Effect of INNOVO® on female SUI symptoms & quality of life
A randomised, controlled, double-blind, clinical study to compare two neuromuscular stimulator devices in female stress urinary incontinence: Effects on symptoms and quality of life.
Several studies have compared the efficacy of NMES (Neuromuscular Electrical Stimulation) devices in treating female SUI (Stress Urinary Incontinence), however, literature research1 indicates the extent and quality of participant randomization, sham treatments, analytical methods, and full reporting methods in many studies means only a few trials give a true representation of all results.2,3 Further appropriate comparative trials are needed.
A randomised, controlled, double-blind, clinical study to compare whether a 12-week treatment programme with an NMES device signi cantly improved the symptoms of female SUI compared with a modi ed NMES device.
50 female German subjects with SUI were randomised into two groups. Subjects in the control group (n=26) received treatment with a modi ed NMES device (Control), while subjects in the active group (n=24) used an active NMES device. The devices looked identical, but the modi ed device was programmed to produce a lower dose of pelvic oor muscle (PFM) stimulation with a strong sensory response compared with the active device. Treatment comprised of a 30-minute session of NMES, in a standing position, 5 days per week, for 12 weeks.
At week 12, the differences in change between the treatment arms were non-significant for the primary and secondary endpoints, apart from the 24-hour pad weight results, which showed statistically significant results at weeks 8 and 12 for the control group and active treatment group. (P=0.027 and P=0.044 respectively)
All subjects had previously failed a 6-week volitional pelvic floor muscle training programme or an equivalent lifestyle and exercise programme.
The significant improvement* from baseline difference between the control group and active group was observed as 60% at week 12.
At week 12, there was also a numerical trend for greater improvements in the active group over the control group in the Incontinence Quality of Life Questionnaire (iQOL) Score and the Kings Health Questionnaire Score. For the Modified Oxford Score (standing position), 40% of subjects in the control group and 47.6% in the active group had either good or moderate contraction in PFM strength at baseline. This increased to 82.4% and 81.3% respectively at 12 weeks. Both treatments were well tolerated.
*Defined as a greater than 50% reduction in pad weight, from baseline on the one-hour pad weight test; ** MOS explanation
Results of this randomised, controlled, double-blind, clinical study showed subjects in both the active and control treatment groups attained an improvement in several condition-speci c study outcomes versus baseline following a 12-week NMES treatment programme, with a non-signi cant di erence between groups in terms of response size. This study demonstrates the device is comfortable, easy to use, and delivers a safe e ective non-invasive treatment for stress urinary incontinence.
Further suitably powered studies in larger populations are warranted to further investigate the active treatment device. For further information contact us at [email protected]