Early sacral neuromodulation ameliorates urinary bladder function and structure in complete spinal cord injury minipigs

Aims

To determine the effects of early sacral neuromodulation (SNM) and pudendal neuromodulation (PNM) on lower urinary tract (LUT) function, minipigs with complete spinal cord injury (cSCI) were analyzed. SNM and PNM have been proposed as therapeutic approaches to improve bladder function, for example after cSCI. However, further evidence on efficacy is required before these methods can become clinical practice.

Methods

Eleven adults, female Göttingen minipigs with cSCI at vertebral level T11-T12 were included: SNM (n = 4), PNM (n = 4), and SCI control (SCIC: n = 3). Tissue from six healthy minipigs was used for structural comparisons. Stimulation was started 1 week after cSCI. Awake urodynamics was performed on a weekly basis. After 16 weeks follow-up, samples from the urinary bladder were taken for analyses.

Results

SNM improved bladder function with better capacities and lower detrusor pressures at voiding and avoided the emergence of detrusor sphincter dyssynergia (DSD). PNM and untreated SCI minipigs had less favorable outcomes with either DSD or constant urinary retention. Structural results revealed SCI-typical fibrotic alterations in all cSCI minipigs. However, SNM showed a better-balanced distribution of smooth muscle to connective tissue with a trend towards the reduced progression of bladder wall scarring.

Conclusion

Early SNM led to an avoidance of the emergence of DSD showing a more physiological bladder function during a 4 month follow-up period after cSCI. This study might pave the way for the clinical continuation of early SNM for the treatment of neurogenic LUT dysfunction after SCI.

     

Comparison of outcomes between minimally invasive and median sternotomy for double and triple valve surgery: A meta-analysis

Background

Limited data exists demonstrating the efficacy of minimally invasive surgery (MIS) compared to median sternotomy (MS) for multiple valvular disease (MVD). This systematic review and meta-analysis aims to compare operative and peri-operative outcomes of MIS vs MS in MVD.

Methods

PubMed, Ovid, and Embase were searched from inception until August 2019 for randomized and observational studies comparing MIS and MS in patients with MVD. Clinical outcomes of intra- and postoperative times, reoperation for bleeding and surgical site infection were evaluated.

Results

Five observational studies comparing 340 MIS vs 414 MS patients were eligible for qualitative and quantitative review. The quality of evidence assessed using the Newcastle-Ottawa scale was good for all included studies. Meta-analysis demonstrated increased cardiopulmonary bypass time for MIS patients (weighted mean difference [WMD], 0.487; 95% confidence interval [CI], 0.365-0.608; P < .0001). Similarly, aortic cross-clamp time was longer in patients undergoing MIS (WMD, 0.632; 95% CI, 0.509-0.755; P < .0001). No differences were found in operative mortality, reoperation for bleeding, surgical site infection, or hospital stay.

Conclusions

MIS for MVD have similar short-term outcomes compared to MS. This adds value to the use of minimally invasive methods for multivalvular surgery, despite conferring longer operative times. However, the paucity in literature and learning curve associated with MIS warrants further evidence, ideally randomized control trials, to support these findings.

     

Development of a multivariable risk model integrating urinary cell DNA methylation and cell-free RNA data for the detection of significant prostate cancer

Background

Prostate cancer exhibits severe clinical heterogeneity and there is a critical need for clinically implementable tools able to precisely and noninvasively identify patients that can either be safely removed from treatment pathways or those requiring further follow up. Our objectives were to develop a multivariable risk prediction model through the integration of clinical, urine-derived cell-free messenger RNA (cf-RNA) and urine cell DNA methylation data capable of noninvasively detecting significant prostate cancer in biopsy naïve patients.

Methods

Post-digital rectal examination urine samples previously analyzed separately for both cellular methylation and cf-RNA expression within the Movember GAP1 urine biomarker cohort were selected for a fully integrated analysis (n = 207). A robust feature selection framework, based on bootstrap resampling and permutation, was utilized to find the optimal combination of clinical and urinary markers in a random forest model, deemed ExoMeth. Out-of-bag predictions from ExoMeth were used for diagnostic evaluation in men with a clinical suspicion of prostate cancer (PSA ≥ 4 ng/mL, adverse digital rectal examination, age, or lower urinary tract symptoms).

