Interventional procedure overview of transcutaneous electrical neuromuscular stimulation for urinary incontinence
Closed for comments This consultation ended on at Request commenting lead permission
Summary of key evidence on transcutaneous electrical neuromuscular stimulation for urinary incontinence
Study 1 Dmochowski R (2019)
Study type | Randomised controlled trial |
|---|---|
Country | US (12 centres) |
Recruitment period | 2015 to 2017 |
Study population and number | n=180 (89 external neuromuscular electrical stimulation [NMES], 91 intravaginal electrical stimulation) Women with SUI |
Age and sex | Mean (years): 45.9 (external NMES), 47.8 (intravaginal electrical stimulation); 100% female |
Patient selection criteria | Participants were women aged 18 to 65 years with a body mass index of 35 kg/m2 or less and clinically diagnosed SUI that had not improved with formal pretrial Kegel exercises taught by a physical therapist. They had to score 9 out of 18 or less on the urge incontinence questions and have predominant SUI according to the Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence Questionnaire at screening and have urine leakage of 3 to 90 g in a 1‐hour provocative pad weight test at baseline. Other SUI treatments, including new pelvic floor muscle training exercises, were not allowed during the study. Main exclusion criteria: medical or physical conditions that could compromise participation (such as reduced sensory perception in electrode contact areas); bladder abnormalities affecting lower urinary tract urinary flow; other urogynaecological disorders or prior treatments that could affect outcomes; metal or conductive implants or devices or conditions that could be adversely affected by electrical stimulation. |
Technique | NMES device: INNOVO (Atlantic Therapeutics, Galway, Ireland), formerly Vital Compact (Bio‐Medical Research Ltd). Controller specifications include 50 Hz frequency, 620 μs pulse width, 0.5‐second ramp‐up and ramp‐down times, 5‐second contraction time, and 5‐second relaxation time. Intravaginal device: iTouch sure (TensCare Ltd, UK). Controller specifications were: 50 Hz frequency, 300 μs pulse width, 1‐second ramp‐up and down, 5‐second plateau, and 10‐second rest. In both groups, treatment continued for 12 weeks and was self‐administered at home after appropriate training in the clinic. Devices were used in accordance with the manufacturers' device instructions for use, including adjustment of stimulation intensity, treatment session frequency, and duration, and overall treatment period. The external NMES device was used for 30 minutes once daily for 5 days per week. The intravaginal device was used for 20 minutes once daily for 7 days per week. |
Follow up | End of treatment (12 weeks) |
Conflict of interest/source of funding | The study was funded by Atlantic Therapeutics Ltd. Two authors are Clinical Advisors to Atlantic Therapeutics Ltd. |
Analysis
Follow-up issues: Patients were evaluated at study sites at screening, baseline, and at 4 and 12 weeks during the treatment period. The 12‐week treatment period was completed by 89% of patients in the external NMES group and 88% in the comparator group. The most common reason for early withdrawal from the study was patient request (external NMES 7%, comparator 6%). Of the 180 patients, 4 were lost to follow up (1 in the external NMES group and 3 in the comparator group).
Study design issues: Prospective, multicentre, single-blind, non-inferiority randomised controlled trial. Treatment was assigned according to a randomisation schedule using a permuted block‐format, stratified by study site. Designated unblinded study personnel trained patients in device use. Investigators and staff doing assessments were blinded to treatment assignment. The primary endpoint was the proportion of patients with more than 50% reduction in pad weight from baseline to 12 weeks in the provocative pad weight test. Noninferiority was established if the lower bound of the 95% CI for the treatment difference for the primary endpoint did not exceed the -5% noninferiority margin. Assuming a comparator device success rate of 52% and an NMES success rate of 71%, a sample size of 87 patients per group provided 90% power using a 1‐sided type I error rate of 0.025 and a noninferiority margin of 5%. Efficacy analyses were done on the intent‐to‐treat population and safety analyses on the safety population (randomised patients who used the device at least once).
Study population issues: There were no statistically significant differences in baseline characteristics between the 2 groups. Most patients (67%) had had SUI symptoms for more than 3 years, and most had mild (58%) or moderate (37%) SUI.
Other issues: The external NMES response rate was lower than the predicted rate (71%) used in the power calculation, so the study may have been underpowered to show non-inferiority.
Key efficacy findings
Number of patients analysed: 180 (89 external NMES, 91 intravaginal electrical stimulation)
Provocative pad weight test - proportion of patients with more than 50% reduction in pad weight from baseline at week 12 (primary endpoint)
External NMES=56.3%
Intravaginal electrical stimulation=63.0%, (difference -6.7%, 95% CI -21.7% to 8.4%)
Proportion of patients in the dry or mild categories of SUI severity at week 12
External NMES=87.2%
Intravaginal electrical stimulation=86.8%
Proportion of patients who reported improvement in SUI symptoms at week 12
External NMES=70.7%
Intravaginal electrical stimulation=63.0%
Pelvic organ prolapse incontinence sexual questionnaire – IUGA revised
A trend towards improved sexual function was observed in both groups at 12 weeks.
Mean (SD) baseline‐adjusted domain scores at week 12 ranged from 0.28 (13.89) to 5.00 (10.65) in the NMES group and from -2.34 (11.45) to 5.21 (20.93) in the comparator group among sexually active women, and from 0.00 (21.08) to 11.11 (21.66) with the NMES and from -10.12 (23.09) to 9.26 (23.61) with the comparator device among non-sexually active women.
