FEMSOFT Insert
The FemSoft Insert was studied in a clinical trial of 150 women at 8 clinical centers. After being evaluated to determine if they were appropriate candidates to use the FemSoft Insert, women used FemSoft Inserts as they desired for 1 year. During the year women had repeated evaluations to determine how the FemSoft Insert was working and whether any adverse events or complications were occurring. Fifty-seven women withdrew from the trial during the follow-up period. Of these 57 women, 50 withdrew during the first 3 months. The following reasons were given for withdrawal from the trial; 15 due to difficulty with insertion or general dissatisfaction with the method of incontinence control, 11 were lost to follow-up after failing to keep appointments and respond to contacts, 8 found the study protocol too demanding, 8 for non-device related health problems, 6 due to urinary tract infections, 3 for personal reasons unrelated to the study, 3 because they could not be properly fit with the FemSoft Insert, 2 were withdrawn by the investigator for non-compliance, and 1 for bladder spasm. Complications Reported with the FemSoft Insert: Approximately two-thirds of all women who participated in the trial experienced at least one adverse event while using the FemSoft Insert. These were as follows: Infection: Women gave urine samples at each visit to check for bacteria in the urine. Twenty-nine percent of the women had bacteria in their urine. Twenty-five percent of the women had a urinary tract infection that was treated with antibiotic medications Urinary Symptoms: Twenty-three percent of the women reported urinary symptoms such as sensation of needing to urinate (urgency), frequent urination and bladder spasm. Bleeding: Six percent of the women experienced bleeding when they injured the skin around the opening to the urethra when trying to insert a FemSoft Insert. No treatment was necessary and the women were able to resume using the FemSoft Insert after 1-2 days. This type of problem usually occurred early when women were still learning how to use the FemSoft Insert. In addition, three women had blood in their urine and three noted spotting of blood. FemSoft Insert Problems: There were nine complaints about the FemSoft Insert. These included reports of expelling FemSoft Inserts and breaking of the FemSoft Insert sleeve with release of the mineral oil. This number reflects 0.01% of all FemSoft Inserts used in the study. Other: The following adverse events occurred infrequently (less than 3%): one woman experienced FemSoft Insert migration into the bladder (the insert was removed by cystoscopy); one woman sustained a small scratch in her urethra near the bladder (the scratch was not severe and did not require treatment); and one woman who was known to have stones in her kidney prior to using the FemSoft Insert had a kidney infection. (It was uncertain whether the kidney infection resulted from using the FemSoft Insert or not. Improvements Reported with the FemSoft Insert: To measure how well the FemSoft Insert was working, women had a pad test. This consisted of exercising with a full bladder with and without a FemSoft Insert in place. During the tests women wore pads that were weighed afterward to determine how much urine the woman had lost during the test. These tests were done at 3, 6 and 12 months after starting to use the FemSoft Insert. At each time period the results showed that the FemSoft Insert was effective in preventing urine loss with a full bladder. By this test, approximately 9 out of 10 women were dry while using the FemSoft Insert. To further test how the FemSoft Insert was working the women kept diaries for a week before each visit, recording the number of leaking accidents they had when they were using a FemSoft Insert and when they were not. The results showed a significant reduction in leaking accidents occurring when the FemSoft Insert was used compared to when it was not used. The women reported, on average, 1 fewer leakage accident per day when using the FemSoft Insert in comparison to when not using the FemSoft Insert. A special questionnaire that measures quality of life was used to see if reducing leaking accidents by using the FemSoft Insert improved a woman’s overall quality of life. The questionnaires were given before starting to use the FemSoft Insert and after. The results showed a significant improvement in the women’s quality of life when using the FemSoft Insert compared to before using the insert. Women also filled out a questionnaire about their experience and satisfaction using the FemSoft Insert. Questionnaires were filled out at 1 week, 1, 3, 6, 9, and 12 months after starting the FemSoft Insert. Results of all questionnaires filled out by women are shown on Tables 1 and 2.
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