{"title":"Efficacy and safety of Vibegron for the treatment of residual overactive bladder symptoms after laser vaporization of the prostate: A single-center prospective randomized controlled trial (VAPOR TRIAL)","authors":"Narihito Seki, Hiroyuki Masaoka, Yoohyun Song, Takashi Dejima, Yoshiaki Sato, Shotaro Maeda","doi":"10.1111/luts.12529","DOIUrl":"10.1111/luts.12529","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>This study aimed to evaluate the efficacy and safety of Vibegron for the treatment of residual overactive bladder (OAB) symptoms after laser vaporization of the prostate (photo-selective vaporization of the prostate, contact laser vaporization of the prostate, and thulium laser vaporization).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This randomized, open-label, parallel-group, single-center superiority trial with a 12-week observation (jRCTs071190040) enrolled male patients with OAB aged 40 years or older who had undergone laser vaporization of the prostate for not less than 12 weeks and not more than 1 year earlier. Patients were allocated to receive Vibegron 50 mg once daily or follow-up without treatment for 12 weeks.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Forty-seven patients were enrolled between January 2020 and March 2023. The median age (interquartile range) was 75.5 (72.5–78.5) years for the Vibegron group and 76.5 (71.0–81.0) years for the control group. The intergroup difference in the mean change (95% confidence interval) in the 24-hour urinary frequency at 12 weeks after randomization was −3.66 (−4.99, −2.33), with a significant decrease for the Vibegron group. The Overactive Bladder Symptom Score, International Prostate Symptom Score, IPSS storage score, and Overactive Bladder Questionnaire score significantly improved for the Vibegron group. Voided volume per micturition also increased for the Vibegron group.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The administration of 50 mg of Vibegron once daily for 12 weeks showed significant improvement compared with follow-up without treatment in bladder storage (OAB) symptoms after laser vaporization of the prostate for symptomatic benign prostatic hyperplasia.</p>\u0000 </section>\u0000 </div>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 4","pages":""},"PeriodicalIF":1.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141492473","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}
M. İrfan Dönmez, Ismail Selvi, Tayfun Oktar, Orhan Ziylan
{"title":"Urotherapy and biofeedback resistant dysfunctional voiding: How to deal with?","authors":"M. İrfan Dönmez, Ismail Selvi, Tayfun Oktar, Orhan Ziylan","doi":"10.1111/luts.12528","DOIUrl":"https://doi.org/10.1111/luts.12528","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To analyze the management strategies in the children who had treatment-resistant dysfunctional voiding (DV).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Among 75 children with DV who underwent pelvic floor biofeedback therapy (BF) between 2013 and 2020, 16 patients (14 girls, 87.5%) with a mean age of 9.81 ± 2.53 years that showed incomplete clinical response following urotherapy and initial BF sessions were retrospectively reviewed. The demographic and clinical characteristics, DVSS, and uroflowmetry parameters were recorded before and after the initial BF sessions. Subsequent treatments after initial BF and clinical responses of patients were noted.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Clinical success was observed in one patient by addition of an anticholinergic and in three patients with combination of salvage BF sessions and anticholinergics, whom had predominant overactive bladder (OAB) symptoms. The success rate of TENS alone and in combination with other treatment modalities was 88.8% (8/9 patients). In addition, salvage BF sessions (range 2 to 3) enabled clinical success in five (50%) of 10 cases as a combination with anticholinergics or TENS. In case of incomplete emptying without OAB, adequate clinical response to Botulinum-A was observed during an average follow-up of 29 months in two boys who did not respond to alpha-blockers, even though one required repeat injection after 10 months. The total clinical success rate was 87.5% (14/16 patients) after a median follow-up of 24 months. VV-EBC and Qmax increased by a mean of 30.89% and 7.13 mL/min, respectively, whereas DVSS decreased by a mean of 8.88 points and PVR-EBC decreased by a median of 19.04%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Our findings showed that clinical success in resistant DV was achieved by various combination treatments in the majority of children. However, a small group may still have persistent, bothersome symptoms despite multiple treatment modalities.</p>\u0000 </section>\u0000 </div>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 4","pages":""},"PeriodicalIF":1.5,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141453572","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}
Jung Hyun Shin, Ju Hyun Park, Chae-Min Ryu, Dong-Myung Shin, Myung-Soo Choo
{"title":"Stem cell therapy for interstitial cystitis/bladder pain syndrome","authors":"Jung Hyun Shin, Ju Hyun Park, Chae-Min Ryu, Dong-Myung Shin, Myung-Soo Choo","doi":"10.1111/luts.12527","DOIUrl":"10.1111/luts.12527","url":null,"abstract":"<p>Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic disease with limited treatment options. Current multidisciplinary approach targeting bladder inflammation and urothelial dysfunction has limited durable effect that major surgery is ultimately required for both Hunner and non-Hunner type IC. Various investigational attempts are underway to avoid such operations and preserve the urinary bladder. Stem cell therapy is a fascinating option for treating chronic illnesses. Stem cells can self-renew, restore damaged tissue, and have paracrine effects. The therapeutic efficacy and safety of stem cell therapy have been demonstrated in numerous preclinical models, primarily chemically induced cystitis rat models. Only one clinical trial (phase 1 study) has investigated the safety of human embryonic stem cell-derived mesenchymal stem cells in three Hunner-type IC patients. Under general anesthesia, participants underwent cystoscopic submucosal stem cell injection (2.0 × 10<sup>7</sup> stem cells/5 mL). No safety issues were reported up to 12 months of follow-up and long-term follow-up (up to 3 years). Although there were variations in therapeutic response, all patients reported significant improvement in pain at 1 month postoperatively. One patient underwent fulguration of the Hunner lesion after the trial, but others reported an overall improvement in pain. The analysis on phase 1/2a trial which had several modifications in protocol is currently ongoing. Despite several limitations that need to be overcome, stem cell therapy could be a potential therapeutic option for treating IC/BPS. Clinical outcome on phase 1/2a trial is important and might provide more insight into the clinical application of stem cell therapy for IC/BPS.</p>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 4","pages":""},"PeriodicalIF":1.3,"publicationDate":"2024-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310992","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}
Eric Wahlstedt, John Lee Graves, John Wahlstedt, Alison D'Alessandro, Will Cranford, Nicholas A. Freidberg, Amul Bhalodi, John R. Bell, Andrew James, Jason Bylund, Stephen E. Strup, Andrew Harris
{"title":"Adherence to AUA guidelines for the work-up, medical management, surgical evaluation and treatment of BPH: Work from a quality improvement collaborative","authors":"Eric Wahlstedt, John Lee Graves, John Wahlstedt, Alison D'Alessandro, Will Cranford, Nicholas A. Freidberg, Amul Bhalodi, John R. Bell, Andrew James, Jason Bylund, Stephen E. Strup, Andrew Harris","doi":"10.1111/luts.12526","DOIUrl":"10.1111/luts.12526","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Previous studies noted varied adherence to clinical practice guidelines (CPGs), but studies are yet to quantify adherence to American Urological Association BPH guidelines. We studied guideline adherence in the context of a new quality improvement collaborative (QIC).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Data were collected as part of a statewide QIC. Medical records for patients undergoing select CPT codes from January 2020 to May 2022 were retrospectively reviewed for adherence to selected BPH guidelines.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Most men were treated with transurethral resection of the prostate. Notably, 53.3% of men completed an IPSS and 52.3% had a urinalysis. 4.7% were counseled on behavioral modifications, 15.0% on medical therapy, and 100% on procedural options. For management, 79.4% were taking alpha-blockers and 59.8% were taking a 5-ARI. For evaluation, 57% had a PVR, 63.6% had prostate size measurement, 37.4% had uroflowmetry, and 12.3% were counseled about treatment failure. Postoperatively, 51.6% completed an IPSS, 57% had a PVR, 6.50% had uroflowmetry, 50.6% stopped their alpha-blocker, and 75.0% stopped their 5-ARI.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>There was adherence to preoperative testing recommendations, but patient counseling was lacking in the initial work-up and preoperative evaluation. We will convey the data to key stakeholders, expand data collection to other institutions, and devise an improvement implementation plan.</p>\u0000 </section>\u0000 </div>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 4","pages":""},"PeriodicalIF":1.3,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141300981","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":"Protective effect of equol intake on bladder dysfunction in a rat model of bladder outlet obstruction","authors":"Nozomu Miyazaki, Ryota Katsura, Chiaki Ozaki, Tatsuo Suzutani","doi":"10.1111/luts.12518","DOIUrl":"10.1111/luts.12518","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>This study evaluates the impact of equol, a metabolite of soy isoflavone, on bladder dysfunction in rats with bladder outlet obstruction (BOO). In addition, we investigate its potential as a neuroprotective agent for the obstructed bladder and discuss its applicability in managing overactive bladder (OAB).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Eighteen male Sprague–Dawley rats were divided into three groups (six rats per group) during the rearing period. The Sham and C-BOO groups received an equol-free diet, while the E-BOO group received equol supplementation (0.25 g/kg). At 8 weeks old, rats underwent BOO surgery, followed by continuous cystometry after 4 weeks of rearing. The urinary oxidative stress markers (8-hydroxy-2′-deoxyguanosine and malondialdehyde) were measured, and the bladder histology was analyzed using hematoxylin–eosin, Masson's trichrome, and immunohistochemical staining (neurofilament heavy chain for myelinated nerves, peripherin for unmyelinated nerves, and malondialdehyde).