Parameter | External NMES | Intravaginal electrical stimulation | treatment difference, mean (SE) | 95% CI | ||||
|---|---|---|---|---|---|---|---|---|
Baselinemean (SD) | week 12, mean (SD) | change, mean (SD) | Baseline mean (SD) | week 12, mean (SD) | change, mean (SD) | |||
Provocative pad weight test – urine leakage, g | 24.33 (20.06) | 15.85 (24.49) | -8.48 (25.05)* | 23.21 (20.45) | 13.55 (23.19) | -9.66 (22.88)^ | 1.18 (3.58) | (-5.88, 8.23) |
24-hour pad weight test – urine leakage, g | 26.37 (32.20) | 13.30 (19.58) | -13.07 (21.53)^ | 24.74 (28.87) | 14.85 (25.62) | -9.89 (19.99)^ | -3.18 (3.12) | (-9.34, 2.99) |
Incontinence episodes/day | 2.98 (2.34) | 1.74 (2.18) | -1.24 (1.56)^ | 2.93 (4.99) | 1.51 (2.06) | -1.43 (4.12)^ | 0.18 (0.47) | (-0.74, 1.11) |
Incontinence Quality of Life questionnaire (total score) | 58.55 (19.80) | 71.97 (21.60) | 13.42 (16.46)^ | 59.47 (19.46) | 74.89 (18.14) | 15.42 (18.38)^ | -2.01 (2.61) | (-7.16, 3.15) |
Pads used per day | 2.05 (1.42) | 1.75 (1.24) | -0.30 (1.00)** | 1.96 (1.23) | 1.52 (1.24) | -0.44 (0.98)^ | 0.14 (0.15) | (-0.15, 0.44) |
Dryness (<1g leakage on provocative pad weight test), n (%) | 0 (0) | 17 (19.1) | - | 0 (0) | 29 (31.9) | - | -12.8 (difference in proportions at week 12) | (-25.4, -0.2) |
* p=0.002, ** p=0.006, ^ p≤0.001
Device usage – median number of sessions per week
External NMES=4.75
Intravaginal electrical stimulation=5.92
Compliance – percent target use, mean (SD)
External NMES=86.3 (28.8)
Intravaginal electrical stimulation=76.5 (25.0)
Key safety findings
Device deficiencies (none led to adverse device effects)
External NMES=11.2% (10/89)
Intravaginal electrical stimulation=16.5% (15/91)
Proportion of patients who discontinued the study because of adverse events
External NMES=3.4%
Intravaginal electrical stimulation=4.4%
Adverse event | External NMES | Intravaginal electrical stimulation | ||
|---|---|---|---|---|
Number of patients (%) | Number of events | Number of patients (%) | Number of events | |
Total adverse events | 17 (19.1) | 24 | 11 (12.1) | 13 |
Gastrointestinal disorders, total | 0 (0) | 0 | 1 (1.1) | 1 |
Abdominal pain | 0 (0) | 0 | 1 (1.1) | 1 |
General disorders or administration site conditions, total | 12 (13.5) | 15 | 2 (2.2) | 2 |
Medical device discomfort | 8 (9.0) | 10 | 1 (1.1) | 1 |
Medical device pain | 4 (4.5) | 4 | 1 (1.1) | 1 |
Pain | 1 (1.1) | 1 | 0 (0) | 0 |
Infections and infestations, total | 0 (0) | 0 | 7 (7.7) | 7 |
Urinary tract infection | 0 (0) | 0 | 3 (3.3) | 3 |
Vaginal infection | 0 (0) | 0 | 2 (2.2) | 2 |
Vulvovaginal infection | 0 (0) | 0 | 2 (2.2) | 2 |
Musculoskeletal and connective tissue disorders, total | 2 (2.2) | 2 | 0 (0) | 0 |
Arthralgia | 1 (1.1) | 1 | 0 (0) | 0 |
Myalgia | 1 (1.1) | 1 | 0 (0) | 0 |
Renal and urinary disorders, total | 2 (2.2) | 2 | 0 (0) | 0 |
Dysuria | 1 (1.1) | 1 | 0 (0) | 0 |
Micturition urgency | 1 (1.1) | 1 | 0 (0) | 0 |
Reproductive system and breast disorders, total | 0 (0) | 0 | 1 (1.1) | 1 |
Vaginal discharge | 0 (0) | 0 | 1 (1.1) | 1 |
Skin and subcutaneous tissue disorders, total | 5 (5.5) | 5 | 2 (2.2) | 2 |
Erythema | 1 (1.1) | 1 | 0 (0) | 0 |
Pruritus | 0 (0) | 0 | 1 (1.1) | 1 |
Rash | 1 (1.1) | 1 | 0 (0) | 0 (0) |
Skin irritation | 3 (3.4) | 3 | 1 (1.1) | 1 |
Study 2 Celenay S (2021)
Study type | Randomised controlled trial |
|---|---|
Country | Turkey |
Recruitment period | Not reported |
Study population and number | n=66 (22 pelvic floor muscle exercises plus electrical stimulation, 22 pelvic floor muscle exercises plus Kinesio taping, 22 pelvic floor muscle exercises only) Women with overactive bladder, including urgency urinary incontinence (OAB-wet) |
Age | Mean age (years): 49.7 (electrical stimulation), 41.3 (Kinesio taping), 44.4 (pelvic floor muscle exercises only); 100% female |
Patient selection criteria | Inclusion criteria: patients diagnosed with overactive bladder in the urology outpatient clinic (age range 18 to 65) were included in the study. Exclusion criteria included pregnancy, concomitant serious cardiovascular or pulmonary diseases, uncontrolled metabolic disease (diabetes, thyroid disease), neurological problems, a concomitant malignancy, loss of sensation, mental problems to prevent evaluation and cooperation, a pacemaker, automatic implanted cardiac defibrillator, metal implant or skin lesions within the area of application of the electrodes, psoriasis, scleroderma, infection, and allergy to Kinesio tape. |
Technique | Electrical stimulation device: INNOVO (Atlantic Therapeutics, Ireland). Treatment parameters: 10 Hz frequency, 250 ms pulse width, 0.5-second ramp-up and ramp-down times and 5-second contraction time. The stimulation duration and frequency were 30 minutes, 3 times a week for 6 weeks. Kinesio taping: a star shaped Kinesio tape was applied on the sacral region (S2 to S4), in standing position. This was done 2 days per week for 6 weeks. Pelvic floor muscle exercises: 1 set of exercises comprised 10 fast and 10 sustained voluntary contractions. During week 1, women were asked to do 5 sets of exercises per day, which was progressively increased by 5 sets a week until week 6. The women were instructed to do the exercises in different positions (supine, sitting, standing, and semi-squat) and to integrate them into their daily activities. |
Follow up | End of treatment (6 weeks) |
Conflict of interest/source of funding | None |
Analysis
Follow-up issues: There was no follow up beyond the end of treatment at 6 weeks. An additional 9 patients were randomised but left the study for personal reasons (3 in each treatment group).
Study design issues: Single-blind, randomised controlled trial. Patients were randomly assigned to 1 of 3 groups according to a computer-generated random number table with random block sizes, prepared by an independent researcher not involved in the study. For the primary outcome, patients were asked to fill out a 24-hour voiding diary for 3 days. The number of voids per day, voids per night, and incontinence episodes per day were determined by taking the average of the data over the 3 days. Symptoms were assessed with the Turkish version of the 8-item Overactive Bladder Questionnaire, which has 8 items scored from 0 to 5, giving a total score from 0 to 40, with higher scores indicating more severe symptoms. The women's perception of improvement was assessed using a 4 item Likert-type scale (worse, same, better, cured). Quality of life was assessed with the Turkish version of the King's Health Questionnaire, which consists of 21 items in 9 domains. The study sample size was calculated according to the number of voids per night. For 80% power, the calculated sample size was 22 patients per group.
Study population issues: The demographic and physical characteristics of the groups were similar except for the parity and mode of delivery. The parity was higher in the pelvic floor muscle exercise only group than in the Kinesio taping group (p=0.018), and vaginal delivery type was higher in the electrical stimulation group (84%) than in the pelvic floor muscle exercise alone group (46%).
Key efficacy findings
Number of patients analysed: 66 (22 electrical stimulation plus pelvic floor muscle exercises, 22 Kinesio taping plus pelvic floor muscle exercises, 22 pelvic floor muscle exercises only)
Outcome | electrical stimulation, n=22 | Kinesio taping, n=22 | pelvic floor muscle exercises only, n=22 | p value (between group) |
|---|---|---|---|---|
Average number of voids/day | ||||
Before treatment | 9.0 (7.7 to 9.5) | 9.8 (8.5 to 11.7) | 9.3 (8.7 to 11.5) | 0.183 |
After treatment | 6.8 (5.5 to 8.0) | 7.2 (6.3 to 8.0) | 9.0 (8.0 to 9.7) | 0.001 |
Within group comparison | p=0.001 | p=0.001 | p=0.002 | |
Average number of voids/night | ||||
Before treatment | 1.3 (1.0 to 2.0) | 1.3 (1.0 to 2.0) | 1.3 (1.0 to 2.0) | 0.498 |
After treatment | 0.7 (0.0 to 1.0) | 0.3 (0.0 to 1.0) | 1.0 (1.0 to 2.0) | 0.002 |
Within group comparison | p=0.001 | p=0.001 | p=0.001 | |
Average number of incontinence episodes | ||||
Before treatment | 0.3 (0.0 to 2.5) | 2.2 (0.0 to 4.0) | 2.3 (1.3 to 3.3) | 0.157 |
After treatment | 0.0 (0.0 to 0.1) | 0.0 (0.0 to 1.0) | 1.0 (0.0 to 2.0) | 0.010 |
Within group comparison | p=0.003 | p=0.001 | p=0.001 | |
Overactive Bladder-Version 8 | ||||
Before treatment | 34.0 (29.0 to 37.0) | 26.0 (18.0 to 29.0) | 27.5 (23.0 to 32.0) | 0.001 |
After treatment | 6.5 (4.0 to 11.0) | 9.5 (3.0 to 17.0) | 21.0 (11.0 to 24.0) | 0.001 |
Within group comparison | p=0.001 | p=0.001 | p=0.001 | |
Pelvic Floor Muscle Strength (kPa) | ||||
Before treatment | 5.0 (3.0 to 6.0) | 5.0. (4.0 to 7.0) | 4.5 (3.0 to 5.0) | 0.314 |
After treatment | 8.0 (6.0 to 10.0) | 8.0 (7.0 to 9.0) | 7.3 (5.5 to 9.0) | 0.209 |
Within group comparison | p=0.001 | p=0.001 | p=0.001 |
Perception of improvement | electrical stimulation, n=22 | Kinesio taping, n=22 | pelvic floor muscle exercises only, n=22 |
|---|---|---|---|
Worse | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Same | 0 (0.0) | 0 (0.0) | 9 (40.9) |
Better | 6 (27.3) | 8 (36.4) | 12 (54.5) |
Cured | 16 (72.7) | 14 (63.6) | 1 (4.5) |
Subscale of KHQ | electrical stimulation, n=22 | Kinesio taping, n=22 | pelvic floor muscle exercises only, n=22 | p value (between group) |
|---|---|---|---|---|
General health perception | ||||
Before treatment | 37.5 (25.0 to 50.0) | 50.0 (25.0 to 50.0) | 50.0 (50.0 to 75.0) | 0.067 |
After treatment | 25.0 (25.0 to 25.0) | 25.0 (25.0 to 50.0) | 50.0 (25.0 to 50.0) | 0.005 |
p (within group) | 0.021 | 0.015 | 0.005 | |
Incontinence impact | ||||
Before treatment | 100.0 (100.0 to 100.0) | 83.3 (50.0 to 100.0) | 100.0 (66.7 to 100.0) | 0.032 |
After treatment | 33.3 (33.3 to 66.7) | 33.3 (11.1 to 50.0) | 66.66 (33.3 to 100.0) | 0.109 |
p (within group) | 0.001 | 0.001 | 0.022 | |
Role limitations | ||||
Before treatment | 83.3 (66.7 to 100.0) | 75.0 (50.0 to 100.0) | 66.7 (33.3 to 100.0) | 0.142 |
After treatment | 25.0 (16.7 to 33.3) | 16.7 (0.0 to 50.0) | 33.3 (16.7 to 66.7) | 0.527 |
p (within group) | 0.001 | 0.001 | 0.002 | |
Physical limitations | ||||
Before treatment | 100.0 (83.3 to 100.0) | 66.7 (33.3 to 100.0) | 66.7 (33.3 to 100.0) | 0.002 |
After treatment | 33.3 (16.7 to 50.0) | 20.8 (0.0 to 50.0) | 33.3 (16.7 to 66.7) | 0.347 |
p (within group) | 0.001 | 0.001 | 0.001 | |
Social limitations | ||||
Before treatment | 55.6 (22.2 to 77.8) | 41.7 (22.2 to 77.8) | 38.9 (22.2 to 77.8) | 0.649 |
After treatment | 0.0 (0.0 to 33.3) | 11.1 (0.0 to 33.3) | 22.2 (11.1 to 44.4) | 0.076 |
p (within group) | 0.001 | 0.001 | 0.011 | |
Limitations in personal relationship | ||||
Before treatment | 16.7 (0.0 to 66.7) | 29.2 (0.0 to 66.7) | 0.0 (0.0 to 66.7) | 0.565 |
After treatment | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 25.0) | 0.0 (0.0 to 33.3) | 0.309 |
p (within group) | 0.005 | 0.028 | 0.023 | |
Emotional problems | ||||
Before treatment | 72.2 (44.4 to 88.9) | 33.3 (22.2 to 55.6) | 38.9 (22.2 to 55.6) | 0.004 |
After treatment | 5.6 (0.0 to 33.3) | 16.7 (0.0 to 22.2) | 22.2 (0.0 to 44.4) | 0.505 |
p (within group) | 0.001 | 0.001 | 0.005 | |
Sleep and energy disturbances | ||||
Before treatment | 66.7 (33.3 to 66.7) | 41.7 (33.3 to 66.7) | 66.7 (33.3 to 100.0) | 0.482 |
After treatment | 16.7 (0.0 to 33.3) | 16.7 (0.0 to 33.3) | 33.3 (16.7 to 66.7) | 0.018 |
p (within group) | 0.001 | 0.001 | 0.003 | |
Severity measures | ||||
Before treatment | 50.0 (33.3 to 73.3) | 40.0 (25.0 to 80.0) | 70.00 (40.0 to 86.7) | 0.412 |
After treatment | 6.7 (0.0 to 20.0) | 22.5 (13.3 to 46.7) | 36.7 (20.0 to 60.0) | 0.001 |
p (within group) | 0.001 | 0.001 | 0.001 | |
Symptom severity | ||||
Before treatment | 15.5 (13.0 to 19.0) | 12.5 (10.0 to 16.0) | 14.0 (9.0 to 17.0) | 0.017 |
After treatment | 1.5 (0.0 to 4.0) | 4.5 (2.0 to 7.0) | 10.0 (6.0 to 12.0) | 0.001 |
p (within group) | 0.001 | 0.001 | 0.001 |
Key safety findings
No patient reported any adverse effects.
