Vaginal Pessary in Women with Symptomatic Pelvic Organ Prolapse

Rachel Y. K. Cheung, Jacqueline H. S. Lee, L. L. Lee, Tony K. H. Chung, and Symphorosa S. C. Chan

Obstetrics & Gynecology Journal, Volume 128, Number 1, July 2016, pg. 73-80

Cora Huit July 18, 2016

 Clinical Question

Are there improvements for women with symptomatic pelvic organ prolapse by using a vaginal pessary?

 

Clinical Bottom Line

There are alternative nonsurgical treatments for pelvic organ prolapse. Women using a vaginal pessary along with pelvic floor exercises improved their prolapse symptoms and quality of life more compared to women who only did pelvic floor exercises.

Description

More than 226,000 women in the U.S. undergo pelvic organ prolapse surgery each year, which equates to more than $1 billion in costs. Women with pelvic organ prolapse have various symptoms and their quality of life is significantly impaired.

This study compared pelvic floor symptoms, quality of life, and complications in women with symptomatic pelvic organ prolapse solely with pelvic floor exercises versus in combination with vaginal pessaries. Women with prolapse symptoms were randomized to either pelvic floor exercise training (control group) or pelvic floor exercise training and insertion of a vaginal pessary (pessary group). All eligible women in the study completed the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire before the first consultation, at the 6-month follow-up, and at the 12-month follow-up. Scores for each were compared at the end of the study.

 Study Design

Randomized controlled trial

Methods

Two hundred seventy-six women who had dominant symptoms of prolapse and examined to have stage I to III pelvic organ prolapse with no previous treatment were included in the study. Out of the 276 women, 137 were randomized into the control group and 139 to the pessary group. This study was conducted in a tertiary urogynecology unit from December 2011 to November 2014.

A physical examination was done using the POP-Q system. A gynecologist then inserted a vaginal ring pessary for women in the pessary group. The largest sized pessary that was comfortable was used. A pelvic floor exercise training course was offered to all women and it included a teaching session within 2 weeks after the first consultation and then 3 individual training sessions at 4, 8, and 16 weeks. The registered nurse specialists who were training the women advised them to practice daily with at least 2 sets of 8-12 repetitions per day, with 8-10 exercises per session at least 2 times a week. Specific exercises were not specified.

At the 6-month and 12-month follow-up, both groups completed the Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and the visual analog scale again before the consultation. Their symptoms were reviewed and the physical examination was repeated. The women’s desired treatment after the 12-month follow-up was asked and they received the treatment accordingly after the study was completed.

Sample Selection

Included: Women with dominant prolapse symptoms and examined to have stage I to stage III pelvic organ prolapse with no prior treatment

Excluded: Active complications arising from prolapse, impaired mobility, cognitive impairment, or language barrier

Measurement

Primary outcomes were the change in pelvic organ prolapse symptoms by using the Pelvic Floor Distress Inventory and the change in quality of life by using the Pelvic Floor Impact Questionnaire at the 6-month and 12-month follow-up. Both use a Likert scale with higher scores representing more symptoms and complications.

Secondary outcomes included the discomfort of prolapse symptoms measured by the visual analog scale score and the preferred prolapse treatment in the first consultation and at the 12-month follow-up.

SPSS 22 was used to analyze data and descriptive statistics were used for demographic data. Median scores for both the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire were reported.

Results

In total, 276 eligible women were randomized into the pessary group (139) or the control group (137). At 12 months, there were 132 (95%) and 128 (93.4%) completed questionnaires, respectively. Baseline demographics were similar in both groups with the mean age being 62.6 years, BMI 25.4, and median parity of 3.

The anterior compartment was the most severe prolapse area and there was no significant difference in baseline Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire scores between the two groups.

The mean difference of Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire score from baseline to 12 months was significantly higher in the pessary group compared to the control group. The mean score differences of the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire were also higher in the pessary group than in the control group.

The median visual analog scores decreased in the pessary group using the Friedman test, but there was no difference in the control group. More women in the pessary group reported that their prolapse symptoms have “improved” (80 out of 132 [60.6%] compared to 36 out of 128 [28.1%]).

At the first consultation, a majority of the women had no preference for preferred treatment. At the end of the study, more than half of the women opted for surgery after knowing the different treatment modalities. More women preferred surgery in the pessary group.

Discussion

Vaginal pessaries used as a brace support can improve pelvic floor symptoms and also correct hydronephrosis (excess fluid in a kidney due to backup of urine) in women with pelvic organ prolapse. A vaginal pessary is effective for different stages of pelvic organ prolapse and should not only be used in poor surgical applicants.

It is difficult to perform a randomized controlled trial lasting over 3 months but the local health care system there had a 12 month waiting period for women who opted for surgery. The women were willing to have a vaginal pessary while waiting and this contributed to the success in recruitment and a high follow-up rate.

Weaknesses

The study only used a ring pessary but not any other types. There is no evidence that shows any type of pessary is better than the others, so a single type was used to reduce any potential bias.

Pelvic floor exercise was taught under their local protocol, which was not describe. The adherence rate was not high compared with the reported figure, but it was similar for both groups. The study also measured quality of life scores as the primary outcome instead of using the POP-Q assessment, which may not have been reliable.

Sexual symptoms were not reported due to lack of validated questionnaires in their population.

Strengths

The study had an adequate sample size consisting of 276 women. The study also had a great follow-up rate at 12 months. The women were willing to participate in the study due to the wait period for surgery. The study was able to change the preferred treatment of some of the women.

After completion of the study, it is clear that women who had a vaginal pessary in addition to pelvic floor exercise had better improvement in prolapse symptoms and quality of life. This provides strong evidence for the use of a vaginal pessary as an effective treatment for women with varying stages of pelvic organ prolapse.