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    Appendix

    The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.

    Additional papers identified

    Article

    Number of patients/

    follow-up

    Direction of conclusions

    Reasons for non-inclusion in summary of key evidence section

    Anderson CA, Omar MI, Campbell SE et al. Conservative management for postprostatectomy urinary incontinence. Cochrane Database of Systematic Reviews 2015, Issue 1. Art. No.: CD001843. DOI: 10.1002/14651858.CD001843.pub5. Accessed 18 November 2021

    Systematic review (Cochrane)

    50 trials (n=4,717)

    Three small trials provided data and the meta‐analysis suggested that electrical stimulation was better than control interventions in terms of less incontinence, regaining continence more quickly and better quality of life, at least in the short term up to 6 months. The quality of evidence was deemed to be moderate, however less information was available for the longer term.

    Review included a range of conservative interventions.

    Electrical stimulation included anal electrical stimulation and sticky patch electrodes.

    Berghmans B, Hendriks E, Bernards A et al. Electrical stimulation with non-implanted electrodes for urinary incontinence in men. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD001202. DOI: 10.1002/14651858.CD001202.pub5.

    Systematic review (Cochrane)

    6 trials

    n=544

    There was some evidence that electrical stimulation enhanced the effect of pelvic floor muscle training in the short term but not after 6 months. There were, however, more adverse effects (pain or discomfort) with electrical stimulation.

    Most of the studies used anal electrical stimulation.

    Cruz E, Miller C, Zhang W et al. (2021) Does non-implanted electrical stimulation reduce post-stroke urinary or fecal incontinence? A systematic review with meta-analysis. International Journal of Stroke DOI: 10.1177/17474930211006301

    Systematic review

    10 trials

    n=894

    Published trials evaluating the effect of non-implanted electrical stimulation on post-stroke incontinence are few and heterogenous. Synthesised trials suggest that early and frequent treatment using electrical stimulation is probably more effective than sham or no treatment. Further trials measuring incontinence in an objective manner are needed.

    The review focused on transcutaneous electrical nerve stimulation and electro-acupuncture. NMES was described in 1 study, which is already included (Guo et al., 2018).

    Demirturk F, Akbayrak T, Karakaya I et al. (2008) Interferential current versus biofeedback results in urinary stress incontinence. Swiss Medical Weekly 138: 317–21

    Randomised controlled trial

    n=40

    Follow up: end of treatment

    All of the parameters improved after the treatments in each group (p<0.05) and both treatment modalities seemed to have similar effects on pad test (95% CI: -1.48 to -4.59), pelvic muscle strength (95% CI: -9.29 to -1.78) and quality of life (95% CI: ‑11.91 to -5.31) outcomes.

    More recent studies are included.

    Dumoulin C, Seaborne DE, Quirion-DeGirardi C et al. (1995) Pelvic-floor rehabilitation, Part 2: Pelvic-floor reeducation with interferential currents and exercise in the treatment of genuine stress incontinence in postpartum women--a cohort study. Physical Therapy 75: 1075–81

    Cohort study

    n=8

    Follow up=1 year

    Five patients became continent, and 3 others improved. A follow-up survey 1 year later confirmed the consistency of these results.

    Larger studies are included.

    Hwang U-J, Kwon O-Y, Lee M-S (2020) Effects of surface electrical stimulation during sitting on pelvic floor muscle function and sexual function in women with stress urinary incontinence. Obstetrics & Gynecology Science 63: 370–78

    Randomised controlled trial

    n=32

    Follow up: end of treatment (8 weeks)

    Surface electrical stimulation during sitting can improve pelvic floor muscle function and sexual function in women with stress urinary incontinence.

    Larger studies are included.

    Hwang U-J, Lee M-S, Jung S-H et al. (2020) Which pelvic floor muscle functions are associated with improved subjective and objective symptoms after 8 weeks of surface electrical stimulation in women with stress urinary incontinence? European Journal of Obstetrics, Gynecology, and Reproductive Biology 247: 16–21

    Randomised controlled trial

    n=32

    Follow up: end of treatment (8 weeks)

    Surface electrical stimulation in a seated position improved both subjective and objective symptoms in females with stress urinary incontinence. Pelvic floor muscle power, the UDI-6 score, and the pad weight test result should be considered when developing intervention guidelines to improve the subjective and objective symptoms of females with stress urinary incontinence.

