The aim of this study was to perform a more detailed analysis of the Quality of Life data captured in two randomized controlled trials (RCTs) of the INNOVO® device.
Click Image to Enlarge Two separate RCTs were performed using the INNOVO® device. RCT1: External versus intravaginal electrical stimulation for the treatment of SUI in women: a randomized
controlled non-inferiority trial, 180 female patients,12 US centers; and RCT2: A randomized, controlled, double-blind clinical study to evaluate the safety and performance of
a new, novel, externally applied neuromuscular electrical stimulation device for the treatment of SUI versus a sham device, 50 female patients, 2 centers in Germany.
Women with SUI, whose condition had not improved using pelvic floor muscle training were randomized:
minutes once daily for 5 days/week for 12 weeks; comparator device 20 minutes once daily every day.
All information provided to the subjects was provided in their native language which included: Incontinence Quality of Life Questionnaire (I-QOL); Device Ease of Use
Questionnaire; device Instructions for Use; Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence Questionnaire (MESA); The Kings Health Questionnaire;
the voiding diary; patient information sheet and consent documents.
RCT1: Subjects had to score ≤9 out of 18 on the urge incontinence questions and have predominant SUI according to the Medical, Epidemiologic and Social Aspects of Aging
Urinary Incontinence (MESA) Questionnaire at screening and have urine leakage of 3–90 g in a provocative pad weight test (stress test following standardized bladder-filling
protocol) at baseline. Other SUI treatments, including new PFMT exercises, were not allowed during the study.
RCT2: Subjects who had scored at least 18 out of 27 for the Stress Incontinence Questions and were confirmed as having predominant SUI on the Medical, Epidemiologic,
and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment.
In RCT1 the age demographics in Age (years) Mean (SD), of the INNOVO® group were 45.9 years (8.86) and the comparator group, 47.8 years (9.27). The mean age of the
subjects in RCT2 was INNOVO® 51.3 (8.91) and Sham device 53.0 (13.6) years respectively.
Device treatment was assigned according to a randomization schedule using a permuted block format, stratified by study site. Designated unblinded study personnel
trained subjects in device use. Investigators and staff performing assessments were blinded to treatment assignment.
There was an overall improvement in the quality of life scores across both clinical trials: RCT1 and RCT2 (Table 1).
RCT 1
RCT1: Participants were evaluated at study sites at screening, baseline, and at 4 and 12 weeks during the treatment period. At 12 weeks, subjects were instructed to perform
PFMT daily until the final visit at 26 weeks. Significant improvements in pad tests, number of incontinence episodes and pads used per day, and Incontinence Quality of Life
score were seen with both active and comparator devices at week 12, with no clinically relevant between-group differences.
At week 12, significant improvements from baseline were seen in both groups for secondary endpoints including mean urine leakage (provocative pad weight test and 24-
hour pad weight test), number of incontinence episodes and number of pads used per day, and I-QOL score.
Quality of life improved in both active and comparator groups during the study, and the mean changes in I-QOL score (INNOVO® 13.42) were more than double the minimal
clinically important difference for this measure (6 points).2
European patient registries support the positive effect of INNOVO® on quality of life in real-life clinical practice [O’Reilly et al. 2016, Haab et al. 2016, Rainsford 1, Rainsford
2] 3-6 and showed that most subjects were satisfied/very satisfied with the treatment modality.5,6
RCT 2
RCT2: Quality of Life questionnaire score was assessed using the I-QOL at baseline, weeks 4, 12 and 26. RCT2 continued to monitor I-QOL up to 12 months. There was a
numerical trend for a greater improvement in the INNOVO® group over the control group in the iQOL Score, Kings Health Questionnaire Score and in the 1-hour pad weight
test at week 12. Here it would appear that there was a definite trend in favour of the INNOVO® arm, both in terms of better numerical scores on outcome measures and
borderline significance in terms of p value scores at Week 12. That said, the difference in outcomes between groups after intervention was found to be statistically nonsignifi
cant (p>0.05). There are a number of plausible explanations for this outcome. Firstly, the sample size for this study was planned to be 140 subjects in order to achieve a
90% power. As the study terminated after 50 subjects were included, it was not sufficiently powered to detect a difference between groups.
The total domain score for the KHQ is calculated by taking the average of each of the nine domain scores (severity score questions not included). The difference between the
mean total domain KHQ scores from baseline at week 12 were –15.03 (SD 22.48) for active treatment and –3.54 (SD 8.96) for control. This represented an improvement of
over four-times (76.5%) for active treatment versus control. The difference between the groups was –2.61. This difference was not significant (95% CI –21.18, 15.96; P=0.771).
There were no significant differences between the two treatment groups in the mean total domain KHQ scores at week 4 and week 8. Results were similar for 26 weeks, nine
months, and 12 months.
Compared with –15.03 for the active treatment group, the difference in mean total domain KHQ scores from baseline at Week 12 for the control group who subsequently
received active treatment was 0.12 (SD 3.39).
Conclusion: INNOVO® is a novel, noninvasive, external electrical muscle stimulation device for the treatment of female SUI demonstrating significant improvement in I-QOL scores in two
independent Randomised Controlled Trials reported here. The external electrical stimulation device INNOVO® provides a safe, clinically effective, conservative treatment
option for female SUI, and a low-risk alternative to intravaginal devices.
The results of the two trials were broadly similar over the 12 week period and these results were maintained at 26 weeks, which demonstrated the longer term benefits of
INNOVO® in strengthening (and maintaining) the pelvic floor musculature.
Roger R. Dmochowski, M.D., MMHC, Professor, Department of Urologic Surgery, Vice Chair for Faculty Affairs and Professionalism, Section of Surgical Sciences, Associate Surgeon-in-Chief, Vanderbilt University Medical Center.
The Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting, SUFU 2019, February 26 - March 2, 2019, Miami, Florida
References:
1. TensCare Ltd. itouch sure: instructions for use. Available from: http:www.tenscare.co.uk [Accessed: 28 Feb 2018].
2. Yalcin I, Patrick DL, Summers K, Kinchen K, Bump RC. Minimal clinically important differences in Incontinence Quality-of-Life scores in stress urinary incontinence. Urology. 2006;67(6):1304-8.
3. O`Reilly B, O`Sullivan O, Siddiqui K, Keane D, Skehan M. Change in Quality-of-Life scores in incontinence patients following an intervention of external electrical stimulation as determined by the Kings Health
Questionnaire [post-er]. Continence Foundation of Ireland (CFI) Annual Study Day, 4 March 2016; Dublin, Ireland.
4. Haab F, Elia D, De Tayrac R. Evaluating the change in Quality-of-Life (QoL) and Sexual Function Scores in incontinence patients following an intervention of external electrical stimulation (EES)[poster]. Presented at: Collège Nation-al des Sages – Femmes de France, 2016.
5. Rainsford G. Evaluating the clinical performance of a novel external electrical stimulation therapy for urinary incontinence - a retrospective case series (n=104) – study 1. Data on fi le.
6. Rainsford G. Evaluating the clinical performance of a novel external electrical stimulation therapy for urinary incontinence - a retrospective case series (n=57) – study 2. Data on fi le
controlled non-inferiority trial, 180 female patients,12 US centers; and RCT2: A randomized, controlled, double-blind clinical study to evaluate the safety and performance of
a new, novel, externally applied neuromuscular electrical stimulation device for the treatment of SUI versus a sham device, 50 female patients, 2 centers in Germany.
Women with SUI, whose condition had not improved using pelvic floor muscle training were randomized:
- to undergo treatment with either the INNOVO® or comparator device for 12 weeks (RCT1)
- to undergo treatment with either the INNOVO® or sham device for 12 weeks (RCT2)
minutes once daily for 5 days/week for 12 weeks; comparator device 20 minutes once daily every day.
All information provided to the subjects was provided in their native language which included: Incontinence Quality of Life Questionnaire (I-QOL); Device Ease of Use
Questionnaire; device Instructions for Use; Medical, Epidemiologic and Social Aspects of Aging Urinary Incontinence Questionnaire (MESA); The Kings Health Questionnaire;
the voiding diary; patient information sheet and consent documents.
RCT1: Subjects had to score ≤9 out of 18 on the urge incontinence questions and have predominant SUI according to the Medical, Epidemiologic and Social Aspects of Aging
Urinary Incontinence (MESA) Questionnaire at screening and have urine leakage of 3–90 g in a provocative pad weight test (stress test following standardized bladder-filling
protocol) at baseline. Other SUI treatments, including new PFMT exercises, were not allowed during the study.
RCT2: Subjects who had scored at least 18 out of 27 for the Stress Incontinence Questions and were confirmed as having predominant SUI on the Medical, Epidemiologic,
and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment.
In RCT1 the age demographics in Age (years) Mean (SD), of the INNOVO® group were 45.9 years (8.86) and the comparator group, 47.8 years (9.27). The mean age of the
subjects in RCT2 was INNOVO® 51.3 (8.91) and Sham device 53.0 (13.6) years respectively.
Device treatment was assigned according to a randomization schedule using a permuted block format, stratified by study site. Designated unblinded study personnel
trained subjects in device use. Investigators and staff performing assessments were blinded to treatment assignment.
There was an overall improvement in the quality of life scores across both clinical trials: RCT1 and RCT2 (Table 1).
RCT 1
RCT1: Participants were evaluated at study sites at screening, baseline, and at 4 and 12 weeks during the treatment period. At 12 weeks, subjects were instructed to perform
PFMT daily until the final visit at 26 weeks. Significant improvements in pad tests, number of incontinence episodes and pads used per day, and Incontinence Quality of Life
score were seen with both active and comparator devices at week 12, with no clinically relevant between-group differences.
At week 12, significant improvements from baseline were seen in both groups for secondary endpoints including mean urine leakage (provocative pad weight test and 24-
hour pad weight test), number of incontinence episodes and number of pads used per day, and I-QOL score.
Quality of life improved in both active and comparator groups during the study, and the mean changes in I-QOL score (INNOVO® 13.42) were more than double the minimal
clinically important difference for this measure (6 points).2
European patient registries support the positive effect of INNOVO® on quality of life in real-life clinical practice [O’Reilly et al. 2016, Haab et al. 2016, Rainsford 1, Rainsford
2] 3-6 and showed that most subjects were satisfied/very satisfied with the treatment modality.5,6
RCT 2
RCT2: Quality of Life questionnaire score was assessed using the I-QOL at baseline, weeks 4, 12 and 26. RCT2 continued to monitor I-QOL up to 12 months. There was a
numerical trend for a greater improvement in the INNOVO® group over the control group in the iQOL Score, Kings Health Questionnaire Score and in the 1-hour pad weight
test at week 12. Here it would appear that there was a definite trend in favour of the INNOVO® arm, both in terms of better numerical scores on outcome measures and
borderline significance in terms of p value scores at Week 12. That said, the difference in outcomes between groups after intervention was found to be statistically nonsignifi
cant (p>0.05). There are a number of plausible explanations for this outcome. Firstly, the sample size for this study was planned to be 140 subjects in order to achieve a
90% power. As the study terminated after 50 subjects were included, it was not sufficiently powered to detect a difference between groups.
The total domain score for the KHQ is calculated by taking the average of each of the nine domain scores (severity score questions not included). The difference between the
mean total domain KHQ scores from baseline at week 12 were –15.03 (SD 22.48) for active treatment and –3.54 (SD 8.96) for control. This represented an improvement of
over four-times (76.5%) for active treatment versus control. The difference between the groups was –2.61. This difference was not significant (95% CI –21.18, 15.96; P=0.771).
There were no significant differences between the two treatment groups in the mean total domain KHQ scores at week 4 and week 8. Results were similar for 26 weeks, nine
months, and 12 months.
Compared with –15.03 for the active treatment group, the difference in mean total domain KHQ scores from baseline at Week 12 for the control group who subsequently
received active treatment was 0.12 (SD 3.39).
Conclusion: INNOVO® is a novel, noninvasive, external electrical muscle stimulation device for the treatment of female SUI demonstrating significant improvement in I-QOL scores in two
independent Randomised Controlled Trials reported here. The external electrical stimulation device INNOVO® provides a safe, clinically effective, conservative treatment
option for female SUI, and a low-risk alternative to intravaginal devices.
The results of the two trials were broadly similar over the 12 week period and these results were maintained at 26 weeks, which demonstrated the longer term benefits of
INNOVO® in strengthening (and maintaining) the pelvic floor musculature.
Roger R. Dmochowski, M.D., MMHC, Professor, Department of Urologic Surgery, Vice Chair for Faculty Affairs and Professionalism, Section of Surgical Sciences, Associate Surgeon-in-Chief, Vanderbilt University Medical Center.
The Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting, SUFU 2019, February 26 - March 2, 2019, Miami, Florida
References:
1. TensCare Ltd. itouch sure: instructions for use. Available from: http:www.tenscare.co.uk [Accessed: 28 Feb 2018].
2. Yalcin I, Patrick DL, Summers K, Kinchen K, Bump RC. Minimal clinically important differences in Incontinence Quality-of-Life scores in stress urinary incontinence. Urology. 2006;67(6):1304-8.
3. O`Reilly B, O`Sullivan O, Siddiqui K, Keane D, Skehan M. Change in Quality-of-Life scores in incontinence patients following an intervention of external electrical stimulation as determined by the Kings Health
Questionnaire [post-er]. Continence Foundation of Ireland (CFI) Annual Study Day, 4 March 2016; Dublin, Ireland.
4. Haab F, Elia D, De Tayrac R. Evaluating the change in Quality-of-Life (QoL) and Sexual Function Scores in incontinence patients following an intervention of external electrical stimulation (EES)[poster]. Presented at: Collège Nation-al des Sages – Femmes de France, 2016.
5. Rainsford G. Evaluating the clinical performance of a novel external electrical stimulation therapy for urinary incontinence - a retrospective case series (n=104) – study 1. Data on fi le.
6. Rainsford G. Evaluating the clinical performance of a novel external electrical stimulation therapy for urinary incontinence - a retrospective case series (n=57) – study 2. Data on fi le