Trial reportAmerican journal of obstetrics and gynecology2015
The effect of hydroxyquinoline-based gel on pessary-associated bacterial vaginosis: a multicenter randomized controlled trial.
Trial report in American journal of obstetrics and gynecology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Pessaries (mechanical devices) for managing pelvic organ prolapse in women.The Cochrane database of systematic reviews · 2020Pooled it
- Sexual Function and Pessary Management among Women Using a Pessary for Pelvic Floor Disorders.The journal of sexual medicine · 2015Trial
- Changes in the Vaginal Microenvironment as Related to Frequency of Pessary Removal.Female pelvic medicine & reconstructive surgeryTrial
- Personalized Management of Hydroxyquinoline Hypersensitivity in Pessary Care: A Case-Based Approach to Tailored Treatment.Reports (MDPI) · 2025Article
- Updates in Pessary Care for Pelvic Organ Prolapse: A Narrative Review.Journal of clinical medicine · 2025Review
- Pessaries for pelvic organ prolapse: evaluation of vaginal discharge and pain during pessary cleaning in an outpatient setting.International urogynecology journal · 2024Article
- Advances in vaginal bioengineering: Applications, techniques, and needs.Current research in physiology · 2023Review
- What is known from the existing literature about self-management of pessaries for pelvic organ prolapse? A scoping review.BMJ open · 2022Article
- Cross sectional study on assessment of ring pessary cleaning and removal every six months: adverse events and complications.International urogynecology journal · 2022Article
- Adapting to Challenging Circumstances: Pessary Care in a Racially Diverse Urban Population Within a U.S. Epicenter of the COVID-19 Pandemic.Female pelvic medicine & reconstructive surgery · 2022Article
- Clinicopathologic characteristics and treatment patterns of pelvic organ prolapse in South Korea.The Pan African medical journal · 2019Article
- Desire for Continued Pessary Use Among Women of Hispanic and Non-Hispanic Ethnic Backgrounds for Pelvic Floor Disorders.Female pelvic medicine & reconstructive surgeryArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
objectivePessaries are important options for women with pelvic floor disorders, but many pessary users experience bacterial vaginosis (BV). The aim of this study was to evaluate the effect of TrimoSan gel (Milex Pessaries, Cooper Surgical, Trumbull, CT) on BV prevalence among pessary users. STUDY
designWomen presenting for a pessary fitting completed questionnaires on vaginal symptoms and hormone therapy use and underwent a BV BLUE test and slide collection for BV analysis by Nugent's criteria. Following pessary fitting, women were randomized to either standard pessary care with the use of TrimoSan placed vaginally twice weekly or to standard pessary care without TrimoSan gel. Women returned 2 weeks and 3 months later for a repeat slide collection for Gram stain, BV BLUE testing, and completion of questionnaires on vaginal symptoms and desire to continue the pessary.
resultsThere were 184 women randomized after successful fitting (92 to the TrimoSan group), and 147 (79%) presented for 3-month follow up. Mean age was 56 ± 16 years; patients were mostly white (57%) or Hispanic (23%), and 36% were using hormone therapy. The groups did not differ in the prevalence of BV by Nugent's criteria at 2 weeks (20% TrimoSan vs 26% no gel, P = .46) or 3 months (24% TrimoSan vs 23% no gel, P = .82), nor did they differ in BV by BV BLUE testing at 2 weeks (0% TrimoSan vs 4% no gel, P = .12) or 3 months (3% TrimoSan vs 0% no gel, P = .15). The prevalence of at least one vaginal symptom did not differ between groups at 2 weeks (44% TrimoSan vs 45% no gel, P = .98) or 3 months (42% TrimoSan vs 32% no gel, P = .30). The TrimoSan group was equally likely to want to continue their pessary use compared with the standard care group at 2 weeks (90% vs 86%, P = .64) and 3 months (63% vs 60%, P = .76).
conclusionTrimoSan gel in the first 3 months of pessary use does not decrease the prevalence of BV or vaginal symptoms and does not alter the likelihood of a woman desiring to continue pessary use.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.