Clinical Trial 3, 2018
Obtinu has been tested in three series of clincal trials at the Copenhagen University Hospital.
Clinical Trial 3 included only very severe cases of stress incontinence, i.e. patients who were all signed up for sling surgery. The last 16 of the included patients tried only one size of Obtinu, which performed as shown in the graphs above. It is quite impressive, given the severity of this group’s incontinence, that a one-size-fits-all Obtinu can make >80% of severely incontinent users continent.
Even more impressive: The shown leakages are totals, triggered by a series of activities: Deep cough tests + jump & activity excercises + bicycling excercise. The latter was an important part, considering daily life here in Scandinavia. The users reported a good comfort, even while cycling. Also the ease-of-use, which was given an extra attention in this test, was reported very good.
User feedbacks: 100% of those testing the final version of Obtinu, said they would like to use this solution, once it gets marketed. 100% of users, testing the final version of Obtinu, said they will recommend this solution to friends, once it gets marketed.
Doctor’s conclusions: “The Obtinu valve catheter, as clinically tested, is observed efficient, user-friendly, tolerable and safe.”
All in all, this is a very encouraging result before starting Clinical Trial 4.
Clinical Trial 2, 2017
For this test, the clinic included 10 women and tested four different sizes of Obtinu, in order to narrow down the dimensions for a hoped one-size-fits-all design. This time, all users got recruited at the hospital, so that only severe cases of incontinence took part in the trials. Once again, Obtinu proved efficient, safe and comfortable.
Clinical Trial 1, 2015
Here, 10 women, all suffering from stress incontinence in varying degrees, got recruited through a Facebook campaign. This test was a feasibility study: Is Obtinu comfortable? Does it provide continence? Does the valve work? Is the urine flow fast enough, when going to the toilet? Is Obtinu safe? All questions got answered by a "Yes". We also learnt, that the tested devices were too small for several of the users.
Clinical Trial 4, Q1 2019
This will be a long-term study, in which we follow 20 users during two months. Here we will learn about long-term efficiency and general user acceptance when Obtinu is used on a daily basis. The Urogynecological Clinic at Copenhagen University Hospital will be in charge of these tests.