity was classified by the Pelvic Organ Prolapse Quantification system (POP-Q) [15] and was evaluated by the principal investigator (TA) at the initial visit and visit 3 (month 6).

All had appointments scheduled for after 3 and 6 months of pessary use. At 3 months the subjects were asked to complete the ICIQ-VS and VASS again. At 6 months, besides the ICIQ-VS and VASS, the POP-Q staging system was re-examined.

The sample size required in this study was calculated for type I and type II errors <0.05 and calculated for further data loss of 20%. The total sample size was 40. A repeated measures ANOVA was used in this study to compare the results at 3 and 6 months by using the mean score and a Wilcoxon signed-rank test.

Patient characteristics of the 40 participants completing are shown in Table 1.

Support pessaries were used in 85% of participants were fitted with a ring; 5% were fitted with Gellhorn pessaries. Three participants did not complete data collection at the end of this study. One quit the Gellhorn pessary because her caregiver could not remove it. Another two were unhappy with the rings and quit. All 40 participants were included in intention-to-treat analysis.

The vaginal symptoms score decreased significantly at both 3 and 6 months after pessary use. The overall quality of life score decreased significantly at both 3 and 6 months after pessary use. The sexual matters score decreased significantly only at 6 months after pessary use (Table 2).

The satisfaction scores increased significantly at both 3 and 6 months after treatment (Table 3).

The prolapse stage did not change in almost all participants. Only 2 cases improved 1 stage, and 1 case improved 2 stages as shown in Table 4.

There were few complications from using pessaries in this study. Three participants (8%) had vaginal erosion and one (3%) had bacterial vaginosis at 3 months after treatment. They were treated successfully and no complication was found at six months.

A vaginal pessary is one type of nonsurgical treatment for pelvic organ prolapse. Pessaries are suitable for women who are poor candidates for surgery because of multiple comorbidities or old age. Previous studies show that pessary use can improve patient’s quality of life by using other questionnaires such as Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) [10-12]. Most patients with pelvic organ prolapse had a favorable outcome in terms of satisfaction with the pessary use, and continued to use a pessary to control pelvic floor symptoms [16]. This finding was similar to that we reported previously [17]. Improvements in prolapse-related symptoms and satisfaction were demonstrated with use of a pessary up to 6 months after initial fitting in this study. These findings confirmed earlier data that showed significant improvements in prolapse-related symptoms, quality of life, and body image with use of vaginal pessary [11]. In Thai culture, there are very few elderly women still sexually active. Even though there were improvements in the sexual matter domain after pessary treatment, the group was too small to determine if pessaries really improved sexual health.

Some participants experienced complications from pessary treatment. All complications were minor such as erosion of the vaginal wall or vaginal discharge. They were improved by adequate lubrication and vaginal estrogen treatment. The continuation rate was high at 93%; this might result from the satisfaction in using pessaries. One strength of this study was a prospective evaluation of subjects as they were treated with pessaries over 6 months. Secondly, the official validated Thai version of the ICIQ-VS and an simple VAS tool to interpret patient’s satisfaction were used. Thirdly, the stage of pelvic organ prolapse, using the standard classification, was used and a single examiner performing all POP-Q exams. Finally, all interviewers were standardized because of the QoL questionnaire and satisfaction evaluation. The limitations of this study were its small sample size and that sexual satisfaction improvement could not be demonstrated. Further studies with a larger sample size and an appropriate number of sexually active women should be conducted. In conclusion, the use of a vaginal pessary for up to 6 months improved vaginal symptoms, QoL, and satisfaction in women with pelvic organ prolapse. The stages of prolapse did not change after 6 months of pessary treatment.