    Larger studies are included.

    Kilpatrick KA, Paton P, Subbarayan S et al. (2020) Non-pharmacological, non-surgical interventions for urinary incontinence in older persons: A systematic review of systematic reviews. The SENATOR project ONTOP series. Maturitas 133: 42–48

    Systematic review

    27 studies

    There is sufficient evidence to warrant recommendation of group exercise therapy for stress incontinence and behavioural therapy for urgency, stress or mixed urinary incontinence in older women. Evidence was insufficient to recommend any other non-drug therapy.

    Only 1 study on 'electrical stimulation' was included, which was not described in detail.

    Maher RM, Caulfield B (2013) A novel externally applied neuromuscular stimulator for the treatment of stress urinary incontinence in women--''a pilot study. Neuromodulation: Journal of the International Neuromodulation Society 16: 590–94

    Case series

    n=9

    Follow up=end of treatment (8 weeks)

    At week 8, patients reported a 98% decrease in leakage (p=0.0001). Changes noted in Incontinence Impact Questionnaire and Modified Oxford scores were statistically significant (p=0.0001 and p=0.0001).

    The device is noninvasive and can be used as a home treatment.

    Larger and more recent studies are included.

    Massari M, Desideri P, Menchinelli P et al. (2015) Urinary incontinence: Clinical observation on 30 patients undergoing treatment with F.R.E.M.S (Frequency Rhythmic Electrical Modulation System). Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica 87: 243–45

    Case series

    n=30

    Follow up=12 months

    Electrodes were placed in bilateral paravertebral lumbosacral region (10 minutes at frequency of 110 Hz and automatic increase of 33% every 3 minutes, pulse duration 20μSec and variable voltage 70 to 250 Volts managed by the patient with sub-threshold remote control (+/-1 Volt); for further 10 minutes with a frequency of 420 Hz, pulse duration 10μSec and variable voltage 70 to 250 Volts managed by the patient) and in suprapubic region (10 minutes with variable frequency 1 to 100 Hz and variable duration 10 to 40 μSec (parameters managed by a software),and variable voltage up to 250 Volts managed by the patient).

    93% of patients had a positive result, with either disappearance or improvement of symptoms.

    Small case series with limited outcomes.

    Okada N, Igawa Y, Ogawa A et al. (1998) Transcutaneous electrical stimulation of thigh muscles in the treatment of detrusor overactivity. British Journal of Urology 81: 560–4

    Case series

    n=19

    Follow up=3 months

    In 11 of the 19 patients, the maximum cystometric capacity was increased by >50% of the pretreatment value; this happened in 8 of 14 of those with detrusor hyperreflexia and in 3 of 5 of those with idiopathic detrusor instability. In 6 of the 11 who had this response, there was a clinical improvement in their urinary incontinence and frequency for several weeks to 3 months after the period of therapy. A second 14-day treatment was also effective in all 4 patients who had a repeat trial.

    Larger and more recent studies are included.

    Rai BP, Cody JD, Alhasso A et al. Anticholinergic drugs versus non-drug active therapies for non-neurogenic overactive bladder syndrome in adults. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No.: CD003193. DOI:10.1002/14651858.CD003193.pub4.

    Systematic review (Cochrane)

    23 trials (n=3,685)

    Subjective improvement rates tended to favour the electrical stimulation group in 3 small trials (54% not improved with the anticholinergic versus 33% with electrical stimulation: risk ratio 0.64, 95% CI 1.15 to 2.34). However, this was statistically significant only for 1 type of stimulation, percutaneous posterior tibial nerve stimulation (risk ratio 2.21, 95% CI 1.13 to 4.33), and was not supported by statistically significant differences in improvement, urinary frequency, urgency, nocturia, incontinence episodes or quality of life.

    Electrical stimulation included intravaginal electrical stimulation, transcutaneous electrical nerve stimulation, the Stoller Afferent Nerve Stimulation System neurom-odulation and percutaneous posterior tibial nerve stimulation.

    Sciarra A, Viscuso P, Arditi A et al. (2021) A biofeedback-guided programme or pelvic floor muscle electric stimulation can improve early recovery of urinary continence after radical prostatectomy: A meta-analysis and systematic review. International Journal of Clinical Practice 75:e14208.

    Systematic review

    26 articles

    Regarding non-invasive treatment of urinary incontinence secondary to radical prostatectomy, the addition of guided programs using biofeedback or pelvic floor electric stimulation improved continence recovery rate, particularly in the first 3-month interval, compared with using of pelvic floor muscle exercises alone.

    11 articles included electrical stimulation, but most referred to anal stimulation None of them described electrical neuromuscular stimulation.

    Stewart F, Berghmans B, Bø K et al. Electrical stimulation with non-implanted devices for stress urinary incontinence in women. Cochrane Database of Systematic Reviews 2017, Issue 12. Art. No.: CD012390. DOI: 10.1002/14651858.CD012390.pub2.

    Systematic review (Cochrane)

    56 trials (n=3,781)

    The current evidence base indicated that electrical stimulation is probably more effective than no active or sham treatment, but it is not possible to say whether it is similar to pelvic floor muscle training or other active treatments in effectiveness or not. Overall, the quality of the evidence was too low to provide reliable results.

    Adverse effects were rare.

    Most of the included trials used intravaginal electrical stimulation.

    Stewart F, Gameiro LF, El Dib R et al. Electrical stimulation with non-implanted electrodes for overactive bladder in adults. Cochrane Database of Systematic Reviews 2016, Issue 12. Art. No.: CD010098. DOI:

    10.1002/14651858.CD010098.pub4.

    Systematic review (Cochrane)

    63 trials (n=4,424)

    Electrical stimulation shows promise in treating overactive bladder, compared to no active treatment, placebo or sham treatment, pelvic floor muscle training and drug treatment. It is possible that adding electrical stimulation to other treatments such as pelvic floor muscle training may be beneficial.

    The quality of the evidence base overall was low.

    Most of the included trials used intravaginal or posterior tibial nerve electrical stimulation.

    Su J, Wen J-G, Wang Q-W et al. (2006) Short-term effects of pelvic floor electrical stimulation on genuine stress urinary incontinence in women. Chinese Journal of Clinical Rehabilitation 10: 131–33

    Case series

    n=50

    Follow up: end of treatment (12 weeks)

    Incontinence symptoms were cured in 24 patients (48%), improved in 21 patients (42%) and did not improve in 5 patients (10%). Comparison of subjective and objective index of urodynamics before and after treatment: the functional cystic capacity, Valsalva leak point pressure, maximal urethral pressure and maximal urethral closure pressure were statistically significantly larger and higher compared with before treatment (p<0.05). The total frequency of uresis, leakage and scores of ICI-Q-SF were statistically significantly lower compared with before treatment (p<0.05).

    Small case series with no follow up beyond the end of treatment.

    Thomas LH, Coupe J, Cross LD et al. Interventions for treating urinary incontinence after stroke in adults. Cochrane Database of Systematic Reviews 2019, Issue 2. Art. No.: CD004462. DOI: 10.1002/14651858.CD004462.pub4.

    Systematic review (Cochrane)

    20 trials (n=1,338)

    Physical therapies, such as transcutaneous electrical nerve stimulation, may reduce the average number of incontinent episodes in 24 hours and probably improves functional ability. The quality of the evidence was limited due to poor reporting of study details (particularly in the earlier studies) and the small number of study participants in most comparisons.

    Although electrical stimulation was included, only trials that used transcutaneous electrical nerve stimulation or transcutaneous posterior tibial nerve stimulation were described.

    Yokozuka M, Namima T, Nakagawa H et al. (2004) Effects and indications of sacral surface therapeutic electrical stimulation in refractory urinary incontinence. Clinical Rehabilitation 18: 899–907

    Case series

    n=18

    Based on subjective findings, sacral surface therapeutic electrical stimulation had therapeutic effects with 56% of patients more than 'improved' and 61% more than 'slightly improved'. Based on objective findings, 44% of patients more than 'improved' and over 80% more than 'slightly improved'.

    Larger and more recent studies are included.