Compliance to pessary therapy with preventive indicatio
Phase 4
- Conditions
- N39.3Stress incontinenceN81.9Female genital prolapse, unspecified
- Registration Number
- DRKS00024733
- Lead Sponsor
- Vivantesklinikum im FriedrichshainKlinik für Gynäkologie und Geburtshilfe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 600
Inclusion Criteria
Currently after delivery in the last 6 weeks and completion of the puerperium
Exclusion Criteria
• Women who do not want to participate in the study
• Women who cannot read
• Women who cannot understand the information sheet
• Women who do not understand the German language
• Women with intact / inflamed vaginal mucosa
• Women with silicone intolerance
• Women who cannot insert or remove the pessary on their own
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptom reduction one year postpartum in 10% of women with urinary incontinence or symptoms of pelvic organ prolapse using a pessary compared to women with symptoms without using a pessary.<br><br>Six weeks postpartum, all study participants will be asked to take an online survey on pelvic floor symptoms. For this purpose, the validated pelvic floor questionnaire for postpartum women will be applied (Metz, et al 2017).<br>The study participants who decided to use the pessary will be informed when to start.<br>Two weeks after they started using the pessary, these study participants will be asked to take an online survey on the use and comfort of the pessary (Beilecke K et al 2017, Baessler K et al 2011). Three months, six months and one year postpartum another survey on the use of the pessary will take place.<br>One year postpartum, all participants will be asked to answer again and for the very last time the online survey on pelvic floor symptoms.
- Secondary Outcome Measures
Name Time Method Compliance of women with urinary incontinence or symptoms of pelciv organ prolapse to wear a pessary for at least 3 months postpartum.