Nonsurgical Treatment Options Research Articles

Surgical Management of Massive Irreparable Cuff Tears/Management of Rotator Cuff Disease: Interpositional Graft for Irreparable Posterosuperior Rotator Cuff Tears.

Increasingly, massive irreparable rotator cuff tears present a treatment challenge due to their high re-tear rates. The reparability of such tears depends on factors like tear size, the number of involved tendons, tendon retraction extent, muscular atrophy, fatty infiltration, and the presence or absence of arthritis. There are non-surgical and several surgical treatment options described each with their specific indications, contraindications, pros, and cons. Bridging reconstruction restores the superior rotator cuff tissue and arrests humeral head superior migration. The purpose of his review is to explore the existing literature on interpositional graft mechanics, indications, surgical technique, and clinical outcomes. It aims to understand how these parameters can facilitate the incorporation of bridging reconstruction using interpositional grafts into a surgeon's practice for managing massive irreparable rotator cuff tears. Interpositional grafts for irreparable massive rotator cuff tears can either be auto-, allo-, xenografts, or synthetic material and are best suited for patients who are relatively younger, no glenohumeral arthritis, and minimal to no fatty infiltration and muscle atrophy. Short to medium term outcome studies available report good functional, clinical, and radiological improvements with bridging reconstruction utilizing acellular dermal matrix allograft. Interpositional grafts for management of irreparable posterosuperior cuff tears provides improved clinical and radiological outcomes with minimal complications and thus a viable and valuable surgical technique for a shoulder surgeon's armamentarium.

Inguinal lymphangioma in an adult patient mimicking an irreducible inguinal hernia: A case report

IntroductionLymphangiomas are rare benign vascular malformations of the lymphatic system. They are usually located in the head, neck, and axilla and are typically present during the first two years of life. A few cases of inguinal lymphangioma have been reported in adults. Case presentationWe report a 35-year-old male who presented with left groin swelling for a one-year duration associated with on and off pain. On examination, he had soft, irreducible left inguinal swelling with positive cough impulse and no tenderness on palpation. Ultrasound (US) and magnetic resonance imaging (MRI) were done for him, showing a well-defined lobulated cystic lesion located between subcutaneous and deep fascia measuring around 6.5 × 4.2 × 8.1 cm with multiple internal septations. The lesion shows Low signal intensity in the T1 weighted image and high signal intensity in the T2 weighted image. 97 % alcohol was injected under US guidance and aspirated after 30 min. The swelling significantly decreased in size clinically and radiologically during the follow-up. Clinical discussionLymphangioma rarely occurs in the inguinal region, presenting a diagnostic challenge as it mimics various inguinal conditions. Differential diagnoses include inguinal hernia, hydrocele of the cord, lymphadenopathy, or hematoma. Imaging is used to determine the size, invasion, relation to surrounding structures, and extension to the abdominal cavity. MRI is the diagnostic modality of choice in non-emergency settings. Complete surgical excision is the gold standard for the management with the lowest risk of recurrence. Alternative non-surgical treatment options have been used successfully in poor surgical candidates. Different sclerosing agents have been used with low complications and rates of recurrence. Ethanol is a widely available sclerosing agent, and it was used with no recurrence or side effects during the follow-up period. ConclusionSurgeons should have a high index of suspicion when investigating any inguinal mass, considering such a rare presentation as part of the differential. Sclerotherapy is an effective treatment for lymphangioma and should be considered as an alternative modality in non-surgical candidates.

Bony Bankart Lesion: Diagnosis, Management, and Outcomes.

