Therapeutic Advances in Urology最新文献

{"title":"A multi-institutional update on surgical outcomes after penile silicone sleeve implantation","authors":"Alexandra R. Siegal, Kenan E. Celtik, Shirin Razdan, Michaela Sljivich, Bryan Kansas, Bhavik Shah, Laurence A. Levine, Robert J. Valenzuela","doi":"10.1177/17562872241241858","DOIUrl":"https://doi.org/10.1177/17562872241241858","url":null,"abstract":"Background:The increasing popularity of the silicone sleeve penile implant has been accompanied by concerns over potential risks and adverse events.Objectives:To provide multi-institutional data on safety outcomes in patients undergoing silicone sleeve penile implant surgery across high-volume implant surgeons. In addition, we discuss preventative techniques to minimize postoperative complications and the management of these events.Design and methods:We performed a retrospective analysis of men undergoing penile silicone sleeve implants between November 2020 and November 2022 with four surgeons, each from a separate institution. Perioperative and postoperative adverse events, including unsatisfactory cosmetic outcomes requiring revision, were determined by physician follow-up. Flaccid penile length and girth were measured preoperatively and postoperatively.Results:A total of 299 male patients underwent silicone sleeve implant surgery, with an average age of 42.5 ± 10.5 years and an average body mass index of 28.5 ± 4.0. The patient cohort exhibited minimal comorbidities, with 5% having hyperlipidemia, 2% being smokers, 2% having cardiovascular disease, and 1% having diabetes. Patients experienced an average increase of 4.1 ± 1.5 cm in their flaccid penile length (a 50% increase) and an average increase of 3.4 ± 1.5 cm in their flaccid girth (a 37% increase) ( p < 0.01). Complication rates included new-onset postoperative erectile dysfunction (0%), infection (1.3%), seroma (2.0%), and erosion (5.0%). The average follow-up time was 11.6 months. Notably, our rates of infection and seroma were lower than those reported in a previous single-center review, while erosion rates were higher.Conclusion:This is the largest study to characterize the safety of the penile silicone sleeve implant across multiple institutions. In men who desire cosmetic size augmentation, silicone sleeve implant surgery is associated with significantly increased flaccid penile length and girth. Complications are mainly cosmetic and may be corrected; however, patients should be appropriately counseled on the risk of erosion, which appears to be higher than previously reported.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"22 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140592561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeted augmented reality-guided transperineal prostate biopsies study: initial experience","authors":"Shenthiuiyan Theivendrampillai, Bob Yang, Mark Little, Christopher Blick","doi":"10.1177/17562872241232582","DOIUrl":"https://doi.org/10.1177/17562872241232582","url":null,"abstract":"Background:Transperineal biopsy of magnetic resonance imaging (MRI)-detected prostate lesions is now the established technique used in prostate cancer (CaP) diagnostics. Virtual Surgery Intelligence (VSI) Holomedicine by Apoqlar (Hamburg, Germany) is a mixed reality (MR)/augmented reality (AR) software platform that runs on the HoloLens II system (Microsoft, Redford, USA). Multiparametric prostate MRI images were converted into 3D holograms and added into a MR space, enabling visualization of a 3D hologram and image-assisted prostate biopsy.Objective:The Targeted Augmented Reality-GuidEd Transperineal (TARGET) study investigated the feasibility of performing AR-guided prostate biopsies in a MR framework, using the VSI platform in patients with MRI-detected prostate lesions.Methods:Ten patients with a clinical suspicion of CaP on MRI (Prostate Imaging-Reporting and Data System, PI-RADS 4/5) were uploaded to the VSI HoloLens system. Two MR/AR-guided prostate biopsies were then acquired using the PrecisionPoint Freehand transperineal biopsy system. Cognitive fusion biopsies were performed as standard of care following the MR/AR-guided prostate biopsies.Results:All 10 patients successfully underwent MR/AR-guided prostate biopsy after 3D MR images were overlaid on the patient’s body. Prostatic tissue was obtained in all MR/AR-guided specimens. Seven patients (70%) had matching histology in both the standard and MR/AR-guided biopsies. The remaining three had ISUP (International Society of Urological Pathology) Grade 2 CaP. There were no immediate complications.Conclusion:We believe this is a world first. The initial feasibility data from the TARGET study demonstrated that an MR/AR-guided prostate biopsy utilizing the VSI Holomedicine system is a viable option in CaP diagnostics. The next stage in development is to combine AR images with real-time needle insertion and to provide further data to formally appraise the sensitivity and specificity of the technique.