Intravaginal Electrical Stimulation Research Articles

Randomised controlled pilot trial to assess effect of electrical stimulation of weak pelvic floor muscles

Introduction and hypothesisPelvic floor muscle training (PFMT) has level 1A scientific evidence for the treatment of urinary incontinence and pelvic organ prolapse. Past studies, however, have often excluded women with very weak pelvic floor muscles (PFM). The aim was to investigate the hypothesis that intravaginal electrical stimulation (iES) improves PFM strength more than PFMT in women with weak PFM, and to use these results to calculate sample size required for a future large randomised controlled trial (RCT).MethodsThis assessor-blinded pilot RCT had a two arm, parallel design with computer-generated Randomisation. Both groups were offered 12 one-to-one physiotherapy sessions over a 6-month period. The iES group received individual tailored electrical pulse parameters. The PFMT group received PFM exercises, with the addition of facilitation techniques at therapy sessions. A power calculator was used to calculate sample size.ResultsFifteen women were recruited. Eight were randomised to iES and 7 to PFMT. Two subjects dropped out of the iES group. Median age was 49 years (range 36–77) and parity 2.1 (range 1–3). Both groups showed increases in PFM strength measured by manometery (iES 12.3, SD 12.0 vs PFMT 10.0, SD 8.1) cmH2O. There was no significant difference between groups. With a power of 0.80 we need a sample size of 95 women in each group to detect a difference between groups.ConclusionThere was no significant difference between the groups in improvements in PFM strength. To detect a difference, we would have required 95 women in each group.

Urinary Incontinence: evidence on conservative management

Urinary incontinence in women is a condition of high incidence and is associated with an impact on quality of life. Conservative treatment modalities are an important resource in the management of this condition, since they can be prescribed based on the clinical diagnosis without the need for additional tests. The present study aims to gather current evidence on conservative treatment modalities available for female incontinence published in the last 5 years. Conducting the search in the Medline and LILACS databases, 28 articles were identified, categorized with level of evidence 1b and 2b by the Oxford classification, which present original results on physical therapy, medication and behavioral modalities in the non-community treatment of female incontinence. The current state of the art demonstrates a domain of studies with a high degree of evidence involving the treatment modalities associated with the physical therapy practice of pelvic floor muscle training. Evidence from 5 analyzed studies statistically demonstrated the superiority of this method in relation to control groups, or to groups submitted to other interventions. Positive evidence related to transcutaneous electrical stimulation therapies, intravaginal electrical stimulation, duloxetine, noradrenaline receptor inhibitors, continence pessaries, and lifestyle changes was also observed.

Comparison of the efficacy of intravaginal electrical stimulation in women with idiopathic overactive bladder naive and refractory to pharmacological agents.

This study aims to compare the effectiveness of intravaginal electrical stimulation (IVES) with regard to quality of life (QoL) and clinical parameters related to incontinence in women with idiopathic overactive bladder (iOAB) naive or refractory to treatment with pharmacological agents (PhA). In this prospective trial, PhA-naive women were included in Group 1 (n = 24) and women with PhA-resistant iOAB were included in Group 2 (n = 24). IVES was performed 3 days a week, with a total of 24 sessions for 8 weeks. Every session lasted 20 minutes. Women were evaluated for the severity of incontinence (24-hour pad test), pelvic floor muscle (PFM) strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and the number of pads), symptom severity (OAB-V8), quality of life (IIQ-7), treatment success (positive response rate), cure/improvement rate, and treatment satisfaction. A statistically significant improvement was found in all parameters for each group at the 8th week compared to the baseline values (p < 0.05). At the 8th week, there were no statistically significant differences in the severity of incontinence, PFM strength, incontinence episodes, nocturia, number of pads, QoL, treatment satisfaction, cure-improvement, or positive response rates between the two groups (p > 0.05). It was found that the frequency of voiding and symptom severity parameters were significantly more improved in Group 1 than in Group 2 (p < 0.05). Although IVES was more effective in PhA-naive women with iOAB, it also appears to be an effective treatment in the management of women with PhA-resistant iOAB. This study was registered with ClinicalTrials.gov under no. NCT05416450.