» Bony Bankart lesions are fractures of the anteroinferior glenoid rim, commonly associated with a traumatic anterior shoulder dislocation, and are diagnosed through radiological imaging and physical examination. Young male athletes playing contact sports are at highest risk of these injuries. Early diagnosis and treatment are crucial because, if left untreated, recurrent anterior shoulder instability and glenoid bone loss can occur. Both nonsurgical and surgical treatment options are available depending on the size of the lesion, with arthroscopic repair being the most common treatment method. After repair, patients typically have favorable outcomes with low rates of recurrent instability. This review aims to discuss the etiology, diagnosis, and treatment of bony Bankart lesions.» Bony Bankart lesions are fractures of the anteroinferior glenoid rim and occur in up to 22% of first-time anterior shoulder dislocations.» Young men involved in contact sports or combat training are at the highest risk of sustaining bony Bankart lesions.» Diagnosis and treatment of bony Bankart lesions are essential to prevent long-term shoulder instability.» Bony Bankart lesions can be treated either nonoperatively or operatively (arthroscopic vs open repair), with the size of the glenoid defect being the primary determinant of treatment.

Cervical spine injuries in elderly patients: Special considerations

High-income countries, including the United States, are confronting an evolving epidemiology of spinal trauma. This rise in geriatric spine trauma is marked by a growing occurrence of cervical spine trauma and incomplete spinal cord injuries. These trends are linked to the age-related prevalence of cervical spondylosis and higher fall risks. Cervical spine injuries in elderly patients require nuanced, patient-centered decision-making. This population is enriched for frailty, high comorbid burden, and poor bone health. This review discusses prevalent injury patterns in this group, evaluates surgical and non-surgical treatment options, and explores unique challenges in managing spine trauma among elderly patients.

Strategies for Treating Traumatic Neuromas with Tissue-Engineered Materials.

Neuroma, a pathological response to peripheral nerve injury, refers to the abnormal growth of nerve tissue characterized by disorganized axonal proliferation. Commonly occurring after nerve injuries, surgeries, or amputations, this condition leads to the formation of painful nodular structures. Traditional treatment options include surgical excision and pharmacological management, aiming to alleviate symptoms. However, these approaches often offer temporary relief without addressing the underlying regenerative challenges, necessitating the exploration of advanced strategies such as tissue-engineered materials for more comprehensive and effective solutions. In this study, we discussed the etiology, molecular mechanisms, and histological morphology of traumatic neuromas after peripheral nerve injury. Subsequently, we summarized and analyzed current nonsurgical and surgical treatment options, along with their advantages and disadvantages. Additionally, we emphasized recent advancements in treating traumatic neuromas with tissue-engineered material strategies. By integrating biomaterials, growth factors, cell-based approaches, and electrical stimulation, tissue engineering offers a comprehensive solution surpassing mere symptomatic relief, striving for the structural and functional restoration of damaged nerves. In conclusion, the utilization of tissue-engineered materials has the potential to significantly reduce the risk of neuroma recurrence after surgical treatment.

Advancements in de Quervain Tenosynovitis Management: A Comprehensive Network Meta-Analysis

This study presents a network meta-analysis aimed at evaluating nonsurgical treatment modalities for de Quervain tenosynovitis. The primary objective was to assess the comparative effectiveness of nonsurgical treatment options. The systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Searches were performed in multiple databases, and studies meeting predefined criteria were included. Data extraction, risk of bias assessment, and statistical analysis were carried out to compare treatment modalities. The analysis was categorized into short-term (within six weeks), medium-term (six weeks up to six months), and long-term (one year) follow-up. The analysis included 14 randomized controlled trials encompassing various treatment modalities for de Quervain tenosynovitis. In the short-term, extracorporeal shockwave therapy demonstrated statistically significant improvement in visual analog scale pain scores compared with placebo. Extracorporeal shockwave therapy also ranked highest in the treatment options based on its treatment effects. Corticosteroid injections (CSIs) combined with casting and laser therapy with orthosis showed favorable outcomes. Corticosteroid injection alone, platelet-rich plasma injections alone, acupuncture, and orthosis alone did not significantly differ from placebo in visual analog scale pain score. In the medium-term, extracorporeal shockwave therapy remained the top-ranking option for visual analog scale pain score, followed by CSI with casting. In the long-term (one year), CSI alone and platelet-rich plasma injections demonstrated sustained pain relief. Combining CSI with orthosis also appeared promising when compared with CSI alone. Corticosteroid injection with a short duration of immobilization remains the primary and effective treatment for de Quervain tenosynovitis. Extracorporeal shockwave therapy can be considered a secondary option. Alternative treatment modalities, such as isolated therapeutic injection, should be approached with caution because they did not show substantial benefits over placebo. Therapeutic I.

