Vaginal Estrogen With Pessary Treatment
Condition: Vaginal Infection; Urinary Tract Infection; Quality of Life
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal
      estrogen cream treatment with the pessary will be randomized amongst the patients and patient
      satisfaction and complication rates will be assessed during follow-up.
    

Detailed description: 
      This will be a double-blinded, placebo-controlled, randomized controlled trial. Eligible
      patients presenting to the urogynaecology clinic with pelvic organ prolapse will be offered
      management with a pessary and participation in the study

      Patients who agree to participate in the study will be given a consent form

      Patients in the study and thus those who have opted for pessary use will be randomized
      between two groups:

        1. Treatment group - will be given instructions for use and prescription for Premarin
           vaginal cream 2g at bedtime twice weekly

        2. Control group - will utilize pessary with an inactive placebo cream

      Both the patient and the investigators will be blinded to patient treatment.

      If a patient has expressed willingness to participate in the study over the phone, the
      research assistant will issue a study number to the patient and pick up the corresponding
      cream from the LHSC pharmacy to give to the patient at their next clinic visit. The cream
      will be provided to the patient once they have read the letter of information and signed the
      consent form.

      For follow-up visits, the research assistant will monitor appointment bookings to ensure that
      the cream is ready in the clinic when the patient has their next follow-up visit.

      Patients of both groups will be fitted with a pessary. Pessary fitting will be individualized
      due to differences in pelvic size and shape and degree of prolapse. Patients may return to
      the clinic for subsequent fittings until a successful fit has been achieved. An unsuccessful
      fitting is defined as discontinued pessary use due to discomfort or expulsion.

      Patients will be assessed for satisfaction and complications 6 wks, 18 wks, 36 wks and 60 wks
      after the successful fitting.

      To determine patient satisfaction and complications, patients will complete a compilation of
      validated questionnaires assessing urinary symptoms, sexual function and quality of life at
      each follow-up.

      At each follow-up, a vaginal exam will be done and a vaginal swab and urine sample (for
      urinalysis and culture and sensitivities) will be taken to assess vaginal bleeding and
      infections.
    

Intervention name(s): Premarin vaginal cream; Placebo cream
Intervention type(s): Drug; Drug
Intervention description(s): 2g at bedtime twice weekly; 2g at bedtime twice weekly
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Pessary; Patient Satisfaction; Estrogen Cream