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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 -
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 -
Best Practice & Research. Clinical... Oct 2015Tissue remodeling with scaring is common in adult EoE patients with long standing disease. This is the major factor contributing to their complaints of solid food... (Review)
Review
Tissue remodeling with scaring is common in adult EoE patients with long standing disease. This is the major factor contributing to their complaints of solid food dysphagia and recurrent food impactions. The best tests to define the degree of remodeling are barium esophagram, high resolution manometry and endoscopy. Many physicians are fearful to dilate EoE patients because of concerns about mucosal tears and perforations. However, multiple recent case series attest to the safety of esophageal dilation and its efficacy with many patients having symptom relief for an average of two years. This chapter will review the sordid history of esophageal dilation in EoE patients and outline how to perform this procedure safely. The key is graduated dilation over one to several sessions to a diameter of 15-18 mm. Postprocedural pain is to be expected and mucosal tears are a sign of successful dilation, not complications. In some healthy adults, occasional dilation may be preferred to regular use of medications or restricted diets. This approach is now supported by recent EoE consensus statements and societal guidelines.
Topics: Airway Remodeling; Dilatation; Eosinophilic Esophagitis; Esophagoscopy; Esophagus; Humans
PubMed: 26552780
DOI: 10.1016/j.bpg.2015.06.015 -
Gastrointestinal Endoscopy Clinics of... Apr 2015Colonic strictures, both benign and malignant, are commonly encountered in clinical practice. Benign strictures are most commonly treated by balloon dilation and less... (Review)
Review
Colonic strictures, both benign and malignant, are commonly encountered in clinical practice. Benign strictures are most commonly treated by balloon dilation and less frequently with stents. Balloon dilation can help forestall or obviate surgery in some patients. Colonic strictures of malignant etiology generally need to be managed by stents and/or surgery. This article reviews endoscopic approaches to the management of colonic strictures.
Topics: Colon; Colonic Diseases; Colonoscopy; Constriction, Pathologic; Dilatation; Humans; Intestinal Obstruction; Stents; Treatment Outcome
PubMed: 25839690
DOI: 10.1016/j.giec.2014.11.001 -
Gastrointestinal Endoscopy Clinics of... Jan 2018In eosinophilic esophagitis, the main cause of solid-food dysphagia is tissue remodeling resulting in strictures and narrowed esophagus. Endoscopy and biopsies help to... (Review)
Review
In eosinophilic esophagitis, the main cause of solid-food dysphagia is tissue remodeling resulting in strictures and narrowed esophagus. Endoscopy and biopsies help to identify the degree of inflammation but often miss the fibrosis. Although initially considered dangerous, esophageal dilation has evolved into an extremely effective and safe treatment in fibrostenotic disease. The key is starting low with small-diameter bougies or balloons, and gradually dilating the esophagus and strictures to 16 to 18 mm. Results in more than 1000 adults and children have shown low rates of complications, especially perforations, and no deaths, but postprocedure chest pain is common.
Topics: Chest Pain; Deglutition Disorders; Dilatation; Endoscopy, Gastrointestinal; Eosinophilic Esophagitis; Esophageal Stenosis; Esophagus; Fibrosis; Humans; Manometry; Practice Guidelines as Topic
PubMed: 29129303
DOI: 10.1016/j.giec.2017.07.009 -
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 -
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