A Novel Externally Applied Neuromuscular Stimulator for the Treatment of Stress Urinary Incontinence in Women—A Pilot Study

Maher, Ruth M.; Caulfield, Brian

doi:10.1111/j.1525-1403.2012.00509.x

Cited by 10 publications

(12 citation statements)

References 19 publications

(18 reference statements)

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“…ES for PFMT is commonly achieved via transvaginal or transanal electrodes, which are invasive and difficult to manage hygienically, and they frequently cause discomfort, thus leading to low compliance. 25 Previous studies indicated that TES, which can be achieved by placement of transcutaneous electrodes in the perivaginal or sacral region, was effective for treating urinary incontinence. 22,26e28 Few studies exist regarding the relationship between PFM function and female sexuality or the training effectiveness of this musculature on sexual function.…”

Section: Introductionmentioning

confidence: 99%

Pelvic Floor Muscle Parameters Affect Sexual Function After 8 Weeks of Transcutaneous Electrical Stimulation in Women with Stress Urinary Incontinence

Hwang

Lee²,

Jung

et al. 2019

Sexual Medicine

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Introduction: Stress urinary incontinence (SUI) is often associated with female sexual dysfunction. We investigated which pelvic floor muscle (PFM) parameters (strength, power, and endurance) are associated with improvement of sexual function after 8 weeks of transcutaneous electrical stimulation (TES) training. Aim: This study was performed to determine the effects of TES in the seated position on PFM parameters and female sexual function and to identify correlation between improved PFM parameters and sexual function after 8 weeks of TES training in women with SUI. Methods: The present study was performed between August 2018 and November 2018 in women with SUI who were randomized into a TES group (n ¼ 17) or a control group (n ¼ 17). One subject in each of the TES and control groups ultimately withdrew during the intervention due to a lack of time. Both groups were measured at baseline and after 8 weeks of intervention. Main Outcome Measure: As outcome measures, PFM parameters (strength, power, and endurance) and female sexual function were assessed using a perineometer and the Female Sexual Function Index (FSFI), respectively. Results: The final study population consisted of 32 women with SUI. There were significant differences in PFM strength, power, and endurance and FSFI domain scores (desire, arousal, orgasm, satisfaction, and total score) in both between-group analyses (TES vs control group) and within-group analyses (pre-TES vs post-TSE). Change in PFM endurance had the highest association with change in total FSFI total score (r ¼ 0.437; P ¼ .006), and change in PFM power had the highest association with change in FSFI satisfaction (r ¼ 0.420; P ¼ .008). Conclusion: TES in a seated position showed a beneficial effect on sexual function in females with SUI. Consideration of PFM parameters associated with FSFI domain scores may be important when developing intervention guidelines to improve female sexual function.

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Section: Introductionmentioning

confidence: 99%

Pelvic Floor Muscle Parameters Affect Sexual Function After 8 Weeks of Transcutaneous Electrical Stimulation in Women with Stress Urinary Incontinence

Hwang

Lee²,

Jung

et al. 2019

Sexual Medicine

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“…This can largely be attributed to the fact that the size of the vaginal space limits electrode size and the ability of the user to reach an intensity sufficient to elicit PFMT, given the relatively high current density [14]. Thus, the evidence supporting the use of PFMT employing ES for SUI has been equivocal [10,14]. After 8 weeks of SESSP for PFMT, the present study observed improvement in PFM functions, urinary leakage and QOL.…”

Section: Discussionmentioning

confidence: 63%

“…Conventional ES devices for PFMT generally use a vaginal or anal electrode, which is invasive and often causes discomfort and injury and leads to low compliance. This can largely be attributed to the fact that the size of the vaginal space limits electrode size and the ability of the user to reach an intensity sufficient to elicit PFMT, given the relatively high current density [14]. Thus, the evidence supporting the use of PFMT employing ES for SUI has been equivocal [10,14].…”

Section: Discussionmentioning

confidence: 99%

“…Inclusion criteria [14] were 1) SUI diagnosed by a urogynecologist, 2) a leakage episode occurring more than once a week, 3) generally healthy (apart from SUI), 4) body mass index < 30 kg/m 2 , 5) age between 30 and 60 years, 6) non-smoker, 7) not addicted to alcohol or drugs, and 8) successfully completed medical screening questionnaire. Exclusion criteria [14] were 1) urogenital prolapse grade III or higher, 2) cardiac pacemakers, 3) devices implanted in the pelvis or hip joint, 4) pregnancy/planning to get pregnant, 5) pelvic or abdominal surgery within the last 6 months, 6) cognitive impairment, 7) concomitant treatment for SUI during the trial period, 8) neurological or psychiatric disease, and 9) urinary tract infection.…”