Study 3 Correia G (2014)
Study type | Randomised controlled trial |
|---|---|
Country | Brazil |
Recruitment period | 2012 to 2013 |
Study population and number | n=45 (15 surface electrical stimulation, 15 intravaginal electrical stimulation, 15 control) Women with SUI |
Age | Mean age (years): 64.5 (surface stimulation), 59.9 (intravaginal stimulation), 60.1 (control); 100% female |
Patient selection criteria | Inclusion criteria: women aged over 50 years, with urinary leakage on stress who had not had physical therapy for UI. Women with symptoms of urgency UI and mixed UI were excluded. Two questions were used to determine patient eligibility. The first question was: ''During the past month, have you involuntarily got wet while performing some kind of physical exertion, e.g. coughing, lifting, sneezing or laughing?'' The second question was: ''During the past month, have you experienced such a strong urge to urinate that it was impossible to get to the toilet in time?'' Only women who answered ''yes'' just to the first question were recruited. Exclusion criteria included latex allergies, vaginal or urinary infections, pelvic organ prolapse greater than grade 2, inability to do voluntary pelvic floor muscle contraction, cognitive or neurological disorder, uncontrolled hypertension, inability to carry out the evaluation or treatment, hormone therapy, use of pacemaker or metal rod implantation |
Technique | Surface stimulation and intravaginal stimulation: 12 individual sessions, 2 weekly sessions of 20 minutes with Dualpex 961 (Quark Medical Products) equipment. The same stimulation parameters were used in both groups (frequency: 50 Hz; pulse duration: 700 ms; time: 20 min; 4-seconds on/8-seconds off cycles; rise: 2 seconds fall: 2 seconds; stimulation intensity: maximal level tolerable). In the surface stimulation group, the women were positioned supine, with 45° of hip and knee flexion. Four surface electrodes of silicone were fixed with masking tape, 2 were placed in the suprapubic region and the other 2 were crossed on the skin and fixed medial to the ischial tuberosity. During the treatment the women used panties. In the intravaginal stimulation group, the women were positioned supine with 45° of hip and knee flexion for the positioning of an intravaginal electrode. During the treatment the women were positioned supine with hip and knee in a neutral position. Women in the control group had no treatment during the study period. Afterwards, they were referred for physical therapy treatment. |
Follow up | End of treatment |
Conflict of interest/source of funding | Funding support came from Sao Paulo Research Foundation, Coordination for the Improvement of Higher Education Personnel and Brazilian National Research Council. |
Analysis
Follow-up issues: There was no follow up beyond the end of the treatment period. An additional 3 patients were randomised but were lost to follow up and were excluded from the analysis.
Study design issues: Prospective single centre randomised controlled trial. Patients were randomised into 3 groups using computer-generated random numbers. A researcher who was not involved in the data collection or analyses created the randomisation list. The main outcomes were urinary leakage, pressure and strength of pelvic floor muscle contraction. The secondary outcome was quality of life evaluated by the KHQ. The sample size was calculated considering the values of pad test (in grams) from previous data on a pilot study of surface electrical stimulation treatment. At a significance level of 5% and power of 90%, it was estimated to need a sample of at least 45 people. A blinded experienced physiotherapist did all evaluations.
Study population issues: There were no statistically significant baseline differences between the groups regarding age, body mass index, number of deliveries and number of vaginal deliveries.