Adipose Derived Stem Cells in Orthopaedics: History and Current Applications

Context: Some studies have shown promising results with adipose-derived stem cell treatments for orthopaedic problems as a nonsurgical treatment option or an augmentation of surgical treatment. Purpose: Review of the history and background, preparation methods, and current applications of adipose-derived stem cells in orthopedics. Provide critical appraisal of the available evidence for the use of Adipose Derived Stem Cells. Results: Most of the studies utilizing adipose-derived stem cells are case series or meta-analyses with a small number of studies, therefore presenting a risk of selection bias. In cases of femoral head avascular necrosis and meniscal repair, no systematic review or meta-analysis has been published and available evidence is derived from smaller studies. Almost every review article concluded that large, multicenter, randomized control trials are needed to establish the value of adipose-derived stem cells in orthopaedics. Conclusion: There is a need in orthopaedics for treatment modalities that increase biological healing potential for some pathologies and adipose derived stem cells represent a potential modality for such a purpose. However, there is a lack of high quality and robust evidence regarding the efficacy and safety of this treatment modality in orthopaedic applications. The use of adipose derived stem cells in orthopaedics requires additional studies of higher quality before they can be considered an appropriate treatment option. Strength of Recommendation: Level C for use of Adipose-derived stem cells in orthopaedics.

Sex-based Differences in Patient Perspectives and Experiences With Shoulder, Hip, and Knee Arthroplasty.

Sex disparities in presentation of osteoarthritis and utilization of joint replacement surgery (JRS) have been demonstrated. The role of patients' unique perspectives on JRS on their treatment decisions is poorly understood. JRS candidates who were offered JRS but declined surgical treatment completed this survey. Survey questions included demographic information, patient experiences and current opinions around JRS, patient experiences with providers, goals and concerns, and barriers to JRS. More women experience barriers to undergoing JRS compared with men (53% versus 16%; P = 0.014). While both men and women indicated pain relief as their primary goal for treatment, women were significantly more likely to prioritize regaining the ability to complete daily tasks and responsibilities when compared with men (P = 0.007). Both men and women indicated that low symptom severity and nonsurgical treatment options were the reasons for not undergoing JRS (P = 0.455). Compared with men, women trended toward feeling that they were not sufficiently educated about JRS (P = 0.051). Women have unique perspectives and goals for JRS that may pose sex-specific barriers to care. A better understanding of how patients' gendered experiences affect their decision making is necessary to improve treatment of osteoarthritis and decrease disparities in care.

Mind the gap: paramedian approach for coccygectomy

Background ContextCoccydynia is pain in the coccyx that typically occurs idiopathically or from trauma. Most forms are self-limiting. However, if symptoms persist, non-surgical treatment options can include offloading, NSAIDs, physical therapy, and steroid injections. If all treatment options fail, a growing body of evidence supports a coccygectomy for symptomatic relief. The standard approach for a coccygectomy involves a midline incision cephalad to the anus along the gluteal cleft. Historically, this method has had high rates of infection. PurposeTo improve healing and decrease infection rate, we propose the paramedian approach to a coccygectomy. This approach has the benefit of distancing the surgical site from the anus, diminishing the crevice effect of the incision, and increasing the dermal and subdermal thickness for improved surgical closure. Study Design/SettingWe present a case series study of 41 patients who underwent the paramedian approach coccygectomy using a 4 to 6 cm incision, approximately 0.5 to 1.5 cm lateral to the midline, for coccyx removal. These patients were evaluated postoperatively to determine infection rate and various outcome measures. Patient SampleForty-one patients suffering from refractory coccydynia had a coccygectomy via the paramedian approach between 2011 and 2022 by the senior author. Outcome MeasuresOutcome measures included self-reported measures (Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) pain scale and satisfaction with procedure), physiologic measures (presence of infection and treatment provided) and functional measures (return to vocation/avocation) MethodsData was compiled and transferred to Microsoft Excel and analyzed. Two-tailed T-tests were used to compare the patient improvement in VAS and ODI as appropriate for statistical analysis. ResultsThe patients' average age was 45.8 years. Patients' average body mass index was 27.9, with 71% of patients overweight or obese. A total of 68% of patients were female. Trauma was the most common precipitating factor (75.6%). Five patients presented with postoperative complications (12.1%), one requiring an incision and drainage, and four others were treated with antibiotics for wound erythema. Postoperative evaluations showed continual improvement, with the most significant improvement reported greater than 1-year postoperatively. The Visual Analogue Scale for pain dropped from 7.5 to 2.3 (p<.001), and the Oswestry Disability Index improved from 30.1 to 9.6 (p<.001). A total of 86.7% of patients reported either a good or excellent result. ConclusionCoccygectomies via the midline approach have a variable infection rate, likely due to proximity of the incision to the anus and due to the crevice effect of the gluteal cleft in terms of aeration. These contributing factors are overcome in the paramedian approach, making it an effective option for treating refractory coccydynia that is non-responsive to conservative management.

