1. TrimoSan© gel was not associated with differences in the prevalence of bacterial vaginosis or vaginal symptoms 3 months after pessary fitting.
2. The prevalence of vaginal symptoms among pessary users was high, and their satisfaction decreased over time.
Evidence Rating Level: 2 (Good)
Study Rundown: Pelvic organ prolapse and stress urinary continence are common health problems affecting many women in the United States. While these conditions may be surgically corrected, patients may experience persistent or recurrent symptoms following surgery. Other women may not be surgical candidates or may opt for non-surgical treatment modalities. Vaginal pessaries, a device that is inserted into the vagina to provide structural support, are an appropriate alternative option. While they are effective in relieving symptoms, many women ultimately discontinue use of pessaries due to undesirable side effects. These include vaginal discharge, odor, irritation, erosions and ulcers. Prior work has found a higher prevalence of bacterial vaginosis (BV) among pessary users, but no randomized controlled trials exploring pessary care have addressed this issue. Here the authors sought to determine whether TrimoSan© lubricant gel is effective in decreasing the prevalence of BV and vaginal symptoms among pessary users; they found no difference in prevalence of BV or vaginal symptoms at 3 months.
Strengths of this study include multi-center randomized controlled trial design. Limitations include lack of blinding of the patients; use of a vaginal applicator only in the TrimoSan© arm may have resulted in differential bacteria exposure. Additionally, >20% of participants were lost to follow-up, with more individuals lost from the TrimoSan© arm, introducing issues of follow-up bias. Further double-blinded randomized controlled trials are needed to determine whether TrimoSan© gel or an alternative agent are effective in reducing the incidence of BV and vaginal symptoms.
Relevant Reading: Bacterial vaginosis increases in pessary users
In-Depth [randomized controlled trial]: This study evaluated the impact of TrimoSan© gel on the incidence of BV among women using pessaries. After pessary fitting, women were randomized to pessary with TrimoSan© gel (n=92) or pessary alone (n=92). The primary outcome of interest was BV by Nugent’s criteria on Gram stain at 3 months. Secondary outcomes were patient satisfaction and vaginal symptoms.
Women randomized to use TrimoSan© gel had a similar prevalence of BV and vaginal symptoms and satisfaction rate at 3 months as their pessary-only peers. Frequency of pessary removal and hormone therapy were not associated with differences in prevalence of BV or symptoms. For both groups, the prevalence of vaginal symptoms increased (>30% at 2 weeks, >40% at 3 months) and satisfaction with the pessary decreased over time (88% at 2 weeks, 62% at 3 months, p<0.01).
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