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Equol reduced BOO-induced smooth muscle layer fibrosis, significantly prolonged the micturition interval (C-BOO: 193 s, E-BOO: 438 s) and increased the micturition volume (C-BOO: 0.54 mL, E-BOO: 1.02 mL) compared to the C-BOO group. Equol inhibited the increase in urinary and bladder tissue malondialdehyde levels. While the C-BOO group exhibited reduced peripherin alone positive nerve fibers within the smooth muscle layer, equol effectively attenuated this decline.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Equol reduces lipid peroxidation and smooth muscle layer fibrosis in the bladder and exhibited neuroprotective effects on bladder nerves (peripheral nerves) and prevented the development of bladder dysfunction associated with BOO in rats. Consumption of equol is promising for the prevention of OAB associated with BOO.</p>\u0000 </section>\u0000 </div>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 3","pages":""},"PeriodicalIF":1.3,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141081934","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":"Factors associated with symptomatic urinary tract infection in persons with spinal cord lesions who perform clean intermittent catheterization with single-use catheters","authors":"Noritoshi Sekido, Ryosuke Takahashi, Fujio Matsuyama, Tatsunori Murata, Mihoko Matsuoka, Atsushi Sengoku, Masashi Nomi, Takeya Kitta, Takahiko Mitsui","doi":"10.1111/luts.12515","DOIUrl":"https://doi.org/10.1111/luts.12515","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To investigate factors associated with symptomatic urinary tract infection (sUTI) in persons with chronic spinal cord lesion (SCL) who were using single-use catheters for intermittent self-catheterization (ISC).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Among respondents to an internet survey on the burden of illness on persons with SCL who were considered to be able to perform ISC, 111 persons using single-use catheters were included to examine factors associated with self-reported sUTI by univariate as well as multivariable analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The incidence of sUTI was significantly higher in males than in females (56.9% vs. 31.6%, <i>p</i> = .011), persons with stocks of antibiotics than those without it (82.9% vs. 28.6%, <i>p</i> < .011), and persons with more frequent bleeding during catheterization than those with less frequent bleeding (100% vs. 46.5%, <i>p</i> = .036). The incidence did not significantly differ between respective groups when various variables were evaluated by other characteristics of the participants, adherence to ISC procedures, and complications. On multivariable analysis, male gender and stocks of antibiotics were significant independent factors for sUTI.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Male gender and stocks of antibiotics were associated with sUTI in persons with SCL who were performing ISC with single-use catheters.</p>\u0000 </section>\u0000 </div>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 3","pages":""},"PeriodicalIF":1.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140818924","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":"Factors related to nocturia-specific quality of life in renal transplantation patients","authors":"Nobuyuki Nakamura, Taiki Emoto, Yuichiro Fukuhara, Takeshi Miyazaki, Chikao Aoyagi, Naotaka Gunge, Yu Okabe, Hiroshi Matsuzaki, Aiko Fujikawa, Chizuru Nakagawa, Masahiro Tachibana, Fumihiro Yamasaki, Kosuke Tominaga, Kazuna Tsubouchi, Shintaro Aso, Nobuhiro Haga","doi":"10.1111/luts.12517","DOIUrl":"https://doi.org/10.1111/luts.12517","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>Patients following renal transplantation (RTX) may experience nocturia exacerbation due to polyuria and reduced bladder capacity, thereby impacting the specific quality of life (QOL) associated with nocturia. The present study aims to investigate factors associated with the deterioration of nocturia-specific QOL in RTX patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The study cohort comprised 59 consecutive patients who had undergone successful RTX. Nocturia-related QOL questionnaires (N-QOL) were employed to evaluate the specific QOL related to nocturia. The Bother/Concern and Sleep/Energy domains of the N-QOL were also assessed. The primary outcome measure was to explore factors related to the aggravation of nocturia-specific QOL in patients post-RTX.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The mean nocturia frequency post-RTX was 1.3 ± 1.0. Univariate and multivariate analyses revealed a significant reduction in the Bother/Concern domain score associated with increased nocturia (<i>p</i> = .042). Aging significantly decreased the total N-QOL score and the Sleep/Energy domain score (<i>p</i> = .001 and .0002, respectively). Prolonged duration after RTX significantly reduced the scores of both the Sleep/Energy domain and the Bother/Concern domain (<i>p</i> = .018 and .037, respectively). However, the duration of dialysis prior to RTX was not significantly associated with the total score or subdomains of N-QOL.