Objective: To demonstrate the effectiveness of medical-grade stainless steel Water Works Douching Device for treating abnormal vaginal odor in comparison with a commercially available over-the-counter plastic douching device.
Materials and methods: In a multicenter study, 140 women with perceived vaginal odor with no vaginal infection were randomized to either Water Works or control group in a 1:1 ratio and were douched daily for 4 weeks. A visual analog scale (VAS) was used to assess the intensity of vaginal odor. Primary outcome included subject assessment of odor improvement and Nugent Gram stain score of vaginal secretions. Secondary outcome compared the efficacy and safety of Water Works with control douching device. Each patient underwent baseline, week 2, and week 4 visits.
Results: The final analytic sample consisted of 96 women. Success score at 4 weeks was 78% for the Water Works group and 38.5% for the control group. Mean VAS was significantly reduced, and Nugent and Lactobacillus scores were maintained in both groups. In the Water Works group, VAS was reduced from 7.3 ± 0.3 to 1.8 ± 0.6 (p < .001) after 4 weeks. In the control group, baseline versus 4 weeks VAS was 7.2 ± 0.3 and 3.4 ± 0.8 (p < .003).
Conclusions: Women reported significant reduction of vaginal odor after douching with water for 4 weeks without any alteration of vaginal flora. The Water Works Douching Device was superior to over- the-counter device in reducing vaginal odor.
Trial registration: ClinicalTrials.gov NCT00417365.