Objective: The primary objective is to investigate the effect on vaginal mucosa damage after the application of a Medical GradeHoney formulation (L-Mesitran ®) six weeks after starting treatment in patients with pelvic organ prolapse and pessary…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vaginaal epitheel/mucosa
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
Secondary objectives are to investigate the effect on complaints (vaginal
bleeding, vaginal discharge, pain, odor, discomfort and pHmucosa with an
additional microbiological swab test result). Moreover, information about side
effect, discomfort and patient globalimpression of improvement will be
collected and compared.
Background summary
Rationale: In accordance with current guideline nearly 98% of urogynecologists
prescribe pessary among patients with pelvic organprolapse (POP), to provide
anatomic support and as a treatment of choice or in those who decline surgery.
Localized pressureeffect, and vaginal epithelium architecture changes, can
result in ulceration and abrasions of the vaginal mucosa, with a wide
varietyamong the different shapes and sizes of the pessary. Rates vary in the
literature among 3 to 24%. It is possible that atrophy and/orthe presence of
bacterial vaginosis (BV) contribute to the development of pressure ulcers.
Currently, the majority ofurogynecologists recommend concurrent vaginal
estrogen therapy with pessary use to limit complications, to treat or
preventdecubitus ulcer; however limited data exists to support this daily
recommended practice. An alternative therapy is not yet known.Recent literature
show that medical grade honey (MGH) has protective, antimicrobial and
immunomodulatory activity and maytherefore be a good alternative treatment. A
parallel can possibly be drawn to the treatment of diabetic (foot) pressure
ulcers withmedicinal honey. The application of MGH effectively enhanced wound
repair. We believe that MGH will modulate the vaginalmicroenvironment by its
anti-inflammatory, anti-oxidative and immunomodulatory properties, and
subsequently may decrease thepresence and vaginal ulceration when compared to
estrogen.
Study objective
Objective: The primary objective is to investigate the effect on vaginal mucosa
damage after the application of a Medical GradeHoney formulation (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).
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 global impression of
improvement will be collected andcompared.
Study design
Study design: feasibility pilot study
Intervention
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 weeks, after these first two
weeks single vaginal insertion (1 ovule of 0.5mg) a day two times a week for a
total period of six weeks.
Intervention 2: Medical Grade Honey Formulation (L-Mesitran®)
As treatment for vaginal ulceration - Single daily application (5 grams with
applicator) during the first two weeks, after these first two weeks single
vaginal application (5 grams with applicator) ) a day two times a week for a
total period of six weeks.
Study burden and risks
No difference between current standard treatment
Henri Dunantstraat 5
Heerlen 6419PC
NL
Henri Dunantstraat 5
Heerlen 6419PC
NL
Listed location countries
Age
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
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86076.096.24 |