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JAMA Jul 2019Case series suggest favorable results of peroral endoscopic myotomy (POEM) for treatment of patients with achalasia. Data comparing POEM with pneumatic dilation, the... (Comparative Study)
Comparative Study Randomized Controlled Trial
Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial.
IMPORTANCE
Case series suggest favorable results of peroral endoscopic myotomy (POEM) for treatment of patients with achalasia. Data comparing POEM with pneumatic dilation, the standard treatment for patients with achalasia, are lacking.
OBJECTIVE
To compare the effects of POEM vs pneumatic dilation as initial treatment of treatment-naive patients with achalasia.
DESIGN, SETTING, AND PARTICIPANTS
This randomized multicenter clinical trial was conducted at 6 hospitals in the Netherlands, Germany, Italy, Hong Kong, and the United States. Adult patients with newly diagnosed achalasia and an Eckardt score greater than 3 who had not undergone previous treatment were included. The study was conducted between September 2012 and July 2015, the duration of follow-up was 2 years after the initial treatment, and the final date of follow-up was November 22, 2017.
INTERVENTIONS
Randomization to receive POEM (n = 67) or pneumatic dilation with a 30-mm and a 35-mm balloon (n = 66), with stratification according to hospital.
MAIN OUTCOMES AND MEASURES
The primary outcome was treatment success (defined as an Eckardt score ≤3 and the absence of severe complications or re-treatment) at the 2-year follow-up. A total of 14 secondary end points were examined among patients without treatment failure, including integrated relaxation pressure of the lower esophageal sphincter via high-resolution manometry, barium column height on timed barium esophagogram, and presence of reflux esophagitis.
RESULTS
Of the 133 randomized patients, 130 (mean age, 48.6 years; 73 [56%] men) underwent treatment (64 in the POEM group and 66 in the pneumatic dilation group) and 126 (95%) completed the study. The primary outcome of treatment success occurred in 58 of 63 patients (92%) in the POEM group vs 34 of 63 (54%) in the pneumatic dilation group, a difference of 38% ([95% CI, 22%-52%]; P < .001). Of the 14 prespecified secondary end points, no significant difference between groups was demonstrated in 10 end points. There was no significant between-group difference in median integrated relaxation pressure (9.9 mm Hg in the POEM group vs 12.6 mm Hg in the pneumatic dilation group; difference, 2.7 mm Hg [95% CI, -2.1 to 7.5]; P = .07) or median barium column height (2.3 cm in the POEM group vs 0 cm in the pneumatic dilation group; difference, 2.3 cm [95% CI, 1.0-3.6]; P = .05). Reflux esophagitis occurred more often in the POEM group than in the pneumatic dilation group (22 of 54 [41%] vs 2 of 29 [7%]; difference, 34% [95% CI, 12%-49%]; P = .002). Two serious adverse events, including 1 perforation, occurred after pneumatic dilation, while no serious adverse events occurred after POEM.
CONCLUSIONS AND RELEVANCE
Among treatment-naive patients with achalasia, treatment with POEM compared with pneumatic dilation resulted in a significantly higher treatment success rate at 2 years. These findings support consideration of POEM as an initial treatment option for patients with achalasia.
TRIAL REGISTRATION
Netherlands Trial Register number: NTR3593.
Topics: Adult; Dilatation; Esophageal Achalasia; Esophageal Sphincter, Lower; Female; Follow-Up Studies; Gastroesophageal Reflux; Humans; Male; Manometry; Middle Aged; Natural Orifice Endoscopic Surgery; Quality of Life; Severity of Illness Index; Sphincterotomy; Treatment Outcome
PubMed: 31287522
DOI: 10.1001/jama.2019.8859 -
The Journal of Urology Apr 2022The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures.
MATERIALS AND METHODS
Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications.
RESULTS
Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria.
CONCLUSIONS
The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.
Topics: Adult; Coated Materials, Biocompatible; Dilatation; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Recurrence; Single-Blind Method; Treatment Outcome; Urethral Stricture
PubMed: 34854748
DOI: 10.1097/JU.0000000000002346 -
Physical Therapy Aug 2020The aim of this systematic review was to identify, evaluate, and synthesize the evidence from studies that have investigated the effect of nonsurgical,... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The aim of this systematic review was to identify, evaluate, and synthesize the evidence from studies that have investigated the effect of nonsurgical, nonpharmacological, pelvic floor muscle interventions on any type of pelvic floor dysfunction or health-related quality of life in patients after any type of treatment for gynecological cancer.
METHODS
Six electronic databases (Cochrane Library 2018, CINAHL 1982-2018, MEDLINE 1950-2018, EMBASE 1980-2018, PsycINFO 1806-2018, and EMCARE 1995-2018) were systematically searched in June 2018. Reference lists of identified articles were hand searched. Randomized controlled trials (RCTs), cohort studies, and case series were included if they investigated the effects of conservative treatments, including pelvic floor muscle training or dilator training, on bladder, bowel, or sexual function in patients who had received treatment for gynecological cancer. Risk of bias was assessed using the Physiotherapy Evidence Database scale for RCTs and the Newcastle-Ottawa scale for cohort studies.
RESULTS
Five RCTs and 2 retrospective cohort studies were included (n = 886). The results provided moderate-level evidence that pelvic floor muscle training with counseling and yoga or core exercises were beneficial for sexual function (standardized mean difference = -0.96, 95% CI = -1.22 to -0.70, I2 = 0%) and health-related quality of life (standardized mean difference = 0.63, 95% CI = 0.38 to 0.88, I2 = 0%) in survivors of cervical cancer and very low-level evidence that dilator therapy reduced vaginal complications in survivors of cervical and uterine cancer (odds ratio = 0.37, 95% CI = 0.17 to 0.80, I2 = 54%). There were insufficient data for meta-analysis of bladder or bowel function.
CONCLUSION
Conservative pelvic floor muscle interventions may be beneficial for improving sexual function and health-related quality of life in survivors of gynecological cancer. Given the levels of evidence reported in this review, further high-quality studies are needed, especially to investigate effects on bladder and bowel function.
IMPACT
This review provides moderate-level evidence for the role of pelvic floor rehabilitation to improve health outcomes in the gynecological cancer survivorship journey. Clinicians and health service providers should consider how to provide cancer survivors the opportunity to participate in supervised pelvic floor rehabilitation programs.
Topics: Adult; Aged; Aged, 80 and over; Conservative Treatment; Counseling; Dilatation; Female; Genital Neoplasms, Female; Humans; Middle Aged; Muscle Contraction; Muscle Strength; Outcome Assessment, Health Care; Pelvic Floor Disorders; Quality of Life; Randomized Controlled Trials as Topic; Retrospective Studies; Sexual Behavior; Urinary Bladder; Yoga
PubMed: 32367126
DOI: 10.1093/ptj/pzaa081 -
Journal of Hypertension Oct 2023Dilation of the proximal aorta is a common clinical manifestation in hypertensive patients. Although it is straightforward to link hypertension with proximal aortic... (Review)
Review
Dilation of the proximal aorta is a common clinical manifestation in hypertensive patients. Although it is straightforward to link hypertension with proximal aortic dilation, previous studies on their interrelation have yielded controversial results. Cross-sectional design, methodology of blood pressure assessment, confounding factors like medications, and inconsistent reference values may lead to the paradoxical conclusions. Recently, advances have been made in the exploration of determinants and clinical value of proximal aortic dilatation. Thus, we reviewed these findings and summarized that aortic dilatation may be the consequence of hemodynamic and nonhemodynamic co-factors' combined action. Moreover, proximal aortic dilatation tends to be a predictor for aortic aneurysm dissection or rupture, hypertensive target organ damage as well as cardiovascular events. The present review contributes to a comprehensive understanding of the pathological process of proximal aortic dilatation in hypertension.
Topics: Humans; Dilatation; Cross-Sectional Studies; Aortic Diseases; Hypertension; Aorta
PubMed: 37642588
DOI: 10.1097/HJH.0000000000003518 -
Chirurgia (Bucharest, Romania : 1990) Feb 2022Achalasia is a condition that can be treated either by surgery, such as Heller myotomy associated with an antireflux procedure, or by pneumatic dilation, the choice of...
Achalasia is a condition that can be treated either by surgery, such as Heller myotomy associated with an antireflux procedure, or by pneumatic dilation, the choice of type of treatment being a widely debated topic nowadays. We selected patients with the diagnosis of achalasia, calculating the Eckardt score on admission and they were treated by pneumatic dilation, respectively by myotomy associated with fundoplication. Therapeutic success at the end of treatment was analyzed, as well as that in subsequent follow-ups. At the same time, other important aspects of the study were quality of life and complications. Forty-eight patients were included, 20 in the group of those treated by pneumatic dilation, and 28 treated by surgery. The results of the therapeutic success were to the advantage of the surgery, both after the completion of the treatment, and in the follow-ups from one year to 2 years (96.4% vs 90%, respectively 92.9% vs. 85%). The quality of life was better in patients with pneumatic dilation throughout the period. Surgical treatment of achalasia has a higher success rate than pneumatic dilation, but the latter is associated with a better quality of life.
Topics: Dilatation; Esophageal Achalasia; Fundoplication; Humans; Quality of Life; Treatment Outcome
PubMed: 35272750
DOI: 10.21614/chirurgia.2683 -
Current Opinion in Gastroenterology Jul 2020The EsoFLIP integrates impedance planimetry technology into a dilator balloon capable of dilating from diameters between 10 and 30 mm via controlled volumetric... (Review)
Review
PURPOSE OF REVIEW
The EsoFLIP integrates impedance planimetry technology into a dilator balloon capable of dilating from diameters between 10 and 30 mm via controlled volumetric distension while providing real-time visualization and objective measurement during the dilation procedure, potentially negating the need for fluoroscopy. This review aims to describe the use and application of EsoFLIP and the potential advantages this novel technology may afford.
RECENT FINDINGS
Small pilot and retrospective studies demonstrate EsoFLIP feasibility and safety, but larger studies are needed to understand its impact on clinical outcomes.
SUMMARY
EsoFLIP is an appealing new technology that offers advantages in therapeutic dilation of the lower esophageal sphincter in achalasia or of esophageal strictures because of previous surgery, gastroesophageal reflux disease, or radiation.
Topics: Dilatation; Esophageal Achalasia; Esophageal Stenosis; Humans; Retrospective Studies; Treatment Outcome
PubMed: 32398561
DOI: 10.1097/MOG.0000000000000639 -
Current Opinion in Otolaryngology &... Feb 2020Eustachian tube dilation is a controversial surgical procedure because the intended problem for which it is meant to address, obstructive Eustachian tube dysfunction, is... (Review)
Review
PURPOSE OF REVIEW
Eustachian tube dilation is a controversial surgical procedure because the intended problem for which it is meant to address, obstructive Eustachian tube dysfunction, is a clinical diagnosis without a reliable diagnostic tool to test.In the past 10 years, balloon dilation Eustachian tuboplasty (BDET) has been the most commonly performed Eustachian tube dilation procedure. The present review seeks to identify the patients who may benefit from this procedure and thus propose the indications.
RECENT FINDINGS
Two randomized controlled trials for BDET published in the past 2 years showed statistically significant improvement in terms of symptomatic relief based on the ETDQ-7 scores and conversion of abnormal tympanograms (type B and type C) to normal tympanograms (type A).
SUMMARY
Based on the review of the evidence available so far, the proposed indication for Eustachian tube dilation using BDET is for a patient with ALL of the following: aural fullness greater than 12 weeks; type B or C tympanogram; ETDQ-7 mean score more than 2; and failed medical management including Valsalva maneuver and either 4 weeks of nasal steroids or 1 week of oral steroids.
Topics: Dilatation; Ear Diseases; Eustachian Tube; Humans; Middle Ear Ventilation; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31789929
DOI: 10.1097/MOO.0000000000000601 -
The Laryngoscope Nov 2021To better assess rates of postoperative complications and mortality following esophageal dilation, and to identify factors associated with adverse outcomes. (Observational Study)
Observational Study
OBJECTIVES/HYPOTHESIS
To better assess rates of postoperative complications and mortality following esophageal dilation, and to identify factors associated with adverse outcomes.
STUDY DESIGN
Observational, retrospective cohort study.
METHODS
We queried a national database of insurance claims for Current Procedural Terminology (CPT) codes representing esophageal dilation performed between 2011 and 2017. Patients aged 18 to 100 who were continuously enrolled with their insurance provider were included. Demographic information, additional CPT codes, concomitant diagnoses, and anticoagulant medication data were collected for all patients included. Postoperative mortality was assessed and International Classification of Diseases (ICD)9/10 codes for complications, including esophageal perforation, hemorrhage, mediastinitis, and sepsis were flagged.
RESULTS
We identified 202,965 encounters for esophageal dilation. Of these procedures, 193 were performed on a patient who underwent percutaneous endoscopic gastrostomy (PEG) during the study period and was analyzed separately. Another 244 dilations were excluded due to repeat entries. Of the remaining 202,528 procedures remaining, 42,310 were repeat dilations in the same patient. Data analysis was confined to each patient's initial dilation. 160,218 initial dilations remained. Of these, 62,107 were performed on male patients and 98,111 were performed on female patients. The average age was 57.7 years. There were 12 mortalities within 30 days postoperatively, representing 0.0075% of all dilations. Esophageal perforation and esophageal hemorrhage were the most common reported complications, with 139 and 110 occurrences, respectively. The overall per-dilation complication rate was 0.215%.
CONCLUSIONS
Evidence from a national insurance claim database suggests that esophageal dilation is a safe procedure with a low rate of serious complications and a 30-day all-cause mortality rate of less than 1 per 10,000 dilations.
LEVEL OF EVIDENCE
4 Laryngoscope, 131:2436-2440, 2021.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Case-Control Studies; Current Procedural Terminology; Databases, Factual; Deglutition Disorders; Dilatation; Esophageal Diseases; Esophageal Perforation; Esophagus; Female; Gastrostomy; Hemorrhage; Humans; International Classification of Diseases; Male; Mediastinitis; Middle Aged; Postoperative Complications; Retrospective Studies; Sepsis
PubMed: 33305828
DOI: 10.1002/lary.29322 -
Esophagus : Official Journal of the... Oct 2020Corrosive (caustic) material ingestion remains a major health issue, particularly in developing countries. The management strategy after corrosive ingestion should be... (Review)
Review
Corrosive (caustic) material ingestion remains a major health issue, particularly in developing countries. The management strategy after corrosive ingestion should be planned according to the signs and symptoms. The management of corrosive ingestion based on endoscopic grading, nothing by mouth, and barium studies should be abandoned. With the new management protocol, esophageal stricture can be predicted with high accuracy using the simple new prognostic DROOL score (≤ 4) rather than endoscopic grading, reduced by immediate oral feeding as soon as the patient can swallow saliva instead of nothing by mouth, diagnosed earlier (10-14 days) by fluoro-endoscopic balloon-assisted esophageal examination for patients with persistent dysphagia instead of relying on a barium study (≥ 21 days), and adequately treated by initiating balloon dilation earlier during the same anesthesia procedure. Fluoroscopically guided balloon dilatation with large balloons (18-20 mm) seems to be safe, with a low frequency of complications and a high success rate. If dilatation fails after a few months, esophagectomy and replacement surgery using the stomach should be considered. The increased risk of developing esophageal carcinoma after ingestion of corrosive substances should be kept in mind.
Topics: Adolescent; Caustics; Child; Child, Preschool; Deglutition Disorders; Dilatation; Eating; Endoscopy, Digestive System; Esophageal Neoplasms; Esophageal Stenosis; Esophagectomy; Female; Fluoroscopy; Humans; Infant; Male; Patient Care Management; Prognosis; Research Design
PubMed: 32372308
DOI: 10.1007/s10388-020-00745-6 -
Sexual Medicine Reviews Apr 2021Vaginal dilators are often prescribed to facilitate an adaptive brain-body connection to decrease anxiety and pain that can be experienced in anticipation of sexual... (Review)
Review
INTRODUCTION
Vaginal dilators are often prescribed to facilitate an adaptive brain-body connection to decrease anxiety and pain that can be experienced in anticipation of sexual intercourse among populations of women with sexual pain syndromes. Postmenopausal women, cancer survivors, and women with a wide variety of pelvic floor disorders who experience genito-pelvic pain/penetration disorder (GPPPD) are often advised to incorporate vaginal dilators into their pelvic floor rehabilitation program and treatment regimens to enable penetrative intercourse with less pain. However, little is known about the behaviors of dilator users, what treatment protocols are most effective, how patients are currently using their dilators, and how effective are clinicians in helping their patients achieve success with their dilation therapy.
METHODS
A recent PubMed literature search was performed using the key words vaginal dilator, vaginal dilator therapy, sexual quality of life, vaginal stenosis, vaginal dilation, vaginismus. A total of 29 English articles were reviewed and summarized. Articles were excluded for the following reasons: not in English and unrelated to dilator therapy.
MAIN OUTCOME MEASURE
This article will summarize the current research on vaginal dilators and discuss needs for future research to maximize patients' compliance and success with this treatment. Much of the summary data regarding user behavior will come from the early survey data with Milli, a novel, patient-controlled electronic dilator that slowly expands 1 mm at a time from its smallest diameter, 15 mm to a maximum diameter of 40 mm. Milli is currently being used by more than 1,000 women, and 3-month follow-up data were recorded on 335 of those patients.
RESULTS
Dilators exist in multiple forms (plastic, latex, and medical grade material), may come individually or in sets, and many have special features such as vibration or the ability to be heated or cooled before use. Little is known about patients' use of dilators and the Milli's 3-month survey serves as an insight to patient dilator behavior. The most common medical goals for patients undergoing dilation treatment were return to penetrative intercourse and pain reduction during coitus. Patients were dilated on average 2.72 days/week; 56.8% of patients had suffered from sexual pain for 2 or more years and 36.3% had previously used static dilators. More than 70% of Milli users purchased Milli and are using Milli without the direct guidance of a clinician. The most common emotions patients used to describe their treatment were not only "anxious," "frustrated," but also "empowered" and "optimistic." The most common dilatory session duration was 6-10 minutes, mostly in the evening/bedtime (68.3%), located in the bedroom (96.8%). Adjunctive treatment included the following: vaginal moisturizers, local estrogen products, coital lubricants, and genital pelvic floor physical therapy. During the dilation sessions, women most often watched TV/videos, practiced mindfulness, or listened to soothing music. Factors that showed trends toward improved patient outcomes were length of dilation treatment (greater than 3 months) and use of meditation and soothing music. Factors not associated with improvement trends were as follows: when/where patients dilated and patient demographics including age, race, or religious preferences.
CONCLUSION
Patients who purchase dilators have often suffered with their condition for a long time and had difficulty finding a competent health-care clinician well versed in sexual pain syndromes that can help them. When patients did find a clinician, there were no clinically proven standardized protocols or formalized guidelines to give to patients about how to best use their dilators. Larger long-term interventions investigating a standardized dilation protocol are planned in future studies to better elucidate the effective and optimal dilation treatment plans. Liu M, Juravic M, Mazza G, et al. Vaginal Dilators: Issues and Answers. Sex Med Rev 2021;9:212-220.
Topics: Constriction, Pathologic; Dilatation; Female; Humans; Quality of Life; Vagina; Vaginismus
PubMed: 32014450
DOI: 10.1016/j.sxmr.2019.11.005