Endobronchial silicone spigot in prolonged air leaks: Nationwide study on outcomes and risk factors for treatment failure

BackgroundThe endobronchial silicone spigot, also known as the endobronchial Watanabe spigot, is used in bronchoscopic interventions to manage prolonged pulmonary air leakage. However, the outcomes of this procedure have not been thoroughly investigated. MethodsUsing a Japanese national inpatient database from April 2014 to March 2022, we assessed the clinical characteristics and outcomes of all eligible patients who received the endobronchial spigot. We also investigated risk factors associated with treatment failure. Treatment failure was defined as in-hospital death or the need for surgery after bronchial occlusion. ResultsWe analyzed data of 1095 patients who underwent bronchial occlusion using the endobronchial spigot. Among them, 252 patients (23.0%) died during hospitalization, and 403 patients (36.8%) experienced treatment failure. Factors associated with treatment failure included age between 85 and 94 years (odds ratio [OR] 1.83; 95% confidence intervals [CI], 1.04–3.21); male sex (OR 2.43; 95% CI, 1.44–4.11); low Barthel index score; comorbidities of interstitial pneumonia (OR 1.71; 95% CI, 1.18–2.48); antibiotics treatment (OR 1.45; 95% CI, 1.02–2.07); steroids treatment (OR 1.59; 95% CI, 1.07–2.36); and surgery prior to bronchial occlusion (OR 2.08; 95% CI, 1.29–3.35). In contrast, pleurodesis after bronchial occlusion (OR 0.49; 95% CI, 0.32–0.75), and admission to high-volume hospitals were inversely associated with treatment failure (OR 0.58; 95% CI, 0.37–0.90). ConclusionsThe endobronchial Watanabe spigot could be a nonsurgical treatment option for patients with prolonged pulmonary air leaks. Our findings will help identify patients who may benefit from such bronchial interventions.

Microscopic Electric Rotary Grinding of Plaques Combined with Graft Repair in the Management of Peyronie's Disease.

Peyronie's Disease (PD) is clinically characterized by the development of localized fibrous plaques, primarily on the tunica albuginea, especially on the dorsal area of the penis. These plaques are the hallmark feature of this condition, resulting in penile curvature, deformity, and painful erections for affected individuals. Although various nonsurgical treatment options exist, their overall effectiveness is limited. As a result, surgical intervention has become the ultimate choice for patients with severe penile curvature deformities and associated erectile dysfunction. Our research team has successfully employed a combined approach involving microscopic electric rotary grinding of the fibrous plaques and the use of tunica vaginalis or bovine pericardium as graft materials for the repairing of the defects of tunica albuginea in the treatment of PD. This approach has consistently yielded highly satisfactory results regarding the restoration of penile shape, with excellent cosmetic results and significantly improved sexual satisfaction. This protocol aims to present a comprehensive surgical management strategy utilizing electric rotary grinding of the plaques and repairing the defects of tunica albuginea by using the tunica vaginalis, which represents an optimal surgical strategy for treating PD.