Results

As ExoMeth risk score (range, 0-1) increased, the likelihood of high-grade disease being detected on biopsy was significantly greater (odds ratio = 2.04 per 0.1 ExoMeth increase, 95% confidence interval [CI]: 1.78-2.35). On an initial TRUS biopsy, ExoMeth accurately predicted the presence of Gleason score ≥3 + 4, area under the receiver-operator characteristic curve (AUC) = 0.89 (95% CI: 0.84-0.93) and was additionally capable of detecting any cancer on biopsy, AUC = 0.91 (95% CI: 0.87-0.95). Application of ExoMeth provided a net benefit over current standards of care and has the potential to reduce unnecessary biopsies by 66% when a risk threshold of 0.25 is accepted.

Conclusion

Integration of urinary biomarkers across multiple assay methods has greater diagnostic ability than either method in isolation, providing superior predictive ability of biopsy outcomes. ExoMeth represents a more holistic view of urinary biomarkers and has the potential to result in substantial changes to how patients suspected of harboring prostate cancer are diagnosed.

     

Acute effect of sacral neuromodulation for treatment of detrusor overactivity on urodynamic parameters

Aim

The aim of this study is to evaluate the acute effects of sacral neuromodulation (SNM) on various urodynamic parameters.

Methods

Patients with overactive bladder and detrusor overactivity (DO) who were planned for percutaneous nerve evaluation (PNE) were included. Directly after the PNE, a urodynamic study (UDS) was performed. The stimulation was turned off during the first UDS (UDS 1), and during the second filling cycle, stimulation was turned on (UDS 2). The UDS was followed by a test phase of 1 week and the bladder diaries were evaluated during an outpatient clinic visit. Primary outcome measures were the differences in UDS parameter values with SNM off and on.

Results

Ten female patients were included in the study and completed the study protocol. Eight patients showed ≥50% improvement of symptoms following a test phase. There were no differences between UDS 1 and UDS 2 in the UDS parameters; bladder volume at first sensation, bladder volume at first DO, highest DO pressure, bladder capacity, maximum flow rate, and pressure at maximum flow rate.

Discussion

None of the aforementioned urodynamic parameters was influenced by acute SNM in patients who responded to SNM. To the best of our knowledge, this is the first study investigating the acute effects of SNM on bladder function.

     

The efficacy and safety of cold‐induced lipolysis in the treatment of pseudogynecomastia

Background

The treatment options for pseudogynecomastia have been limited. Cold‐induced lipolysis provides a noninvasive, localized subcutaneous adipocyte destruction by inducing adipocyte apoptosis.

Objective

This study has been designed to evaluate the efficacy of cold‐induced lipolysis as a treatment modality for pseudogynecomastia.

Methods

In this 28‐week prospective trial, a total of 12 male pseudogynecomastia patients (Korean) were treated twice with cold‐induced lipolysis. Efficacy was determined by chest circumference, ultrasonographic measurement of fat thickness, Simon's Gynecomastia class (SGC), photographic assessment, and the patient's satisfaction (baseline, weeks 4, 8, 16, and 28). Using a questionnaire, safety was evaluated at each visit.

Results

For 10 subjects that completed the trial, chest circumference and fat thickness significantly improved by week 8. This same improvement was gradually noticed through week 28. The patients SGC scores continuously decreased after two sessions. Photographic assessment showed an improvement until week 28. The result of the patient's satisfaction score was also meaningful. While there were no adverse events observed, transient pain and bruising at the treatment site were noticed.

Limitations

We recruited a limited number of participants. Also, we could not exclude there might be other individual factors in association with the patients pseudogynecomastia.

Conclusion

Cold‐induced lipolysis is a safe, effective therapeutic option in the treatment of pseudogynecomastia. Lasers Surg. Med. 48:584–589, 2016. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals Inc.

     

Mortality and renal prognosis in isolated metformin-associated lactic acidosis treated with continuous renal replacement therapy and citrate-calcium-anticoagulation

Introduction

Use of metformin increases plasma lactate concentration and may lead to metformin-associated lactic acidosis (MALA). Previous studies have suggested severe MALA to have a mortality of 17%-21%, but have included patients with other coincident conditions such as sepsis. The treatment of choice is continuous renal replacement therapy (CRRT), which has been performed using heparin analogues or no anticoagulation in former studies.

