NCT00503542

Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Agency for Healthcare Research and Quality (AHRQ) · Federal
• Sex: Female
• Age: 18 Years – 52 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaginitis

Interventions

Type	Name	Description
DRUG	Terazol or oral fluconazole for candidal vaginitis	Intravaginal terazol qhs x 5 nights; oral fluconazole 150 mg po x 1
DRUG	Metronidazole or Clindamycin for Bacterial Vaginosis	Metronidazole 500 mg bid x 5 days; Intravaginal metronidazole bid x 5 days; intravaginal clindamycin
DRUG	Flagyl for definitively diagnosed vaginal trichomoniasis	Metronidazole 2 gms po x 1
OTHER	Empiric Management	In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-07-18
• Last updated: 2014-01-08

Locations

1 site across 1 country: United States