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Nocturia-specific QOL affected not only the nocturia itself, but also aging and the prolonged duration after RTX. Thus, comprehensive approaches to the RTX patients were needed to improve the Nocturia-specific QOL in RTX patients.</p>\u0000 </section>\u0000 </div>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 3","pages":""},"PeriodicalIF":1.3,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140818923","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":"Correction to “Effects of onabotulinum toxin-A injection on sexual function in women with refractory interstitial cystitis/bladder pain syndrome: A prospective study”","authors":"","doi":"10.1111/luts.12514","DOIUrl":"https://doi.org/10.1111/luts.12514","url":null,"abstract":"<p>\u0000 <span>Karaburun, MC</span>, <span>Kubilay, E</span>, <span>Öztuna, D</span>, <span>Gökçe, Mİ</span>, <span>Süer, E</span>, <span>Gülpınar, Ö</span>. <span>Effects of onabotulinum toxin-A injection on sexual function in women with refractory interstitial cystitis/bladder pain syndrome: a prospective study</span>. <i>Lower Urinary Tract Symptoms</i>. <span>2024</span>; <span>16</span>(<span>2</span>):e12511. doi:10.1111/luts.12511\u0000 </p><p>The revised date should be 29 January 2024 instead of 17 January 2024.</p><p>We apologize for this error.</p>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 3","pages":""},"PeriodicalIF":1.3,"publicationDate":"2024-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/luts.12514","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140808151","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":"Correction to “Longitudinal deterioration in lower urinary tract symptoms after artificial urinary sphincter implantation in patients with a history of pelvic radiation therapy”","authors":"","doi":"10.1111/luts.12516","DOIUrl":"https://doi.org/10.1111/luts.12516","url":null,"abstract":"<p>\u0000 <span>Kataoka, M</span>, <span>Yokoyama, M</span>, <span>Waseda, Y</span>, et al. Longitudinal deterioration in lower urinary tract symptoms after artificial urinary sphincter implantation in patients with a history of pelvic radiation therapy. <i>Lower Urinary Tract Symptoms</i>. <span>2024</span>; <span>16</span>(<span>1</span>):e12507. doi:10.1111/luts.12507\u0000 </p><p>In the abstract section, ‘0.43/year, <i>p</i> = .006’ should read as ‘0.42/year, <i>p</i> = .018’ and the citation of ‘Figure 2’ on page 3 should be corrected to ‘Figure 1’.</p><p>We apologize for this error.</p>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 3","pages":""},"PeriodicalIF":1.3,"publicationDate":"2024-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/luts.12516","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140808150","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":"Long-term safety of desmopressin orally disintegrating tablets in men with nocturia due to nocturnal polyuria: Interim results of a specified drug use–results survey in Japan","authors":"Yoshimasa Ogawa, Shujiro Murata, Kiyotoshi Kuramoto, Atsushi Nakano","doi":"10.1111/luts.12513","DOIUrl":"https://doi.org/10.1111/luts.12513","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>This interim report presents the 12-week results of a post-marketing surveillance evaluating the safety of desmopressin orally disintegrating tablets 25 and 50 μg in Japanese men with nocturia due to nocturnal polyuria.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Of the planned study population of 1000 Japanese men receiving desmopressin for the first time for nocturia due to nocturnal polyuria, 971 cases were enrolled. In this interim analysis, 9 cases, including 6 registry violations and 3 cases of unconfirmed desmopressin dosing, were excluded from the 354 case report forms collected and fixed by the end of December 2021, and data up to 12 weeks after administration in 345 cases were defined as the safety analysis set.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The mean age was 74.5 ± 9.9 years and 88.7% of the survey participants were aged ≥65 years. Desmopressin was started at a dose of 25 μg in 153 cases (44.3%). There were 102 adverse drug reactions (ADRs) reported in 71 cases, including 6 serious ADRs in 3 cases (0.9%). The most common ADR was hyponatremia occurring in 29 cases (8.4%). Eight of the hyponatremic cases were asymptomatic. Symptoms were resolved or slightly improved within 4 weeks of onset in 13 of 29 cases of hyponatremia. In addition, hyponatremia occurred in 11 of 217 cases (5.1%), with a serum sodium level before the administration of desmopressin of ≥140 mmol/L, and in 13 of 87 cases (14.9%), with a level of 135–139 mmol/L, and was not measured in 5 hyponatremia cases. Patient characteristics that showed significant differences in the occurrence of hyponatremia included body weight, body mass index, renal function, and pretreatment serum sodium level. Regular monitoring of serum sodium is necessary for early detection of hyponatremia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Hyponatremia was the most common ADR when desmopressin orally disintegrating tablets were used to treat nocturia due to nocturnal polyuria over a 12-week period.</p>\u0000 </section>\u0000 </div>","PeriodicalId":18028,"journal":{"name":"LUTS: Lower Urinary Tract Symptoms","volume":"16 3","pages":""},"PeriodicalIF":1.3,"publicationDate":"2024-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/luts.12513","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140552049","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}