Materials and Methods

Patients admitted to the Intensive Care Unit of Turku University Hospital Finland with lactic acidosis without any other recognizable etiology than concomitant metformin treatment who required CRRT between years 2010 and 2019 were included. CRRT was performed using regional citrate-calcium-anticoagulation. Data extracted included patient demographics, comorbidities, and clinical parameters at 6-hour intervals about 72 hours from admission. Creatinine and estimated glomerular filtration rate (eGFR) were measured at 1 year after MALA.

Results

A total of 23 patients with isolated MALA were included in the study. Median (IQR) pH was 6.88 (6.81-7.07) and lactate 16.1 (11.9-23.0) mmol/L on admission. Median (IQR) duration of CRRT was 62 (41-70) hours. Seven patients (30%) required mechanical ventilation with a mean duration of 6.0 ± 3.0 days. 90-day mortality was 4.3% and 1-year mortality 13.0%. Creatinine (P = .02) and eGFR (P = .03) remained significantly altered at 1 year of follow-up compared to baseline.

Conclusions

MALA can be treated effectively and safely with CRRT and citrate-calcium-anticoagulation, usually required for 2-3 days. Mortality of patients with MALA treated with CRRT is low when other conditions inducing lactic acidosis are excluded. MALA episode may be associated with long-lasting kidney injury.

     

Lung volume changes in Apnoeic Oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) compared to mechanical ventilation in adults undergoing laryngeal surgery

Background

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) using high-flow 100% oxygen during apnoea has gained increased use during difficult airway management and laryngeal surgery due to a slower carbon dioxide rise compared to traditional apnoeic oxygenation. We have previously demonstrated high arterial oxygen partial pressures and an increasing arterial-alveolar carbon dioxide difference during THRIVE. Primary aim of this study was to characterise lung volume changes measured with electrical impedance tomography during THRIVE compared to mechanical ventilation.

Methods

Thirty adult patients undergoing laryngeal surgery under general anaesthesia were randomised to THRIVE or mechanical ventilation. Subjects were monitored with electrical impedance tomography and repeated blood gas measurement perioperatively. The THRIVE group received 100% oxygen at 70 l min⁻¹ during apnoea. The mechanical ventilation group was intubated and normoventilated with an FiO₂ of 0.4.

Results

Mean age were 48.2 (19.9) and 51.3 (12.3) years, and BMI 26.0 (4.5) and 26.0 (3.9) in the THRIVE and mechanical ventilation group respectively. Mean apnoea time in the THRIVE group was 17.9 (4.8) min. Mean apnoea to end-of-surgery time was 28.1 (12.8) min in the mechanical ventilation group. No difference in delta End Expiratory Lung Impedance was seen between groups over time. In the THRIVE group all but three subjects were well oxygenated during apnoea. THRIVE was discontinued for the three patients who desaturated.

Conclusions

No difference in lung volume change over time, measured by electrical impedance tomography, was detected when using THRIVE compared to mechanical ventilation during laryngeal surgery.

     

Intraurethral Erbium:YAG laser for the management of urinary symptoms of genitourinary syndrome of menopause: A pilot study

Objectives

Genitourinary syndrome of menopause (GSM) combines the conditions of vulvovaginal atrophy (VVA) and urinary tract dysfunction, which is a result of urethral atrophy. There are several treatment methods available for the management of vulvovaginal symptoms of GSM, whereas urinary tract dysfunction often remains overlooked and undertreated. The objective of this pilot study was to assess the safety and efficacy of intraurethral Er:YAG laser treatment of urinary symptoms of GSM.

Patients and Methods

Patients with diagnosed GSM, having less than 5% of vaginal superficial cells in the cytology, vaginal pH higher than 5, with urinary symptoms of GSM (dysuria, frequency, urgency) and impaired continence due to urethral atrophy, received two sessions of intraurethral Er:YAG laser with a 3‐week interval in‐between the sessions. Laser energy was delivered in non‐ablative way using Erbium SMOOTH? mode technology and a 4‐mm thick cannula. Therapeutic efficacy was determined using ICIQ‐SF, the 1‐hour pad test and VAS scores. Occurrence of adverse effects was followed at every visit. Follow ups (FU) were at 3 and 6 months.

Results

29 female patients fulfilling the inclusion criteria were included in this pilot study and received two sessions of the intraurethral non‐ablative Erbium SMOOTH? laser therapy. Significant improvement was observed in all measured parameters at both FU. ICIQ‐SF improved by an average of 64% at 3 months FU and by 40% at 6 months. The 1‐hour pad test showed a reduction of the quantity of leaked urine by 59% at 3 months FU and by 42% at 6 months FU. All urinary symptoms of GSM improved. Dysuria dropped to 13% and 31% of baseline values at three and 6 months respectively, urinary urgency dropped to 23% and 47% and frequency dropped to 22% and 43% after 3 and 6 months, respectively. Adverse effects were mild and transient.

Conclusions

Our findings suggest that intraurethral Er:YAG laser is an efficacious and safe modality for treatment of urinary symptoms of GSM, however, prospective, randomized, and controlled trials with larger number of patients are needed to better assess the long‐term effect of this novel procedure. Lasers Surg. Med. 50:802–807, 2018. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

     

PTEN and ERG expression in MRI-ultrasound guided fusion biopsy correlated with radical prostatectomy findings in men with prostate cancer

Background

Conventional systematic prostate biopsies (SBx) have multiple limitations, and magnetic resonance imaging (MRI)-ultrasound fusion targeting is increasingly applied (fusion biopsies [FBx]). In our previous studies, we have shown that loss of the tumor suppressor gene phosphatase and tensin homolog (PTEN) in radical prostatectomy (RP) specimens predicts poor disease-specific survival, and in active surveillance (AS), PTEN loss in SBx predicts an adverse AS outcome, although SBx PTEN status does not correlate well with the corresponding RP status. Here, we have hypothesized that PTEN and erythroblast transformation-specific related gene (ERG) status in FBx correlate better with RP than they would in SBx.

Methods

A total of 106 men, who had undergone FBx and subsequent RP in a single center between June 2015 and May 2017 were included. Fifty-three of the men had concomitant or previous SBx's. All biopsy and RP specimens were collected, and tissue microarrays (TMA) were constructed from RP specimens. Immunohistochemical stainings for PTEN and ERG expression were conducted on biopsies and RP TMAs and results were compared by using Fisher's exact test.

Results

The immunohistochemical predictive power of FBx, determined by the concordance of biopsy PTEN and ERG status with RP, is superior to SBx (77.6% vs 66.7% in PTEN, 92.4% vs 66.6% in ERG). FBx was superior to SBx in correlation with RP Gleason Grade Groups and MRI prostate imaging reporting and data system scores.

Conclusion

FBx grading correlates with RP histology and MRI findings and predicts the biomarker status in the RP specimens more accurately than SBx. A longer follow-up is needed to evaluate if this translates to better prediction of disease outcomes, especially in AS and radiation therapy where prostatectomy specimens are not available for prognostication.

     

Association among plasma 1,25(OH)2D,ratio of 1,25(OH)2D to 25(OH)D,and prostate cancer aggressiveness

Background

African-American (AA) men tend to present with more aggressive prostate cancer (Gleason score >7) than European-American (EA) men. Vitamin D and its metabolites are implicated in prostate cancer biology with vitamin D deficiency, indicated by its metabolite levels in serum or plasma, usually observed in AA men.

Objective

To determine if 1, 25-dihydroxy vitamin D3 [1,25(OH)₂D] plasma levels in AA and EA prostate cancer patients alter the risk of having aggressive prostate cancer.

Design

Research subjects from the North Carolina-Louisiana Prostate Cancer Project (AA n = 435 and EA n = 532) were included. Plasma metabolites 1,25(OH)₂D and 25-hydroxyvitamin D3 [25(OH)D] were measured using liquid chromatography with tandem mass spectrophotometry. Research subjects were classified into low (Gleason sum < 7, stage T1-T2, and Prostate-specific antigen (PSA) < 9 ng/mL) or high (Gleason sum > 8 or Gleason sum = 7 with 4 + 3, or PSA > 20 ng/mL, or Gleason sum = 7 and stage T3-T4) aggressive disease.

