vaginal decibitus ulcers associated with pessary use
Conditions
Interventions
Intervention 1: Estrogen (Synapause-E3®). Therapy according manufacturer*s
instructions. As treatment for vaginal ulceration: single daily vaginal
insertion (1 ovule of 0.5mg) during the first two w
Sponsors
Zuyderland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Postmenopausal patients with a pessary because of pelvic organ prolapse or incontinence with clinical signs of vaginal ulceration. • Women with a pessary because of pelvic organ prolapse or incontinence • postmenopausal (last menstrual bleeding one year ago) • Clinical diagnosis of at least symptoms correlated with vaginal epithelium architecture changes, signs of atrophy and/or vaginal ulceration. • Capacity to understand, consent, and comply with the trial procedures
Exclusion criteria
Exclusion criteria: • Women who are premenopausal • Women using vaginal medication during the last three months prior to inclusion • Women using immunosuppressants • Women with a history of vasculitis and/or diabetes mellitus • Known allergies or contra-indications for honey or estrogen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to investigate the effect on vaginal mucosa damage after the application of a Medical Grade Honeyformulation (L-Mesitran ®) six weeks after starting treatment in patients with pelvic organ prolapse and pessary treatment. The vaginal mucosa damage is categorized in yes or no, and a more differentiated scoring of the stage of disturbance, using a modification of the staging I-IV of Campbell (the decubitus ulcer) and pictures will be made of the ulcer to compare before and after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are to investigate the effect on complaints (vaginal bleeding, vaginal discharge, pain, odor, discomfort and pHmucosa). Moreover, information about side effect, discomfort and patient globalimpression of improvement will be collected and compared. | — |
Countries
Netherlands
Contacts
Public ContactM Weemhoff
Zuyderland
Outcome results
None listed