Clinical outcomes of drug-coated balloons dilatation for benign esophageal stricture.

BACKGROUND: Drug-coated balloons (DCBs) angioplasty is safe and effective for coronary artery disease. However, DCBs dilatation for the treatment of benign esophageal strictures is rarely reported. PURPOSE: We aimed to report the clinical outcomes of DCBs dilatation for patients with benign esophageal strictures. METHODS: From May 2020 to August 2023, 18 patients underwent DCBs dilatation for benign esophageal strictures. Baseline demographics were recorded and evaluated, including gender, age, comorbidities, stricture diameter and length, dilatation session, complications. RESULTS: A total of 24 dilatation sessions of DCBs were performed, with a mean of 1.3 ± 0.6 sessions per patients (range 1.0-5.0). Dysphagia score decreased significantly after DCBs dilatation (2.6 ± 1.1 vs. 0.9 ± 1.3, p = 0.0002). Both stricture diameter and stricture index decreased significantly after DCBs dilatation (p < 0.0001). No procedure-related death, massive bleeding or esophageal perforation was observed during or after DCBs dilatation. Minor complications were found in only 3 patients (16.7%). All 18 patients were successfully followed up for a median period of 12.0 months. By the end of follow up, 10 patients showed no dysphagia, 6 patients showed mild dysphagia and 2 patients showed no improvement in dysphagia. The clinical success rate of DCBs dilatation is 88.9%. CONCLUSION: DCBs dilatation may be a safe, effective and feasible treatment for benign esophageal strictures, and can be utilized as an alternative option after standard dilatation has failed. Prospective studies with large samples are needed to further validate its clinical efficacy.

Treatment methods for oesophageal strictures in paediatric patients with epidermolysis bullosa: a systematic review.

BACKGROUND: Epidermolysis bullosa (EB) is a collection of rare, inherited disorders that require treatment in specialised centres by multidisciplinary teams knowledgeable about the unique features and challenges of EB manifestations and complications.A major gastrointestinal complication in patients with EB is oesophageal strictures. Effective management of oesophageal strictures can significantly improve patients' quality of life. This study systematically reviews the current literature on treatment options for oesophageal strictures in paediatric patients with EB. METHODS: In September 2023, we conducted a systematic search for articles on the treatment of oesophageal stricture in patients with EB. We searched PubMed, Scopus, Embase and Ovid database without language or publication date restrictions. We screened 1042 articles, 15 of them were included in the current review. We extracted the following data from these studies: patient demographics, stricture characteristics, procedural details, clinical outcomes, complications and recurrences. RESULTS: Overall, in the reviewed papers, strictures were located mostly in cervical oesophagus followed by thoracic lesions. Moreover, in most of the cases only a single stricture was reported, but multiple strictures were not uncommon. Stricture treatment approaches included medical management, bougienage, as well as fluoroscopic and endoscopic balloon dilation or a combination of these methods. In most studies, fluoroscopic dilation was used as the primary treatment method in 756 procedures. They commonly used general anaesthesia for the procedure, only one study used sedation. Hospital stays were usually brief, with an average duration of 1 day, and in one study patients were discharged after just 4 hours. Most patients experienced symptom relief, could resume oral intake and gained weight soon after the procedure. However, recurrence rates had large variations from 12% to 83%. Studies reported median recurrence intervals ranging from 7 to 18 months. This review showed that complications such as perforation, fever and odynophagia were relatively uncommon, and were controlled by conservative treatment. CONCLUSIONS: Both fluoroscopic and endoscopic balloon dilation are widely used methods for the management of oesophageal strictures in patients with EB. Each technique presents its own set of advantages and potential complications. Although the current evidence is notably limited, practical clinical decision-making may favour the fluoroscopic technique over endoscopic balloon dilation due to a comparatively reduced risk of procedural trauma. To ascertain the most effective approach, high-quality randomised controlled trials are imperative to delineate the superiority of one technique over the other.

[Percutaneous transhepatic papillary balloon dilation combined with dual-frequency double-pulse laser lithotripsy for large-diameter common bile duct stones].