Results

Research subjects in the second and third tertiles of plasma levels of 1, 25(OH)₂D had lower odds of high aggressive prostate cancer (AA [OR_T2vsT1: 0.66, 95%CI: 0.39-1.12; OR_T3vsT1: 0.83, 95%CI: 0.49-1.41] and EA [OR_T2vsT1: 0.68, 95%CI: 0.41-1.11; OR_T3vsT1: 0.67, 95%CI: 0.40-1.11]) compared with the first tertile, though confidence intervals included the null. Greater 1,25(OH)₂D/25(OH)D molar ratios were associated with lower odds of high aggressive prostate cancer more evidently in AA (OR_Q4vsQ1: 0.45, CI: 0.24-0.82) than in EA (OR_Q4vsQ1: 0.64, CI: 0.35-1.17) research subjects.

Conclusions

The 1,25(OH)₂D/25(OH)D molar ratio was associated with decreased risk of high aggressive prostate cancer in AA men, and possibly in EA men. Further studies analyzing vitamin D polymorphisms, vitamin D binding protein levels, and prostatic levels of these metabolites may be useful. These studies may provide a better understanding of the vitamin D pathway and its biological role underlying health disparities in prostate cancer.

     

Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial—Protocol and statistical analysis plan

Introduction

Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.

Methods

The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.

Discussion

The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.

     

Transcranial laser stimulation improves human cerebral oxygenation

Background and Objective

Transcranial laser stimulation of the brain with near‐infrared light is a novel form of non‐invasive photobiomodulation or low‐level laser therapy (LLLT) that has shown therapeutic potential in a variety of neurological and psychological conditions. Understanding of its neurophysiological effects is essential for mechanistic study and treatment evaluation. This study investigated how transcranial laser stimulation influences cerebral hemodynamics and oxygenation in the human brain in vivo using functional near‐infrared spectroscopy (fNIRS).

Materials and Methods

Two separate experiments were conducted in which 1,064‐nm laser stimulation was administered at (1) the center and (2) the right side of the forehead, respectively. The laser emitted at a power of 3.4 W and in an area of 13.6 cm², corresponding to 0.25 W/cm² irradiance. Stimulation duration was 10 minutes. Nine healthy male and female human participants of any ethnic background, in an age range of 18–40 years old were included in each experiment.

Results

In both experiments, transcranial laser stimulation induced an increase of oxygenated hemoglobin concentration (Δ[HbO₂]) and a decrease of deoxygenated hemoglobin concentration (Δ[Hb]) in both cerebral hemispheres. Improvements in cerebral oxygenation were indicated by a significant increase of differential hemoglobin concentration (Δ[HbD] = Δ[HbO₂] ? Δ[Hb]). These effects increased in a dose‐dependent manner over time during laser stimulation (10 minutes) and persisted after laser stimulation (6 minutes). The total hemoglobin concentration (Δ[HbT] = Δ[HbO2] + Δ[Hb]) remained nearly unchanged in most cases.

Conclusion

Near‐infrared laser stimulation applied to the forehead can transcranially improve cerebral oxygenation in healthy humans. Lasers Surg. Med. 48:343–349, 2016. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

     

Evaluation of stimulated raman scattering microscopy for identifying squamous cell carcinoma in human skin

Background and Significance

There is a need to develop non‐invasive diagnostic tools to achieve early and accurate detection of skin cancer in a non‐surgical manner. In this study, we evaluate the capability of stimulated Raman scattering (SRS) microscopy, a potentially non‐invasive optical imaging technique, for identifying the pathological features of s squamous cell carcinoma (SCC) tissue.

Study Design

We studied ex vivo SCC and healthy skin tissues using SRS microscopy, and compared the SRS contrast with the contrast obtained in reflectance confocal microscopy (RCM) and standard histology.

Results and Conclusion

SRS images obtained at the carbon‐hydrogen stretching vibration at 2945 cm^?1 exhibit contrast related protein density that clearly delineates the cell nucleus from the cell cytoplasm. The morphological features of SCC tumor seen in the SRS images show excellent correlation with the diagnostic features identified by histological examination. Additionally, SRS exhibits enhanced cellular contrast in comparison to that seen in confocal microscopy. In conclusion, SRS represents an attractive approach for generating protein density maps with contrast that closely resembles histopathological contrast of SCC in human skin. Lasers Surg. Med. 45:496–502, 2013. © 2013 Wiley Periodicals, Inc.

     

Proof‐of‐concept of a laser mounted endoscope for touch‐less navigated procedures

Background and Objectives

During navigated procedures a tracked pointing device is used to define target structures in the patient to visualize its position in a registered radiologic data set. When working with endoscopes in minimal invasive procedures, the target region is often difficult to reach and changing instruments is disturbing in a challenging, crucial moment of the procedure. We developed a device for touch less navigation during navigated endoscopic procedures.

Materials and Methods

A laser beam is delivered to the tip of a tracked endoscope angled to its axis. Thereby the position of the laser spot in the video‐endoscopic images changes according to the distance between the tip of the endoscope and the target structure. A mathematical function is defined by a calibration process and is used to calculate the distance between the tip of the endoscope and the target. The tracked tip of the endoscope and the calculated distance is used to visualize the laser spot in the registered radiologic data set.

Results

In comparison to the tracked instrument, the touch less target definition with the laser spot yielded in an over and above error of 0.12 mm. The overall application error in this experimental setup with a plastic head was 0.61 ± 0.97 mm (95% CI ?1.3 to +2.5 mm).

Conclusion

Integrating a laser in an endoscope and then calculating the distance to a target structure by image processing of the video endoscopic images is accurate. This technology eliminates the need for tracked probes intraoperatively and therefore allows navigation to be integrated seamlessly in clinical routine. However, it is an additional chain link in the sequence of computer‐assisted surgery thus influencing the application error. Lasers Surg. Med. 45:377–382, 2013. © 2013 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals, Inc.

     

Comparative efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents in overactive bladder: A systematic literature review and network meta‐analysis

Aims

To compare efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents for the treatment of overactive bladder (OAB).

Methods

Literature searches of MEDLINE, Embase, and the Cochrane Library were undertaken to identify randomized controlled trials in OAB (2000‐2015) for antimuscarinic agents. A network meta‐analysis (NMA) was performed to estimate efficacy and tolerability outcomes for solifenacin 5 mg/day relative to other antimuscarinics.

Results

The NMA included 53 eligible trials (published, n = 48; unpublished on search date, n = 5). Solifenacin 5 mg/day was significantly more effective than tolterodine 4 mg/day for reducing incontinence and urgency urinary incontinence (UUI) episodes, but significantly less effective than solifenacin 10 mg/day for micturition; no other statistically significant differences were noted for efficacy. Solifenacin 5 mg/day had a statistically significant lower risk of dry mouth compared with darifenacin 15 mg/day, fesoterodine 8 mg/day, oxybutynin extended‐release 10 mg/day, oxybutynin immediate‐release (IR) 9‐15 mg/day, tolterodine IR 4 mg/day, propiverine 20 mg/day, and solifenacin 10 mg/day. There were no significant differences between solifenacin 5 mg/day and other antimuscarinics for risk of blurred vision, or for 11 of 17 active comparators for risk of constipation.

Conclusions

This NMA suggests that the efficacy of solifenacin 5 mg/day is at least similar to other common antimuscarinics across the spectrum of OAB symptoms analyzed, and is more effective than tolterodine 4 mg/day in reducing incontinence and UUI episodes. Solifenacin 5 mg/day has a lower risk of dry mouth compared with several agents.

     

Safety and efficacy of cryolipolysis for non‐invasive reduction of submental fat

Background and Objectives

Cryolipolysis has previously received FDA clearance for fat reduction in the abdomen, flanks, and thighs. There is also interest in small volume fat reduction for areas such as the chin, knees, and axilla. This article reports the results of a cryolipolysis pivotal IDE study for reduction of submental fullness.

Study Design/Material and Methods

A prototype small volume vacuum applicator (CoolMini applicator, CoolSculpting System, ZELTIQ Aesthetics) was used to treat 60 subjects in the submental area. At each treatment visit, a single treatment cycle was delivered at ?10°C for 60 minutes, the same temperature and duration used in current commercially‐available cryolipolysis vacuum applicators. At the investigator's discretion, an optional second treatment was delivered 6 weeks after the initial treatment. The primary efficacy endpoint was 80% correct identification of baseline photographs by independent physician review. The primary safety endpoint was monitoring incidence of device‐ and/or procedure‐related serious adverse events. Secondary endpoints included assessment of fat layer thickness by ultrasound and subject satisfaction surveys administered 12 weeks after final cryolipolysis treatment.

Results

Independent photo review from 3 blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicated mean fat layer reduction of 2.0 mm. Patient questionnaires revealed 83% of subjects were satisfied, 80% would recommend submental cryolipolysis to a friend, 77% reported visible fat reduction, 77% felt that their appearance improved following the treatment, and 76% found the procedure to be comfortable. No device‐ or procedure‐related serious adverse events were reported.

Conclusion

The results of this clinical evaluation of 60 patients treated in a pivotal IDE study demonstrate that submental fat can be reduced safely and effectively with a small volume cryolipolysis applicator. Patient surveys revealed that submental cryolipolysis was well‐tolerated, produced visible improvement in the neck contour, and generated high patient satisfaction. These study results led to FDA clearance of cryolipolysis for submental fat treatment. Lasers Surg. Med. 48:3–13, 2016. © 2015 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

     

Outcome and complications of adjustable continence therapy (ProACT™) after radical prostatectomy: 10 years’ experience in 143 patients

Aims

To evaluate our outcomes of the adjustable continence balloons ProACT? for the treatment of male stress urinary incontinence after radical prostatectomy.

Methods

Between May 2007‐August 2016 the ProACT? was implanted in 143 patients without a history of radiotherapy. Endpoints were patient‐reported changes in pad counts and complications. Treatment was considered successful if no pad or just one “security” pad per day sufficed, and improved if daily pad use was reduced by ≥50%.

Results

Incontinence before implantation was mild in 36 (25%), moderate in 57 (40%), and severe in 50 (35%) patients. Complications within 30 days were classified by the Clavien‐Dindo classification; eight (5.6%) grade I, three (2.1%) grade II, three (2.1%) grade IIIb, and 129 (90.2%) patients had no complication. Revision was done in 43 (30%) patients. The IPSS quality of life item improved significantly from 5.0 (IQR 4.0‐5.0) preoperative to 2.0 (IQR 1.0‐4.0) and 1.0 (IQR 0.0‐3.0) 6 and 12 months after implantation, respectively. After a median follow up of 56 months (range 28 to 79, n = 112), 72 (64%) patients were improved, including 51 (45%) patients were successful. Daily pad use decreased from 3.0 to 1.0 (67% reduction). The median outcome on the Patient Global Impression of Improvement scale was “much better,” and 97 (87%) patients perceived improvement.

Conclusions

The minimally invasive ProACT? device showed a clear beneficial continence outcome in patients with stress urinary incontinence after radical prostatectomy. The majority of the patients were satisfied and perceived improvement ≥50% on daily pad use on the long term.

     

Comparison of the ICIQ-SF and 24-hour pad test with other measures for evaluating the severity of urodynamic stress incontinence

This study compared the International Consultation on Incontinence Questionnaire—Short Form (ICIQ-SF) and the 24-h pad test with other measures that assess severity of urinary loss in women with urodynamic stress incontinence (USI). Ninety-five women with primary or recurrent (secondary) USI were recruited. Assessment of the severity of urinary loss was made using the ICIQ-SF, a 24-h pad test, continence questionnaire, Stamey grade, and 3-day frequency volume diary. The relationship between these measures of incontinence severity was analysed. The mean age was 54 years (SD±12) and median parity 2 (IQR 1–3). In the primary USI group there was a strong correlation between the ICIQ-SF and the 24-h pad test (r=0.458, P =0.000). Both the ICIQ-SF (Kendalls tau b=0.331, p =0.003) and 24-h pad test (Kendalls tau b=0.399, p =0.002) also correlated with the mean frequency of urinary loss on diary but not with the Stamey grade. No subjective or objective tests correlated with each other in women with secondary USI. These results demonstrate a good correlation between the 24-h pad test diary loss, and ICIQ-SF in women with primary USI. Because it also includes a measure of quality of life impact in a short user-friendly format, we suggest that the ICIQ-SF should have widespread applicability as an outcome measure in patients with stress incontinence. Editorial Comment: This study demonstrates that the International Consultation on Incontinence Questionnaire—Short Form (ICIQ-SF) measures subjective severity of incontinence and correlates both with the 24-hour pad test, and the leakage episodes on a diary. Hopefully, further studies will support the authors conclusions.