Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network
Condition: Vaginitis
MeSH terms: Vaginitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Many women present in primary care with vaginal complaints. The best way of managing these
      complaints is unclear. This trial will test two different methods of managing patients with
      vaginal complaints. This is a pilot trial.
    

Detailed description: 
      Setting: The study will be carried out at two sites within the New York City Research and
      Improvement Network (NYC RING) an urban Practice Based Research Network comprising 21
      clinical sites. Problem: Vaginal symptoms are the most common reason for outpatient
      gynecological consultation, yet the management of these symptoms is not well grounded in
      evidence from primary care. Purpose: To prepare for a randomized clinical trial (RCT) to test
      whether the current standard of care for evaluating vaginal symptoms (which involves looking
      for specific pathogens) produces better clinical outcomes than a simpler approach, which
      treats patients based on their symptoms. Methods: 55 premenopausal non-pregnant adult women
      presenting with vaginal complaints will be randomized into two groups. Women in Group A will
      be managed on the basis of presenting complaint without physical examination or office
      laboratory work. Women in Group B will receive a physical examination and office evaluation
      looking for trichomonads, candida and bacterial vaginosis. They will be managed according to
      the clinical and office laboratory findings. Patients will be contacted by phone two weeks
      after consultation to assess symptom resolution, adverse reaction to drugs, satisfaction with
      care and treatment experiences. Patients will be screened for infection with gonorrhea and
      chlamydia using a urine antigen test and for trichomoniasis using vaginal culture. Patients
      whose tests demonstrate trichomoniasis, chlamydia or gonorrhea or who remain symptomatic at
      the two-week follow-up call will be re-evaluated promptly. Outcomes: AIM 1: Feasibility: The
      pilot will assess 1) ability to recruit and retain patients, 2) acceptability of study
      protocols to subjects and 3) prevalence and detection of important sexually transmitted
      diseases (STD's). AIM 2: Initial evidence of effectiveness: The pilot will provide data on
      key planned RCT outcome measurements including 1) treatment success rates (allowing
      estimation of future sample size), 2) need for reconsultation 3) adverse reactions, 4)
      medication usage and 5) patient satisfaction. Benefit to public health: This pilot study will
      lead to a RCT of the management of vaginal complaints in primary care. This RCT may support
      current practice, reinforcing the need for physical exam and laboratory testing in all
      patients. On the other hand, the trial may support a more limited approach that avoids a
      pelvic examination. This could result in substantial savings of health care dollars with
      equivalent clinical outcomes.
    

Intervention name(s): Terazol or oral fluconazole for candidal vaginitis; Metronidazole or Clindamycin for Bacterial Vaginosis; Flagyl for definitively diagnosed vaginal trichomoniasis; Empiric Management
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Intravaginal terazol qhs x 5 nights; oral fluconazole 150 mg po x 1; Metronidazole 500 mg bid x 5 days; Intravaginal metronidazole bid x 5 days; intravaginal clindamycin; Metronidazole 2 gms po x 1; In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.
Other intervention name(s): Flagyl; Cleocin; Flagyl; Flagyl; Metronidazole; Fluconazole; Diflucan
Intervention MeSH terms: Metronidazole; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaginitis; Bacterial Vaginosis; Vaginal trichomoniasis; Vulvovaginal candidiasis