Objective: To evaluate the safety and efficacy of percutaneous transhepatic papillary balloon dilation (PTPBD) combined with flexible ureteroscopy-guided dual-frequency double-pulse ND:YAG (FREDDY) laser lithotripsy (PTPBD-FREDDY) for the treatment of giant (>1.5 cm diameter) common bile duct stones. Methods: A retrospective analysis was conducted on 26 patients with large-diameter difficult choledocholithiasis admitted to two medical centers from December 2017 to October 2021. Among these patients, four could not tolerate surgery or endoscopic treatment, six experienced failure of endoscopic treatment, and 16 refused to undergo endoscopic or surgical treatment. All patients underwent the PTPBD-FREDDY procedure. The FREDDY laser lithotripsy was performed under ureteroscopic guidance, followed by a balloon to push the stones into the duodenum. The primary endpoint was the technical success rate, and the secondary endpoints included the rate of stone recurrence and related complications. Results: All 26 patients successfully completed the operation, achieving a technical success rate of 100%. The average lithotripsy frequency and operation time for bilirubin stones were significantly higher than those of mixed stones and cholesterol stones (P<0.01). The main postoperative complications included mild fever (n=3), abdominal pain (n=3), nausea (n=2) and vomiting (n=1). One patient experienced biliary tract bleeding, which improved after conservative treatment. No serious complications such as pancreatitis, sepsis, or biliary perforation were observed. After 2 years of follow-up, no cases of stone recurrence were observed. Conclusions: PTPBD-FREDDY is a safe and effective treatment for patients with giant common bile duct stones. It provides a new therapeutic option for patients with giant choledocholithiasis who can not tolerate surgery or have failed endoscopic treatment, demonstrating promising prospects.

Temporal trends and treatment patterns in anal fissure management: insights from a multicenter study in Italy.

INTRODUCTION: Anal fissure (AF) poses a common challenge in clinical practice, prompting various treatment approaches. This multicenter study, conducted by the Italian Society of Colorectal Surgery, aimed to assess treatment trends in AF over a 10 year period. METHODS: A survey of proctologists and retrospective analysis of patient records were conducted to evaluate treatment modalities and outcomes across six different clinical scenarios based on AF presentation (acute/chronic) stratified by sphincter function (normal/hypertonic/hypotonic). RESULTS: Analysis of data from 17 principal investigators and 22,016 patients revealed significant variability in treatment approaches, influenced by factors such as symptom duration, anal tone, and surgeon preference. Conservative treatments were commonly utilized, while surgical interventions were reserved for refractory cases. Specifically, pharmaceutical treatment was administered to 66-75% of patients in cases of acute AF and 63-67% for chronic AF, while 10-15% underwent anal dilation, and < 2% received botulinum toxin injection. Among medical treatments, nifedipine with lidocaine and glycerin film-forming ointments were the most utilized. The most performed surgical techniques were fissurectomy and anoplasty, except for patients with chronic AF and hypertonic sphincter where sphincterotomy prevailed. Trends in treatment utilization varied depending on the clinical scenario, with notable shifts observed over time. CONCLUSIONS: This study provides insights into the evolving landscape of AF management, highlighting the need for further research to elucidate optimal treatment strategies and improve patient outcomes.

ANCA-negative granulomatosis polyangiitis: an airway emergency.

Granulomatosis polyangiitis (GPA) is an autoimmune condition causing inflammation of small blood vessels. It is a rare disorder that may affect various parts of the body. The diagnosis is often based on clinical examination, laboratory investigations and tissue biopsy. In about 10-20% of patients, the anti-neutrophilic cytoplasmic antibody (ANCA) can be negative, and histology maybe inconclusive, which can lead to diagnostic uncertainty. Failure to treat vasculitis can lead to morbidity and even mortality. We present a case report of a gentleman who was presented with an airway emergency with inflammation of the nasal cavity and subglottic involvement amounting to airway stenosis. His ANCA was negative and tissue biopsy from the subglottis was inconclusive. He underwent urgent dilatation of his airway, local therapies to the nose and was commenced on 10 cycles of cyclophosphamide. A follow-up of over 4 years has not shown any relapse of his disease clinically or biochemically. We discuss the clinical findings, diagnostic dilemma and multidisciplinary management of this life-threatening condition.

