None listed
Conditions
Brief summary
The purpose of this study is to assess the acceptability and effectiveness of using a vaginal pessary in post-partum women at high risk of developing prolapse. The study seeks to determine if wearing a vaginal pessary after delivery can reduce the severity and/or the development of prolapse. The pessary will be well tolerated and the support provided to the pelvic organs by a vaginal pessary used in the early post-partum period will facilitate the healing of damaged pelvic organ supporting structures and reduce the prevalence and/or severity of subsequent POP.
Interventions
The pilot study will assess the acceptability and effectiveness of using a vaginal pessary in post-partum women who have anatomic Pelvic Organ Prolapse (POP) immediately post-partum or are at high risk of developing POP.
Participants choosing to wear a pessary, who fulfil the inclusion criteria and agree to participate in the study, will be fitted with an appropriately sized and shaped vaginal pessary and assigned to group 1.
The pessary fitting visit will take place at Epworth Freemasons in t
The pilot study will assess the acceptability and effectiveness of using a vaginal pessary in post-partum women who have anatomic Pelvic Organ Prolapse (POP) immediately post-partum or are at high risk of developing POP. Participants choosing to wear a pessary, who fulfil the inclusion criteria and agree to participate in the study, will be fitted with an appropriately sized and shaped vaginal pessary and assigned to group 1. The pessary fitting visit will take place at Epworth Freemasons in the private consulting suite of the investigator. A post-partum visit in clinic will occur between weeks 2 and 8, during this visit participants consent to the pilot study, undergo a POP-Q exam, complete the Pelvic Organ Prolapse Symptom Score (POP-SS) Questionnaire and for the participants who elect to be fitted with the pessary will receive self-care training. Depending on the complexity of the visit/review, the duration will be between 15 and 60 minutes. Participants will be examined by the suitably trained/experienced study investigators who will provide training on self-care which includes removal/clean and replacing of the participants pessary. Adherence to the intervention is assessed at the 2-week post pessary phone follow up and 12-week clinic visit by the investigators for the study. Group 1 participants will have a clinical review via the phone at 1-2 weeks post fitting of the pessary and a clinic review at 12 weeks post pessary fitting. The final clinic visit will be at 6 months post pessary fitting. At this visit participants will undergo a POP-Q exam, complete the POP-SS and the Short Assessment of Patient Satisfaction (SAPS) Questionnaires these will take approximately 2-3 minutes each to complete. Participants will be invited to take part in a semi structured qualitative interview lasting between 15-45 minutes including topics listed below. The interview will be audio-recorded with participant consent and transcribed verbatim. It will be conducted by suitably trained/experienced study investigators and will take place at a time convenient to the participants either face-to-face, via telehealth(video), or via telephone. • experience of pessary fitting, insertion, and removal, • comfort and practical issues, • psychological and social aspects of pessary use, • perceived effectiveness and body awareness, • experiences of postpartum recovery and pelvic health education, and • reasons for continuation or discontinuation of pessary use.
Sponsors
Epworth HealthCare
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Primiparous women with stage 2 POP following singleton forceps or vacuum-assisted vaginal delivery, and/or fetal macrosomia (birth weight >4,000gm) at or beyond term. • Willingness to participate either as pessary using (Group 1), or not using a pessary (Group 2). • At least 18 years of age.
Exclusion criteria
• Refusal to participate. • Any obstetric post-natal complication that precludes safe fitting of a vaginal pessary e.g. abnormal perineal wound healing, infection, pain. • Multiparous women. • Pre-term delivery. • Non-singleton delivery. • Delivery by any method other than forceps or vacuum-assisted vaginal delivery • Prior treatment for POP and/or anti-incontinence (e.g. pelvic floor surgery, vaginal pessary, pelvic floor muscle training. • Known congenital conditions associated with POP (e.g. Ehlers-Danlos syndrome, spina bifida, ectopia vesicae). • Under 18 years of age.
Outcome results
None listed