Key efficacy findings
Number of patients analysed: 45 (15 surface electrical stimulation, 15 intravaginal stimulation, 15 control)
Outcome | Treatment group | Before treatment | After treatment | Intragroup p value |
|---|---|---|---|---|
1 hour pad test (g) | Surface stimulation | 6.28 (15.19) | 3.31 (12.10) | 0.010 |
Intravaginal stimulation | 2.20 (4.65) | 0.41 (0.78) | 0.010 | |
Control | 7.33 (16.02) | 7.62 (15.27) | 0.61 | |
Intergroup p value | 0.18 | 0.0005 | ||
Muscle strength | Surface stimulation | 2.06 (0.80) | 2.53 (0.83) | 0.07 |
Intravaginal stimulation | 2.00 (1.00) | 2.66 (0.81) | 0.007 | |
Control | 2.16 (0.83) | 2.25 (0.86) | 0.99 | |
Intergroup p value | 0.95 | 0.29 | ||
Pressure (cmH2O) | Surface stimulation | 39.41 (17.65) | 47.37 (19.16) | 0.004 |
Intravaginal stimulation | 37.42 (22.89) | 44.23 (20.10) | 0.04 | |
Control | 37.92 (22.95) | 37.65 (19.16) | 0.58 | |
Intergroup p value | 0.74 | 0.52 |
Outcome | Treatment group | Before treatment | After treatment | Intragroup p value |
|---|---|---|---|---|
General health | Surface stimulation | 40.00 (26.39) | 33.33 (32.27) | 0.68 |
Intravaginal stimulation | 38.33 (18.58) | 26.66 (17.59) | 0.07 | |
Control | 37.50 (25.00) | 43.75 (21.65) | 0.61 | |
Intergroup p value | 0.74 | 0.17 | ||
Incontinence impact | Surface stimulation | 57.78 (32.04) | 6.66 (13.80) | 0.0005 |
Intravaginal stimulation | 64.44 (32.03) | 4.44 (11.73) | 0.0005 | |
Control | 58.33 (37.94) | 61.11 (37.15) | 0.44 | |
Intergroup p value | 0.80 | <0.0001 | ||
Limitations of daily activities | Surface stimulation | 34.44 (42.00) | 0.00 (0.00) | 0.01 |
Intravaginal stimulation | 36.66 (26.12) | 0.00 (0.00) | 0.001 | |
Control | 56.94 (39.85) | 54.16 (40.27) | 1.00 | |
Intergroup p value | 0.39 | <0.0001 | ||
Physical limitations | Surface stimulation | 43.33 (31.37) | 1.11 (4.30) | 0.0003 |
Intravaginal stimulation | 43.33 (39.74) | 1.11 (4.30) | 0.004 | |
Control | 54.16 (44.45) | 51.38 (42.91) | 0.68 | |
Intergroup p value | 0.52 | <0.0001 | ||
Social limitations | Surface stimulation | 18.52 (32.71) | 1.85 (5.00) | 0.22 |
Intravaginal stimulation | 21.48 (31.83) | 0.00 (0.00) | 0.02 | |
Control | 33.79 (34.85) | 31.01 (36.19) | 0.68 | |
Intergroup p value | 23 | 0.0007 | ||
Personal relationships | Surface stimulation | 4.44 (11.73) | 0.00 (0.00) | 0.47 |
Intravaginal stimulation | 13.33 (35.74) | 0.00 (14.08) | 0.22 | |
Control | 13.88 (23.39) | 22.22 (33.58) | 1.00 | |
Intergroup p value | 0.35 | 0.04 | ||
Emotions | Surface stimulation | 28.15 (38.23) | 2.96 (8.88) | 0.01 |
Intravaginal stimulation | 48.15 (33.77) | 2.96 (7.82) | 0.0008 | |
Control | 49.07 (32.29) | 56.48 (33.65) | 0.75 | |
Intergroup p value | 0.1548 | <0.0001 | ||
Sleep and disposition | Surface stimulation | 27.77 (41.62) | 0.00 (0.00) | 0.02 |
Intravaginal stimulation | 14.44 (28.08) | 0.00 (0.00) | 0.07 | |
Control | 30.55 (43.13) | 30.55 (43.13) | 0.68 | |
Intergroup p value | 0.8140 | 0.003 | ||
Severity measures | Surface stimulation | 37.77 (29.67) | 8.09 (14.60) | 0.0005 |
Intravaginal stimulation | 38.66 (21.56) | 1.77 (4.69) | 0.0003 | |
Control | 47.22 (26.12) | 58.33 (25.60) | 0.75 | |
Intergroup p value | 0.7605 | <0.0001 |
Key safety findings
None reported
Study 4 Karaman E (2020)
Study type | Randomised controlled trial |
|---|---|
Country | Turkey |
Recruitment period | 2019 to 2020 |
Study population and number | n=48 (20 external NMES and Kegel exercises, 28 Kegel exercises only) Patients who had surgery for SUI |
Age and sex | Mean age 42 years; 100% female |
Patient selection criteria | Patients diagnosed with predominantly SUI who had anti-incontinence surgery were included. Exclusion criteria included patients who had chronic severe diseases, cardiac pacemakers, neurological or psychiatric disorders or urinary tract infections. Patients who were pregnant were also excluded. |
Technique | NMES device: INNOVO All patients had anti-incontinence surgery (39 had a transvaginal tape procedure, 7 had a transobturator tape procedure and 2 had Burch colposuspension). All patients were taught how to do Kegel exercises (at least 3 sets of 10 to 15 repetitions a day for 1 month during the study period). Patients had either electrical stimulation (for 30 minutes twice a week) together with Kegel exercises or Kegel exercises only for 4 weeks after their surgery. |
Follow up | End of treatment (4 weeks) |
Conflict of interest/source of funding | The study was supported by the Van Yuzuncu Yil University, Department of Scientific Research Project. |
Analysis
Follow-up issues: there was no follow up beyond the end of the treatment period of 4 weeks.
Study design issues: Prospective single centre randomised controlled trial. The main aim was to evaluate the effect of functional electrical stimulation therapy on SUI recurrence and quality of life of patients in the postoperative period after anti-incontinence surgery. Patients were randomised into 2 groups after their surgery, according to given sequential numbers. A bladder diary diagram was used to assess urinary leakage during the last 3 days of the month. Quality of life was assessed by a patient-completed questionnaire at the end of treatment (using Wagner's quality of life scale, with higher scores denoting worse quality of life). The 24-hour pad test was used as an objective measure of urinary leakage.
Study population issues: The 2 groups were comparable in terms of baseline demographic characteristics and clinical features. There were no statistically significant differences in mean parity number, body mass index, smoking status and number of previous vaginal births.
Key efficacy findings
Number of patients analysed: 48 (20 external NMES plus Kegel exercises, 28 Kegel exercises only)
Clinical outcome | External NMES plus Kegel exercises, n=20 | Kegel exercises only, n=28 | p value |
|---|---|---|---|
Patients with recurrence of urinary incontinence, n (%) | 2 (10%) | 5 (17.8%) | 0.02 |
24-hour pad test, g, mean (SD) | 5.4 (4.2) | 7.4 (6.4) | 0.169 |
Number of urine leakages in 24-hour bladder diary, mean (SD) | 1.6 (1.2) | 3.2 (1.8) | 0.03 |
Quality of life score, mean (SD) | 7.3 (6.2) | 18.4 (6.52) | 0.01 |
Key safety findings
None reported.
Study 5 Guo G (2018)
Study type | Randomised controlled trial |
|---|---|
Country | China (2 centres) |
Recruitment period | 2016 to 2018 |
Study population and number | n=82 (41 external NMES, 41 sham) Patients with urinary incontinence after stroke |
Age and sex | Mean age (years): 64.2 (external NMES), 62.5 (sham) p=0.50; 43% (35/82) female |
Patient selection criteria | Patients with urinary incontinence after stroke were diagnosed according to the Diagnosis Criteria of the American Stroke Association and International Continence Society. All patients aged 40 to 75 years were included in the study. In addition, all patients had more than 6 months duration of stroke; and urinary incontinence after the stroke; normal consciousness, effectively communication; and written informed consent. Exclusion criteria included urinary retention; urinary incontinence caused by other diseases (such as spinal injury, multiple sclerosis); acute or chronic urinary incontinence before the stroke; severe diseases of important organs, such as heart, liver, kidney; psychological disorders; taken other medications that affected the urinary incontinence; pregnancy or breastfeeding; received electrical stimulation, such as NMES, or electroacupuncture 2 months before the study; or patients who did not agree to continue the study. |
Technique | NMES device: portable NMES stimulator (Globus ACTIVA 600 Pro, Globus, Italy). The device has 2 electrode pads. The positive pad was placed at the region of the second sacral level on opposite sides of the vertebral column. The negative pad was placed at the inside of the middle and lower third of the junction between the posterior superior iliac spine and the ischial node. Treatment parameters: 50 Hz frequency, 250ms pulse duration, and 10 seconds on and 30 seconds off for 30 minutes each session, once daily, 5 sessions weekly for a total of 10 weeks. Patients in the sham group had sham NEMS at the same location, treatment protocol, using same NMES device, but without an active probe. |
Follow up | To end of treatment (10 weeks) |
Conflict of interest/source of funding | None |
Analysis
Follow-up issues: There was no follow up beyond the end of the treatment period. Of the 82 randomised patients, 4 (5%) were lost to follow up, 2 in each group. An additional 4 patients withdrew consent (1 in the NMES and 3 in the sham arm). All primary and secondary efficacy endpoints were measured at baseline and at the end of 10 weeks treatment.
Study design issues: Randomised sham-controlled trial. Patients were allocated randomly to a NMES group or a sham group by a statistician. All randomisation and allocation information were concealed in opaque, sealed envelopes. All investigators were masked to the randomisation assignment and allocation. The outcome assessors and data analysts were also blinded. The primary efficacy endpoints were measured by the urodynamic outcome, and Overactive Bladder Symptom Score (total score ranges from 0 to 15, with higher scores indicating more severe symptoms). An intention-to-treat approach was used.
Study population issues: There were no statistically significant differences regarding all baseline values between the 2 groups. These values included age, sex, body mass index, duration of stroke, duration of urinary incontinence, disease types, region, co-morbidities, and outcome measurements at baseline.
Key efficacy findings
Number of patients analysed: 82 (41 external NMES, 41 sham)
Urodynamic values | External NMES, n=41 | Sham, n=41 | difference | p value |
|---|---|---|---|---|
Maximum cystometric capacity, ml | 105.3 (76.5 to 142.8) | 10.3 (3.1 to 13.9) | 95.6 (81.2 to 120.4) | <0.01 |
Detrusor pressure, cmH2O | -11.8 (-19.4 to -6.6) | -1.7 (-2.6 to -0.8) | -10.2 (-13.7 to -8.1) | <0.01 |
Maximum flow rate, ml/second | 8.9 (5.6 to 12.3) | 0.4 (-0.5 to 1.0) | 8.5 (6.3 to 10.1) | <0.01 |
Overactive Bladder Symptom Score | External NMES, n=41 | Sham, n=41 | difference | p value |
|---|---|---|---|---|
After treatment, mean (SD) | 8.1 (3.4) | 12.3 (3.0) | - | <0.01 |
Difference from baseline, mean (range) | -4.5 (-6.1 to -2.7) | -0.5 (-1.0 to -0.1) | -4.0 (-5.2 to -2.9) | <0.01 |
ICIQ-SF Score | External NMES, n=41 | Sham, n=41 | difference | p value |
|---|---|---|---|---|
After treatment, mean (SD) | 7.8 (3.3) | 10.5 (3.1) | - | <0.01 |
Difference from baseline, mean (range) | -3.8 (-5.0 to -2.2) | -0.6 (-1.2 to -0.2) | -3.3 (-4.7 to -2.4) | <0.01 |
Barthel index | External NMES, n=41 | Sham, n=41 | difference | p value |
|---|---|---|---|---|
After treatment, mean (SD) | 15.7 (3.1) | 11.1 (3.4) | - | <0.01 |
Difference from baseline, mean (range) | 5.3 (2.4 to 7.7) | 0.3 (0.1 to 0.6) | 5.1 (2.8 to 7.2) | <0.01 |
Key safety findings
There were no adverse effects in either group.
Study 6 Pané‐Alemany R (2021)
Study type | Randomised controlled trial |
|---|---|
Country | Spain |
Recruitment period | 2019 |
Study population and number | n=70 (35 surface electrodes, 35 intra-anal probe) Men with persistent stress urinary incontinence after radical prostatectomy |
Age and sex | Mean age 62.8 years; 100% (70/70) male |
Patient selection criteria | Men with persistent stress urinary incontinence after radical prostatectomy were included. Patients with the following were excluded: pharmacological treatment for urinary incontinence, anatomical malformations of the pelvic floor musculature, a pacemaker, anal fistulas, serious psyche disorders, a history of lower urinary tract infections, required radiotherapy as adjuvant treatment, urethral stricture after surgery, pelvic floor denervation, or neuromuscular diseases. |
Technique | Transcutaneous electrical stimulation: Neurotrac Pelvitone® muscular electrostimulator was used. Two round surface electrodes were stuck to the patients' perineum and at the base of their penis. Intra-anal probe: Analys Plus® anal stimulation probe. Selected treatment parameters included 10 minutes of biphasic intermittent current, frequency 30 Hz, pulse width 0.25 ms, and current intensity between 10 and 30 mA, with no on–off cycles. Additionally, a total of 5 minutes extra stimulation at a frequency of 50 Hz, pulse width 0.25 ms, and current intensity between 1 and 50mA was given, with individually adapted on‐off (duty) cycles based on each man's ability to hold a voluntary contraction. On time ranged from 0.5 to 10 seconds, and off time from 10 to 30 seconds. If the ability to hold the contraction improved, the duty cycle was progressed each month. All patients were encouraged to tolerate as high an intensity as possible to get a contraction. A total of 10 treatment physiotherapy sessions were held on a weekly basis. Kegel active exercises were done under the supervision and correction of the physiotherapist in each of the treatment sessions and also at home in both groups. |
Follow up | End of treatment (10 weeks) |
Conflict of interest/source of funding | None |
Analysis
Follow-up issues: There was no follow up beyond the end of the treatment period. Of the 70 patients, 4 (5.7%) were lost to follow up (2 in each group).
Study design issues: Randomised controlled trial held at a pelvic floor specialised physiotherapy centre and a pelvic floor rehabilitation unit. Patients were randomised 1:1 into 2 groups using Sealed Envelope Ltd. 2015 online randomisation. The sample size was estimated to give 80% power, including 10% losses to follow up. The established equivalence range was between −22 and 22 g of urine loss. The estimation was made using weight leakage (24 hour pad test) as the main variable. Equivalence was assessed by estimating the difference (along with its 90% CI) between initial and final urine leakage mean values. The analysis was done per protocol and by intention‐to‐treat.