Efficacy of intravaginal electrical stimulation with different treatment frequency in women with refractory idiopathic overactive bladder

ABSTRACTObjective The aim of this study is to evaluate the effect of intravaginal electrical stimulation (IVES) therapies with different treatment frequencies (two or five days in a week) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with refractory idiopathic overactive bladder (OAB).Material and Methods Fifty-two women with refractory idiopathic OAB were randomized into two groups as follows: Group 1 (n:26) received BT and IVES, two times in a week, for 10 weeks and Group 2 (n:26) received BT and IVES five times in a week, for 4 weeks. IVES was performed 20 minutes in a day, a total of 20 sessions for both groups. Women were evaluated for incontinence severity (24h pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and the number of pads), symptom severity (OAB-V8), quality of life (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale).Results There was no statistically significant differences in all parameters between the two groups at the end of the treatment. It was found that the treatment satisfaction scores, cure/improvement and positive response rates were not significantly different between two groups (p>0.05).Conclusion We concluded that the application of IVES twice a week or 5 times a week added to BT were both effective on incontinence-related QoL and clinical parameters in women with refractory idiopathic OAB. These two IVES frequencies had similar clinical efficacy and patient satisfaction with a slight difference between them; 5 times per week IVES has a shorter treatment duration.

Effectiveness of intravaginal electrical stimulation combined with electromyography biofeedback-mediated pelvic floor muscle training for postpartum symptomatic pelvic organ prolapse: protocol for the PROSPECT randomized trial

BackgroundPelvic organ prolapse (POP) is seen in up to 30–70% of women presenting for routine gynecology care and 10% of women suffering from bothersome POP symptoms. Vaginal childbirth is one of the most prominent contributing factors for POP. Pelvic muscle training (PFMT) is considered effective to improve mild to moderate POP symptoms. In addition, higher-intensity, supervised PFMT aided by biofeedback and electrical stimulation may confer greater benefit. However, the long-term efficacy of the PFMT combined with electromyography biofeedback is unknown, which indicates the need for further evidence.MethodsThis multicenter randomized controlled trial compares the effectiveness and cost-effectiveness of conventional PFMT versus biofeedback-mediated PFMT plus neuromuscular electrical stimulation (NMES) for postpartum symptomatic POP women. The primary outcome is the proportion of patients with the improvement of at least one POP-Q stage at 36 months after randomization. The primary economic outcome measure is incremental cost per quality-adjusted life year at 36 months. Two hundred seventy-four women from four outpatient medical centers are randomized and followed up with pelvic floor examination, questionnaires, and pelvic ultrasonography imaging. All participants are arranged for three appointments over 12 weeks. NMES and electromyography biofeedback via intravaginal probe are added to PFMT for participants in the biofeedback-mediated PFMT group. Group allocation could not be blinded from participants and healthcare staff that deliver intervention but remain masked from medical staff that carry out PFM assessment. An intention-to-treat analysis of the primary outcome will estimate the difference of the proportion of POP-Q stage improvement between the trial groups right after the intervention, and during the follow-up until 36 months, using the chi-square test and multilevel mixed models respectively. A logistic regression analysis was used for adjusting for important baseline variables that are unbalanced.DiscussionThe trial results will provide evidence of the effectiveness of electromyography biofeedback-mediated PFMT in improving women’s POP-Q staging, quality of life, and cost-effectiveness.Trial registrationCCTR Registry ChiCTR210002171917. Registered on March 6, 2019

Effects of nonsurgical, minimally or noninvasive therapies for urinary incontinence due to neurogenic bladder: a systematic review and meta-analysis.

Objective:To determine the effects of nonsurgical, minimally or noninvasive therapies on urge urinary incontinence (UUI) symptoms and quality of life (QoL) in individuals with neurogenic bladder (NGB).Data Sources:Cochrane library, EMBASE, MEDLINE, PEDro, Scopus, and Web of Science databases were searched from inception to September 2021.Review Methods:Randomized controlled trials that compared therapies such as intravaginal electrical stimulation (IVES), transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES), transcutaneous tibial nerve stimulation (TTNS), pelvic floor muscle training (PFMT), and behavioural therapy (BT) to control were included. Study screening, data extraction, and study quality assessments were performed by two independent authors.Results:Fourteen trials with 804 participants were included in the study after screening of 4281 potentially relevant articles. Meta-analyses revealed a significant effect of electrical stimulation on UUI due to multiple sclerosis (standardized mean difference (SMD): −0.614; 95% confidence interval (CI): −1.023, −0.206; p = 0.003) and stroke (SMD: −2.639; 95% CI: −3.804, −1.474; p = 0.000). The pooled analyses of TTNS (weighted mean difference (WMD): −12.406; 95% CI: −16.015, −8.797; p = 0.000) and BT (WMD: −9.117; 95% CI: −14.746, −3.487; p = 0.002) revealed significant effects of these interventions on QoL in people with Parkinson’s disease. However, meta-analyses revealed nonsignificant effects for PFMT (WMD: −0.751; 95% CI: −2.426, 0.924; p = 0.380) and BT (WMD: −0.597; 95% CI: −1.278, 0.083; p = 0.085) on UUI due to Parkinson’s disease.Conclusions:Our meta-analyses found electrical stimulation to be beneficial for improving the symptoms of UUI among people with multiple sclerosis and those with stroke. Our review also revealed that TTNS and BT might improve QoL for people with NGB due to Parkinson’s disease, although the effects of PFMT and BT on UUI warrant further investigation.