Cell-Based Therapies for Rotator Cuff Injuries: An Updated Review of the Literature.

This review focuses on non-surgical treatment options for rotator cuff injuries and highlights the potential of mesenchymal stem cells (MSCs) as a potential regenerative approach. MSCs, sourced from various tissues like bone marrow and adipose tissue, exhibit promising mechanisms in vitro, influencing tendon-related gene expression and microenvironment modulation. Animal studies support this, showcasing MSCs' ability to reduce inflammation, improve tissue remodeling, and enhance repaired tendon strength. Human trials, while varied and limited, suggest that MSCs might lower retear rates and enhance post-repair outcomes, but randomized controlled trials yield mixed results, emphasizing the necessity for standardized investigations. Ultimately, while cell-based therapies demonstrate an excellent safety profile, more rigorous clinical trials are necessary to determine their efficacy in improving patient outcomes and achieving lasting structural changes in rotator cuff injuries.

Abstract B024: Immune exhaustion and reversal of progestin-related immune modulation in adaptive resistance to levonorgestrel intrauterine device for treatment of atypical hyperplasia and early endometrial cancer

Abstract Background: A growing proportion of women diagnosed with atypical hyperplasia (AH) and early-stage endometrioid endometrial cancer (EEC) require nonsurgical treatment options. Our previously published phase II clinical trial of the levonorgestrel intrauterine device (LIUD) for AH and grade 1 EEC (G1EEC) demonstrated 83% response rate at 1 year; however, prospective long-term follow-up data and determinants for duration of response to LIUD are limited. Methods: Follow-up data from patients that participated in our prospective phase II trial of LIUD as a nonsurgical approach for AH and G1EEC were collected from medical records. Duration of response and time to relapse were evaluated. Spatial transcriptomic profiling from longitudinal biopsy samples from pre-treatment (n=5), on-treatment (n=5), and disease relapse lesions (n=3) were evaluated using digital spatial profiling (DSP, Nanostring GeoMX Whole Transcriptome Atlas). In silico cell type deconvolution was performed and pathway analyses was conducted using gene set variation analysis enrichment. Results: Of 43 participants exhibiting initial response to LIUD, 41 had follow-up data. Sixteen experienced disease relapse (39%) with a median time to relapse of 17 months after initial response. Clinical factors associated with shorter duration of response included age (HR 0.95, p=0.021), initial diagnosis of G1EEC (HR 3.51, p=0.014), premenopausal status (HR 3.85, p=0.039), and Hispanic ethnicity (HR 3.45, p=0.017). Pre-treatment IGF1 and IGF2 expression levels were positive predictors of duration of response (HR 0.44 and 0.45, respectively, p&amp;lt;0.05). DSP results revealed that LIUD increased NK cells (log2FC=46.13, FDR=0.004), and lymphocyte cytotoxicity signaling markers GZMB (log2FC=1.06, padj=0.023) and PRF1 (log2FC=1.62, padj=0.004), but NK cells were reduced in relapse lesions (log2FC=-55.96, FDR=0.02) as was PRF1 expression (log2FC=-1.87, padj=0.038). Multiple immune-related pathways (IFNα and IFNγ response, TGFβ signaling) were significantly upregulated in relapse lesions compared to matched pre-treatment lesions (FDR&amp;lt;0.05). IDO1 expression, a marker for immune exhaustion, was upregulated in relapse lesions compared to matched pre-treatment and on-treatment lesions (log2FC=2.56, FDR=0.01). Conclusions: While LIUD for treatment of AH or G1EEC has excellent initial response rates, upfront resistance, and relapse after initial response to LIUD impacts nearly half of patients. Our study shows progestin-related immunomodulatory effects, including increased NK cell infiltration and lymphocyte cytotoxicity. Immune mechanisms for relapse are implicated here, including reversal of progestin-related immunomodulatory effects (decreased NK cell infiltration and lymphocyte cytotoxicity) and increased immune exhaustion (prolonged IFNα and IFNγ response and increased IDO1 expression in relapse lesions). Thus, relieving immune exhaustion may increase durability of response to LIUD for treatment of AH or G1EEC. Citation Format: Mikayla B. Bowen, Brenda Melendez, Qian Zhang, Richard Yang, Bryan Fellman, Barrett Lawson, Naomi Adjei, Joseph Celestino, Tri Nguyen, Khalida Wani, Bhavana Singh, Christof Straub, Liang Zhang, Cheryl Tan, Felicia New, Diana Urbauer, Alexander Lazar, Karen Lu, Jennifer Wargo, Shannon N. Westin, Melinda S. Yates. Immune exhaustion and reversal of progestin-related immune modulation in adaptive resistance to levonorgestrel intrauterine device for treatment of atypical hyperplasia and early endometrial cancer [abstract]. In: Proceedings of the AACR Special Conference on Endometrial Cancer: Transforming Care through Science; 2023 Nov 16-18; Boston, Massachusetts. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(5_Suppl):Abstract nr B024.

