geen, hulpmiddel is dummy but the condition (OAB) will not be examinated patients with over active bladder are participants in the study as well as patients without over active bladder
Conditions
Interventions
insertion of vaginal ring
Sponsors
LiGalli BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 8.4.1 Inclusion criteria 1. Subject is female. 2. Subject is willing and able to give written consent for study participation. 3. Subject is aged >=25 and
Exclusion criteria
Exclusion criteria: 1. Pregnancy. 2. Irregular vaginal bleeding. 3. The subject has a history of vaginal surgery. 4. The subject has a clinical relevant genital prolaps (POP-Q stage 2). 5. Known hypersensitivity to device material (polypropylene, styrene triblock copolymer, parafin oil, glue, primer, coloring agents). 6. The subject has symptomatic vaginal discharge (e.g. with itching or bad odour). 7. Any current illness that would jeopardize the subject*s health or interpretation of the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7.1 Primary objective The primary objective of the study is to assess the attitude towards the use of the MedRing | — |
Secondary
| Measure | Time frame |
|---|---|
| 7.2 Secondary objective The secondary objectives of the study are to assess device related adverse events, device damage and physician satisfaction. | — |
Countries
Netherlands
Outcome results
None listed