Patient-reported outcomes in the setting of a randomized control trial on the efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome.

AIM: To compare the efficacy of transcutaneous tibial nerve stimulation (TTNS) with percutaneous tibial nerve stimulation (PTNS) regarding patient-reported outcomes measures, specifically quality-of-life (QoL) improvement and patient's treatment benefit, on symptoms associated with overactive bladder (OAB). METHODS: Patients with refractory OAB symptoms and detrusor overactivity were randomized to receive TTNS or PTNS for 12 weeks. Data from self-report OAB questionnaire short form (q-SF) and incontinence (I)-QoL questionnaires were collected pretreatment and at Weeks 6 and 12. Patients' self-perceived benefits on symptoms (treatment benefit scale, TBS) were also gathered. Mean change in scores within and between groups were estimated. RESULTS: Sixty-eight adult patients (67.6% women) were included in the intention to treat analysis. Of those, 61 completed all questionnaires and were analyzed as per protocol. Statistically significant improvements in OAB-q-SF and I-QoL between baseline and end-of-treatment scores were observed in both TTNS and PTNS groups (p < .001), being the differences much higher than the minimal important difference in both questionnaires. The scores of the OAB-q-SF scales (symptoms bother and health-related QoL) showed no statistically significant differences between the two groups. Similarly, the differences regarding the I-QoL questionnaire were statistically nonsignificant either (p = .607). When assessing the treatment benefit on symptoms, TBS responses between groups showed no statistical differences. CONCLUSION: A significant improvement of QoL was observed in both TTNS and PTNS groups. However, no patient-reported outcomes measures scores support a difference between the two groups. Therefore, these findings along with TTNS ease of application and less invasiveness may lead to an increased indication of this technique for OAB.

Efficacy of transcutaneous posterior tibial nerve stimulation in children with functional voiding disorders.

AIMS: To assess the efficacy of transcutaneous posterior tibial nerve stimulation (TPTNS) on functional voiding disorder (FVD) and investigate the utility of urine biomarkers (UBs: nerve growth factor, transforming growth factor-beta 1, and tissue inhibitor of metalloproteinases 2) in diagnosis and follow-up. METHODS: A total of 44 children were included to this randomized controlled trial prospectively. After randomization, 20 of 30 children with storage phase dysfunction those were unresponsive or noncompliant to medical treatment received TPTNS treatment (test group) and 10 children underwent TPTNS with no current (sham group) for 12 weeks. Fourteen healthy children constituted the nonsymptomatic group. UB levels, dysfunctional voiding and incontinence scoring system (DVISS), voiding diary, and quality of life (QoL) scores were assessed before and after treatment in the treatment groups. RESULTS: QoL scores, overall and day-time DVISS scores were significantly decreased in both sham and test groups (p < 0.05). In addition to these findings, the frequency of incontinence and urgency episodes were also significantly reduced (p < 0.05) in the TPTNS treatment group. This effect in the test group was still valid 2 years after intervention. There was no significant difference in UBs measurements between treatment and nonsymptomatic groups and between pretreatment and posttreatment measurements of test and sham groups. CONCLUSIONS: TPTNS is an efficient minimally invasive treatment in children with FVD who do not respond to medical treatment. TPTNS provides a significant improvement on episodes of frequency, episodes of incontinence, overall and day-time DVISS scores, and QoL scores. The effectiveness of treatment continues even at the end of the second year of intervention. UBs were not found to be predictive in terms of diagnosis and evaluating the treatment response.

Treatment patterns and costs among patients with OAB treated with combination oral therapy, sacral nerve stimulation, percutaneous tibial nerve stimulation, or onabotulinumtoxinA in the United States.