Computer Simulation of Heat and Mass Transfer Effects on Nanofluid Flow of Blood Through an Inclined Stenosed Artery With Hall Effect

Abstract The present study deals with the analysis of heat and mass transfer for nanofluid flow of blood through an inclined stenosed artery under the influence of the Hall effect. The effects of hematocrit-dependent viscosity, Joule heating, chemical reaction and viscous dissipation are taken into account in the governing equations of the physical model. Non-dimensional differential equations are solved using the finite difference method, by taking into account the no-slip boundary condition. The effects of different thermophysical parameters on the velocity, temperature, concentration, shear stress coefficient and Nusselt and Sherwood numbers of nano-biofluids are exhaustively discussed and analysed through graphs. With an increase in stenosis height, shear stress, the Nusselt number and the Sherwood number are computed, and the impacts of each are examined for different physical parameters. To better understand the numerous phenomena that arise in the artery when nanofluid is present, the data are displayed graphically and physically described. It is observed that as the Hartman number and Hall parameter increase, the velocity drops. This is as a result of the Lorentz force that the applied magnetic field has generated. Blood flow in the arteries is resisted by the Lorentz force. This study advances the knowledge of stenosis and other defects’ non-surgical treatment options and helps reduce post-operative consequences. Moreover, ongoing research holds promise in the biomedical field, specifically in magnetic resonance angiography (MRA), an imaging method for artery examination and anomaly detection.

Use of Himplant® for correction of residual deformity following prior treatment of peyronie's disease: a case series.

Over the years, numerous non-surgical and surgical treatment options have been explored for Peyronie's disease. Current options may result in incomplete correction of the deformity, which can be bothersome to the patient. This is a two-center case series of three patients who had previously undergone treatment for Peyronie's disease. Patient 1 underwent plication with extratunical grafting. Patient 2 underwent a series of Xiaflex® injections and then subsequent surgical plication for residual curvature. Patient 3 underwent a series of Xiaflex® injections. The Himplant® subcutaneous silicone penile prosthesis was placed in a standardized manner through a scrotal incision in all cases to mask residual penile deformities and enhance penile girth after Peyronie's disease treatment. Patients were contacted and asked 18 questions regarding satisfaction and erectile function with the responses recorded. This pilot study presents findings of high patient satisfaction, increases in flaccid penile length and girth, and an acceptable profile of adverse events following Himplant® placement. Based on our limited experience, we would consider offering Himplant® implantation when residual curvature is <40° and the penile indentation does not cause instability/buckling during penetrative sexual activity. Further research and larger studies are warranted to validate these findings and assess long-term outcomes and patient-reported satisfaction.

A review of nonsurgical facial rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1% in periorbital revitalization.

The demand for nonsurgical facial rejuvenation options is growing, yet the periorbital region remains an area of relative unmet need. This review explores nonsurgical options for facial rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1%, in treating age-related blepharoptosis as part of periorbital rejuvenation. Advisors experienced in facial rejuvenation met to discuss existing literature on the upper face and periorbital rejuvenation and the role of oxymetazoline hydrochloride ophthalmic solution, 0.1%, in treating facial aging. An array of nonsurgical options exist to address the signs of aging, including minimally invasive treatments, such as botulinum toxin injections and dermal fillers, and noninvasive therapy, such as lasers, chemical peels, and microdermabrasion. However, treating age-related ptosis in periorbital rejuvenation is mainly addressed surgically. The newly approved α-adrenergic receptor agonist oxymetazoline hydrochloride ophthalmic solution, 0.1%, provides a novel non-interventional approach to blepharoptosis. Facial rejuvenation is highly sought-after in this post-pandemic era. Each nonsurgical treatment option has its advantages and drawbacks. A patient-centered approach is necessary to select the appropriate procedure considering the patient's concerns and aesthetic sensibilities. The eyes are an area of primary concern for patients, yet surgery is the gold standard for treating ptosis. Oxymetazoline hydrochloride ophthalmic solution, 0.1%, is a safe and effective nonsurgical treatment for blepharoptosis.

(401) Treatment Utilization and Temporal Trends in Peyronie’s Disease: A Retrospective Analysis of an Insurance Claims Database

Abstract Introduction The current treatment algorithm for Peyronie’s Disease (PD) was updated in 2015 to exclude oral therapies. Non-surgical pharmacological management is now limited to intralesional therapy with Collagenase Clostridium Histolyticum (CCh), Interferon, or Verapamil. Surgical options include tunical plication, plaque incision/excision with or without grafting, and penile prosthesis surgery with or without adjunctive procedures. An understanding of trends in management of PD since the updated guidelines is limited. Objective Our objective is to assess treatment utilization and temporal trends in PD with the change in guidelines. Methods We conducted a retrospective review of men with PD using data in the IBM MarketScan insurance claims database. Patients were identified using ICD 9/10 codes and treatments were identified using J and CPT codes. Only patients aged ≥18 years with at least 1 year before and after a PD diagnosis were included in the analysis. Descriptive statistics were used to describe non-surgical and surgical treatment groups. Linear regressions were also performed to assess the trends of each year based on initial PD treatment. Results Between 2011-2019, we identified a total of 45,114 patients with a diagnosis of PD. Overall, while the majority (91.9%) chose conservative management with no intervention, 1,041 (2.3%) pursued intralesional therapy and 2,594 (5.8%) pursued surgical intervention as an initial treatment option. Among the patients who initially opted for intralesional therapy, 67 (6.4%) sought subsequent surgical treatment whereas 974 (93.6%) did not pursue additional treatment. In comparison, 116 (4.5%) patients who initially underwent surgical intervention sought subsequent treatment with the remaining 2,478 (95.5%) not pursuing additional treatment. Annual overall treatment rates increased from 7.2% to 8.1%. There was a statistically significant increase in the utilization of intralesional therapies from 0.3% in 2011 to 4.1% in 2019 (p=0). Surgical interventions significantly declined from 6.8% to 3.9% over the same time period (p=0.004). Conclusions The present study demonstrates that PD treatment trends have changed over time. With overall low secondary treatment rates for patients initially pursuing either non-surgical or surgical treatment options, a greater proportion of patients are initially pursuing less invasive, non-surgical treatment options with intralesional therapy over time. These findings emphasize the dynamic nature of treatment decisions and contribute to a deeper understanding of the treatment landscape that can be incorporated into patient counseling. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Paterna bio, Firmtech, Turtle health, Maximus, Carrot, Contraline, endo pharmaceuticals, inherent biosciences, techfields inc, macro trials, alto neurosciences, curebase, vivify medical.

(244) Participants with Penile Pain at Baseline May Benefit from Collagenase Clostridium Histolyticum Treatment: A Post Hoc Analysis

Abstract Introduction Peyronie’s disease (PD) is traditionally categorized into 2 phases: acute (active) and chronic (stable) phase; however, clinical definitions and distinction between the phases vary in the literature and remain blurred.[1] The American Urological Association guidelines outline changing symptoms with the presence of pain as a defining symptom of acute disease, but provide little guidance about timeframe.[2] Historically, acute-phase characteristics include presence of penile pain and progressing deformity (eg, worsening penile curvature), with time from symptom onset to acute phase completion being &amp;lt;3–18 months.[1] While there may be academic utility in temporally categorizing PD, it may limit or postpone the treatment options for patients suffering from the condition. Collagenase clostridium histolyticum (CCH) is an approved nonsurgical PD treatment option and several studies suggest its safety and efficacy in acute phase PD.[3-6] In light of these studies and ambiguity in dichotomizing phases, previous clinical trial data were reanalyzed to investigate the potential for opening the gamut of treatment options at earlier timepoints in the disease process. Objective This analysis examines CCH treatment efficacy on improving penile curvature in participants presenting with/without penile pain at baseline and disease duration of 12–18 months or &amp;gt;18 months from the CCH clinical trial program. Methods Literature related to CCH treatment of acute phase PD was compiled and treatment outcomes assessed. Additionally, a post hoc analysis of pooled data from two phase 3 randomized, double-blind trials of CCH in PD (IMPRESS I, NCT01221597; IMPRESS II, NCT01221623) was conducted. CCH-treated participants were stratified by the reporting of moderate-severe pain or no pain at baseline based on the following study measures: penile pain on palpation, penile pain on erection, PD questionnaire (PDQ) combined questions 7–9, and PDQ question 10 only. Additional subgroup analyses stratified participants by presence of pain and disease duration (12–18 or &amp;gt;18 months). The primary efficacy endpoint was the percentage change in penile curvature at week 52 from baseline. Results The IMPRESS I/II data analysis found that participants who experienced moderate-severe pain at baseline had penile curvature improvements by week 52 similar to participants with no pain at baseline. Across all pain measures, the percentage decreases in mean penile curvature from baseline ranged from 29%–42% for moderate-severe pain groups and 35%–37% for no penile pain groups. There were no clear differences in mean penile curvature improvement between groups for any specific pain measure when stratified by disease duration of 12–18 months (moderate-severe pain, 32%–40% improvement; no pain, 23%–29% improvement) versus &amp;gt;18 months (moderate-severe pain, 24%–44% improvement; no pain, 37%–40% improvement). Outcomes from the IMPRESS trials were comparable in context with published literature. Conclusions Based on a subanalysis of IMPRESS data, there were no clear differences identified in CCH treatment outcomes between participants experiencing moderate-severe pain or no pain at baseline regardless of disease duration (12–18 versus &amp;gt;18 months). These analyses are consistent with other literature evaluating the efficacy of CCH in the acute phase of disease and suggest that ongoing pain is not a contraindication to CCH therapy. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals Inc; Boston Scientific Corporation; Antares Pharma, Inc; PathRight Medical.

Development of a long term, ex vivo, patient-derived explant model of endometrial cancer.

Incidence of endometrial cancer (EC) is rising in the developed world. The current standard of care, hysterectomy, is often infeasible for younger patients and those with high body mass index. There are limited non-surgical treatment options and a lack of biologically relevant research models to investigate novel alternatives to surgery for EC. The aim of the present study was to develop a long-term, patient-derived explant (PDE) model of early-stage EC and demonstrate its use for investigating predictive biomarkers for a current non-surgical treatment option, the levonorgestrel intra-uterine system (LNG-IUS). Fresh tumour specimens were obtained from patients with early-stage endometrioid EC. Tumours were cut into explants, cultured on media-soaked gelatin sponges for up to 21 days and treated with LNG. Formalin-fixed, paraffin embedded (FFPE) blocks were generated for each explant after 21 days in culture. Tumour architecture and integrity were assessed by haematoxylin and eosin (H&E) and immunohistochemistry (IHC). IHC was additionally performed for the expression of five candidate biomarkers of LNG resistance. The developed ex vivo PDE model is capable of culturing explants from early-stage EC tumours long-term (21 Days). This model can complement existing models and may serve as a tool to validate results obtained in higher-throughput in vitro studies. Our study provides the foundation to validate the extent to which EC PDEs reflect patient response in future research.

Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) – protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

IntroductionUterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications...