Douching With Water Works Device for Perceived Vaginal Odor With or Without Complaints of Discharge in Women With No Infectious Cause of Vaginitis: A Pilot Study
Ashwin J. Chatwani, Sarmina Hassan, [...], and Vani Dandolu
All subjects were instructed on how to use the treatment device and asked to douche once daily with the exception of the days of evaluation and menstruation. They were refrained from the use of other douches and intravaginal products (eg, feminine deodorant sprays, spermicides, tampons, and diaphragms) during the 4-week study period. They were not allowed to take oral/intravaginal antibiotics or antifungal agents during the 4-week study periods. Each subject kept a brief diary where they recorded their own assessment of vaginal odor and other vaginal symptoms during the whole length of study period. During 2nd and 3rd visits the speculum examination of the vagina were repeated. Swabs for vaginal pH, whiff test, saline and 10% KOH microscopy, were taken. Gram stain for Nugent score was sent to the central laboratory. Perceived vaginal odor score by the subjects were recorded.
SAMPLE SIZE AND STATISTICAL ANALYSIS
This is a pilot study designed to estimate potential effect sizes so we can more reliably estimate sample size requirements for a randomized, controlled trial. Based upon data from 10 subjects, simple descriptive statistics were calculated. We used Student's t-test for continuous, paired variables.
We screened 50 symptomatic women who were examined by the same gynecologist at Temple University Hospital, Department of OB/GYN between May 2005 and September 2005. Ten subjects met criteria and were enrolled for this pilot study. All the enrolled patients were African American. The mean age of the participants was 37.3 ± 10.15 (mean ± standard deviation) years.
At the screening visit (Entry visit), all women complained of strong vaginal odor. The mean vaginal odor score was 4.4± 0.3 (range 0–5). This odor was significantly reduced (P = .016) after 2 weeks of vaginal douching to 2.4 ± 0.6 (mean ± standard error). Odor score was further reduced to 1.7 ± 0.6 (P = .0006) after 4 weeks of douching (Figure 1). Five out of 10 subjects perceived complete abatement of odor at the end of study. Lactobacilli score from the Nugent slide was 4.0 ± 0 (mean ± standard error) on entry visit, and showed no significant decrease during 2nd (3.3 ± 0.3) and 3rd (3.5 ± 0.4) visits (Figure 2). Mean vaginal pH was 4 at both entry visit and final visit. At the end of treatment no statistically significant change of vaginal pH was noted.