INTRODUCTION: Treatment patterns and costs were characterized among patients with overactive bladder (OAB) receiving later-line target therapies (combination mirabegron/antimuscarinic, sacral nerve stimulation [SNS], percutaneous tibial nerve stimulation [PTNS], or onabotulinumtoxinA). METHODS: In a retrospective cohort study using 2013 to 2017 MarketScan databases, two partially overlapping cohorts of adults with OAB ("IPT cohort": patients with incident OAB pharmacotherapy use; "ITT cohort," incident target therapy) with continuous enrollment were identified; first use was index. Demographic characteristics, treatment patterns and costs over the 24-month follow-up period were summarized. Crude mean (standard deviation [SD]) OAB-specific (assessed by OAB diagnostic code or pharmaceutical dispensation record) costs were estimated according to target therapy. RESULTS: The IPT cohort comprised 54 066 individuals (mean [SD] age 58.5 [15.0] years; 76% female), the ITT cohort, 1662 individuals (mean [SD] age 62.8 [14.9] years; 83% female). Seventeen percent of the IPT cohort were treated with subsequent line(s) of therapy after index therapy; among those, 73% received antimuscarinics, 23% mirabegron, and 1.4% a target therapy. For the ITT cohort, 32% were initially treated with SNS, 27% with onabotulinumtoxinA, 26% with combination mirabegron/antimuscarinic, and 15% with PTNS. Subsequently, one-third of this cohort received additional therapies. Mean (SD) costs were lowest among patients receiving index therapy PTNS ($6959 [$7533]) and highest for SNS ($29 702 [$26 802]). CONCLUSIONS: Costs for SNS over 24 months are substantially higher than other treatments. A treatment patterns analysis indicates that oral therapies predominate; first-line combination therapy is common in the ITT cohort and uptake of oral therapy after procedural options is substantial.

Superficial peroneal neuromodulation of nonobstructive urinary retention in cats.

AIMS: To determine if superficial peroneal nerve stimulation (SPNS) can improve nonobstructive urinary retention (NOUR). METHODS: In α-chloralose anesthetized cats, NOUR was induced by repetitive application (4-16 times) of 30-minute tibial nerve stimulation (TNS: 5 Hz frequency, 0.2 ms pulse width) at 4 to 6 times threshold intensity (T) for inducing toe twitches. SPNS (1 Hz, 0.2 ms) at 2 to 4 times threshold intensity (T) for inducing posterior thigh muscle contractions was applied either continuously (SPNSc) during a cystometrogram (CMG) or during voiding (SPNSv) by a surgically implanted cuff electrode or by skin surface electrodes to determine if the stimulation reduced NOUR induced by prolonged TNS. RESULTS: During control CMGs, efficient (86.4% ± 5.5%) voiding occurred with a postvoid residual (PVR) volume equal to 14.9% ± 6.2% of control bladder capacity. NOUR elicited by prolonged TNS significantly (P < .05) increased bladder capacity to 168.6% ± 15.5% of control, reduced voiding efficiency to 30.4% ± 4.8%, and increased PVR to 109% ± 9.2% of control. Using the implanted cuff electrode, SPNSc and SPNSv significantly (P < .05) increased voiding efficiency to 66.7% ± 7.4% and 65.0% ± 5.9%, respectively, and reduced PVR to 52.2% ± 11.4% and 64.3% ± 11.6%, respectively. SPNSc but not SPNSv significantly (P < .05) reduced bladder capacity to 133.4% ± 15% of control. Transcutaneous SPNSv but not SPNSc also significantly (P < .05) reversed the TNS-induced NOUR responses. CONCLUSIONS: This study shows that SPNS is effective in reversing NOUR induced by prolonged TNS. Transcutaneous SPNS provides the opportunity to develop a noninvasive neuromodulation therapy for NOUR to treat more patients than current sacral neuromodulation therapy.

Contemporary Patterns of Third-line Treatments for Privately Insured Individuals With Overactive Bladder in the United States.

OBJECTIVE: To evaluate utilization of third-line overactive bladder (OAB) treatments including percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation (SNS), and intradetrusor botulinum toxin A (BTX) among privately insured patients and examine factors associated with their use. MATERIALS AND METHODS: Using MarketScan claims (2015-2017), we identified patients who underwent third-line OAB treatments based on procedure codes. Factors of interest included location, age, health plan, among others. We fit multivariable logistic regression models to estimate associations between pertinent factors with receipt of PTNS and SNS relative to BTX and associations between provider type and practice location with each treatment modality. RESULTS: We identified 7383 patients (mean age 50.9) in our cohort. SNS was used most frequently (n = 3602, 48.8%), while PTNS was used least frequently (n = 955, 12.9%). PTNS patients were more likely to reside in metropolitan areas (vs BTX: OR 1.6, 95%CI 1.3-2.1; vs SNS: OR 2.2, 95%CI 1.7-2.8), be aged 55 years or older (vs BTX: 54% vs 47%, OR 1.6, 95%CI 1.2-2.1; vs SNS: 54% vs 45%, OR 1.6, 95%CI 1.2-2.0), and be covered under a health maintenance organization (vs BTX: 17% vs 10%; vs SNS: 17% vs 10%, P <.01). Urologists were most likely to perform SNS, and gynecologists were most likely to perform BTX. 91% of PTNS procedures were performed in office settings. CONCLUSION: Among patients receiving third-line OAB treatment, PTNS was used infrequently. PTNS utilization was concentrated within urban areas, and among older patients and those covered by cost-conscious health maintenance organizations.

Rehabilitation strategies for low anterior resection syndrome. A systematic review.

OBJECTIVE: To summarize the evidence in the literature about rehabilitative treatments that reduce low anterior resection syndrome (LARS) symptoms in patients who underwent surgery for colorectal cancer. METHODS: We have search in PubMed, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health and Scopus databases. Studies selected were limited to those including only patient undergone low rectal resection with sphincter preservation and with pre-post assessment with a LARS score. Five articles fit the criteria. RESULTS: The percutaneous tibial nerve stimulation demonstrated moderate results and sacral nerve stimulation was found to be the best treatment with greater symptom improvement. Only one study considered sexual and urinary problems in the outcomes assessment. CONCLUSIONS: In clinical practice patients should evaluate with the LARS and other score for evaluation of urinary and sexual problems. Future research must be implemented with higher quality studies to identify the least invasive and most effective treatment/s.

Different electrode positioning for transcutaneous electrical nerve stimulation in the treatment of urgency in women: a study protocol for a randomized controlled clinical trial.

BACKGROUND: Urgency is a complaint of sudden, compelling desire to pass urine, which is difficult to defer, caused by involuntary contraction of the detrusor muscle during the bladder-filling stage. To enable detrusor inhibition, electrotherapy resources such as transcutaneous tibial nerve stimulation (TTNS) and parasacral transcutaneous electrical stimulation (PTES) have been used. The objective this study is to publish the study protocol that aims to investigate whether urgency decreases after treatment with both of the techniques. METHODS: This randomized controlled clinical trial will include 99 women, aged more than 18 years old, with urgency (score ≥ 8 in the Overactive Bladder-Validated 8-Question Awareness Tool [OAB-V8]). Women will be randomly allocated into three groups: TTNS, PTES, and placebo. The following questionnaires will be applied: the Anamnesis Record, the Incontinence Questionnaire Overactive Bladder, the King's Health Questionnaire, the 24-Hour Voiding Diary, and the OAB-V8, at four different time points: at baseline prior to the first session, at the 6th session, the 12th session and at follow-up. The current used for the transcutaneous electrical stimulation will be a symmetrical balanced biphasic pulsed current, for 12 sessions, twice a week, for 20 minutes. Qualitative variables will be displayed as frequency and percentage, quantitative variables as mean and standard deviation. Comparison of urgency severity among groups will be performed with a repeated measures ANOVA, considering the effect of the three groups and the four evaluations, and interactions among them. DISCUSSION: The present study aims to contribute evidence for a more in-depth discussion on electrode positioning for electrostimulation used in urgency treatment. It should be emphasized that, based on the possibility of confirming the hypothesis that urgency will decrease in a similar way after both treatments (TTNS and PTES), the PTES will be used as an option for positioning the electrodes alternatively to the tibial nerve region in special populations, such as amputees or people with severe lower limb sensory impairment. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-9rf33n, date of registration: 17 May 2018.

Comparing the Efficacy of OnabotulinumtoxinA, Sacral Neuromodulation, and Peripheral Tibial Nerve Stimulation as Third Line Treatment for the Management of Overactive Bladder Symptoms in Adults: Systematic Review and Network Meta-Analysis.

The American Urological Association guidelines for the management of non-neurogenic overactive bladder (OAB) recommend the use of OnabotulinumtoxinA, sacral neuromodulation (SNM), and peripheral tibial nerve stimulation (PTNS) as third line treatment options with no treatment hierarchy. The current study used network meta-analysis to compare the efficacy of these three modalities for managing adult OAB syndrome. We performed systematic literature searches of several databases from January 1995 to September 2019 with language restricted to English. All randomized control trials that compared any dose of OnabotulinumtoxinA, SNM, and PTNS with each other or a placebo for the management of adult OAB were included in the study. Overall, 17 randomized control trials, with a follow up of 3-6 months in the predominance of trials (range 1.5-24 months), were included for analysis. For each trial outcome, the results were reported as an average number of episodes of the outcome at baseline. Compared with the placebo, all three treatments were more efficacious for the selected outcome parameters. OnabotulinumtoxinA resulted in a higher number of complications, including urinary tract infection and urine retention. Compared with OnabotulinumtoxinA and PTNS, SNM resulted in the greatest reduction in urinary incontinence episodes and voiding frequency. However, comparison of their long-term efficacy was lacking. Further studies on the long-term effectiveness of the three treatment options, with standardized questionnaires and parameters are warranted.

Prolonged nonobstructive urinary retention induced by tibial nerve stimulation in cats.

Nonobstructive urinary retention (NOUR) is a medical condition without an effective drug treatment, but few basic science studies have focused on this condition. In α-chloralose-anesthetized cats, the bladder was cannulated via the dome and infused with saline to induce voiding that could occur without urethral outlet obstruction. A nerve cuff electrode was implanted for tibial nerve stimulation (TNS). The threshold (T) intensity for TNS to induce toe twitch was determined initially. Repeated (6 times) application of 30-min TNS (5 Hz, 0.2 ms, 4-6T) significantly (P < 0.05) increased bladder capacity to 180% of control and reduced the duration of the micturition contraction to 30% of control with a small decrease in contraction amplitude (80% of control), which resulted in urinary retention with a low-voiding efficiency of 30% and a large amount of residual volume equivalent to 130% of control bladder capacity. This NOUR condition persisted for >2 h after the end of repeated TNS. However, lower frequency TNS (1 Hz, 0.2 ms, 4T) applied during voiding partially reversed the NOUR by significantly (P < 0.05) increasing voiding efficiency to 60% and reducing residual volume to 70% of control bladder capacity without changing bladder capacity. These results revealed that tibial nerve afferent input can activate either an excitatory or an inhibitory central nervous system mechanism depending on afferent firing frequencies (1 vs. 5 Hz). This study established the first NOUR animal model that will be useful for basic science research aimed at developing new treatments for NOUR.

How can we better manage drug-resistant OAB/DO? ICI-RS 2018.

AIMS: Botulinum toxin A (BTX-A), sacral nerve stimulation (SNM), and posterior tibial nerve stimulation (PTNS) are established treatments for idiopathic overactive bladder (OAB) refractory to oral drug therapy. At the ICI-RS meeting in Bristol in 2018 a think tank was convened to address the question of how to better manage drug-resistant OAB/DO (detrusor overactivity). METHODS: The think tank conducted a literature review and an expert consensus meeting focusing on the evidence for predicting response and adverse events (AEs) with the current therapies for drug-resistant idiopathic OAB. RESULTS: Several factors have been associated with poor outcomes using BTX-A including increasing age, body mass index, male sex, and frailty. Voiding dysfunction with BTX-A also appears to be more prevalent in those with increasing age, male sex, higher baseline postvoid residual and with poorer contractility as assessed by urodynamic parameters. SNM full implantation appears to be higher with the first stage tined lead placement procedure compared to percutaneous nerve evaluation. Urodynamics do not appear to predict outcomes with SNM. Patients with psychiatric comorbidity are more likely to experience AEs with SNM. Outcomes related to lead positioning and the number of active electrodes are mixed in predicting long term success. Patients with increased daytime frequency and lower first sensation of bladder filling were independent factors associated with success with PTNS. CONCLUSIONS: Further research is required to optimize these procedures and to better understand which patients will benefit from the various options available in managing refractory OAB.

Severe hyperhomocysteinemia and peripheral neuropathy as side effects of nitrous oxide in two patients with sickle cell disease.

Nitrous oxide (N2O) is a widely used anesthetic agent. We report two patients with sickle cell disease (SCD) who presented with complications following the use of N2O. Patient 1, a 15-year-old girl, presented severe hyperhomocysteinemia, pancytopenia, vitamin B12 deficiency, and peripheral polyneuropathy after massive use of N2O for pain management. At the 1-year follow-up, hyperhomocysteinemia and B12 deficiency had resolved, but she had persisting mild symptoms of polyneuropathy. Patient 2, a 17-year-old boy, presented only severe hyperhomocysteinemia, only partially corrected by initial B12 supplementation. Careful monitoring of N2O use, especially in patients with SCD, is mandatory to prevent complications.

Evaluation of the anorectal motor response after percutaneous stimulation of the posterior tibial nerve in patients with fecal incontinence.

BACKGROUND: The effect of posterior tibial nerve stimulation (PTNS) on the mechanisms of anal continence has not been fully demonstrated. The aim of this study was to assess the anal manometric response after percutaneous PTNS in patients with fecal incontinence (FI). METHODS: This was a prospective study in patients with FI undergoing 1 weekly session of percutaneous PTNS for 8 weeks. A clinical assessment (Wexner scale) and a complete study of up to 22 manometric parameters were carried out prior to treatment and 2-4 weeks after the end of treatment. RESULTS: A total of 32 patients were evaluated. After therapy, there was a decrease in the average Wexner score [12.6 (± 5.2) to 9.5 (± 5.2) (P < 0.005)] and an increase in the "anal canal length at rest" [4.55 (± 0.60) to 4.95 (± 0.21) P = 0.004], without observing variations in other manometric parameters. The decrease in the Wexner score was significantly correlated with an increase in the "pressure at 5 cm at rest" after therapy (r = 0.464 P = 0.030). CONCLUSIONS: In our study, PTNS was associated with a significant decrease in the Wexner score and with an increase in the functional length of the anal canal at rest. The improvement in the Wexner scale was correlated with an increase in pressure at rest in the theoretical area of the anorectal junction.

Isolated injury to the tibial division of sciatic nerve after self-massage of the gluteal muscle with massage ball: A case report.

INTRODUCTION: An isolated injury to the tibial division is rare among compressive sciatic neuropathy. To date, isolated injury to the tibial division of the sciatic nerve after self-massage of the gluteal muscle has not been reported. Here, we report a case of compressive sciatic neuropathy diagnosed after self-massage of the gluteal muscle using magnetic resonance image (MRI) and ultrasound images and its associated therapeutic process. PATIENT CONCERNS: A 50-year-old woman presented right lower extremity pain for the past 7 days. DIAGNOSIS: Electrophysiological findings were consistent with right tibial neuropathy proximal to the branch to hamstring muscles. However, T2-weighted MRI showed high signal intensity and swelling in the right sciatic nerves from the superior gemellus level to the quadratus femoris level. After considering both radiologic and electrophysiological findings, the patient was diagnosed with an isolated injury to the tibial division of the right sciatic nerve. INTERVENTIONS: The patient agreed to an ultrasound-guided perineural steroid injection upon receiving detailed explanation of the procedure. OUTCOMES: After the injection, there was significant improvement in pain. CONCLUSION: Therefore, in making a diagnosis of sciatic neuropathy, it may be important to find the lesion via MRI than relying solely on the patient's history or electrophysiologic study.

Factors associated with overactive bladder symptom improvement after 1 year of monthly percutaneous tibial nerve stimulation therapy.

AIMS: To investigate patient characteristics associated with overactive bladder (OAB) symptom improvement after 1 year of monthly percutaneous tibial nerve stimulation (PTNS) therapy. METHODS: This was a retrospective chart review of women who underwent PTNS for refractory OAB symptoms between January 2011 and December 2017 in our tertiary center. Patients who received 12 monthly PTNS maintenance treatments after achieving success with 12 weekly PTNS treatments were included in the study. Reports on subjective changes in urinary frequency, nocturia, and urgency urinary incontinence were submitted at each visit. Patients were categorized to symptom improve and no improve groups. A multivariate analysis was performed to identify patient characteristics that predicted symptomatic improvement. RESULTS: Sixty-six patients were identified. Average subjective improvement after 12 monthly sessions compared with 12 weekly sessions was 5.2% on a scale of -100% to +100%. A history of urogynecologic surgery remained a significant negative predictor of symptom change from 12 weekly sessions to 12 monthly treatment sessions (odds ratio, 0.19; P = .01). CONCLUSIONS: OAB symptoms remain relatively stable after 12 monthly treatments of PTNS, as compared with the 12-week time point. A history of urogynecologic surgery was a negative predictor of OAB symptom improvement in patients receiving monthly PTNS for at least 12 months.

A systematic review and network meta-analysis comparing treatments for faecal incontinence.

BACKGROUND: Although numerous treatments exist for fecal incontinence (FI), no consensus exists on the best treatment strategy. The aim was to review the literature and to compare the clinical outcomes and effectiveness of treatments available for FI. MATERIALS AND METHOD: A systematic literature review was performed, from inception to May 2018, of the following databases: MEDLINE, EMBASE, Science Citation Index Expanded, Cochrane Library. The search terms used were "faecal incontinence" and "treatment". Only randomized controlled trials (RCTs) comparing treatments for FI were considered. A Bayesian network meta-analysis was performed using the Markov chain Monte Carlo method. RESULT: Forty-seven RCTs were included comparing 37 treatments and reporting on 3748 participants. No treatment ranked best or worst with high probability for any outcome of interest. No significant difference was identified between treatments for frequency of FI per week, or in changing the resting pressure, maximum resting pressure, squeeze pressure, and maximum squeeze pressure. Radiofrequency resulted in more adverse events compared to placebo. Sacral nerve stimulation (SNS) and zinc-aluminium improved the fecal incontinence quality of life questionnaire (FIQL) lifestyle, coping, and embarrassment domains compared to placebo. Transcutaneous posterior tibial nerve stimulation (TPTNS) improved the FIQL embarrassment domain compared to placebo. Autologous myoblasts and zinc-aluminium improved the FIQL depression domain compared to placebo. SNS, artificial bowel sphincter (ABS), and zinc-aluminium significantly improved incontinence scores compared to placebo. Injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA/Dx) resulted in more patients with ≥50% reduction in FI episodes compared to placebo. CONCLUSION: SNS, ABS, TPTNS, NASHA/Dx, zinc-aluminium, and autologous myoblasts resulted in isolated improvements in specific outcomes of interest. No difference was identified in incontinence episodes, no treatment ranked best persistently or persistently improved outcomes, and many included treatments did not significantly benefit patients compared to placebo. Large multicentre RCTs with long-term follow-up and standardized inclusion criteria and outcome measures are needed.

A single-blind, randomized controlled trial to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in Overactive Bladder symptoms in women responders to percutaneous tibial nerve stimulation (PTNS).

OBJECTIVES: To evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared to percutaneous tibial nerve stimulation (PTNS) in sustaining symptom improvement over a 6-month period in women with idiopathic Overactive Bladder (OAB) who had responded to an initial 12-week course of PTNS. DESIGN: Randomized, active-controlled trial. PARTICIPANTS: Twenty-four women diagnosed with idiopathic OAB successfully treated with PTNS were included in this study. INTERVENTIONS: Twelve subjects were allocated to receive monthly sessions of PTNS for six months, and twelve subjects followed a flexible home-based TTNS regime after instruction on the use of a TENS device for the same follow-up time. OUTCOMES: Participants were assessed at six weeks, three months and six months after completing the initial course of PTNS. Primary outcomes were changes from baseline in urinary frequency, number of episodes of urgency and number of episodes of urge urinary incontinence (UUI). Subjectively reported severity of symptoms and quality of life (QoL) were assessed using the validated OAB questionnaire (OAB-q). RESULTS: Urinary frequency, episodes of urinary urgency and episodes of UUI did not change significantly between baseline and six months in either group. Similarly, OAB-q scores for severity of symptoms and QoL were maintained within both arms for the duration of the study. There were no statistically significant differences between the groups in any of the outcome measures at any of the study points. CONCLUSION: TTNS is effective in the maintenance of symptom improvement in women with OAB who had positively responded to a course of 12 weekly PTNS sessions. The trial was registered in the Clinicaltrials.gov PRS database (Identifier: NCT02377765).

Effect of hyperbaric oxygen therapy on HMGB1/NF-κB expression and prognosis of acute spinal cord injury: A randomized clinical trial.

Although there are reports of the beneficial effects of hyperbaric oxygen (HBO) therapy in experimental settings, there are few clinical trials of HBO therapy for acute spinal cord injury (SCI). We investigated the effect of HBO in acute SCI by measuring plasma high mobility group box 1 (HMGB1) and nuclear factor kappa-B (NF-κB) levels, and by monitoring changes in electromyogram F-persistence (the percentage of discernible F-waves) and F-chronodispersion (the difference between minimal and maximal latency). We enrolled 79 acute SCI patients and randomly divided them into control (conventional treatment) and the treatment (conventional treatment plus HBO therapy) groups. Plasma was collected before treatment and after treatment on 1st, 3rd, 7th, 10th and 30th day for the measurement of HMGB1 and NF-κB. Electromyogram F-waves were detected before therapy and after therapy on the 10th and 30th days. Clinical profiles and neurological outcomes were evaluated using American Spinal Injury Association (ASIA) and Frankel Grade scores. Compared to the control group, HBO therapy down-regulated HMGB1 and NF-κB expression in patients with acute SCI on days 3, 7, 10 and 30 (p < 0.05). F-wave chronodispersion decreased at days 10 and 30 (p < 0.01) following HBO. ASIA and Frankel Grade motor/pain scores in the treatment group were significantly improved on day 30 (p < 0.01). There was a positive correlation between plasma NF-κB at day 7 and F-wave dispersion at day 30 (r = 0.76, p = 0.00). In summary, HBO therapy regulated the inflammatory reaction in secondary SCI by decreasing plasma HMGB1/NF-κB levels and reducing the dispersion of electromyogram F-waves of the lower limbs, thereby promoting neurological function recovery.

Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial.

AIM: To evaluate the non-inferiority of the transcutaneous electrical stimulation technique, as compared with the percutaneous therapy (PTNS), regarding the efficacy in symptoms and QoL improvement in patients with overactive bladder (iOAB). METHODS: Patients with overactive detrusor (DO) and persisting symptoms after first-line or second-line treatment were randomized to receive either transcutaneous therapy or PTNS 1 day a week (30 min at 20 Hz and 200 cycles/s) for 12 weeks. Data from a 3-day voiding diary and a self-reported QoL-questionnaire were collected pre-treatment and at week 12. Non-inferiority was analyzed by estimating the mean change (95% confidence interval) of daytime micturition frequency. Statistical significance level was set at P < 0.05. RESULTS: Sixty-eight patients were included (67.6% women), mean age 59.6 years (SD 16.1). According to ITT analysis, daytime frequency decreased in both groups without statistically significant differences between them at the end of the treatment (adjusted difference 0.8; 95%CI; -0.1; 1.7); nor were differences in symptoms improvement for the variables collected through the 3-day voiding diary. Both techniques lessened urgency incontinence episodes by more than 50% and greatly improved the QoL. There were no relevant side effects and overall adherence to the treatment was 89.7%. CONCLUSIONS: This is the first RCT that evaluates the efficacy of the transcutaneous technique compared to the PTNS, and demonstrates non-inferiority in decreasing daytime frequency. Reduction in urgency incontinence episodes and improvement of QoL were also observed. These results and ease of application of transcutaneous neuromodulation may lead to a greater prescribing of this technique.

Diagnosis and Management of Fecal Incontinence.

PURPOSE OF REVIEW: The purpose of this review is to highlight current and newer therapeutic approaches to treat fecal incontinence in patients who do not respond to conservative measures. RECENT FINDINGS: Neurostimulation techniques, injection of bulking agents, and radiofrequency energy delivery to the anal canal have been proposed and tested for fecal incontinence over the last decade. Sacral stimulation is both effective and durable and is now the most popular of the invasive techniques whereas percutaneous tibial stimulation, radiofrequency energy, and bulking agents are either less effective or their evaluation has been handicapped by suboptimal study designs. The precise indications for the new vaginal control device and anal plugs remain to be established. The magnetic anal sphincter is disappointing. Stem cell therapy is a potentially exciting approach, which is in its infancy. There continues to be an unmet need for innovative approaches to patients with fecal incontinence who do not respond to conservative measures. The efficacy of current and future therapies should be assessed using criteria more stringent than has been used in the past to provide a more realistic assessment of meaningful efficacy.