A Clinical Learning Curve Study of Polydimethylsiloxane Urolastic for Stress Urinary Incontinence: Does Safety Improve when Expertise Grow?

OBJECTIVES: The aim of the study was to characterize the learning curve of bulk injection therapy polydimethylsiloxane Urolastic (PDMS-U) for stress urinary incontinence. DESIGN: Secondary analysis from three clinical studies on efficacy and safety outcomes of PDMS-U was performed. PARTICIPANTS/MATERIALS, SETTING, METHODS: PDMS-U-certified physicians who performed ≥4 procedures were included. The primary outcome was the number of PDMS-U procedures needed to achieve acceptable failure rates for "complications overall," "urinary retention," and "excision," using the LC-CUSUM method. For the primary outcome, physicians who performed ≥20 procedures were used. For the secondary outcome, logistic and linear regression analysis was used to assess the relationship between number of procedures, complications (complications overall, urinary retention, pain, exposure, excision of PDSM-U), and duration of treatment. RESULTS: In total, 203 PDMS-U procedures were performed by nine physicians. Five physicians were used for the primary outcome. For "complications overall," "urinary retention," and "excision," two physicians reached a level of competence: one at procedure 20 and one at procedure 40. The secondary outcome showed no statistically significant association between procedure number and complications. There was a statistically significant increase in the duration of treatment with more physician experience (mean difference 0.83 min per 10 additional procedures, 95% CI: 0.16-1.48). LIMITATIONS: One limitation is that retrospectively collected data might have underreported the number of complications. Secondly, there was variation in the way the technique was applied between physicians. CONCLUSIONS: Physicians' experience in the PDMS-U procedure did not influence safety outcomes. There was large inter-physician variability and most physicians did not reach acceptable failure rates. There was no relationship between PDMS-U complications and the number of performed procedures.

Does the Polydimethylsiloxane Urethral Injection (Macroplastique®) Improve Sexual Function in Women, in Fertile Age, Affected by Stress Urinary Incontinence?

Background and Objectives: Stress urinary incontinence (SUI) negatively affects women's quality of life, including sexual function. The aim of the current study was to evaluate the effect of polydimethylsiloxane (Macroplastique®) on sexual function in women of fertile age affected by SUI. Materials and Methods: Single-center prospective study. Sexually active women of fertile age with symptoms of pure SUI, which were urodynamically proven, were submitted to intraurethral Macroplastique® injection. At 6-months follow-up, their sexual function was evaluated with Female Sexual Function Index (FSFI), while the SUI cure rate was objectively assessed through a negative stress test and subjectively by a Patient Global Impression of Improvement (PGI-I) score < 3. The difference of coital incontinence prevalence was assessed between the baseline and the 6-month follow-up. Peri- and postoperative complications of Macroplastique® injection were recorded and classified according to the Clavien-Dindo system. Results: Twenty-one women fulfilled inclusion criteria and were submitted to Macroplastique® procedure. The concerning sexual function, desire, satisfaction, and overall FSFI score significantly improved. Since other domains were less impaired at the baseline, we could not assess significant improvement for all of them. We observed a complete regression of coital incontinence (0/21, 0%) in comparison with the baseline (5/21, 23.8%; p = 0.04). The objective SUI cure rate was 76% (16/21), while the subjective SUI cure rate was 80.9% (17/21). One woman developed de novo overactive bladder, and two women developed postoperative voiding dysfunction (self-solved in 24 h). Conclusions: The Macroplastique® urethral injection was demonstrated to be safe and effective in improving sexual function in sexually active women of fertile age affected by pure SUI, urodinamically proven at 6-months follow-up.

Urethral bulking agents: a retrospective review of primary versus salvage procedure outcomes.

PURPOSE: Urethral bulking agents (UBA) have traditionally been offered as salvage procedures for recurrent stress urinary incontinence (SUI). We compare the success of UBA in patients that had undergone a previous procedure for SUI (Salvage-UBA) to the SUI surgery naïve (Primary-UBA). We hypothesised a positive effect in both Primary and Salvage-UBA with potentially poorer rates of response in the salvage group. METHODS: Retrospective case series of patients having their first UBA (2010-2018). Primary outcome was to assess any difference in patient reported success between groups. Patient-reported improvement was assessed on a 4-point scale: 'cured, improved, no change, worse' and treatment 'success' defined as 'cured' or 'improved'. A multivariate analysis, adjusting for plausible differences between groups, was undertaken in IBM SPSS Statistics (2016). RESULTS: 135 Primary-UBA and 38 Salvage-UBA were performed. Complete follow-up was obtained for 114 patients (66%): 86 Primary and 28 Salvage. Median follow-up time: 33 months. In 2012, 47% (8/17) of all UBA were Salvage-UBA, whilst in 2018, the majority were Primary-UBA (92%, 46/50). Success was not significantly different between Salvage-UBA 75% (21/28) versus Primary-UBA 67% (58/86) (Wald χ2 = 0.687, df = 1, p = 0.407). Top-up rates were similar: 14% (n = 4/28, Salvage-UBA) versus 15% (n = 13/86, Primary-UBA) (χ2 = 0.011, df = 1, p = 0.914). CONCLUSION: The number of women opting for UBA has increased substantially. No significant differences were noted for success with Salvage-UBA compared to Primary-UBA.

