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

Primary Purpose

Vaginitis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Terazol or oral fluconazole for candidal vaginitis
Metronidazole or Clindamycin for Bacterial Vaginosis
Flagyl for definitively diagnosed vaginal trichomoniasis
Empiric Management
Sponsored by
Agency for Healthcare Research and Quality (AHRQ)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginitis focused on measuring Vaginitis, Bacterial Vaginosis, Vaginal trichomoniasis, Vulvovaginal candidiasis

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Eligible patients will be premenopausal, non-pregnant women presenting with a chief complaint of vaginal itch, malodor, discharge, pain, irritation or rash. We will accept patient history of being pre-menopausal as valid.

Exclusion Criteria:

  • We will exclude women over 45 who have undergone hysterectomy. We will exclude patients who cannot be reached by phone for follow-up interviews. We will exclude pregnant women because of concerns that the diagnosis and treatment of bacterial vaginosis plays a role in pre-term labor prevention.

Sites / Locations

  • Family Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Patients primarily with itching or irritation are treated for candidal vaginitis. Patients primarily with vaginal odor are treated for bacterial vaginosis. Patients who did not fit either of the previous groups are treated for both candidal vaginitis and bacterial vaginosis.

Patient are examined and a wet mount is prepared. If a definitive diagnosis is made patient is treated for the condition diagnosed. If no diagnosis is made the clinician has the option of either foregoing treatment (watchful waiting) or following the protocol in the experimental group

Outcomes

Primary Outcome Measures

Self-reported improvement in symptoms

Secondary Outcome Measures

Adverse reactions to treatment.
Incidence of STD's
Vaginal Complaints Scale

Full Information

First Posted
July 17, 2007
Last Updated
January 7, 2014
Sponsor
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00503542
Brief Title
Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network
Acronym
VCAT
Official Title
Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginitis
Keywords
Vaginitis, Bacterial Vaginosis, Vaginal trichomoniasis, Vulvovaginal candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients primarily with itching or irritation are treated for candidal vaginitis. Patients primarily with vaginal odor are treated for bacterial vaginosis. Patients who did not fit either of the previous groups are treated for both candidal vaginitis and bacterial vaginosis.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patient are examined and a wet mount is prepared. If a definitive diagnosis is made patient is treated for the condition diagnosed. If no diagnosis is made the clinician has the option of either foregoing treatment (watchful waiting) or following the protocol in the experimental group
Intervention Type
Drug
Intervention Name(s)
Terazol or oral fluconazole for candidal vaginitis
Intervention Description
Intravaginal terazol qhs x 5 nights; oral fluconazole 150 mg po x 1
Intervention Type
Drug
Intervention Name(s)
Metronidazole or Clindamycin for Bacterial Vaginosis
Other Intervention Name(s)
Flagyl, Cleocin
Intervention Description
Metronidazole 500 mg bid x 5 days; Intravaginal metronidazole bid x 5 days; intravaginal clindamycin
Intervention Type
Drug
Intervention Name(s)
Flagyl for definitively diagnosed vaginal trichomoniasis
Other Intervention Name(s)
Flagyl
Intervention Description
Metronidazole 2 gms po x 1
Intervention Type
Other
Intervention Name(s)
Empiric Management
Other Intervention Name(s)
Flagyl, Metronidazole, Fluconazole, Diflucan
Intervention Description
In this arm of the study women are treated for vaginal complaints purely on the basis of their symptoms.
Primary Outcome Measure Information:
Title
Self-reported improvement in symptoms
Time Frame
within 2 weeks
Secondary Outcome Measure Information:
Title
Adverse reactions to treatment.
Time Frame
within two weeks
Title
Incidence of STD's
Time Frame
at time of presentation
Title
Vaginal Complaints Scale
Time Frame
within 2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligible patients will be premenopausal, non-pregnant women presenting with a chief complaint of vaginal itch, malodor, discharge, pain, irritation or rash. We will accept patient history of being pre-menopausal as valid. Exclusion Criteria: We will exclude women over 45 who have undergone hysterectomy. We will exclude patients who cannot be reached by phone for follow-up interviews. We will exclude pregnant women because of concerns that the diagnosis and treatment of bacterial vaginosis plays a role in pre-term labor prevention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R. Anderson, MD, MSc
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Health Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10458
Country
United States

12. IPD Sharing Statement

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

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