Study population issues: The baseline characteristics were similar between the 2 groups.
Other issues: there is some discrepancy between the baseline pad weight values reported in the tables in the publication. The figures below have been taken from table 2A, which also includes follow up results.
Key efficacy findings
Number of patients analysed: 70 (35 surface electrodes, 35 intra-anal probe)
Surface electrodes group, n=33 | Intra-anal probe group, n=33 | |
|---|---|---|
Baseline pad weight, g, mean (SD) | 335.2 (418.0) | 324.4 (440.1) |
Week 5, mean (SD) | 202.8 (274.6) | 200.3 (347.5) |
Difference (90% CI) | 132.5 (71.6 to 193.3) | 124.1 (69.2 to 179.1) |
p value | 0.001 | 0.001 |
Baseline pad weight, g, mean (SD) | 335.2 (418.0) | 324.4 (440.1) |
Week 10 | 103.4 (182.6) | 79.2 (182.4) |
Difference (90% CI) | 231.9 (134.4 to 329.3) | 245.2 (149.6 to 340.7) |
p value | <0.001 | <0.001 |
Surface electrodes group, n=35 | Intra-anal probe group, n=35 | |
|---|---|---|
Baseline pad weight, g, mean (SD) | 355.9 (428.9) | 310.5 (431.1) |
Week 5, mean (SD) | 196.8 (727.6) | 188.8 (340.5) |
Difference (90% CI) | 159.1 (84.9 to 233.3) | 121.7 (69.8 to 181.5) |
p value | 0.001 | <0.001 |
Baseline pad weight, g, mean (SD) | 346.0 (426.5) | 310.5 (431.1) |
Week 10 | 97.5 (178.8) | 74.7 (177.9) |
Difference (90% CI) | 248.5 (148.3 to 348.8) | 235.8 (145.2 to 326.4) |
p value | <0.001 | <0.001 |
The differences in urine loss between the intra‐anal group and the surface group were not statistically significant.
Outcome measure | Surface electrodes group, n=33 | Intra-anal probe group, n=33 | ||||||
|---|---|---|---|---|---|---|---|---|
Baseline, mean (SD) | week 10, mean (SD) | Difference (90% CI) | p | Baseline, mean (SD) | Week 10, mean (SD) | Difference (90% CI) | p | |
ICIQ‐SF | 15.2 (3.8) | 11.2 (5.4) | 4.0 (2.6 to 5.5) | <0.001 | 13.6 (4.9) | 9.2 (5.7) | 4.4 (3.0 to 5.7) | <0.001 |
I‐QOL | 55.7 (24.9) | 29.1 (26.7) | 26.6 (20.1 to 33.0) | <0.001 | 51.9 (31.2) | 29.6 (26.2) | 22.4 (15.7 to 29.0) | <0.001 |
SF‐12 (mental) | 2.3 (3.7) | 3.9 (3.9) | -1.7 (-2.8 to ‑0.5) | 0.017 | 1.4 (3.7) | 3.1 (3.2) | -1.7 (-2.4 to ‑1.1) | <0.001 |
SF‐12 (physical) | 6.4 (37) | 8.5 (4.5) | -2.2 (-3.1 to ‑1.2) | <0.001 | 4.9 (4.1) | 7.8 (4.2) | -2.9 (-3.9 to -1.8) | <0.001 |
Outcome measure | Surface electrodes group, n=33 | Intra-anal probe group, n=33 | ||||||
|---|---|---|---|---|---|---|---|---|
Baseline, mean (SD) | week 10, mean (SD) | Difference (90% CI) | p | Baseline, mean (SD) | Week 10, mean (SD) | Difference (90% CI) | p | |
ICIQ‐SF | 15.4 (3.8) | 11.6 (5.5) | 3.8 (2.4 to 5.2) | <0.001 | 13.7 (4.7) | 9.5 (5.7) | 4.1 (2.8 to 5.5) | <0.001 |
I‐QOL | 56.5 (25) | 31.4 (28.2) | 25.1 (18.7 to 31.4) | <0.001 | 53.2 (30.9) | 32.1 (27.7) | 21.1 (14.6 to 27.5) | <0.001 |
SF‐12 (mental) | 2 (3.7) | 3.6 (4.0) | -1.6 (-2.6 to -0.5) | 0.017 | 1.3 (3.7) | 2.9 (3.2) | -1.6 (-2.3 to -1.0) | <0.001 |
SF‐12 (physical) | 6.3 (3.7) | 8.3 (4.5) | -2 (-2.9 to -1.2) | <0.001 | 5.1 (4.0) | 7.7 (4.1) | -2.7 (-3.7 to -1.7) | <0.001 |
Key safety findings
No serious adverse events were recorded during the trial. Overall adherence to treatment was 94.3%, with no statistically significant difference between the two study groups.
Study 7 Shen S (2018)
Study type | Non-randomised comparative study |
|---|---|
Country | China |
Recruitment period | 2014 to 2017 |
Study population and number | n=163 (103 external NMES and pelvic muscle exercises, 60 pelvic muscle exercises only) Women with post-stroke urinary incontinence |
Age and sex | Mean age (years): 58.6 (external NMES), 56.4 (control) p=0.21; 100% female |
Patient selection criteria | All patients were confirmed diagnosed with post-stroke urinary incontinence by the diagnosis criteria of the American Stroke Association and the International Continence Society. Exclusion criteria included pregnancy, unconsciousness, psychiatric problems, severe organ diseases, having a cardiac pacemaker, or lack of communication ability and recognition. In addition, patients were also excluded if they had electrical stimulation therapy, including electroacupuncture 1 month before the study. Patients with incomplete information were also excluded. |
Technique | Device: NMES device (HANS-100, Nanjing Jisheng Medical Technology Co., Ltd) The device had 2 gel pads attached to a silicon patch, which were attached to the selected local bilateral acupoint area (over the first, second, third and fourth sacral foramen, and lateral to the posterior midline, on the level of the tip of the coccyx) for 30 minutes daily, each pair of points 6 minutes, 3 times weekly for a total of 8 weeks. Frequency was 2 to 100 Hz and the current intensity was gradually increased to the maximum tolerance for each patient. All patients were asked to practice pelvic muscle exercises for 5 minutes a day for 8 weeks. |
Follow up | End of treatment (8 weeks) |
Conflict of interest/source of funding | None |
Analysis
Follow-up issues: There was no follow up beyond the end of the treatment period. Results at 4 and 8 weeks were presented for all patients.
Study design issues: Retrospective, single centre, non-randomised comparative study. Outcome measures included the amount of urine leakage, urinary symptoms, and quality of life. The amount of urine leakage was measured by the 1-hour pad test. Urinary symptoms were measured by the BFUSQ score, with a higher score meaning worse condition or quality of life, and quality of life was measured by the ICIQ-SF score. The data analyst was blinded to treatment group allocation.
Study population issues: There were no statistically significant differences in baseline characteristics between the 2 groups.
Key efficacy findings
Number of patients analysed: 163 (103 NMES plus pelvic muscle exercises, 60 pelvic muscle exercises only)
Outcome | NMES group | Control group | Difference | p value |
|---|---|---|---|---|
Urine leakage, mL | -6.5 (-9.1 to -4.2) | -4.5 (-7.3 to -2.0) | -2.0 (-3.5 to -0.9) | 0.07 |
BFUSQ score: inconvenience in activities of daily life | -9.3 (-12.6 to -7.5) | -7.1 (-9.2 to -5.9) | -2.2 (-3.7 to -1.0) | 0.10 |
BFUSQ score: urinary symptoms | -3.0 (-5.0 to -2.2) | -1.9 (-3.4 to -0.8) | -1.0 (-1.8 to -0.4) | 0.25 |
ICIQ-SF score | -1.8 (-2.7 to -1.0) | -0.9 (-1.7 to -0.3) | -0.8 (-1.3 to -0.3) | 0.19 |
Outcome | NMES group | Control group | Difference | p value |
|---|---|---|---|---|
Urine leakage, mL | -10.9 (-13.4 to -7.2) | -5.0 (-7.9 to -2.6) | -6.0 (-8.1 to -4.3) | <0.01 |
BFUSQ score: inconvenience in activities of daily life | -21.7 (-24.9 to -17.7) | -8.6 (-10.5 to -6.4) | -13.1 (-16.2 to -9.9) | <0.01 |
BFUSQ score: urinary symptoms | -7.3 (-10.1 to -4.9) | -2.5 (-4.2 to -1.1) | -4.8 (-6.3 to -3.3) | <0.01 |
ICIQ-SF score | -4.2 (-6.6 to -2.5) | -1.3 (-2.4 to -0.6) | -2.9 (-4.1 to -1.6) | <0.01 |
Key safety findings
No adverse events were recorded in either group during the 8-week treatment period.
Study 8 Kolb G (2019)
Study type | Cohort study |
|---|---|
Country | US |
Recruitment period | Not reported |
Study population and number | n=20 Women with mild or moderate SUI |
Age and sex | Mean age 46.4 years (range 18 to 80 years); 100% female |
Patient selection criteria | Inclusion criteria for symptom severity were a self-reported minimum of 2 urinary incontinence episodes per 36 hours and no more than 5 urinary incontinence episodes per 24 hours. Exclusion criteria included current or recent pregnancy, recent pelvic surgery, body mass index more than 30 kg/m2, active urinary tract infection, an implanted cardiac device or cardiac condition, and predominant urge urinary incontinence. |
Technique | Device: Elitone (Elidah, US) The device delivers electrical muscle stimulation through the perineal region. It is composed of 2 components, a disposable electrode and a reusable control unit. The thin electrode has an hourglass shape and fits the perineal region, with the anterior end positioned proximate the pubic symphysis and the posterior end positioned near the ischial tuberosities. Four electrically conductive regions positioned at the extents of the electrode use hydrogel to adhere the device to the skin and transmit electrical stimulation to the adjacent tissues. Patients can wear clothes over the device and resume other activities while having treatment. The device delivers a defined treatment regimen comprising 4 seconds of stimulation at 50 Hz, 2 seconds of stimulation at 10 Hz, and 6 seconds of relaxation, after which the cycle is repeated for a total of 20 minutes. Patients were instructed to self-administer the pre-programmed 20-minute treatment sessions 4 to 5 times per week for 6 weeks. |
Follow up | End of treatment (6 weeks) |
Conflict of interest/source of funding | 2 of the 4 authors have principal ownership in Elidah, the manufacturer of the device under investigation and 1 author provides consulting services for Elidah. |
Analysis
Follow-up issues: there was no follow up beyond the end of the treatment period of 6 weeks. An additional 9 women entered the study, but 5 were lost to follow up, 1 stopped the study because of time constraints, and 3 were excluded from the analysis because they did not meet the criteria of mild or moderate SUI.
Study design issues: Single-centre cohort study. Participants were recruited from the senior author's practice and through social media advertisements. After providing informed consent, participants were sent a device with a user manual, a description of the patient protocol, pre- and post-treatment questionnaires, and a daily log. The main outcome measures were the reduction in incontinence episodes per day, a favourable change in the I-QoL survey score, and a reduction in pad use. A reduction of 50% or more in leaks per day, a change in 2.5 points on the I-QoL survey score and 50% reduction in pad usage (in those people who reported regular pad usage before the study) were used to define responders.
Study population issues: Half of the participants had pure SUI and the other half had mixed incontinence with predominant SUI symptoms. 65% of women had previously completed a regimen of Kegel exercises or other pelvic floor therapy without satisfactory results.
Other issues: Mean treatment frequency started at 5.1 treatments per week and reduced to 4.3 in the sixth week.
Key efficacy findings
Number of patients analysed: 20
Reduction in leaks per day=71%
Proportion of women with clinically significant reduction in leakage episodes=75%
Proportion of women with clinically significant improvement in I-QoL score=85%
Proportion of women using pads regularly with clinically significant reduction in pad usage=67%
Proportion of women who were satisfied with their treatment=83%
All women reported that the electrode shape and stimulation were comfortable.
Outcome Measure | n (pairs) | Before treatment mean (SD) | End of treatment mean (SD) | SE of difference | 95% CI of difference | t value | p value |
|---|---|---|---|---|---|---|---|
Leaks per day | 20 | 1.84 (1.04) | 0.58 (0.73) | 0.21 | 0.82 to 1.70 | 6.02 | <0.0001 |
I-QoL score | 20 | 70.3 (18.0) | 84.8 (17.4) | 3.21 | -21.3 to -7.8 | 4.54 | <0.0002 |
Pads per day | 15 | 1.8 (1.1) | 0.8 (0.8) | 0.25 | 0.46 to 1.54 | 3.94 | <0.001 |
Key safety findings
The paper states that no adverse events were reported that resulted in an injury or health risk.
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions