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A randomised, controlled, double blind, clinical study in comparison of external NMES devices in patients with stress urinary incontinence: effects on symptoms and quality of life
IUGA Academy. Soeder S. 06/28/18; 213228; 159 Topic: Stress Incontinence
Sonja Soeder
Sonja Soeder

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159

A randomised, controlled, double blind, clinical study in comparison of external NMES devices in patients with stress urinary incontinence: Effects on symptoms and quality of life

Soeder, S1; Götze, M2; Fink, T3; Neymeyer, J4; Tunn, R5

1: Physiotherapy Department German Pelvic Floor Center St. Hedwig Hospital; 2: Kontinenzzentrum Brandenburg; 3: Urogynäkologie Sana Klinikum Lichtenberg; 4: Urogynäkologie Charite Berlin Campus Benjamin Franklin; 5: CA Urogynäkologie German Pelvic Floor Center St. Hedwig Hospital

Introduction: While results from several studies report that NMES (Neuromuscular Electrical Stimulation) can be effective in treating SUI (stress urinary incontinence), the issues of treatment technique, comfort and compliance often limit patient outcomes.1–3 This has led to the development of a novel, NMES device that includes a wired garment that uses external skin contact electrodes placed around the pelvic area to deliver electrical stimulation to pelvic floor muscles.

Objective: To assess whether a 12-week treatment programme with an NMES device significantly improved the symptoms of SUI in female subjects compared with a modified NMES device.

Methods: 50 female UK subjects with SUI were randomised into two groups. Subjects in the control group (n=26) received treatment with a modified NMES device, while subjects in the active group (n=24) used an active NMES device. The devices looked identical, but the modified device was programmed to produce a lower dose of pelvic floor muscle 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. All subjects had previously failed a 6-week volitional pelvic floor muscle training programme or an equivalent lifestyle and exercise programme. Evaluations were completed at baseline and at screening, at study enrolment, and at 4, 8 and 12 weeks, and at 6, 9 and 12 months follow-up. Primary endpoints included reduction from baseline to 12 weeks in urine leakage with a one-hour pad weight test, and improvement from baseline to 12 weeks in the Incontinence Quality of Life Questionnaire (iQOL) Score. Secondary endpoints included the QoL Kings Health Questionnaire Score; incontinence episodes/day, voids/day, pads used/day; pelvic floor strength and quality of contraction scores; ease of use questionnaire, adverse events, and 24-hour pad weight test. Analyses were carried out using an Intention to Treat population and a Per Protocol population.

Results: At week 12, the difference in change between treatment arms was 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) (Figure 1). At week 12, there was also a numerical trend for greater improvements in the active group over the control group in iQOL Score (Figure 2) 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 pelvic muscle strength at baseline. This increased to 82.4% and 81.3% respectively at 12 weeks. Both treatments were well tolerated.

Conclusion: 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-specific study outcomes versus baseline following a 12-week NMES treatment programme, with a non-significant difference between groups in terms of response size. Further suitably powered studies in larger populations are warranted to further investigate this novel treatment device.

References

  1. Mørkved S, Bø K, Fjørtoft T. Obstet Gynecol. 2002;4:730–739.
  2. Bø K, Talseth T, Holme I. BMJ. 1999;318:487–493.
  3. Alves PG, Nunes FR, Guirro EC. Rev Bras Fisioter. 2011;5:393–398.

Figure 1: Mean change from baseline in 24-hour pad weight at weeks 8 and 12 for control and active treatment.


Figure 2: Mean change from baseline in iQOL at week 12 with control and active treatment.

Disclosure:


Work supported by industry: yes, by Biomedical Research Ltd..

159

A randomised, controlled, double blind, clinical study in comparison of external NMES devices in patients with stress urinary incontinence: Effects on symptoms and quality of life

Soeder, S1; Götze, M2; Fink, T3; Neymeyer, J4; Tunn, R5

1: Physiotherapy Department German Pelvic Floor Center St. Hedwig Hospital; 2: Kontinenzzentrum Brandenburg; 3: Urogynäkologie Sana Klinikum Lichtenberg; 4: Urogynäkologie Charite Berlin Campus Benjamin Franklin; 5: CA Urogynäkologie German Pelvic Floor Center St. Hedwig Hospital

Introduction: While results from several studies report that NMES (Neuromuscular Electrical Stimulation) can be effective in treating SUI (stress urinary incontinence), the issues of treatment technique, comfort and compliance often limit patient outcomes.1–3 This has led to the development of a novel, NMES device that includes a wired garment that uses external skin contact electrodes placed around the pelvic area to deliver electrical stimulation to pelvic floor muscles.

Objective: To assess whether a 12-week treatment programme with an NMES device significantly improved the symptoms of SUI in female subjects compared with a modified NMES device.

Methods: 50 female UK subjects with SUI were randomised into two groups. Subjects in the control group (n=26) received treatment with a modified NMES device, while subjects in the active group (n=24) used an active NMES device. The devices looked identical, but the modified device was programmed to produce a lower dose of pelvic floor muscle 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. All subjects had previously failed a 6-week volitional pelvic floor muscle training programme or an equivalent lifestyle and exercise programme. Evaluations were completed at baseline and at screening, at study enrolment, and at 4, 8 and 12 weeks, and at 6, 9 and 12 months follow-up. Primary endpoints included reduction from baseline to 12 weeks in urine leakage with a one-hour pad weight test, and improvement from baseline to 12 weeks in the Incontinence Quality of Life Questionnaire (iQOL) Score. Secondary endpoints included the QoL Kings Health Questionnaire Score; incontinence episodes/day, voids/day, pads used/day; pelvic floor strength and quality of contraction scores; ease of use questionnaire, adverse events, and 24-hour pad weight test. Analyses were carried out using an Intention to Treat population and a Per Protocol population.

Results: At week 12, the difference in change between treatment arms was 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) (Figure 1). At week 12, there was also a numerical trend for greater improvements in the active group over the control group in iQOL Score (Figure 2) 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 pelvic muscle strength at baseline. This increased to 82.4% and 81.3% respectively at 12 weeks. Both treatments were well tolerated.

Conclusion: 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-specific study outcomes versus baseline following a 12-week NMES treatment programme, with a non-significant difference between groups in terms of response size. Further suitably powered studies in larger populations are warranted to further investigate this novel treatment device.

References

  1. Mørkved S, Bø K, Fjørtoft T. Obstet Gynecol. 2002;4:730–739.
  2. Bø K, Talseth T, Holme I. BMJ. 1999;318:487–493.
  3. Alves PG, Nunes FR, Guirro EC. Rev Bras Fisioter. 2011;5:393–398.

Figure 1: Mean change from baseline in 24-hour pad weight at weeks 8 and 12 for control and active treatment.


Figure 2: Mean change from baseline in iQOL at week 12 with control and active treatment.

Disclosure:


Work supported by industry: yes, by Biomedical Research Ltd..

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