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"35 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140071851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The incidence, pathogenesis, and management of non-clear cell renal cell carcinoma","authors":"Priyanka Naik, Harshitha Dudipala, Yu-Wei Chen, Brent Rose, Aditya Bagrodia, Rana R. McKay","doi":"10.1177/17562872241232578","DOIUrl":"https://doi.org/10.1177/17562872241232578","url":null,"abstract":"Renal cell carcinoma (RCC) is the most common type of kidney cancer and is divided into two distinct subtypes, clear cell renal cell carcinoma (ccRCC) and non-clear cell renal cell carcinoma (nccRCC). Although many treatments exist for RCC, these are largely based on clinical trials performed in ccRCC and there are limited studies on the management of nccRCC. Non-clear cell RCC consists of multiple histological subtypes: papillary, chromophobe, translocation, medullary, collecting duct, unclassified, and other rare histologies. Due to variations in pathogenesis and therapeutic response, therapy should be tailored to specific variant histologies. For patients with localized nccRCC, surgical resection remains the gold standard. In the metastatic setting, the standard of care has yet to be clearly defined, and most guidelines recommend clinical trial participation. General therapeutic options include immunotherapy, either as monotherapy or in combination, targeted therapies such as vascular endothelial growth factor tyrosine kinase inhibitors and MET inhibitors, and chemotherapy in certain subtypes. Here we present a review of the incidence and pathogenesis of the various subtypes, as well as available clinical data to support therapeutic recommendations for these subtypes. We also highlight currently available clinical trials in nccRCC and future directions in investigating novel treatment modalities tailored to patients with variant histology.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"37 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140006850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Carboplatin in metastatic castration-resistant prostate cancer patients with molecular alterations of the DNA damage repair pathway: the PRO-CARBO phase II trial.","authors":"Elodie Coquan, Nicolas Penel, Justine Lequesne, Raphaël Leman, Pernelle Lavaud, Zoé Neviere, Pierre-Emmanuel Brachet, Emeline Meriaux, Aurélien Carnot, Jérémy Boutrois, Marie Castera, Nicolas Goardon, Etienne Muller, Alexandra Leconte, Antoine Thiery-Vuillemin, Bénédicte Clarisse, Florence Joly","doi":"10.1177/17562872241229876","DOIUrl":"10.1177/17562872241229876","url":null,"abstract":"<p><strong>Introduction: </strong>DNA damage repair genes are altered in 20-35% of metastatic castration-resistant prostate cancer (mCRPC). Poly-ADP (Adénosine Diphosphate)-ribose polymerase inhibitors (PARPi) showed significant activity for these selected tumors, especially with homologous recombination repair (HRR) deficiency. These alterations could also predict platinum sensitivity. Although carboplatin was inconclusive in unselected mCRPC, the literature suggests an anti-tumoral activity in mCRPC with HHR gene alterations. We aimed to assess the efficacy of carboplatin monotherapy in mCRPC patients with HRR deficiency.</p><p><strong>Methods: </strong>This prospective multicenter single-arm two-stage phase II addressed mCRPC men with HRR somatic and/or germline alterations, pretreated with ⩾2 taxane chemotherapy regimens and one androgen receptor pathway inhibitor. Prior PARPi treatment was allowed. Enrolled patients received intravenous carboplatin (AUC5) every 21 days for 6-9 cycles. The primary endpoint was the best response rate according to adapted PCWG3 guidelines: radiological response (RECIST 1.1 criteria) and/or biological response [⩾50% prostate-specific antigen (PSA) decline].</p><p><strong>Results: </strong>A total of 15 out of 16 enrolled patients started carboplatin treatment. Genomic alterations were identified for <i>BRCA2</i> (<i>n</i> = 5), <i>CDK12</i> (<i>n</i> = 3), <i>ATM</i> (<i>n</i> = 3) <i>CHEK2</i> (<i>n</i> = 2), <i>CHEK1</i> (<i>n</i> = 1), and <i>BRCA1</i> (<i>n</i> = 1) genes. Objective response (partial biological response + stable radiological response) was achieved in one patient (6.7%), carrying a BRCA2 mutation and not pre-treated with PARPi; stable disease was observed for five patients (33.5%). Among seven patients (46.7%) with previous PARPi treatment, four patients (57.1%) had a stable disease. The median progression-free and overall survivals were 1.9 [95% confidence interval (95% CI), 1.8-9.5] and 8.6 months (95% CI, 4.3-19.5), respectively. The most common severe (grade 3-4) treatment-related toxicities were thrombocytopenia (66.7%), anemia (66.7%), and nausea (60%). Overall, 8 (53.3%) patients experienced a severe hematological event.