Section: Subjects and Designmentioning

confidence: 99%

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Effect of surface electrical stimulation in a seated position on pelvic floor muscle functions, urinary leakage, and quality of life in women with stress urinary incontinence

Hwang

Lee²,

Kim³

et al. 2019

Preprint

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Background The aim of this study was to demonstrate the effect of surface electrical stimulation in a seated position (SESSP), as pelvic floor muscle (PFM) training, on PFM functions (time to reach maximal pressure [TRMP], muscle strength, power and endurance), urinary leakage and quality of life in patients with stress urinary incontinence (SUI).Methods Women with SUI were randomized into an SESSP group (n = 18) or control group (n = 18). Quality of life were assessed by the Incontinence Quality of Life Questionnaire (I-QOL). Ultra-short pad test results and PFM functions were measured by perineometer. Changes in the outcomes were assessed before and 8 weeks after SESSP training.Results Thirty-three participants were included in the analysis. There were significant differences in I-QOL (avoidance and limiting behaviors, psychosocial impacts, social embarrassment and total score) in between (SESSP vs. control group) and within (pre vs. post) group analyses. Significant increases in PFM strength, power, and endurance, and significant decreases in the TRMP and pad weight, were observed between (SESSP vs. control group) and within (pre vs. post) groups.Conclusion SESSP in a seated position can be recommended to improve QOL, urinary leakage, and PFM functions in SUI patients. Trial registration Current Controlled Trials KCT0003357 (the date of registration: 2018.11.16) and retrospectively registered.

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“…A novel neuromuscular external stimulator (INNOVO®; hereafter “NMES”) has been developed that is a garment holding a set of skin contact electrodes in place around the pelvic area to ensure satisfactory recruitment of the pelvic floor muscles. Ultrasound studies showed that the device facilitated appropriate pelvic floor muscle contractions . Pilot studies in women with SUI found significant reductions in urine leakage after 8 or 12 weeks’ treatment .…”

Section: Introductionmentioning

confidence: 98%

External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial

Dmochowski

Lynch

Efros

et al. 2019

Neurourology and Urodynamics

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Aims: To compare the efficacy and safety of a neuromuscular external electrical stimulation device (INNOVO; "NMES") with an FDA-approved intravaginal device (iTouch sure; "comparator device") for the treatment of stress urinary incontinence (SUI).Methods: This prospective, single-blind, multicenter, noninferiority study randomized women with SUI to treatment with the NMES or the comparator device for 12 weeks. The primary endpoint was the proportion achieving >50% reduction in pad weight from baseline to 12 weeks in the provocative pad weight test.Results: Most subjects in both groups achieved >50% reduction in pad weight in the provocative pad test at week 12 (NMES 56.3%; comparator 63.0%), although noninferiority was not established. Significant improvements in pad tests, number of incontinence episodes, and pads used per day, and incontinence quality of life score were seen with both devices at week 12, with no clinically relevant between-group differences. Adverse events were predominantly mild/moderate and there were few discontinuations due to adverse events. The incidence of urinary tract/vaginal infections was higher with the comparator device than the NMES (7.7% versus 0%). The most common device-related adverse effect with the NMES was device discomfort (9.0%), which was generally manageable by modifying the stimulation intensity. Conclusions: The NMES significantly improved objective and subjective measures of SUI, although statistical noninferiority was not established. The NMES was well tolerated and associated with fewer urinary tract infections than the comparator. The NMES provides a safe, clinically effective, conservative treatment option for female SUI and a low-risk alternative to intravaginal devices. K E Y W O R D Sbladder control, electrical stimulation, pelvic floor, stress incontinence, urinary incontinence.

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A Novel Externally Applied Neuromuscular Stimulator for the Treatment of Stress Urinary Incontinence in Women—A Pilot Study

Cited by 10 publications

References 19 publications

Pelvic Floor Muscle Parameters Affect Sexual Function After 8 Weeks of Transcutaneous Electrical Stimulation in Women with Stress Urinary Incontinence

Pelvic Floor Muscle Parameters Affect Sexual Function After 8 Weeks of Transcutaneous Electrical Stimulation in Women with Stress Urinary Incontinence

Effect of surface electrical stimulation in a seated position on pelvic floor muscle functions, urinary leakage, and quality of life in women with stress urinary incontinence

External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial

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