In a randomised, single-blind controlled trial, 123 women with stress, urgency or mixed urinary incontinence were randomised between an active control group and an active group.
ICIQ-UI
A condition specific quality of life tool for urinary incontinence
Statistically significant 4x greater improvement in ICIQ-UI scores in Pelviva group (p exact = 0.014)
Pelviva group (median decrease) – 5 points (45%)
Exercise group (median decrease) – 1 point (10%)
Scored out of 6
Where 0 is ‘never’ leaking and 5 is leaking ‘all the time’
p exact = 0.005
Equates to an improvement from leaking about once per day to once or less per week for the Pelviva group and 3 times per week for the exercise group.
Scored out of 10
Where 10 is interfering a ‘great deal’ with your everyday life
p exact = 0.018
PGI Severity is measured on a 4-point scale 1 = normal, 2 = mild, 3 = moderate, 4 = severe
PGI improvement is measured on a 7-point scale 1 = very much better, 4 = no change and 7 = very much worse
84% of women in the Pelviva group reported an improvement compared to 69.6% in the exercise only group.
4.6% of women in the exercise group reported that their symptoms got worse, no women in the Pelviva group reported worsening of symptoms.
A questionnaire specific to the relationship of urinary incontinence and sexual function, developed and validated by the Bristol Urological Institute.
Both groups reported that their incontinence did not spoil or cause discomfort during sex. For those that did find incontinence ‘bothersome during sex’ the Pelviva group had a significant improvement (p= 0.026) with the majority of women affected in this group reporting that their incontinence was ‘no longer bothersome’ post treatment.
During the study women were asked to fill in a ‘user diary’. This captured data with regard to comfort, ease of use and side effects. The majority of women found the device comfortable and easy to use and there were no apparent adverse incidents (e.g., allergic reactions, bleeding, undue pain, inability to remove the device) associated with using the device.
PEL/000016/UK September 2018