Complementary pneumatic dilations are an effective and safe treatment when laparoscopic myotomy fails: A 30-year experience at a single tertiary center.

BACKGROUND: In the last 3 decades, laparoscopic Heller myotomy (LHM) has represented the treatment of choice for esophageal achalasia, solving symptoms in most patients. Little is known about the fate of patients relapsing after LHM or their treatment. In this study, we aimed at evaluating the results of complementary pneumatic dilations (CPDs) after ineffective LHM. METHODS: We evaluated the patients who underwent LHM with Dor fundoplication (LHD) from 1992 to 2022 and were submitted to CPD for persistent or recurrent symptoms. The patients were followed clinically and with manometry, barium swallow, and endoscopy when necessary. An Eckardt score (ES) of > 3 was used as threshold for failure. RESULTS: Of 1420 patients undergoing LHD, 120 (8.4%) were considered failures and were offered CPD. Ten patients refused further treatment; in 5 CPD was not indicated for severe esophagitis; 1 patient had surgery for a misshaped fundoplication and 1 patient developed cancer 2 years after LHD; that leaves 103 patients who underwent a median 2 CPDs (IQR, 1-3), at a median of 15 (IQR, 8-36) months after surgery, with 3.0- to 4.0-cm Rigiflex dilator (Boston Scientific, Massachusetts, USA). No perforations were recorded. Only 6 patients were lost to follow-up. Thus, 97 were followed for a median of 37 months (IQR, 6-112) after the last CPD: 70 (72%) were asymptomatic, whereas 27 (28%) had significant persistent dysphagia (ES > 3). The only differences between the 2 groups were the ES after surgery (P < .01) and the number of required CPD. Overall, the combination of LHD + CPD provided a satisfactory outcome in 96.5% of the patients. CONCLUSION: CPDs represent an effective and safe option to treat patients after a failed LHD: when the postsurgery ES consistently remains high and the number of CPDs required to control symptoms exceeds 2, this may suggest the need for further invasive treatments.

Endovascular Perclose ProGlide complication puncture site, treated successful by cutting balloon dilatation: A case report and literature review.

Perclose ProGlide were created as preferred for puncture site closure of femoral artery. Femoral artery occlusion is one of the serious device-related complications. This report presents a continuous endovascular technique combined with peripheral cutting balloon (PCB) treatment for a case of a 32s woman diagnosed with lower extremity ischaemia caused by right superficial femoral artery (SFA) occlusion following the use of the Perclose ProGlide system in minimally invasive cardiac surgery. During the primary operation, limb ischaemia symptoms were relieved with vessel perfusion and reconstruction after regular balloon dilatation. A secondary operation was conducted 6 weeks later, and the obstructive lesions were recanalised without residual stenosis after PCB dilatation. No vessel-related adverse events such as dissection, rupture or distal embolisation occurred during the perioperative period. The patient recovered uneventfully after the operation, with complete alleviation of symptoms. Follow-up computed tomography angiography 3 month post-operatively revealed an undeformed shape and excellent patency of the right SFA.

Clinical study on the establishment of radio-cephalic autogenous arteriovenous fistulas in small blood vessels by multi-segment balloon dilation technique.

