Long-Term Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial.

BACKGROUND: Increased smartphone ownership has led to the development of mobile smoking cessation programs. Although the related body of evidence, gathered through the conduct of randomized controlled trials (RCTs), has grown in quality and rigor, there is a need for longer-term data to assess associated smoking cessation durability. OBJECTIVE: The primary aim was to compare smoking cessation outcomes at 52 weeks in adult smokers randomized to a mobile smoking cessation program, Pivot (intervention), versus QuitGuide (control). The secondary aims included comparison of other smoking-related behaviors, outcomes and participant feedback, and exploratory analyses of baseline factors associated with smoking cessation. METHODS: In this remote pilot RCT, cigarette smokers in the United States were recruited on the web. Participants were offered 12 weeks of free nicotine replacement therapy (NRT). Data were self-reported via a web-based questionnaire with videoconference biovalidation in participants who reported 7-day point-prevalence abstinence (PPA). Outcomes focused on cessation rates with additional assessment of quit attempts, cigarettes per day (CPD), self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire, NRT use, and participant feedback. Cessation outcomes included self-reported 7- and 30-day PPA, abstinence from all tobacco products, and continuous abstinence. PPA and continuous abstinence were biovalidated using witnessed breath carbon monoxide samples. Exploratory post hoc regression analyses were performed to identify baseline variables associated with smoking cessation. RESULTS: Participants comprised 188 smokers (n=94, 50% in the Pivot group and n=94, 50% in the QuitGuide group; mean age 46.4, SD 9.2 years; n=104, 55.3% women; n=128, 68.1% White individuals; mean CPD 17.6, SD 9.0). Several cessation rates were higher in the Pivot group (intention to treat): self-reported continuous abstinence was 20% (19/94) versus 9% (8/94; P=.03) for QuitGuide, biochemically confirmed abstinence was 31% (29/94) versus 18% (17/94; P=.04) for QuitGuide, and biochemically confirmed continuous abstinence was 19% (18/94) versus 9% (8/94; P=.046) for QuitGuide. More Pivot participants (93/94, 99% vs 80/94, 85% in the QuitGuide group; P<.001) placed NRT orders (mean 3.3, SD 2.0 vs 1.8, SD 1.6 for QuitGuide; P<.001). Pivot participants had increased self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire (mean point increase 3.2, SD 7.8, P<.001 vs 1.0, SD 8.5, P=.26 for QuitGuide). QuitGuide participants made more mean quit attempts (7.0, SD 6.3 for Pivot vs 9.5, SD 7.5 for QuitGuide; P=.01). Among those who did not achieve abstinence, QuitGuide participants reported greater CPD reduction (mean -34.6%, SD 35.5% for Pivot vs -46.1%, SD 32.3% for QuitGuide; P=.04). Among those who reported abstinence, 90% (35/39) of Pivot participants and 90% (26/29) of QuitGuide participants indicated that their cessation program helped them quit. CONCLUSIONS: This pilot RCT supports the long-term effectiveness of the Pivot mobile smoking cessation program, with abstinence rates durable to 52 weeks. TRIAL REGISTRATION: ClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial.

BACKGROUND: Cigarette smoking remains the leading cause of preventable illness and death, underscoring ongoing need for evidence-based solutions. Pivot, a US Clinical Practice Guideline-based mobile smoking cessation program, comprises a personal carbon monoxide breath sensor; a smartphone app; in-app, text-based human-provided coaching; nicotine replacement therapy; and a moderated web-based community. Promising Pivot cohort studies have established the foundation for comparative assessment. OBJECTIVE: This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide, a US Clinical Practice Guideline-based smoking cessation smartphone app from the National Cancer Institute. METHODS: In this remote pilot randomized controlled trial, cigarette smokers in the United States were recruited on the web and randomized to Pivot or QuitGuide. Participants were offered 12 weeks of free nicotine replacement therapy. Data were self-reported via weekly web-based questionnaires for 12 weeks and at 26 weeks. Outcomes included engagement and retention, attitudes toward quitting smoking, smoking behavior, and participant feedback. The primary outcome was self-reported app openings at 12 weeks. Cessation outcomes included self-reported 7- and 30-day point prevalence abstinence (PPA), abstinence from all tobacco products, and continuous abstinence at 12 and 26 weeks. PPA and continuous abstinence were biovalidated via breath carbon monoxide samples. RESULTS: Participants comprised 188 smokers (94 Pivot and 94 QuitGuide): mean age 46.4 (SD 9.2) years, 104 (55.3%) women, 128 (68.1%) White individuals, and mean cigarettes per day 17.6 (SD 9.0). Engagement via mean "total app openings through 12 weeks" (primary outcome) was Pivot, 157.9 (SD 210.6) versus QuitGuide, 86.5 (SD 66.3; P<.001). Self-reported 7-day PPA at 12 and 26 weeks was Pivot, 35% (33/94) versus QuitGuide, 28% (26/94; intention to treat [ITT]: P=.28) and Pivot, 36% (34/94) versus QuitGuide, 27% (25/94; ITT: P=.12), respectively. Self-reported 30-day PPA at 12 and 26 weeks was Pivot, 29% (27/94) versus QuitGuide, 22% (21/94; ITT: P=.32) and Pivot, 32% (30/94) versus QuitGuide, 22% (21/94; ITT: P=.12), respectively. The biovalidated abstinence rate at 12 weeks was Pivot, 29% (27/94) versus QuitGuide, 13% (12/94; ITT: P=.008). Biovalidated continuous abstinence at 26 weeks was Pivot, 21% (20/94) versus QuitGuide, 10% (9/94; ITT: P=.03). Participant feedback, including ease of setup, impact on smoking, and likelihood of program recommendation were favorable for Pivot. CONCLUSIONS: In this randomized controlled trial comparing the app-based smoking cessation programs Pivot and QuitGuide, Pivot participants had higher engagement and biovalidated cessation rates and more favorable user feedback at 12 and 26 weeks. These findings support Pivot as an effective, durable mobile smoking cessation program. TRIAL REGISTRATION: ClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Durability of Abstinence After Completing a Comprehensive Digital Smoking Cessation Program Incorporating a Mobile App, Breath Sensor, and Coaching: Cohort Study.

BACKGROUND: Despite decreasing prevalence over the last several decades, cigarette smoking remains the leading cause of preventable death and disease, underscoring the need for innovative, effective solutions. Pivot is a novel, inclusive smoking cessation program designed for smokers along the entire spectrum of readiness to quit. Pivot leverages proven methods and technological advancements, including a personal portable breath carbon monoxide sensor, smartphone app, and in-app text-based coaching. We previously reported outcomes from the end of active Pivot program participation in 319 adult smokers. Herein, we report longer-term follow up in this cohort. OBJECTIVE: The aim of this study was to assess and report participant outcomes 3 months after completion of Pivot, including smoking behavior, quit rates, continuous abstinence rates and durability, and predictors of abstinence. METHODS: This prospective remote cohort study included US-based cigarette smokers aged 18 to 65 years who smoked ≥5 cigarettes per day (CPD). Three months after completion of active participation in Pivot, final follow-up data were collected via an online questionnaire. Outcomes included smoking behavior (CPD and quit attempts), self-reported quit rates (7- and 30-day point prevalence abstinence [PPA]), and continuous abstinence rates (proportion who achieved uninterrupted abstinence) and duration. Exploratory regression analyses were performed to identify baseline characteristics associated with achievement of 7-day PPA, 30-day PPA, and continuous abstinence. RESULTS: A total of 319 participants completed onboarding (intention-to-treat [ITT]); 288/319 participants (90.3%) completed follow up (completers) at a mean of 7.2 (SD 1.2) months after onboarding. At final follow up, CPD were reduced by 52.6% (SE 2.1; P<.001) among all 319 participants, and most completers (152/288, 52.8%) reduced their CPD by at least 50%. Overall, most completers (232/288, 80.6%) made at least one quit attempt. Quit rates increased after the end of Pivot; using ITT analyses, 35.4% (113/319) achieved 7-day PPA and 31.3% (100/319) achieved 30-day PPA at final follow up compared with 32.0% (102/319) and 27.6% (88/319), respectively, at the end of the Pivot program. Continuous abstinence was achieved in about a quarter of those who onboarded (76/319, 23.8%) and in most who reported 30-day PPA at the end of Pivot (76/88, 86.4%), with a mean abstinence duration of 5.8 (SD 0.6) months. In exploratory regression analyses, lower baseline CPD, more positive baseline attitudes reflecting higher self-efficacy (higher confidence to quit and lower perceived difficulty of quitting), and higher education were associated with achieving abstinence. CONCLUSIONS: This study provides the first longer-term outcomes of the Pivot smoking cessation program. At final follow up, quit rates increased and continuous abstinence was favorable; the majority who achieved abstinence at the end of Pivot sustained abstinence throughout follow up. Decreases in CPD persisted and most participants made a quit attempt. Overall, final follow-up outcomes were stable or improved when compared to previous outcomes from the end of the program. These findings validate earlier results, and suggest that Pivot is an effective and durable solution for smoking cessation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643.

Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study.

BACKGROUND: Tobacco use is the leading cause of preventable morbidity and mortality. Existing evidence-based treatments are underutilized and have seen little recent innovation. The success of personal biofeedback interventions in other disease states portends a similar opportunity in smoking cessation. The Pivot Breath Sensor is a personal interactive FDA-cleared (over-the-counter) device that measures carbon monoxide (CO) in exhaled breath, enabling users to link their smoking behavior and CO values, and track their progress in reducing or quitting smoking. OBJECTIVE: The objective of this study is to assess the Pivot Breath Sensor in people who smoke cigarettes, evaluating changes in attitudes toward quitting smoking, changes in smoking behavior, and use experience. METHODS: US adults (18-80 years of age, ≥10 cigarettes per day [CPD]) were recruited online for this remote 12-week study. Participants completed a screening call, informed consent, and baseline questionnaire, and then were mailed their sensor. Participants were asked to submit 4 or more breath samples per day and complete questionnaires at 1-4, 8, and 12 weeks. Outcomes included attitudes toward quitting smoking (Stage of Change, success to quit, and perceived difficulty of quitting), smoking behavior (quit attempts, CPD reduction, and 7-, 30-day point prevalence abstinence [PPA]), and use experience (impact and learning). RESULTS: Participants comprised 234 smokers, mean age 39.9 (SD 11.3) years, 52.6% (123/234) female, mean CPD 20.3 (SD 8.0). The 4- and 12-week questionnaires were completed by 92.3% (216/234) and 91.9% (215/234) of participants, respectively. Concerning attitude outcomes, at baseline, 15.4% (36/234) were seriously thinking of quitting in the next 30 days, increasing to 38.9% (84/216) at 4 weeks and 47.9% (103/215) at 12 weeks (both P<.001). At 12 weeks, motivation to quit was increased in 39.1% (84/215), unchanged in 54.9% (118/215), and decreased in 6.0% (13/215; P<.001). Additional attitudes toward quitting improved from baseline to 12 weeks: success to quit 3.3 versus 5.0 (P<.001) and difficulty of quitting 2.8 versus 4.3 (P<.001). Regarding smoking behavior, at 4 weeks, 28.2% (66/234) had made 1 or more quit attempts (≥1 day of abstinence), increasing to 48.3% (113/234) at 12 weeks. At 4 weeks, 23.1% (54/234) had reduced CPD by 50% or more, increasing to 38.5% (90/234) at 12 weeks. At 12 weeks, CPD decreased by 41.1% from baseline (P<.001), and 7- and 30-day PPA were 12.0% (28/234) and 6.0% (14/234), respectively. Concerning use experience, 75.3% (171/227) reported the sensor increased their motivation to quit. More than 90% (>196/214) indicated the sensor taught them about their CO levels and smoking behavior, and 73.1% (166/227) reported that seeing their CO values made them want to quit smoking. CONCLUSIONS: Use of the Pivot Breath Sensor resulted in a significant increase in motivation to quit, a reduction in CPD, and favorable quit attempt rates. These outcomes confer increased likelihood of quitting smoking. Accordingly, the results support a role for biofeedback via personal CO breath sampling in smoking cessation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04133064; https://clinicaltrials.gov/ct2/show/NCT04133064.

Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study.

BACKGROUND: Cigarette smoking is the leading cause of preventable morbidity and mortality, excess health care expenditure, and lost work productivity. Otherwise effective evidence-based treatments have had limited success owing to challenges with access, engagement, and scale. Pivot is a comprehensive digital smoking cessation program that incorporates a Food and Drug Administration-cleared carbon monoxide breath sensor, smartphone app, and text-based human coaching. OBJECTIVE: This initial evaluation of Pivot aimed to assess participant engagement, changes in attitudes toward quitting, and changes in smoking behavior. METHODS: US cigarette smokers aged 18 to 65 years who smoked ≥5 cigarettes per day (CPD) were recruited online. Participants completed a screening call, electronic informed consent, registration, and onboarding before beginning Pivot. Pivot includes 5 sequential stages (Explore, Build, Mobilize, Quit, and Secure), taking 14.5 to 18.5 weeks to complete. Data were collected via app and online questionnaires. Outcomes included engagement and retention (ie, weeks of active engagement and Pivot stage progression); attitudes toward quitting (ie, quit readiness, quit confidence, and expected difficulty maintaining quit); and smoking behavior (ie, quit attempts, cigarette reduction, and abstinence (7- and 30-day point prevalence abstinence [PPA]). RESULTS: A total of 319 participants completed onboarding (intention-to-treat [ITT] sample); 272/319 participants (85.3%) completed the end-of-Pivot questionnaire (study completer sample). Most (212/319, 66.5%) were not ready to quit in the next 30 days at baseline. On average, participants actively engaged in the program for a mean 12.4 (SD 7.1) weeks. Pivot stage completion rates were Explore: 88.7% (283/319), Build: 57.4% (183/319), Mobilize: 43.6% (139/319), Quit: 41.1% (131/319), and Secure: 39.5% (126/319). Repeated measures linear mixed model analyses demonstrated positive changes in attitudes from baseline to Mobilize (pre-Quit): increased confidence to quit (4.2 to 7.4, P<.001) and decreased expected difficulty maintaining quit (3.1 to 6.8, P<.001). The quit attempt rate (ie, those making ≥1 quit attempt lasting ≥1 day) was 79.4% (216/272, completer). At the end of Pivot, 7-day PPA rates were 32.0% (102/319, ITT) and 37.5% (102/272, completer); 30-day PPA rates were 27.6% (88/319, ITT) and 32.4% (88/272, completer). Moreover, 30-day PPA rates were comparable among those ready and not ready to quit in the next 30 days at baseline. Of those not achieving abstinence, 25.9% (44/170, completer) achieved ≥50% reduction in CPD by study end. CONCLUSIONS: This study evaluated Pivot's initial performance with comparable quit rates among those ready and not ready to quit in the next 30 days at entry. The present data, considered with the program's accessibility, innovation, evidence-based foundation, and design for all smokers, suggest Pivot has the potential to address limitations of reach and scale and thereby advance smoking cessation efforts. TRIAL REGISTRATION: ClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643 (Archived by WebCite at http://www.webcitation.org/75TiNe6BE).

A Comprehensive Digital Program for Smoking Cessation: Assessing Feasibility in a Single-Group Cohort Study.

BACKGROUND: Cigarette smoking remains the leading cause of preventable death and disease worldwide. Evidence-based approaches are available, but few people access them. Although digital solutions offer great promise for population reach, few multicomponent programs exist. Pivot is a comprehensive digital solution combining a Food and Drug Administration-cleared carbon monoxide (CO) breath sensor; cigarette logging; a 6-phase, app-delivered smoking cessation program based on the US Clinical Practice Guidelines; and dedicated human coaching via text-based chat. OBJECTIVE: The purpose of this study was to assess program engagement, changes in attitudes toward smoking, self-reported changes in smoking behavior, and program acceptability for the initial phase of Pivot: Explore. METHODS: A total of 48 participants enrolled, and 41 completed the study. About half the participants (54%, 22/41) were men, and the mean age was 43 years. Most (85%, 35/41) were daily smokers and smoked an average of 12 cigarettes per day. Explore includes CO breath sensing, logging cigarettes in-app, learning via in-app activities, and dedicated human coaching through a text messaging interface. Participants completed surveys at baseline and exit assessing attitudes toward quitting including readiness, perceived difficulty, and confidence in quit success. At exit, participants also completed a survey of changes in smoking behavior and ratings of program acceptability. RESULTS: More than 80% of participants (34-39 of 41) took ≥1 CO breath sample each day, and more than 55% (23-27 of 41) took ≥5 samples each day. More than 65% of participants (27-34 of 41) logged ≥1 cigarette using the in-app logging feature each day. All 9 in-app activities had completion rates ≥80% (33-40 of 41). Response to coach-initiated outreach was also high, with all contacts receiving ≥73% (30-39 of 41) response. In matched pair analyses, significant positive changes in mean attitudes toward quitting (scale 1-10) were evident from baseline (T1) to study exit (T2), including increased readiness to quit (T1 mean=6.1, T2 mean=7.4, P=.005), lower perceived difficulty (T1 mean=3.7, T2 mean=5.6, P=.001), and greater expectations of success (T1 mean=4.5, T2 mean=6.5, P<.001). At exit, 78% (32/41) of participants reported decreasing the number of cigarettes smoked per day during the study. Participants rated program quality and satisfaction very high (mean ≥8 for all items). CONCLUSIONS: These results support the feasibility and acceptability of the initial 9-day phase of Pivot: Explore. Participants had high levels of engagement with sensing, logging, learning, and coaching. Attitudes toward quitting improved significantly, and the majority of users indicated decreasing smoking behavior. Explore was designed to raise smoker awareness and motivation. Additional research is underway to assess how users progress through the full Pivot smoking cessation program and determine the program's effectiveness for achieving sustained cessation.

Complete ablation of esophageal epithelium with a balloon-based bipolar electrode: a phased evaluation in the porcine and in the human esophagus.

BACKGROUND: The aim of this study was to evaluate the endoscopic and the histologic effects of a balloon-based bipolar radiofrequency electrode for ablation of porcine and human esophageal epithelium. METHODS: All procedures were performed with a balloon-based, bipolar radiofrequency system that creates a circumferential, thin-layer epithelial ablation zone within the esophagus. In Phase I, multiple ablations were created in 10 farm swine, followed by acute euthanasia and histologic assessment for completeness of epithelial removal and ablation depth. In Phase II, multiple ablations were created in 19 farm swine, with varying power and energy density, followed by endoscopy at 2 and 4 weeks to assess stricture formation. In Phase III, 3 ablations were created in 12 farm swine, with varying energy density (5, 8, 10, 12, 15, or 20 J/cm 2 ) at 350 W. Animals were euthanized at 48 hours. Histologic examination determined the percentage of epithelium removed and the ablation depth. In Phase IV, 3 patients underwent esophageal epithelial ablation before esophagectomy, creating separate lesions proximal to the tumor. Completeness of epithelial ablation and ablation depth was quantified histologically. RESULTS: In Phase I, complete removal of esophageal epithelium was achieved at energy density settings of 9.7 to 29.5 J/cm 2 . In Phase II, 9.7 and 10.6 J/cm 2 produced no stricture, whereas more than 20 J/cm 2 produced a stricture in every case. In Phase III, 8-20 J/cm 2 resulted in 100% epithelial ablation. Five and 8 J/cm 2 spared the muscularis mucosae, whereas 10 J/cm 2 caused injury to the muscularis mucosae but preserved the submucosa. In Phase IV, histologic examination demonstrated full-thickness epithelial removal in areas of electrode contact. Ablation extended only to the muscularis mucosae, without injury to submucosa. CONCLUSIONS: In the porcine and the human esophagus, circumferential, full-thickness ablation of epithelium without direct injury to the submucosa is possible and was well tolerated. In all cases, depth of ablation was linearly related to energy density of treatment.

The Stretta procedure: device, technique, and pre-clinical study data.

The initial concept of delivering RF energy to the gastroesophageal junction for the treatment of GERD was based on the well-established safety profile and scientific clinical evidence supporting the effectiveness of this technology in other disease states. As described in this article, the Stretta procedure is an endoluminal procedure inducing collagen tissue contraction, remodeling, and modulation of the triggering threshold for transient LES relaxations. The preclinical experience with this device included feasibility studies to determine optimal treatment parameters and device design. This was followed by longitudinal animal studies to elucidate the mechanism of safety and effect of this intervention as it relates to LES physiology and histopathology. In these studies, RF elevated the LES pressure and gastric yield pressure in a porcine model of botulinum toxin induced LES hypotension. The elevation in GYP more than 6 months was confirmed in a subsequent evaluation. Thickening of the LES after RF delivery has been demonstrated using histopathological evaluation and EUS. Additionally, using a canine model of triggered transient LES relaxations (tLESR), RF significantly reduced the frequency of tLESRs and reflux events. Additional evaluation was performed in human subjects undergoing esophagectomy, confirming feasibility and Histopathologic results of the treatment. Subsequent clinical trials confirm the safety and mechanism of action data of these pre-clinical studies and are presented in this publication.

Radiofrequency energy delivery to the gastric cardia inhibits triggering of transient lower esophageal sphincter relaxation and gastroesophageal reflux in dogs.

BACKGROUND: Delivery of radiofrequency energy to the lower esophageal sphincter and gastric cardia is a new endoluminal technique proposed for the treatment of reflux disease. The mechanisms by which it achieves its effects are unclear. The study assessed the effect of radiofrequency energy delivery to the gastric cardia on the triggering of transient lower esophageal sphincter relaxations and gastroesophageal reflux in dogs. METHODS: In 13 dogs, esophageal motility and pH were measured for 1 hour after a standard liquid meal and air infusion, as well as before and 3 months after radiofrequency energy treatment. At 7 months, histologic evaluation of the gastroesophageal junction was performed. RESULTS: Radiofrequency energy delivery reduced the frequency of transient lower esophageal sphincter relaxations from 4.0 (3.0-6.75) (median [interquartile range]) per hour to 3.0 (2.0-3.0) per hour (p < 0.05). This was accompanied by a significant reduction in acid reflux episodes and esophageal acid exposure. Basal lower esophageal sphincter pressure and lower esophageal sphincter relaxation during swallowing were unchanged. There was a 63% increase in wall thickness at the gastric cardia compared with that in 2 control dogs, but no gross or histopathologic abnormalities of the esophageal or gastric mucosa. CONCLUSION: Radiofrequency energy delivery to the gastric cardia in dogs inhibits the triggering of transient lower esophageal sphincter relaxations and thereby reduces gastroesophageal reflux.

Radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence.

PURPOSE: In this prospective study we investigated the feasibility, safety, and efficacy of radio-frequency energy delivery deep to the mucosa of the anal canal for the treatment of fecal incontinence. METHODS: We studied ten patients with fecal incontinence of varying causes. All patients underwent anoscopy, anorectal manometry, endorectal ultrasound, and pudendal nerve terminal motor latency testing at baseline and six months. The Cleveland Clinic Florida scale for fecal incontinence (Wexner, 0-20), fecal incontinence-related quality of life score, and Short Form 36 were administered at baseline, 1, 2, 3, 6, and 12 months. Using conscious sedation and local anesthesia, we delivered temperature-controlled radio-frequency energy via an anoscopic device with multiple needle electrodes to create thermal lesions deep to the mucosa of the anal canal. RESULTS: Ten females (age, 55.9 +/- 9.2 years; range, 44-74) were enrolled and treated. Median discomfort by visual analog scale (0-10) was 3.8 during and 0.9 two hours after the procedure. Bleeding occurred in four patients (14-21 days after procedure), spontaneous resolution (n = 3) and anoscopic suture ligation (n = 1). At 12 months, the median Wexner score improved from 13.5 to 5 (P < 0.001), with 80 percent of patients considered responders. All parameters in the fecal incontinence-related quality of life were improved (lifestyle (from 2.3 to 3.4), coping (from 1.4 to 2.7), depression (from 2.2 to 3.5), and embarrassment (from 1.3 to 2.8); P < 0.05 for all parameters). Protective pad use was eliminated in five of the seven baseline users. At six months, there was a significant reduction in both initial and maximum tolerable rectal distention volumes. Anoscopy was normal at six months. CONCLUSION: Radio-frequency energy delivery to the anal canal for treatment of fecal incontinence is a new modality that, in this study group, safely improved Wexner and fecal incontinence-related quality of life scores, eliminated protective pad use in most patients, and improved patient quality of life.

The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial.

BACKGROUND: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. METHODS: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (