Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60–150 cc)

Introduction

To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation.

Methods

Men with LUTs secondary to BPH (60–150 cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250).

Results

One hundred seven males with mean age of 67.3?±?6.5 years were treated with Aquablation; mean prostate volume was 99.4?±?24.1 cc. The pooled results show that large prostates have an average procedure time of less than 36 min and discharge on average 1.6?±?1 days. The IPSS decreased by 16.7?±?8.1 points at 3 months and Q_max increased by 11.2?±?12.4 ml/s. The Clavien-Dindo (CD) grade 2 or higher event rate at 3 months was 29%. A non-hierarchical breakdown for CD events yielded 18% grade 2 and 19% grade 3 or higher.

Conclusion

Men with LUTS secondary to BPH (60–150 cc) in a pooled analysis were treated safely and effectively with Aquablation up to 3 months postoperatively.

Trial Registration

ClinicalTrials.gov identifiers, NCT02505919 and NCT03123250.

Funding

PROCEPT BioRobotics.

     

Comparison of Crestal Bone Loss Around Dental Implants Placed in Healed Sites Using Flapped and Flapless Techniques: A Systematic Review

Background : The aim of the present systematic review is to compare the crestal bone loss (CBL) around dental implants placed in healed sites using flapped and flapless surgical techniques. Methods: The focused question was, “Does flapped and flapless surgical technique influence CBL around dental implants placed in healed sites?” Databases were searched from 1975 up to and including May 2014 using different combinations of the following keywords: “crestal bone loss”; “dental implant”; “surgery”; “flap”; and “flapless.” Unpublished data, experimental studies, letters to the editor, review articles, case reports, commentaries, and articles published in languages other than English were excluded. In all studies, the test group comprised implants placed using flapless surgery, and the control group, implants placed after reflection of a full‐thickness mucoperiosteal flap. Results: Ten clinical studies were included. In five studies, CBL around implants was comparable between the test and control groups. In four studies, implants in the test group showed significantly less CBL compared with the control group. In one study, CBL was significantly higher in the test group than the control group. Conclusion: CBL around dental implants placed in healed sites using flapped and flapless techniques is comparable.     

Testosterone and benign prostatic hyperplasia

The use of testosterone to treat the symptoms of late-onset hypogonadal men has increased recently due to patient and physician awareness. However, concerns regarding the effect of testosterone on the prostate, in particular any possible effect on the risk of prostate cancer have prompted further research in this regard. Surprisingly, numerous retrospective or small, randomized trials have pointed to a possible improvement in male lower urinary tract symptoms (LUTS) in patients treated with testosterone. The exact mechanism of this improvement is still debated but may have a close relationship to metabolic syndrome. For the clinician, the results of these studies are promising but do not constitute high levels of evidence. A thorough clinical examination (including history, examination and laboratory testing of testosterone) should be undertaken before considering the diagnosis of late-onset hypogonadism or instigating treatment for it. Warnings still remain on the testosterone supplement product labels regarding the risk of urinary retention and worsening LUTS, and these should be explained to patients.     

Is Titanium Sensitivity Associated with Allergic Reactions in Patients with Dental Implants? A Systematic Review

Background: A worrying correlation which seems to be overlooked by clinicians is allergic reactions to titanium (Ti) in patients with dental implants. Purpose: The aim of the present review study was to assess whether or not Ti sensitivity is associated with allergic reactions in patients with dental implants. Materials and Methods: To address the focused question “Can Ti cause allergic reactions in patients with dental implants?”, databases were explored from 1977 until May 2010 using a combination of the following keywords: “allergy,”“dental,”“hypersensitivity,”“implant,”“oral,” and “Titanium.” Letters to the editor and unpublished data were excluded. Results: Seven studies (six clinical and one experimental) were included. The participants were aged between 14.3 and 84.1 years. In five clinical studies, Ti implants were inserted in the mandible. Five studies reported dermal inflammatory conditions and gingival hyperplasia as allergic reactions in patients with Ti dental implants. A case report presented swelling in submental and labial sulcus and hyperemia of soft tissues in a patient with Ti dental implants. Two studies reported that Ti implants are well tolerated in host tissues. The patch test was performed in two clinical studies for the diagnosis of allergic reactions. Memory lymphocyte immunostimulation assay and lymphocyte transformation tests were also performed. Conclusion: The significance of Ti as a cause of allergic reactions in patients with dental implants remains unproven.     

Oral health status in children with acute lymphoblastic leukemia

Leukemia is a malignancy of the bone marrow. Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy and accounts for nearly 75% of all newly diagnosed leukemias and 25% of all malignancies in childhood. The aim of the present study was to review the oral health status in children with ALL. Databases were explored using various combinations of the following keywords: "acute lymphoblastic leukemia", "children", "inflammation", "pediatric", "periodontal disease" and "periodontitis". Oral inflammatory conditions including chelitis, gingivitis, herpetic gingivostomatitis, mucositis, oral candidiasis, periodontitis and ulcerations are common manifestations in children with ALL. RESULTS: Periodontal inflammatory conditions and oral mucositis were reported to be significantly higher in children with ALL as compared to healthy controls. Tooth morphological disorders including agenesis, microdontia, short roots and developmental defects in the enamel and dentin were more often observed in children with ALL as compared to healthy controls. Children with ALL have a reduced salivary flow rate, which makes them more susceptible to dental caries as compared to healthy children. Malocclusion due to microdontia may also trigger temporomandibular joint disorders in children with ALL; however, this relationship needs further investigations. CONCLUSION: Oral inflammatory conditions including mucositis and gingivitis are common in children with ALL as compared to healthy children. Tooth morphological disorders including microdontia and enamel and dentin are common manifestations in children with ALL.     

Trends in internet search activity,media coverage,and patient-centered health information after the FDA safety communications on surgical mesh for pelvic organ prolapse

Introduction

In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information.

Methods

Google Trends? was utilized to evaluate search engine trends for the term “pelvic organ prolapse” and associated terms between 1 January 2004 and 31 December 2014. Google News? was utilized to quantify the number of news articles annually under the term “pelvic organ prolapse.” The search results for the term “pelvic organ prolapse” were assessed for quality using the Health On the Net Foundation (HON) certification.

Results

There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p?=?0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r²?=?0.88, with a coefficient of 186. Quality assessment demonstrated that 42 % of websites were HON-certified, with .gov sites providing the highest quality information.

Conclusions

Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare.