Stress urinary incontinence (SUI) is a common condition affecting women in all ages. The gold standard is surgical treatment with a midurethral sling. However, women might prefer conservative treatment either due to young or old age, fear of surgical complications, or if the patient has recurrence after surgery. In some cases, intra-vaginal devices are effective for treating SUI, but in others, the device may be ineffective, displace, cause discharge, or discomfort. Intraurethral devices have been limited by the fact that they must be removed during each void. Obtinu is a novel intraurethral valve catheter where the valve can be opened with a magnet by the woman during voiding. The device consists of soft silicone and has a malecot tip for support in the bladder neck and a wide distal end and is disposable. Placement, opening of the valve, and removal of the device is shown in figure 1.
This study aimed to investigate the efficacy, comfort, user satisfaction, and immediate side-effects associated with the short-term and long-term use of the new intraurethral valve catheter (Obtinu).

A total of 50 women with SUI participated in a total of four clinical trials. The purpose of trial I (N=10) was feasibility, trial II (N=10) aimed to test different device sizes and a different device shape, trial III (N=20) comprised extended activity tests, including cycling and running with different device shapes, while in trial IV (N=10) trial users tested at home and for a longer duration use. Two standardized pad tests were used in all four tests before and after introducing the device. The first pad test was made with 10 forceful coughs and the second during 10 jumping jacks, 10 standing knee-lift, 3 deep squats, 30 times running on the spot and two flight of stairs (3 times up and 3 times down) 
During each trial, the users were asked to score the effect on a 5-point patient’s global impression of improvement scale (PGI-I, 1 = very much better, 2 = much better, 3 = no change, 4 = little worse, 5 = much worse) when using Obtinu. They scored the discomfort during insertion, wearing and removal of Obtinu on a 10-point numeric rating scale (NRS) from 0-10 (0 = no pain; 10 = significant pain). Participants in each trial were also asked if they would like to continue the use of Obtinu (if it had been possible) and whether they would recommend Obtinu to a friend. All medical device adverse events were recorded.

Key inclusion criteria were predominant SUI, symptoms >6 months, positive cough stress test with >150 mL in the bladder, incontinence episode frequency ≥1/day, no previous surgical treatment of SUI, post-void residual<100 mL, POP-Q stage ≤ 2, negative urine dipstick or negative urine culture. Key exclusion criteria were allergy to silicone, recurrent urinary tract infection, hematuria, previous or current inflammatory or malignant disease in the bladder/ urethra, stones in the urinary tract, urethral diverticulum, vesico-vaginal fistula, and antithrombotic treatment.
Statistics: The pad tests with and without Obtinu were compared with a paired t-test

In total, 44 women from the four clinical trials completed the pad test with and without the device, the results shown in table 1. 

Mean PGI-I score in trial I (N=10) was 1.2 (range: 1-2). The discomfort during inserting, wearing and removal was on NRS mean and (range): 2.5 (1-6), 1.7 (0-3) and 2.5 (1-9) respectively. Out of 10 women, 7 women would like to continue with Obtinu (if it had been possible), and 10 out of 10 women would recommend Obtinu to a friend.

Mean PGI-I in trial II (N=10) score was 1.9 (range: 1-4). The discomfort during inserting, wearing and removal was on NRS mean and (range): 3.4 (1-6), 2.2 (0-7) and 2.1 (0-6) respectively. Out of 10 women, 6 women would like to continue with Obtinu (if it had been possible), and 8 out of 10 women would recommend Obtinu to a friend.

Mean PGI-I score in trial III (N=19) for design 1 was 1.3 (range: 1-2). The discomfort during inserting, wearing and removal was on NRS mean and (range): 3.8 (0-9), 2.1 (0-6) and 4.3 (0-10) respectively. Eight of these women tested a second design and reported a mean PGI-I 1.1 (range: 1-2). The discomfort during inserting, wearing and removal of the second design was on NRS mean and (range): 4.0 (0-9), 2.1 (0-6) and 4.6 (1-8) respectively. Out of 19 women, 17 women would like to continue with Obtinu (if it had been possible), and 17 out of 19 women would recommend Obtinu to a friend.

Nine women were included in trial IV for long-time home use of the device. One stopped due to pain during introduction of the device in the clinic. Eight were instructed in daily use and started using the device at home. Two stopped after 1-2 days’ use due to pain. Four women completed 2 weeks test period where they used the device in 2, 3, 5 and 11 days at home. Two completed a 4-week test period (device used in 19 and 23 days). None would like to continue with the device but four out of nine would recommend the device to a friend. 
Following medical device adverse events were reported during the four trials: Six users had dysuria, tree users had spotting and four women had hematuria. Tree women experienced a small teer during removal of the device. No urinary tract infection or migration of the device were observed during or after the trials.

The Obtinu device has a significant effect on incontinence episodes during standardized cough and activity pad tests. It is possible to empty the bladder with the device in situ.  The comfort in long-term use is not acceptable. The hypothesis is that this is due to the lack of coating of the device and the comfort can be improved by adding a hydrophilic coat. 
Only mild medical device adverse events were reported during and after the trials.

The Obtinu valve catheter, designed for management of SUI, has been clinically tested in women with SUI, demonstrating efficacy, tolerability, and safety in short-term use. The comfort in long-term use was not acceptable. A new, hydrophilic coated device has been developed and will be tested for long-term use during Q2 of 2024.