Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women.

Background: Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. Objective: To assess the efficacy of mechanotherapy provided by the Flyte® intra-vaginal device during pelvic floor muscle training (PFMT). Design: This was a randomized, controlled, double-blinded trial. Materials and methods: Flyte is a repeat use device for conditioning and strengthening the pelvic floor muscles (PFMs). It provides two-part mechanotherapy. Part 1 is the stretching and preloading of the PFM from the internal wand. Part 2 integrates mechanical pulses which elicit muscle cellular and tissue level responses that trigger cellular regeneration, improve neuromuscular facilitation and motor learning. Subjects used the device for 5 min/day for 12 weeks. Subjects (144) were randomized and evaluated at 6 and 12 weeks. Arm A (72) received both Part 1 and Part 2 mechanotherapy for 12 weeks, whereas Arm B (72) received Part 1 therapy for 6 weeks, then crossed over to full therapy. Mean age was 50, 49, respectively, prior pelvic/abdominal surgery 26%, 46%, and previous incontinence treatments 13%, 22%. The primary endpoint was 24-h pad weight (24-HR PW) at 6 weeks. Secondary endpoints were 24-HR PW at 12 weeks and QoL [International Consultation on Incontinence Questionnaire (ICIQ), Urinary Incontinence Quality of Life (IQOL)]. Results: Part 1 therapy had a greater than anticipated therapeutic effect. Thus, the study was underpowered to identify differences between study arms. Therefore, data were pooled to assess the effects of mechanotherapy. Twenty four-HR PW was significantly reduced at 6 weeks (p = <0.0001), with further reduction from 6 to 12 weeks (p = <0.0001). Data were stratified based on 24-HR PW severity. Significant reductions were noted in all severity groups (mild p = <0.0001, moderate p = <0.0001, severe p = <0.01). QoL was similarly improved at 6 weeks (ICIQ p = <0.0001, IQOL p = <0.0001), and 12 weeks (ICIQ p = <0.0001, IQOL p = <0.0001). Compliance was >80% at 6 weeks and 70% at 12 weeks. Conclusion: Two-part mechanotherapy significantly improved 24-HR PW and QoL across all severities of SUI. Improvements were noted in as little as 2 weeks and appeared to be sustained through 2-year follow up. Trial registration: Registered on ClinTrials.gov (NCT02954042).

Novel mechanical stimulation therapy for stress urinary incontinence Stress urinary incontinence is the involuntary loss of urine during activities such as sneezing, coughing, lifting and exercise. It negatively affects quality of life, and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. Pelvic floor muscle training, sometimes referred to as Kegel exercise, is the usual initial therapy to treat stress urinary incontinence. This study assessed the effectiveness and safety of the two types of mechanical stimulation therapy provided by the Flyte® intra-vaginal wand during pelvic floor muscle training. The first type stretches the muscles to optimize the effect of the pelvic floor muscle exercises. The second type is the delivery of specially tuned mechanical pulses that trigger muscle cell and tissue responses that accelerate muscle cell healing, increase muscle awareness and improve coordination. Due to an inadequate number of study subjects in the two study arms, the study data were combined into one analysis group to better assess the benefits of Flyte therapy in the participants. The volume of urine loss was very significantly reduced at 6-weeks, with further reduction from 6-12 weeks. Data were then divided into subgroups based on the severity of urine loss at the beginning of the study. Very significant reductions were noted in women with Mild, Moderate and Severe incontinence. Quality of life was similarly improved at 6 and 12 weeks, as measured by two quality of life questionnaires. These improvements were noted in as little as 2 weeks. More than 80% of participants performed the therapy at 6 weeks and 70% at 12 weeks. Improved quality of life was sustained through two years after the study ended in women who voluntarily continued participation in the study.

Percutaneous perfusion monitoring for the detection of hemodialysis induced cardiovascular injury.

INTRODUCTION: The safe delivery of hemodialysis (HD) faces dual challenges; the accurate detection of systemic circulatory stress producing cardiovascular (CV) injury, and the ability to enable effective preemptive intervention for such injury. We performed a pilot study to examine the capability of a new noninvasive, real-time monitoring system to detect the deleterious effects of HD on CV stability. METHODS: Eight patients were evaluated with echocardiography prior to the initiation of HD and again at peak HD stress. Continuous CV physiologic monitoring was performed throughout using oximeter-based pulse waveform analysis (CVInsight® Monitoring System, Intelomed, Inc., Warrendale, PA, USA). Longitudinal strain (LS) values for 12 left ventricular segments were generated using speckle-tracking software (EchoPac, GE), to assess the presence of HD-induced regional wall motion abnormalities (RWMA), indicative of myocardial stunning. FINDINGS: A reduction in pulse strength (PS) of ≥40% detected by CVI was associated with the development of RWMA (P = 0.005). This reduction occurred in 6/8 patients, all of whom exhibited myocardial stunning. Two patients had no significant reduction in PS nor evidence of myocardial stunning. In subjects with cardiac stunning, the decrease in PS was evident early during HD, 11.49 ± 10 minutes into HD treatment, prior to the detection of RWMA, which were assessed at peak HD stress, mean 210 ± 16.43 minutes into HD treatment. DISCUSSION: Percutaneous perfusion monitoring, using pulse wave analysis, appears to be useful in identifying circulatory stress during HD and predicting the development of HD-induced myocardial stunning with a lead time long enough to consider timely intervention.

Mechanisms and clinical consequences of untreated central sleep apnea in heart failure.

Central sleep apnea (CSA) is a highly prevalent, though often unrecognized, comorbidity in patients with heart failure (HF). Data from HF population studies suggest that it may present in 30% to 50% of HF patients. CSA is recognized as an important contributor to the progression of HF and to HF-related morbidity and mortality. Over the past 2 decades, an expanding body of research has begun to shed light on the pathophysiologic mechanisms of CSA. Armed with this growing knowledge base, the sleep, respiratory, and cardiovascular research communities have been working to identify ways to treat CSA in HF with the ultimate goal of improving patient quality of life and clinical outcomes. In this paper, we examine the current state of knowledge about the mechanisms of CSA in HF and review emerging therapies for this disorder.

Impact of rate-modulated pacing on quality of life and exercise capacity--evidence from the Advanced Elements of Pacing Randomized Controlled Trial (ADEPT).

BACKGROUND: Ninety-nine percent of pacemakers implanted in the United States include an option for rate modulation. OBJECTIVE: The purpose of this study was to determine whether dual-chamber rate-modulated pacing, when compared with dual-chamber pacing alone, improved quality of life. METHODS: This was a single-blind randomized controlled trial comparing dual-chamber with rate-modulated dual-chamber pacing. Patients were enrolled between January 12, 2000, and January 10, 2002, with 1-year follow-up ending December 19, 2002. The study was a U.S. multicenter trial, with 95 sites participating. All patients received a rate modulation-capable dual-chamber pacemaker for standard indications. Patients were screened with an exercise test (Chronotropic Assessment Exercise Protocol) 1 month later. One thousand two hundred seventy-three patients were enrolled; 401 proved ineligible, and 872 (68%) made up the randomized patient cohort. Randomized patients had a mean age of 71 years, 64% were men, and 64% had sinus node dysfunction. Randomization was in a factorial design to (1) dual-chamber rate-modulated pacing versus dual-chamber pacing and (2) automatic mode switching versus no automatic mode switching. The present report is limited to the comparison of rate modulation with no rate modulation (DDDR vs. DDD). The primary endpoint was the score on the Specific Activity Scale, an activity-based cardiovascular disease-specific instrument at 1 year. Secondary endpoints included 6-month treadmill time and additional cardiovascular disease-specific, and generic health-related quality-of-life instruments at 1 year. RESULTS: At 6 months, patients with rate modulation had a higher peak exercise heart rate (rate modulation 113.3 +/- 19.6, no rate modulation 101.1 +/- 21.1; P <.0001). Total exercise time was not different between groups. At 1 year, there were no significant differences between groups with respect to Specific Activity Scale or the secondary quality-of-life endpoints. CONCLUSIONS: We conclude that rate modulation is ineffective in improving the functional status or quality of life of patients with a bradycardia indication for dual-chamber pacing.

Preventing tomorrow's sudden cardiac death today: part I: Current data on risk stratification for sudden cardiac death.

Accurate and timely prediction of sudden cardiac death (SCD) is a necessary prerequisite for effective prevention and therapy. Although the largest number of SCD events occurs in patients without overt heart disease, there are currently no tests that are of proven predictive value in this population. Efforts in risk stratification for SCD have focused primarily on predicting SCD in patients with known structural heart disease. Despite the ubiquity of tests that have been purported to predict SCD vulnerability in such patients, there is little consensus on which test, in addition to the left ventricular ejection fraction, should be used to determine which patients will benefit from an implantable cardioverter defibrillator. On July 20 and 21, 2006, a group of experts representing clinical cardiology, cardiac electrophysiology, biostatistics, economics, and health policy were joined by representatives of the US Food and Drug administration, Centers for Medicare Services, Agency for Health Research and Quality, the Heart Rhythm Society, and the device and pharmaceutical industry for a round table meeting to review current data on strategies of risk stratification for SCD, to explore methods to translate these strategies into practice and policy, and to identify areas that need to be addressed by future research studies. The meeting was organized by the Duke Center for the Prevention of SCD at the Duke Clinical Research Institute and was funded by industry participants. This article summarizes the presentations and discussions that occurred at that meeting.

Can current minute ventilation rate adaptive pacemakers provide appropriate chronotropic response in pediatric patients?

Since children have different activity patterns and exercise responses, uncertainty exists as to whether minute ventilation (MV) sensors designed for adults provide adequate chronotropic response in pediatrics. In particular, high respiratory rates (RR > 48 breaths/min), which are characteristic of the ventilatory response to exercise in children, cannot be sensed by MV rate responsive pacemakers. The purpose of this study was to evaluate the MV sensor rate response of the Medtronic Kappa 400 using exercise data from healthy children in a computer simulation of its rate response algorithm. Thirty-eight healthy children, ages 6-14, underwent a treadmill maximal exercise test. Subjects were divided based on body surface area (BSA) and MV rate response parameters were selected. Respiratory rates and tidal volumes were entered into the Kappa 400 rate response algorithm to calculate sensor-driven rates. Intrinsic heart rate (HR), oxygen uptake, and sensor-driven rates were normalized to HR reserve (HRR), metabolic reserve (MR), and sensor-driven reserve to compare across groups. Linear regression analysis among sensor-driven rate reserve, HRR, and MR was performed as described by Wilkoff. The mean slopes (+/- SD) of the relationships between the sensor-driven rate reserve and HRR were 1.06 +/- 0.34, 1.07 +/- 0.28, and 1.01 +/- 0.19 for children with BSA < 1.10 m2, 1.10 < BSA < 1.40 m2, and BSA > 1.40 m2, respectively. High correlations were found between sensor-drive rates and HR responses and between sensor-drive rates and MV throughout exercise. No significant differences were noted between sensor-drive rates and HR using the Wilkoff model. From this study the authors conclude that: (1) MV is a good physiological parameter to control heart rate and (2) simulated sensor-driven rates closely match intrinsic HRs during exercise in healthy children, which supports the appropriateness of clinical validation in pediatric pacemaker patients.