Intravaginal electrical stimulation increases voluntarily pelvic floor muscle contractions in women who are unable to voluntarily contract their pelvic floor muscles: a randomised trial.

In women who are unable to contract their pelvic floor muscles voluntarily, what is the effect of an intravaginal electrical stimulation regimen on their ability to contract the pelvic floor muscles and on self-reported urinary incontinence? Randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. Sixty-four women with pelvic floor muscle function assessed by bi-digital palpation to be grade 0 or 1 on the Modified Oxford Scale. For 8 weeks, participants randomised to the experimental group received weekly 20-minute sessions of intravaginal electrical stimulation with instructions to attempt pelvic floor muscle contractions during the bursts of electrical stimulation in the final 10 minutes of each session. The control group received no intervention. The primary outcome was ability to voluntarily contract the pelvic floor muscles, evaluated through vaginal palpation using the Modified Oxford Scale. Secondary outcomes were prevalence and severity of urinary incontinence symptoms assessed by the International Consultation on Incontinence Questionnaire on Urinary Incontinence-Short Form (ICIQ-UI-SF) score from 0 to21. Sixty-one participants provided outcome data. After the intervention, the ability to contract the pelvic floor muscles was acquired by 36% of the experimental group and 12% of the control group (absolute risk difference 0.24, 95% CI 0.02 to 0.43). The experimental group also improved by a mean of 2 points more than the control group on the ICIQ-UI-SF score (95% CI 0.02 to 3.97). In women who are unable to contract their pelvic floor muscles voluntarily, 8 weeks of intravaginal electrical stimulation with voluntary contraction attempts improved their ability to contract their pelvic floor muscles and reduced the overall severity and impact of urinary incontinence on quality of life. Although the main estimates of these effects indicate that the effects are large enough to be worthwhile, the precision of these estimates was low, so it is not possible to confirm whether the effects are trivial or worthwhile. NCT03319095.

Efficacy of intravaginal electrical stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial.

ABSTRACTPurpose:To evaluate the efficacy of intravaginal electrical stimulation (IVES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB).Materials and Methods:Sixty-two women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n:31), and Group 2 received BT+IVES (n:31). IVES was performed for twenty minutes three days a week over a course of eight weeks for a total of 24 sessions. Patients were evaluated in terms of incontinence severity (24-hour pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes and number of pads), symptom severity (OAB-V8), incontinence-related QoL (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale).Results:A statistically significant improvement was found in all parameters for all groups at the end of the treatment compared to the baseline values except pelvic floor muscles strength in Group 1 (p <0.05). At the end of treatment, incontinence severity, frequency of voiding, nocturia, incontinence episodes, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p <0.05). Treatment satisfaction, cure/improvement, and positive response rates were significantly higher in group 2 compared to Group 1 (p <0.05).Conclusion:We conclude that BT+IVES were more effective than BT alone on both incontinence-related QoL and clinical parameters in women with idiopathic OAB.

Intravaginal electrical stimulation associated with pelvic floor muscle training for women with stress urinary incontinence: study protocol for a randomized controlled trial with economic evaluation

IntroductionPelvic floor muscle training (PFMT) exercises and neuromuscular electrical stimulation (NMES) are described as conservative interventions to prevent or treat female stress urinary incontinence (SUI). However, it has not been described yet the effect of PFMT associated to intravaginal NMES which evaluated the cost-effectiveness and cost-utility of treating.AimsTo evaluate the effects of intravaginal NMES associated with the PFMT protocol on urinary loss and quality of life in women with SUI and to evaluate the cost-effectiveness and cost-utility and pelvic floor muscle in women with SUI.MethodsRandomized controlled trial study with economic evaluation. Inclusion criteria are woman (biological), aged ≥ 18 years old and with a report of SUI ≥ once/week. Exclusion criteria are presence of vaginal or urinary infection, virginity, being in the gestational or puerperium period, or neurological disease. Participants will undergo physical therapy assessment and intervention: anamnesis, pelvic floor muscle assessment by vaginal palpation and manometry (PeritronTM), questionnaires (Short-Form 6 Dimensions—Brazil (SF-6D), King's Health Questionnaire (KHQ) and King´s Health Questionnaire for Scoring Algorithm), health costs, and voiding diary. Participants will be randomly allocated into 3 groups: CG (control group), IG 1 (intervention group 1, PFMT), and IG2 (intervention group 2, PFMT + NMES). The statistical analysis will be performed by intention to treat, and multivariate analysis of mixed effects will be used to compare outcomes. Effect size measurements will be calculated and will be provided by Cohen’s d test. A significance level of 5% will be adopted. Additionally, the incremental cost-effectiveness and incremental cost-utility ratios will be used.DiscussionThis protocol can corroborate with the literature in order to identify the effect of techniques, based on the possibility of confirming the hypothesis that the NMES associated with PFMT performed concurrently will be the best treatment option; considering the effectiveness, cost-effectiveness, and cost-utility analysis, it will be used as an option for optimization of the treatment of SUI.Trial registrationBrazilian Registry of Clinical Trials (ReBEC) ID: RBR-6gtzg4. Registered on September 3, 2019.

Combination Therapy for Bladder Dysfunction in Patients with Neurogenic Detrusor Overactivity

Neurogenic bladder is a common condition and top health priority present in 20–70% of patients with neurologic diseases including multiple sclerosis (MS), Parkinson’s disease (PD), spinal cord injury (SCI), and cerebrovascular accidents (CVA). Current gold-standard medications for overactive bladder (OAB), such as anti-muscarinics, have undesirable side effects, or have limited data in neurogenic patients. Combining therapy for urinary urge incontinence (UUI) has shown the potential to increase efficacy while maintaining or improving tolerability of treatment. Our objective was to review and synthesize recent combination therapy studies for UUI in patients with neurogenic detrusor overactivity (NDO). Non-pharmacologic and pharmacologic combination therapies have been investigated for UUI in patients with NDO. Adding intravaginal neuromuscular electrical stimulation (IVES) or transcutaneous tibial stimulation (TTNS) may not be superior to pelvic floor muscle training (PFMT) on its own. Recent studies on dual therapies have focused on combining drugs with different mechanisms. In adults, a combination of desmopressin with mirabegron showed superior efficacy compared to either drug alone or solifenacin. In children, combination studies have focused on adding gabapentin to drug regimens with promising safety and efficacy. Overall, there are few combination therapy trials for OAB in neurogenic patients compared to those in patients with idiopathic OAB. There is an unmet medical need for combination therapies in patients with UUI due to neurogenic bladder. It is important to gather practice patterns and encourage providers to share their experiences. In addition, more rigorous clinical studies are needed to explore new combinations.

Effect of intravaginal vibratory versus electric stimulation on the pelvic floor muscles: A randomized clinical trial.

IntroductionAccording to the International Urogynecological Association and International Continence Society people with normal pelvic floor muscle function should have the ability to voluntarily and involuntarily contract and relax these muscles. However, many women are unaware of their pelvic floor, and it is estimated that about 30–50% do not know how to actively contract these muscles. Within this context, therapeutic strategies to improve pelvic floor muscle strength and function are particularly relevant.AimsTo compare the use of an intravaginal vibratory stimulus (IVVS) versus intravaginal electrical stimulation (IVES) on pelvic floor muscle functionality in women with pelvic floor dysfunctions who cannot voluntarily contract these muscles.Materials and methodsRandomized clinical trial performed at a tertiary care hospital from June 2016 to September 2017. The sample comprised adult women with pelvic floor dysfunction who were unable to contract their pelvic floor muscles voluntarily. Women with latex allergy or other allergies in the pelvic region, vaginal or urinary tract infection, gynecological cancer, significant pain on palpation, or pelvic floor training over the preceding 6 months were excluded. After baseline assessment, women that met the inclusion criteria were randomized to receive once-weekly 20-minute sessions of IVVS or IVES for 6 weeks.ResultsTwenty-one women were randomly assigned to each group; 18 completed the IVVS and 17 completed the IVES protocols. The IVVS group presented a significant increase in PFM strength in relation to the IVES group (p = 0.026). There was a significant interaction between time and type of intervention for the same variable (p = 0.008) in the IVVS group.ConclusionBoth techniques were beneficial, but IVVS was significantly superior to IVES in improving pevic floor muscle strength. Additional studies are warranted to consolidate the utility of IVVS as a treatment modality for pelvic floor dysfunction.

The effect of pelvic floor muscle training and intravaginal electrical stimulation on urinary incontinence in women with incomplete spinal cord injury: an investigator-blinded parallel randomized clinical trial.

Urinary incontinence is a prevalent problem in women with spinal cord injury. The aim of this study was to examine the effect of pelvic floor muscle training (PFMT) alone and combined with intravaginal electrical stimulation (IVES) on urinary incontinence in women with incomplete spinal cord injury. In this investigator-blinded randomized clinical trial, we recruited women aged 18-75 with incomplete spinal cord injury and urinary incontinence from a single spinal cord injury clinic in Denmark. Women were randomly assigned to either PFMT or PFMT combined with IVES daily at home for 12weeks. All women were trained by a physiotherapist using vaginal palpation and electromyography biofeedback. Outcome measures were recorded at baseline (week 0), post-intervention (week 12) and follow-up (week 24) and included change in the total score on the International Consultation on Incontinence Questionnaire urinary incontinence short form (ICIQ-UI-SF) and daily episodes of urinary incontinence. From 27 April 2015-9 September 2016, we randomly assigned 36 women (17 in the PFMT group and 19 in the PFMT+IVES group); 27 completed the interventions (13 in the PFMT group and 14 in the PFMT+IVES group). The results showed no difference between the groups on ICIQ-UI-SF or episodes of urinary incontinence at 12 and 24weeks. Only the PFMT group had a significant change from baseline on ICIQ-UI-SF [-2.4 (95% CI -4.3--0.5), p = 0.018] and daily episodes of urinary incontinence [-0.4 (95% CI -0.8--0.1), p = 0.026] at 12weeks. PFMT+IVES is not superior to PFMT alone in reducing urinary incontinence in women with incomplete spinal cord injury.

Effects of three interventions in facilitating voluntary pelvic floor muscle contraction in women: a randomized controlled trial

ObjectiveTo evaluate the effect of vaginal palpation, vaginal palpation associated with posterior pelvic tilt, and intravaginal electrical stimulation in facilitating voluntary contraction of the pelvic floor muscles in women. MethodsA randomized controlled trial in which 132 women with pelvic floor muscles function graded at 0 or 1 using the Modified Oxford Scale were randomized into four groups: vaginal palpation (n=33); vaginal palpation with posterior pelvic tilt (n=33); intravaginal electrical stimulation (n=33) and a control group (n=33) that only received verbal instructions. The primary outcome was evaluated by the Modified Oxford Scale and the secondary using the ICIQ-UI-SF. The assessment was performed at baseline with follow-up assessment after eight weeks. ResultsA total of 69.7% of the women from posterior pelvic tilt; 63.6% from vaginal palpation; 33.3% from intravaginal electrical stimulation; and 18.2% from control group (p<0.001) were able to attain Modified Oxford Scale greater than or equal to 2 after eight weeks. In comparison with control group, the posterior pelvic tilt (OR=10.35; 95% CI=3.26–32.84) and vaginal palpation (OR=7.87; 95% CI=2.53–24.47) had the most significant improvement as opposed to intravaginal electrical stimulation (OR=2.25; 95% CI=0.72–7.06). There was significant improvement among all of the groups in UI. The largest changes respectively were noted in the vaginal palpation, posterior pelvic tilt, intravaginal electrical stimulation and control group. There were no reports of adverse effects. ConclusionVaginal palpation with posterior pelvic tilt and vaginal palpation were more effective interventions to facilitate pelvic floor muscles contraction when compared with intravaginal electrical stimulation and controls. Vaginal palpation was the most effective in improving urinary incontinence.Clinical Trials Identifier: ClinicalTrial.gov: NCT02062242.

Evaluation of treatment outcomes in pelvic floor muscle training with biofeedback versus intra-vaginal electrical stimulation in women with urinary incontinence in Hong Kong Pamela Youde Nethersole Eastern Hospital

Evaluation of treatment outcomes in pelvic floor muscle training with biofeedback versus intra-vaginal electrical stimulation in women with urinary incontinence in Hong Kong Pamela Youde Nethersole Eastern Hospital

Effects of surface and intravaginal electrical stimulation in the treatment of women with stress urinary incontinence: randomized controlled trial

ObjectiveTo evaluate the effects of surface electrical stimulation (SES) and to compare them with the effects of the intravaginal electrical stimulation (IVES) in women with stress urinary incontinence (SUI). Study designThis randomized controlled study included 48 women aged over 50 years, who complained of SUI evaluated according to two structured questions of King's Health Questionnaire (KHQ) and who had not previously undergone physical therapy for SUI. The calculation of the sample size estimated a sample of 45 volunteers with a significance level of 5% and statistical power of 90%. The women were randomized to: Surface Electrical Stimulation Group (SESG) (n=15), Intravaginal Electrical Stimulation Group (IVESG) (n=15) and Control Group (CG) (n=15). Subjects in the intervention groups were treated with the same parameters of electrical stimulation for 12 sessions. The SESG had four silicone electrodes fixed in the suprapubic and ischial tuberosity regions. The IVES group used an intravaginal electrode. The CG did not receive any treatment during the corresponding time. They were evaluated before and after treatment by a physical therapist who was blind to group allocation. The primary outcomes were urinary leakage, pressure and strength of pelvic floor muscle (PFM) contraction. The secondary outcome was quality of life (QOL) evaluated by KHQ. Forty-five women completed the study and were included in the analysis. Statistical analysis was performed using the Wilcoxon test for intragroup analysis and Kruskal–Wallis and Mann–Whitney tests for intergroup analysis (p<0.05). ResultsThere was significant improvement in urinary loss and pressure of contraction in the SESG and IVESG. PFM strength increased only in the IVESG. Intergroup analysis found differences after the treatment in: urinary leakage between the SESG and CG (p<0.001) and the IVESG and CG (p<0.001). Regarding QOL, there was significant reduction in the incontinence impact, limitations of daily activities, physical limitation, emotion, sleep and disposition and severity domains in the SESG (all p<0.02) and IVESG (all p<0.04) after the treatments. ConclusionSES and IVES are important treatments to improve the SUI. Both improved the QOL, urinary leakage, and strength and pressure of PFM contraction.

Female urinary incontinence and intravaginal electrical stimulation: an observational prospective study

ObjectiveTo assess the efficacy of intravaginal electrical stimulation in the management of female urinary incontinence. Study design359 Women with urinary incontinence (207 with stress incontinence [group A], 33 with urge incontinence [group B] and 119 with mixed urinary incontinence [group C]) were included in this multicenter prospective observational study. Patients were managed by home intravaginal electrical stimulation of the pelvic floor for 20–30min per day, 5 days a week, for a period of 10 weeks. Identical clinical assessments were performed before and after pelvic floor rehabilitation, comprising a voiding diary and validated symptom and quality of life scores. ResultsObjective assessment demonstrated an overall cure rate of 63.5% (228/359): 65.7% (136/207) for group A, 57.6% (19/33) for group B, and 61.3% (73/119) for group C. The overall significant improvement rate was 15.6% (56/359): 14.6% (30/207) for group A, 24.2% (8/33) for group B and 15.1% (18/119) for group C. All domains of quality of life were significantly improved after pelvic floor muscle training (p<0.0001) with a patient satisfaction rate of 83.6%. Treatment was well tolerated with 1.4% (5/359) of patients describing pain at the highest stimulation intensities. No significant difference was observed between the various types of electrodes used (p<0.0001). ConclusionThe quantitative and qualitative efficacy in terms of social and psychological consequences and quality of life of home pelvic floor muscle training stimulators probably make this treatment modality one of the first-line treatments for female stress urinary incontinence.

Electrical Stimulation for Urinary Incontinence in Women: A Systematic Review

Electrical stimulation is commonly recommended to treat urinary incontinence in women. It includes several techniques that can be used to improve stress, urge, and mixed symptoms. However, the magnitude of the alleged benefits is not completely established. To determine the effects of electrical stimulation in women with symptoms or urodynamic diagnoses of stress, urge, and mixed incontinence. Our review included articles published between January 1980 and January 2012. We used the search terms ″urinary incontinence″, ″electrical stimulation ″, ″ intravaginal ″, ″ tibial nerve ″ and ″ neuromodulation ″ for studies including female patients. We evaluated randomized trials that included electrical stimulation in at least one arm of the trial, to treat women with urinary incontinence. Two reviewers independently assessed the data from the trials, for inclusion or exclusion, and methodological analysis. A total of 30 randomized clinical trials were included. Most of the trials involved intravaginal electrical stimulation. Intravaginal electrical stimulation showed effectiveness in treating urge urinary incontinence, but reported contradictory data regarding stress and mixed incontinence. Tibial-nerve stimulation showed promising results in randomized trials with a short follow-up period. Sacral-nerve stimulation yielded interesting results in refractory patients. Tibial-nerve and intravaginal stimulation have shown effectiveness in treating urge urinary incontinence. Sacral-nerve stimulation provided benefits in refractory cases. Presently available data provide no support for the use of intravaginal electrical stimulation to treat stress urinary incontinence in women. Further randomized trials are necessary to determine the magnitude of benefits, with long-term follow-up, and the effectiveness of other electrical-stimulation therapies.

Anticholinergic drugs versus non-drug active therapies for non-neurogenic overactive bladder syndrome in adults

Overactive bladder syndrome is defined as urgency with or without urgency incontinence, usually with frequency and nocturia. Pharmacotherapy with anticholinergic drugs is often the first line medical therapy, either alone or as an adjunct to various non-pharmacological therapies after conservative options such as reducing intake of caffeine drinks have been tried. Non-pharmacologic therapies consist of bladder training, pelvic floor muscle training with or without biofeedback, behavioural modification, electrical stimulation and surgical interventions. To compare the effects of anticholinergic drugs with various non-pharmacologic therapies for non-neurogenic overactive bladder syndrome in adults. We searched the Cochrane Incontinence Group Specialised Register (searched 4 September 2012), which includes searches of the Cochrane Central Register of Controlled Trials (CENTRAL) and MEDLINE, and the reference lists of relevant articles. All randomised or quasi-randomised, controlled trials of treatment with anticholinergic drugs for overactive bladder syndrome or urgency urinary incontinence in adults in which at least one management arm involved a non-drug therapy. Trials amongst patients with neurogenic bladder dysfunction were excluded. Two authors evaluated the trials for appropriateness for inclusion and risk of bias. Two authors were involved in the data extraction. Data extraction was based on predetermined criteria. Data analysis was based on standard statistical approaches used in Cochrane reviews. Twenty three trials were included with a total of 3685 participants, one was a cross-over trial and the other 22 were parallel group trials. The duration of follow up varied from two to 52 weeks. The trials were generally small and of poor methodological quality.During treatment, symptomatic improvement was more common amongst those participants on anticholinergic drugs compared with bladder training in seven small trials (73/174, 42% versus 98/172, 57% not improved: risk ratio 0.74, 95% confidence interval 0.61 to 0.91). Augmentation of bladder training with anticholinergics was also associated with more improvements than bladder training alone in three small trials (23/85, 27% versus 37/79, 47% not improved: risk ratio 0.57, 95% confidence interval 0.38 to 0.88). However, it was less clear whether an anticholinergic combined with bladder training was better than the anticholinergic alone, in three trials (for example 74/296, 25% versus 95/306, 31% not improved:risk ratio 0.80, 95% confidence interval 0.62 to 1.04).The other information on whether combining behavioural modification strategies with an anticholinergic was better than the anticholinergic alone was scanty and inconclusive. Similarly, it was unclear whether these complex strategies alone were better than anticholinergics alone.In this review, seven small trials comparing an anticholinergic to various types of electrical stimulation modalities such as Intravaginal Electrical Stimulation (IES), transcutaneous electrical nerve stimulation (TENS), the Stoller Afferent Nerve Stimulation System (SANS) neuromodulation and percutaneous posterior tibial nerve stimulation (PTNS) were identified. Subjective improvement rates tended to favour the electrical stimulation group in three small trials (54% not improved with the anticholinergic versus 28/86, 33% with electrical stimulation: risk ratio 0.64, 95% confidence interval 1.15 to 2.34). However, this was statistically significant only for one type of stimulation, percutaneous posterior tibial nerve stimulation (risk ratio 2.21, 95% confidence interval 1.13 to 4.33), and was not supported by significant differences in improvement, urinary frequency, urgency, nocturia, incontinence episodes or quality of life.The most commonly reported adverse effect among anticholinergics was dry mouth, although this did not necessarily result in withdrawal from treatment. For all comparisons there were too few data to compare symptoms or side effects after treatment had ended. However, it is unlikely that the effects of anticholinergics persist after stopping treatment. The use of anticholinergic drugs in the management of overactive bladder syndrome is well established when compared to placebo treatment. During initial treatment of overactive bladder syndrome there was more symptomatic improvement when (a) anticholinergics were compared with bladder training alone, and (b) anticholinergics combined with bladder training were compared with bladder training alone. Limited evidence from small trials might suggest electrical stimulation is a better option in patients who are refractory to anticholinergic therapy, but more evidence comparing individual types of electrostimulation to the most effective types of anticholinergics is required to establish this. These results should be viewed with caution in view of the different classes and varying doses of individual anticholinergics used in this review. Anticholinergics had well recognised side effects, such as dry mouth.

The effect of intravaginal electrical stimulation on the quality of life and changes in function and anatomy of pelvic floor in women with stress urinary incontinence

Abstract Introduction: Urinary incontinence (UI), according to the Committee of the International Continence Society Standards, is defined as any involuntary urine loss associated to exertion conditions. This urine loss can be called Stress Urinary Incontinence (SUI) and when the detrusor muscle becomes inactive Material and methods: The goal of this study was verifying intravaginal electrical stimulation effects on bladder floor mobility, pelvic floor muscles´ width, their contraction ability and the quality of life of 40 women whose age ranged from 35 to 55 and who were diagnosed with Stress Urinary Incontinence disorder. They were split into two groups: Geletro (underwent 16 perineal electrical stimulation sessions) and control group, Gc (no intervention). The variables were respectively evaluated by the following instruments: transvaginal ultrassonography (Toshiba trademark), Phenix electromyographic biofeedback and King´s Health Questionnaire. Results: The results were bladder floor mobility reduction (Δ% = -9,13%, p=0,0930), width increase on pelvic floor muscles (Δ% = 11,64%, p= 0,2924), both not significant, muscle strength increase due to biofeedback (Δ% =60,49%, p= 0,0001) and to AFA* (Δ% = 24,53%, p=0,0001), and significant decrease of all questionnaire scores: DOM 1 (Δ% = -50,00%, p = 0,000), DOM 2 (Δ% = -55,14%, p= 0,005), DOM 3 (Δ% =-74,98 %, p= 0,002), DOM 4 (Δ% = -73,87%, p= 0,002), DOM 5 (Δ% = -68,91%, p= 0,001), DOM 6 (Δ% = -85,90%, p= 0,000), DOM 7 (Δ% = -72,48%, p= 0,014), DOM 8 (Δ% =-71,88 %, p= 0,030), DOM 9Δ% =-73,29 %, p= 0,023) Conclusions: The Geletro group in comparison to the Gc which showed that intravaginal electrical stimulation improved the pelvic floor anatomically and functionally and also the quality of life of Geletro group. Stress Urinary Incontinence improvement could only be subjectively demonstrated.

Comparison of intravaginal electrical stimulation and trospium hydrochloride in women with overactive bladder syndrome: a randomized controlled study

Objective: To compare the effects of trospium hydrochloride and electrical stimulation on urodynamic parameters, bladder diary, quality of life and psychological symptoms in female patients with overactive bladder syndrome. Design: Prospective, randomized controlled trial. Setting: Department of Physical Medicine and Rehabilitation, University Hospital. Subjects: Thirty-five patients were divided into either trospium chloride (Group 1) or intravaginal electrical stimulation therapy (Group 2). Main outcome measures: All patients were assessed at the beginning of the treatment, at weeks 6 (end of treatment), 10 and 18 according to urodynamic parameters, voiding diary parameters, severity of urgency (visual analogue scale, VAS), the Incontinence Impact Questionnaire Short Form (IIQ-7), and the Beck Depression Inventory. Results: Statistically significant improvements were observed in both groups according to some urodynamic parameters, voiding diary parameters, VAS urgency severity, Incontinence Impact Questionnaire Short Form and Beck Depression Inventory scores at the end of the treatment (P<0.05). During the 18-week follow-up period, deteriorations were observed in many parameters in both groups although improvements in the frequency of urgency, the frequency of incontinence episodes, VAS urgency severity, and Beck Depression Inventory score in Group 2 persisted (P<0.05). Significant differences were not detected between groups at the end of the treatment or during the posttreatment follow-up controls (P>0.05). Conclusion: No difference was detected between trospium hydrochloride and intravaginal electrical stimulation in the treatment of female overactive bladder syndrome. Discontinuation of both treatments caused deterioration in most of the objective and subjective symptoms of overactive bladder syndrome.