Mycoplasma Species and the Genitourinary System
Condition: Sexually Transmitted Diseases, Bacterial
MeSH terms: Sexually Transmitted Diseases; Sexually Transmitted Diseases, Bacterial
Study type: Observational

Summary: 
      The purpose of this study is to determine if the presence of Mycoplasma hominis bacteria is
      associated with Bacterial vaginosis (BV), non-gonococcal urethritis (NGU) or vaginitis in
      patients attending sexual health clinic. Patients were participants of the MYCO WELL D-ONE
      study. Ethics for this follow-on pathway-to-portfolio study (IRAS:253889) is now approved by
      NRES and HCRW.

      The important primary aim of this study is to determine if Mycoplasma hominis (M.hominis) is
      associated with BV, NGU and vaginitis in the genitourinary system of patients or if they are
      bacterial commensals. This is important proof of concept work. The secondary aim for this
      research is to determine if there are clinical and social parameters that are associated with
      Mycoplasma infection.

      Preliminary analysis of 100 patients yielded pilot data suggesting M.hominis is strongly
      associated with BV, NGU and vaginitis. We aim to consolidate these findings by expansion to
      1000 patients from our completed MYCOWELL D-ONE study.
    

Detailed description: 
      The clinical study site is The Department of Sexual Health, Dewi Sant Hospital, Cwm Taf
      University Health Board. This study will retrospectively examine the clinical notes of
      consented participants (IRAS project ID:253889) in the MYCO WELL D-ONE study (IRAS project
      ID:230693).

      Notes will be identified by the sexual health clinic number. The clinic proforma records the
      following parameters:

        1. Gender the patient identifies with

        2. Age of the patient when the MYCO WELL D-ONE study sample collected

        3. Symptoms and signs that were recorded in the patient notes e.g. BV/NGU

        4. Previous sexually transmitted infections diagnosed

        5. Drug history

        6. Treatments the patient received

        7. Sexual history e.g. type of sexual activity On completion, he parameters associated with
           positive M.hominis result; bacteria load quantification/antimicrobial resistance) and
           statistical analysis will be examined as below. I Statistical analysis This will be
           performed on anonymised data. The primary outcome measure of this study is to determine
           if M.hominis is associated with BV, NGU and vaginitis in the genitourinary system of
           patients or if it is a bacterial commensal. The secondary outcome for this research is
           to determine if there are clinical and social parameters that are associated with
           M.hominis infection.
    

Intervention name(s): Test:mycoplasma
Intervention type(s): Other
Intervention description(s): Retrospective analysis of records of recruits to a previous mycoplasma study.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are sexually active and attending a walk-in sexual health clinic in the UK.