Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis

NCT01471457 | Completed Phase 2 Results DMC

• 1 other identifier: 2009-028
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this prospective, randomized, controlled study is to assess the effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for \>1 year are recruited in to the study and randomized to using Trimo-San gel daily or not using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain, but will have a positive effect on the subjective symptoms experienced by women wearing pessaries.

Conditions

Bacterial Vaginosis

Keywords

bacterial; vaginosis; pessary; discharge

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Bacterial Vaginosis at 3 Months

  The primary outcome is the rate of bacterial vaginosis after pessary fitting as measured by OSOM BV blue (Genzyme) and gram stain, measured in women using and women not using Trimo-San gel after pessary fitting, at 3 months, with the denominator being the number of women having a gram stain at the 3 months time point in each group

  3 months

Secondary Outcomes (1)

• Participants With Any Bothersome Vaginal Symptom at 3 Months

  3 months

Study Arms (2)

Trimo-San group

EXPERIMENTAL

Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly

Drug: Trimo-San gel

Control group

NO INTERVENTION

Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel

Interventions

Trimo-San gel DRUG

Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly

Trimo-San group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Indications for initiation of pessary use and planning to be fitted for and wear a pessary

You may not qualify if:

• Male
• Already using a pessary or have used in the last year
• History of recurrent or chronic bacterial vaginosis with \> 2 episodes per year or symptoms reported for \> 6 months out of last year
• Active known vaginal infection (symptomatic and/or untreated) or completion of treatment for BV or cervical/vaginal infection within one week of recruitment
• History of active vaginal ulcerative disease (active ulcers from atrophy, herpes symptoms at recruitment, or HSV with \> 2 outbreaks per year or last outbreak \< 1 month ago)
• Chronic antibiotic use for indications not listed above

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (2)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (11)

• Alnaif B, Drutz HP. Bacterial vaginosis increases in pessary users. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(4):219-22; discussion 222-3. doi: 10.1007/pl00004026.

  PMID: 11005473 BACKGROUND

• Eschenbach DA, Hillier S, Critchlow C, Stevens C, DeRouen T, Holmes KK. Diagnosis and clinical manifestations of bacterial vaginosis. Am J Obstet Gynecol. 1988 Apr;158(4):819-28. doi: 10.1016/0002-9378(88)90078-6.

  PMID: 3259075 BACKGROUND

• Landers DV, Wiesenfeld HC, Heine RP, Krohn MA, Hillier SL. Predictive value of the clinical diagnosis of lower genital tract infection in women. Am J Obstet Gynecol. 2004 Apr;190(4):1004-10. doi: 10.1016/j.ajog.2004.02.015.

  PMID: 15118630 BACKGROUND

• Powers K, Lazarou G, Wang A, LaCombe J, Bensinger G, Greston WM, Mikhail MS. Pessary use in advanced pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Feb;17(2):160-4. doi: 10.1007/s00192-005-1311-8. Epub 2005 May 10.

  PMID: 15883856 BACKGROUND

• Myziuk L, Romanowski B, Johnson SC. BVBlue test for diagnosis of bacterial vaginosis. J Clin Microbiol. 2003 May;41(5):1925-8. doi: 10.1128/JCM.41.5.1925-1928.2003.

  PMID: 12734228 BACKGROUND

• Bradshaw CS, Morton AN, Garland SM, Horvath LB, Kuzevska I, Fairley CK. Evaluation of a point-of-care test, BVBlue, and clinical and laboratory criteria for diagnosis of bacterial vaginosis. J Clin Microbiol. 2005 Mar;43(3):1304-8. doi: 10.1128/JCM.43.3.1304-1308.2005.

  PMID: 15750100 BACKGROUND

• Forsum U, Hallen A, Larsson PG. Bacterial vaginosis--a laboratory and clinical diagnostics enigma. APMIS. 2005 Mar;113(3):153-61. doi: 10.1111/j.1600-0463.2005.apm1130301.x.

  PMID: 15799757 BACKGROUND

• Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.

  PMID: 33207004 DERIVED

• Gupta A, Cox C, Dunivan GC, Gaskins JT, Rogers RG, Iglesia CB, Meriwether KV. Desire for Continued Pessary Use Among Women of Hispanic and Non-Hispanic Ethnic Backgrounds for Pelvic Floor Disorders. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):172-177. doi: 10.1097/SPV.0000000000000652.

  PMID: 30807423 DERIVED

• Fregosi NJ, Hobson DTG, Kinman CL, Gaskins JT, Stewart JR, Meriwether KV. Changes in the Vaginal Microenvironment as Related to Frequency of Pessary Removal. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):166-171. doi: 10.1097/SPV.0000000000000520.

  PMID: 29474292 DERIVED

• Meriwether KV, Rogers RG, Craig E, Peterson SD, Gutman RE, Iglesia CB. The effect of hydroxyquinoline-based gel on pessary-associated bacterial vaginosis: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2015 Nov;213(5):729.e1-9. doi: 10.1016/j.ajog.2015.04.032. Epub 2015 Apr 30.

  PMID: 25935783 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial; Vaginal Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Kate Meriwether
• Organization: University of New Mexico

meriwet2@salud.unm.edu

5052495967

Study Officials

• Kate V Meriwether, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 15, 2011
• Study Start: September 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 22, 2020
• Results First Posted: April 22, 2020

Record last verified: 2020-04

Locations

US (2)