</p><p><strong>Conclusion: </strong>The study was prematurely stopped as pre-planned considering the limited activity of carboplatin monotherapy in heavily pre-treated, HHR-deficient mCRPC patients. Larger experience is needed in mCRPC with BRCA alterations.</p><p><strong>Trial registration: </strong>NCT03652493, EudraCT ID number 2017-004764-35.</p>","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"16 ","pages":"17562872241229876"},"PeriodicalIF":2.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10903225/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139997452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formation of vesicovaginal fistula after modified McDonald cerclage placement: a case report with literature review","authors":"Deama AlGhamdi, Samera F. AlBasri","doi":"10.1177/17562872241232581","DOIUrl":"https://doi.org/10.1177/17562872241232581","url":null,"abstract":"Cervical cerclage is a common procedure employed to prevent preterm birth in women with cervical insufficiency. Complications such as injuries to the cervix and bladder, and premature membrane rupture are well-documented, while genitourinary fistulas are a rare occurrence. This article reports a rare case of vesicovaginal fistula (VVF) formation in a 27-year-old woman following the placement of a McDonald cervical cerclage. The patient presented with continuous watery vaginal leakage, which began during the last 2 months of her pregnancy. Clinical and cystoscopic examinations revealed the presence of a VVF, which was further confirmed through voiding cystourethrography and perineal magnetic resonance imaging. Notably, the patient had undergone the cerclage procedure 18 months prior to the onset of symptoms, making this case particularly unusual. We believe that the VVF formation was associated with the use of Mersilene tape, which may have slowly eroded through the cervix and subsequently breached the urothelium. This case underscores the importance of considering cerclage-related genitourinary fistulas as potential complications, especially when evaluating and counseling patients who have undergone cervical procedures like the McDonald technique. In conclusion, this case highlights the need for vigilant monitoring and a high index of suspicion in patients presenting with symptoms of genitourinary fistulas after such procedures. Further research and awareness in this area are warranted to better understand the risk factors and mechanisms underlying this unusual complication.","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"5 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139954662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is suction the future of endourology? Overview from EAU Section of Urolithiasis","authors":"Victoria Jahrreiss, Carlotta Nedbal, Daniele Castellani, Vineet Gauhar, Christian Seitz, Guohua Zeng, Patrick Juliebø-Jones, Etienne Keller, Lazaros Tzelves, Rob Geraghty, Karan Rangarajan, Olivier Traxer, Joe Philip, Andreas Skolarikos, Panagiotis Kallidonis, Ewa Bres-Niewada, Bhaskar Somani","doi":"10.1177/17562872241232275","DOIUrl":"https://doi.org/10.1177/17562872241232275","url":null,"abstract":"","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"1 3 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139954754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of prognostic group classification on prostate cancer progression in intermediate-risk patients according to the European Association of Urology system: results in 479 patients treated with robot-assisted radical prostatectomy at a single tertiary referral center.","authors":"Antonio Benito Porcaro, Alberto Bianchi, Andrea Panunzio, Sebastian Gallina, Alessandro Tafuri, Emanuele Serafin, Rossella Orlando, Giovanni Mazzucato, Stefano Vidiri, Damiano D'Aietti, Francesca Montanaro, Giulia Marafioti Patuzzo, Francesco Artoni, Alberto Baielli, Francesco Ditonno, Riccardo Rizzetto, Alessandro Veccia, Alessandra Gozzo, Vincenzo De Marco, Matteo Brunelli, Maria Angela Cerruto, Alessandro Antonelli","doi":"10.1177/17562872241229260","DOIUrl":"10.1177/17562872241229260","url":null,"abstract":"<p><strong>Background: </strong>Treatment outcomes in intermediate-risk prostate cancer (PCa) may be impaired by adverse pathology misclassification including tumor upgrading and upstaging. Clinical predictors of disease progression need to be improved in this category of patients.</p><p><strong>Objectives: </strong>To identify PCa prognostic factors to define prognostic groups in intermediate-risk patients treated with robot-assisted radical prostatectomy (RARP).</p><p><strong>Design: </strong>Data from 1143 patients undergoing RARP from January 2013 to October 2020 were collected: 901 subjects had available follow-up, of whom 479 were at intermediate risk.</p><p><strong>Methods: </strong>PCa progression was defined as biochemical recurrence and/or local recurrence and/or distant metastases. Study endpoints were evaluated by statistical methods including Cox's proportional hazards, Kaplan-Meyer survival curves, and binomial and multinomial logistic regression models.</p><p><strong>Results: </strong>After a median (interquartile range) of 35 months (15-57 months), 84 patients (17.5%) had disease progression, which was independently predicted by the percentage of biopsy-positive cores ⩾ 50% and the International Society of Urological Pathology (ISUP) grade group 3 for clinical factors and by ISUP > 2, positive surgical margins and pelvic lymph node invasion for pathological features. Patients were classified into clinical and pathological groups as favorable, unfavorable (one prognostic factor), and adverse (more than one prognostic factor). The risk of PCa progression increased with worsening prognosis through groups. A significant positive association was found between the two groups; consequently, as clinical prognosis worsened, the risk of detecting unfavorable and adverse pathological prognostic clusters increased in both unadjusted and adjusted models.</p><p><strong>Conclusion: </strong>The study identified factors predicting disease progression that allowed the computation of highly correlated prognostic groups. As the prognosis worsened, the risk of PCa progression increased. Intermediate-risk PCa needs more prognostic stratification for appropriate management.</p>","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"16 ","pages":"17562872241229260"},"PeriodicalIF":2.0,"publicationDate":"2024-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10860426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139724053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Current role of intraoperative cell salvage techniques in the management of renal tumors with level III and IV inferior vena cava thrombus extension.","authors":"Cristian Surcel, Robert Dotzauer, Cristian Mirvald, Calin Popa, Cosmin Olariu, Catalin Baston, Mihai Harza, Constantin Gangu, Igor Tsaur, Ioanel Sinescu","doi":"10.1177/17562872241229248","DOIUrl":"10.1177/17562872241229248","url":null,"abstract":"<p><strong>Background: </strong>En bloc removal of the kidney with tumor thrombus excision in a multidisciplinary team remains the standard treatment for renal cell carcinoma (RCC) with tumor thrombus extension. In order to minimize the hemodynamic impact of the surgical blood loss, intraoperative cell salvage (IOCS) techniques can decrease the need for allogeneic blood and prevent blood transfusion related complications.</p><p><strong>Objective: </strong>In this article, we evaluated the safety of IOCS during radical nephrectomy with inferior vena cava thrombectomy under cardiopulmonary bypass with or without deep hypothermic circulatory arrest.</p><p><strong>Design and method: </strong>In this retrospective comparative multicenter analysis, clinical characteristics of 27 consecutive patients who underwent surgery with or without IOCS between 2012 and 2022 in three referral care units were collected into a database. The need for an allogenic blood transfusion (ABT) was also recorded, defined as any transfusion that occurred either intraoperatively or during the hospital stay.</p><p><strong>Results: </strong>The need for ABT in the cell saver arm was significantly smaller due to the reinfusion of rescued blood (<i>p</i> < 0.015). In multivariate analysis, no cell saver usage was an independent predictor for complications ⩾3 Clavien 3a [odds ratio (OR) 18.71, 95% CI 1.056-331.703, <i>p</i> = 0.046]. No usage of IOCS was an independent predictor for a lower risk of death (OR 0.277, 95% CI 0.062-0.825, <i>p</i> = 0.024). During follow-up, patients who received salvaged blood did not experience an increased risk for developing local recurrence or distant metastases.</p><p><strong>Conclusion: </strong>Transfusion of autologous blood is safe and can be using during nephrectomy and thrombectomy for advanced RCC.</p>","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"16 ","pages":"17562872241229248"},"PeriodicalIF":2.0,"publicationDate":"2024-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139707945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oncological outcomes in robot-assisted radical prostatectomy: the value of PSA density as a preoperative predictive factor.","authors":"Roser Vives Dilme, Juan Gómez Rivas, Laura Fernández Hernández, Irene De la Parra Sánchez, Rafael Sánchez Del Hoyo, María Isabel Galante Romo, Enrique Redondo González, José Luis Senovilla Pérez, Lorena Fernández Montarroso, Jesús Moreno Sierra","doi":"10.1177/17562872241229250","DOIUrl":"10.1177/17562872241229250","url":null,"abstract":"<p><strong>Background: </strong>Pretreatment assessment of patients diagnosed with localized prostate cancer (PCa) is essential for therapeutic decision-making. Currently available staging systems based on prostate-specific antigen (PSA), Gleason score, and clinical stage allow for determining the prognostic characteristics of these patients. Several studies have evaluated the preoperative use of prostate-specific antigen density (PSAD) as a prognostic factor for further risk stratification. To date, the role of PSAD in this setting is still an object of debate.</p><p><strong>Objectives: </strong>The present analysis aimed to assess the predictive potential of PSAD for adverse oncological outcomes after robot-assisted radical prostatectomy (RARP) and to compare its accuracy to preoperative PSA (pPSA).</p><p><strong>Design and methods: </strong>We retrospectively reviewed 427 patients diagnosed with localized PCa who underwent RARP at a single institution between January 2015 and January 2020. Generating receiver operator characteristic (ROC) curves, calculating areas under the curves (AUCs), and using a linear regression model, we analyzed the association of PSAD and pPSA with postoperative positive surgical margins (PSM), Gleason score ⩾ 7, persistent PSA, and biochemical recurrence (BCR), with a median follow-up of 47 months.</p><p><strong>Results: </strong>PSAD showed a significant association with PSM (<i>p</i> < 0.0001), PSA persistence (<i>p</i> < 0.0001), and Gleason ⩾ 7 (<i>p</i> < 0.0001), without being statistically significant in predicting BCR (<i>p</i> = 0.098). The predictive value of PSAD was comparable to pPSA for outcomes of PSA persistence (AUC 0.727 <i>versus</i> 0.771) and Gleason ⩾ 7 (AUC 0.683 <i>versus</i> 0.649).</p><p><strong>Conclusion: </strong>PSAD is a predictive factor for postoperative oncological outcomes of PSM, Gleason score ⩾ 7, and persistence of PSA. Despite the need for further studies, PSAD could be useful as a prognostic parameter in conjunction with established staging systems.</p>","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"16 ","pages":"17562872241229250"},"PeriodicalIF":2.6,"publicationDate":"2024-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851720/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139707946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women.","authors":"Nissrine Nakib, Suzette Sutherland, Kevin Hallman, Marcus Mianulli, David R Boulware","doi":"10.1177/17562872241228023","DOIUrl":"10.1177/17562872241228023","url":null,"abstract":"<p><strong>Background: </strong>Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking.</p><p><strong>Objective: </strong>To assess the efficacy of mechanotherapy provided by the Flyte^® intra-vaginal device during pelvic floor muscle training (PFMT).</p><p><strong>Design: </strong>This was a randomized, controlled, double-blinded trial.</p><p><strong>Materials and methods: </strong>Flyte is a repeat use device for conditioning and strengthening the pelvic floor muscles (PFMs). It provides two-part mechanotherapy. Part 1 is the stretching and preloading of the PFM from the internal wand. Part 2 integrates mechanical pulses which elicit muscle cellular and tissue level responses that trigger cellular regeneration, improve neuromuscular facilitation and motor learning. Subjects used the device for 5 min/day for 12 weeks. Subjects (144) were randomized and evaluated at 6 and 12 weeks. Arm A (72) received both Part 1 and Part 2 mechanotherapy for 12 weeks, whereas Arm B (72) received Part 1 therapy for 6 weeks, then crossed over to full therapy. Mean age was 50, 49, respectively, prior pelvic/abdominal surgery 26%, 46%, and previous incontinence treatments 13%, 22%. The primary endpoint was 24-h pad weight (24-HR PW) at 6 weeks. Secondary endpoints were 24-HR PW at 12 weeks and QoL [International Consultation on Incontinence Questionnaire (ICIQ), Urinary Incontinence Quality of Life (IQOL)].</p><p><strong>Results: </strong>Part 1 therapy had a greater than anticipated therapeutic effect. Thus, the study was underpowered to identify differences between study arms. Therefore, data were pooled to assess the effects of mechanotherapy. Twenty four-HR PW was significantly reduced at 6 weeks (<i>p</i> = <0.0001), with further reduction from 6 to 12 weeks (<i>p</i> = <0.0001). Data were stratified based on 24-HR PW severity. Significant reductions were noted in all severity groups (mild <i>p</i> = <0.0001, moderate <i>p</i> = <0.0001, severe <i>p</i> = <0.01). QoL was similarly improved at 6 weeks (ICIQ <i>p</i> = <0.0001, IQOL <i>p</i> = <0.0001), and 12 weeks (ICIQ <i>p</i> = <0.0001, IQOL <i>p</i> = <0.0001). Compliance was >80% at 6 weeks and 70% at 12 weeks.</p><p><strong>Conclusion: </strong>Two-part mechanotherapy significantly improved 24-HR PW and QoL across all severities of SUI. Improvements were noted in as little as 2 weeks and appeared to be sustained through 2-year follow up.</p><p><strong>Trial registration: </strong>Registered on ClinTrials.gov (NCT02954042).</p>","PeriodicalId":23010,"journal":{"name":"Therapeutic Advances in Urology","volume":"16 ","pages":"17562872241228023"},"PeriodicalIF":2.0,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10848796/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139703511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}