BACKGROUND: To investigate the effect of dilating small blood vessels using a balloon dilation (BD) technique on the occurrence of radio-cephalic autogenous arteriovenous fistulas in terms of patency, blood flow, and vein diameter (VD). METHODS: The subjects included in this study were all patients with chronic renal failure and required radio-cephalic arteriovenous fistula surgery for the first time and had not received dialysis before. Patients with VDs <2 mm were included as study subjects. They were either assigned treatment using a BD group or a control group that received hydrostatic dilation. The differences between the 2 groups were analyzed in terms of patency, blood flow, and VD. RESULTS: A total of 22 patients were enrolled in the balloon dilatation group and 20 patients in the control group. The diameters of cephalic veins (mm) of the experimental and control group were compared at various time points: immediately postoperation, 2.89 ±â€…0.42 versus 1.99 ±â€…0.28 (P < .001); 1 week later, 3.16 ±â€…0.59 versus 2.66 ±â€…0.60 (P = .022); 1 month later, 3.76 ±â€…0.91 versus 3.18 ±â€…0.83 (P = .087); and 2 months later, 4.08 ±â€…1.15 versus 3.38 ±â€…1.13 (P = .169). Brachial artery flows (mL/min) of the 2 groups at various time points were given as follows: immediately postoperation, 413.49 ±â€…145.09 versus 235.61 ±â€…87.77 (P < .001); 1 week later, 563.26 ±â€…206.83 versus 331.30 ±â€…126.78 (P < .001); 1 month later, 679.34 ±â€…218.56 versus 376.79 ±â€…156.25 (P < .001); and 2 months later, 736.31 ±â€…202.61 versus 394.60 ±â€…161.96 (P < .001). The primary patency at 1 year for the experimental group was 61.9% compared to 11.1% for the control group (P = .045). Similarly, the secondary patency rates at 1 year were 90.5% for the experimental group and 55.6% for the control group (P = .030). The results showed that the functional primary patency rate within 1 year was 57.1% versus 16.7% (P = .032), and the functional secondary patency rate within 1 year was 85.7% versus 50.0% (P = .038). CONCLUSION SUBSECTIONS: BD has obvious advantages over hydrostatic dilation for chronic renal failure patients with small veins in establishing arteriovenous fistula in terms of patency and blood flow.

Comparative analysis of surgical prognostic between HIC and NHIC patients after cystoscopy with hydrodistention.

This study aims to clarify the pathogenic mechanism of interstitial cystitis (IC), which has led to uncertainty in its diagnosis and treatment. We examined data from 18 interstitial cystitis with Hunner lesions (HIC) and 18 interstitial cystitis without Hunner lesions (NHIC) patients, including their clinical information, urodynamic test results, and maximum bladder capacity. A 1-year follow-up tracked disease progression. Postoperative recovery showed that HIC patients experienced significantly greater improvements in Visual Analog Scale pain scores compared to NHIC patients (P = .0049). This trend continued at the 6-month mark (P = .0056). Over the 1-year follow-up, NHIC patients exhibited a statistically significant improvement in Pain and Urgency/Frequency scores, while HIC patients had a gradual overall score increase from preoperative to postoperative stages. However, no significant differences were observed in either group at 1 year postoperatively compared to preoperative scores. This study revealed distinct differences between HIC and NHIC patients, including reduced bladder volumes and more severe nociceptive pain in HIC patients. Early analgesic interventions effectively alleviated discomfort in HIC patients. The combination of cystoscopic hydrodistention and water dilatation was highly effective in relieving pain symptoms in HIC patients but increased the risk of recurrence, necessitating recurrent bladder infusion and timely therapeutic adjustments. In contradiction to prior paradigms, the surgical intervention of cystoscopic water hydrodistention also yielded favorable outcomes among NHIC patients.

[Transurethral resection of the prostate versus transurethral columnar balloon dilatation of the prostate in the treatment of benign prostatic hyperplasia].

OBJECTIVE: To compare the effects of transurethral resection of the prostate (TURP) and transurethral columnar balloon dilatation of the prostate (TUCBDP) in the treatment of BPH. METHODS: This study included 218 BPH patients treated in Qinhuangdao Workers' Hospital from July 2021 to November 2022, 109 by TURP and the other 109 by TUCBDP. We followed up the patients for 12 months, observed their postoperative recovery, complications, serum pain, inflammatory index, cytokine level, urodynamic index, symptom improvement and quality of life (QOL) and compared the data obtained between the two groups of patients. RESULTS: At 12 months after surgery, the total effectiveness rate was significantly higher in the TUCBDP than in the TURP group (93.58% vs 84.40%, P< 0.05), and the postoperative recovery was better in the former than in the latter (P< 0.05). Compared with the baseline, the levels of serum prostaglandin E2 (PGE2), substance P, tumor necrosis factor-alpha (TNF-α) and high sensitive C-reactive protein (hs-CRP) were remarkably increased in both of the groups on the first day after surgery (P< 0.05), more significantly in the TURP than in the TUCBDP group (P< 0.05), while the levels of serum PSA and E2 decreased and the T level elevated in all the patients at 3 months postoperatively (P< 0.05), more significantly in the TUCBDP than in the TURP group (P< 0.05). Before and at 3 and 12 months after operation, the postvoid residual urine volume (PVR) and NIH-CPSI, IPSS and QOL scores showed a decreasing trend, while the maximum urinary flow rate (Qmax), maximum cystometric capacity (MCC) and maximum urethral closure pressure (MUCP) exhibited an increasing trend in both of the two groups, even more significantly in the TUCBDP than in the TURP group (P< 0.05). CONCLUSION: TUCBDP is advantageous over TURP in promoting postoperative recovery, improving QOL, reducing postoperative pain, inflammation and complications, regulating the levels of serum cytokines, and improving urodynamics and clinical symptoms in BPH patients. However, with the extension of postoperative time, the two strategies are basically comparable in improving the urodynamics, symptoms and QOL of the patients.

The long-term efficacy and safety of balloon dilation eustachian tuboplasty combined with tympanostomy tube insertion for patients with otitis media with effusion: study protocol for a prospective randomized controlled trial.

BACKGROUND: Otitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure. METHODS AND ANALYSIS: This is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs). DISCUSSION: This is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial's rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452 .

Unraveling the spectrum of airway complications following lung transplantation: a comprehensive overview.

PURPOSE OF REVIEW: This review delves into the intricate landscape of airway complications post lung transplantation. With the rising prevalence of end-stage lung disease and the increasing number of lung transplantation worldwide, understanding and effectively managing airway complications are crucial. Given the nuanced nature of these complications and the array of treatment options available, this review aims to provide a comprehensive overview of how to identify, classify, mitigate risk factors for, and manage these complications. RECENT FINDINGS: Several donor, recipient, and surgical risk factors are associated with the increased risk of airway complications. In managing these complications, bronchoscopic interventions, notably balloon dilation and stenting, are pivotal. Although self-expanding metallic stents offer versatility, silicone stents are preferred in certain scenarios for their durability. Emerging techniques such as biodegradable stents and advancing imaging modalities show promise in mitigating complications and improving outcomes. SUMMARY: These findings underscore the significance of a multidisciplinary approach and personalized treatment algorithms in managing airway complications post lung transplantation. By elucidating specific indications and complications of treatment modalities, this review serves as a valuable resource for optimally managing airway complications. Ongoing research into novel interventions holds promise for further enhancing outcomes in this challenging clinical setting.

A Multicenter, Single-Arm, Objective Performance Criteria-Controlled Clinical Study of the Safety and Efficacy of the Double-Lumen Eustachian Tube Balloon Catheter.

BACKGROUND: To prospectively evaluate the technical efficacy and safety of the double-lumen eustachian tube (ET) balloon catheter in patients with ET dysfunction. METHODS: Patients who were diagnosed with ET dysfunction and needed balloon eustachian tuboplasty (BET) were prospectively enrolled. A double-lumen ET balloon catheter was used to dilate the ET and inject medicine. Efficacy results were assessed by the injection channel patency (ICP) rate, the injection reached the expected site (IRES) rate, and the improvement in eustachian tube function was evaluated by the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Safety results were assessed in terms of adverse events and device defects. RESULTS: BET was successfully attempted in 87 patients from April 2022 to August 2022 at two academic medical centers in China (01, 02). The ICP rate was 100%, and the IRES rate was 88.51%. The overall ETDQ-7 score was significantly reduced ( p < 0.001) postsurgically at both centers. There were no major complications or device defects. CONCLUSION: The double-lumen ET balloon catheter is technically effective and safe for the treatment of ET dysfunction.

[Puncture dilatation tracheostomy in children during transoral neurosurgical interventions]. / Punktsionnaya dilatatsionnaya trakheostomiya u detei pri transoral'nykh neirokhirurgicheskikh vmeshatel'stvakh.

Neurosurgical interventions within the ventral surface of the clivus and upper cervical vertebrae in childhood are sometimes carried out through transoral approach. In this situation, tracheostomy is safer for airway protection and mechanical ventilation compared to prolonged intubation. The world experience of percutaneous dilation tracheostomy in pediatric patients is limited due to anatomical and physiological features, such as difficult orientation in anatomical landmarks, high mobility of the trachea and small tracheal lumen. Also, the trachea easily collapses when pressed in pediatric patients that complicates safe puncture of anterior wall and can lead to perforation of posterior tracheal wall. OBJECTIVE: To describe a modified technique of video-assisted percutaneous dilation tracheostomy using additional thin guide and dilator in children of primary school age. MATERIAL AND METHODS: We considered 11 patients aged 6-12 years who underwent video-assisted percutaneous dilation tracheostomy. RESULTS: There were no perioperative complications (bleeding, false course, perforation of posterior tracheal wall). Infection of tracheostomy, fistulas or tracheal stenosis was absent. CONCLUSION: Percutaneous dilation tracheostomy may be alternative to classical surgical tracheostomy for pediatric patients. Endoscopic control and certain technical changes of percutaneous tracheostomy are necessary and provide safe manipulation. Surgery time, less trauma and minimal cosmetic defect after tracheostomy are significant advantages of this technique compared to surgical tracheostomy.

The case for balloon eustachian tuboplasty in children.

PURPOSE OF REVIEW: Balloon dilation of the cartilaginous portion of the Eustachian tube has increasingly gained acceptance among otolaryngologists in the treatment of obstructive Eustachian tube dysfunction. There is however little data on the procedure performed in children. The purpose of this study is to review the recent developments regarding balloon dilation in pediatric patients. RECENT FINDINGS: Balloon dilation of the Eustachian tube is safe in pediatric patients. The effects of the procedure are durable during long term follow-up. Diagnosing obstructive dysfunction remains challenging. There is no single test or questionnaire for diagnosing the condition; instead a series of appropriate tests should be used. The pediatric Eustachian tube is very responsive to the effects of balloon dilation. While the treatment is effective, overtreatment can have unwanted results such as patulous symptoms. Reducing the time of dilation should therefore be considered. SUMMARY: Otolaryngologists performing the procedure should be familiar with the effects of balloon dilation on the pediatric Eustachian tube and consider altering the duration of dilation accordingly. Further studies are needed especially regarding patient selection, optimal age for dilation and balloon parameters for pediatrics (e.g. dimensions, inflation duration, inflation pressure).

Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery. METHODS: A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months. RESULTS: A total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (p = 0.040; two-tailed Fisher's test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related. CONCLUSIONS: The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.

Risk and protective factors for secondary procedures after endoscopic dilatation of primary obstructive megaureters.

PURPOSE: High-pressure balloon dilatation (HPBD) of the ureterovesical junction with double-J stenting is a minimally invasive alternative to ureteral reimplantation or cutaneous ureterostomy for first-line surgical treatment of primary obstructive megaureter (POM). The aim of our study was to identify the risk factors associated with the need for secondary procedures due to HPBD failure. METHODS: Prospective data were collected from patients who underwent HPBD for POM between 2007 and 2021 at a single institution. The collected data included patient demographics, diagnostic modalities, surgical details, results, and follow-up. Multivariate logistic regression analysis was performed. RESULTS: Fifty-five ureters underwent HPBD for POM in 50 children, with a median age of 6.4 months (IQR: 4.5-13.8). Nineteen patients (37.25%) underwent secondary ureteric reimplantation, with a median of 9.8 months after primary HBPD (95% CI 6.2-9.9). The median follow-up was 29.4 months (IQR: 17.4-71). Independent risk factors for redo-surgery in a multivariate logistic regression model were: progressive ureterohydronephrosis (OR = 7.8; 95% CI 0.77-78.6) and early removal of the double-J stent. A risk reduction of 7% (95% CI 2.2%-11.4%) was observed per extra-day of catheter maintenance. The optimal cut-off point is 55 days, ROC curve area: 0.77 (95% CI 0.62-0.92). Gender, distal ureteral diameter, pelvis diameter, dilatation balloon diameter and preoperative differential renal function did not affect the need for reimplantation. CONCLUSIONS: The use of a double-J stent for at least 55 days seems to avoid the need for a secondary procedure. Therefore, we recommend removing the double-J catheter at least 2 months after the HBPD.