None listed
Conditions
Brief summary
This research project is testing a new treatment. The new treatment is a vaginal ring pessary that delivers estriol to treat both pelvic organ prolapse (POP) and genitourinary syndrome of menopause (GSM) at the same time. We hypothesise that, compared to the existing vaginal pessary and estrogen therapy in the market, the estriol integrated vaginal pessary is an effective treatment for symptomatic pelvic organ prolapse and genitourinary syndrome of menopause (GSM) without additional treatment side effects.
Interventions
This study is Phase III unblinded, randomised controlled equivalence trial aiming to assess the safety, tolerability, and efficacy profiles of an estriol eluting pessary versus a standard care comparator as a non-surgical treatment for women with pelvic organ prolapse and genitourinary syndrome of menopause.
The Investigational Medicinal Product (IMP) is a homogenous ring-shaped vaginal pessary made of the chemically inert biocompatible silicone elastomer (DDU-4870, Nusil) and loaded with the
This study is Phase III unblinded, randomised controlled equivalence trial aiming to assess the safety, tolerability, and efficacy profiles of an estriol eluting pessary versus a standard care comparator as a non-surgical treatment for women with pelvic organ prolapse and genitourinary syndrome of menopause. The Investigational Medicinal Product (IMP) is a homogenous ring-shaped vaginal pessary made of the chemically inert biocompatible silicone elastomer (DDU-4870, Nusil) and loaded with the active pharmaceutical ingredient (API) estriol at a low concentration (0.55g for all rings). The IMP carries potential clinical benefits for managing vaginal atrophy in menopausal women. It is the first to offer hormonal replacement and mechanical support. It will be provided in two ring sizes: 57mm and 69mm with the same drug profile. Dose: sustained release of low estriol doses (0.00330-0.00550 mug/day) Duration: 1 month Mode: Vaginal pessary remaining insitu The intervention will not be personalised. The size of vaginal pessary used for participants will be determined by best fit (IMP 57mm or 69mm) based on an individual vaginal exam by appropriate expert at site, eg urogynaecologist or Grade 4 women's health physiotherapist, who will also fit the pessary. Pessary insertion only takes about 30sec, however full exam appointment may be around 30-60min to include questionnaires, sizing exam, and confirmation of comfort. Adherence to the device will be recorded by confirmation that the device remains insitu and has not been removed or expelled at review appointment (1 month)
Sponsors
Bespoke Clinical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women who have/who are: • At least 18 years old with symptomatic prolapse • Able to comprehend and complete study materials • Able to provide informed consent to participate in the study • Symptomatic pelvic organ prolapse from any single compartment or multi-compartment prolapse • Urinary incontinence • Willing to use vaginal pessary • Willing and able to adhere to follow up visits.
Exclusion criteria
Women who have/who are: • Unable to provide informed consent to participate. • English as a second language if not ?uent and no medical interpreter able to be sourced • Presence of abnormal uterine or undiagnosed vaginal bleeding • Active vaginal infection per patient symptom report • Chronic vaginal fungal infections such as Candida per patient symptom report • Prior systemic or topical vaginal estrogen therapy in the 3 months before the study
Outcome results
None listed