Patients' satisfaction and safety of bulk injection therapy Urolastic for treatment of stress urinary incontinence: A cross-sectional study.

AIMS: Primary outcome was to evaluate patients' satisfaction after being treated with bulk injection therapy polydimethylsiloxane Urolastic (PDMS-U) for stress urinary incontinence (SUI). Secondary outcomes were: subjective cure, objective cure, severity of SUI symptoms, complications, reintervention rate, and disease-specific quality of life. Furthermore, to determine if outcomes worsened during time-after-treatment (time-frames: 0-12, 13-24, and ≥25 months). METHODS: In a cross-sectional design, patients treated with PDMS-U were recruited for hospital revisit. The primary outcome, patients' satisfaction, was assessed by the surgical satisfaction questionnaire. Subjective cure, objective cure, and severity of symptoms were assessed by the patients global impression of improvement, standardized cough stress test, and Sandvik severity scale, respectively. Medical charts and face-to-face interviews were used to determine complications and reinterventions. RESULTS: About 110 patients participated, 87 revisited the hospital. Median follow-up was 25 months (interquartile range: 14;35 months). Patients' satisfaction rate was 51%. Subjective and objective cure were respectively 46% and 47%. Most prevalent complications were: urinary retention (22%), pain (15%), and dyspareunia (15%). Exposure and erosion occurred in 7% and 5%, respectively. Reintervention rate of reinjection and excision of bulk material was 6% and 18.0%, respectively. Objective cure significantly worsened during time-after-treatment (P = < .05). CONCLUSIONS: About half of the patients being treated with PDMS-U were satisfied and subjectively cured 2 years after treatment, although the majority still experienced symptoms of SUI. Most complications were mild and transient, however, in 18% excision of bulk material was indicated for severe or persistent complications such as pain, exposure, or erosion.

Outcomes of Macroplastique injections for stress urinary incontinence after suburethral sling removal.

INTRODUCTION: To evaluate outcomes following urethral Macroplastique (MPQ) injection in women with stress urinary incontinence (SUI) following suburethral sling removal (SSR) for synthetic sling complications. METHODS: Following Institutional Review Board approval, charts of non-neurogenic women with SUI after SSR who underwent MPQ injection(s) and had at least 6 months minimum follow-up were reviewed from a prospectively maintained database. Demographic data, questionnaire (Urogenital Distress Inventory-6 [UDI-6] and Quality of Life) scores, and pad usage were recorded. Patients were followed with repeat questionnaires and three-dimensional ultrasound evaluating MPQ volume. Success following MPQ was defined as a composite score of a UDI-6 question 3 score of 0 to 1 at last visit and no additional anti-incontinence therapy. RESULTS: From 2011 to 2018, 70 women with mean age 62.7 years met study criteria. At a mean follow-up of 46.4 ± 1.5 months, the success rate after the first MPQ injection was 46%. Following a repeat MPQ injection when indicated, the overall success rate for the entire cohort was 69%. Despite the objective failure, the majority of patients reported subjective improvement (83%) and reduced pad usage (78%). On multivariate analysis: age, body mass index, previous hysterectomy, hormone replacement therapy, type of sling removed and baseline urodynamics (UDS) parameters were not predictors of MPQ failure. Higher parity was a predictor of MPQ failure (hazard ratio = 1.980; P = .032). CONCLUSION: MPQ injection is a durable and effective management option for SUI following SSR, although a second injection may be required to achieve the desired success.

Efficacy and safety of polydimethylsiloxane injection (Macroplastique® ) for the treatment of female stress urinary incontinence: results of a series of 85 patients with ≥3 years of follow-up.

OBJECTIVE: To assess the long-term efficacy and safety of polydimethylsiloxane injection (Macroplastique® , Cogentix Medical, Orangeburg, New York, USA) for the treatment of female stress urinary incontinence (SUI), with a minimum follow-up of 3 years. PATIENTS AND METHODS: This is an observational analytical prospective cohort study conducted in a single uro-gynaecological unit. All consecutive women with urodynamically confirmed pure SUI treated with the Macroplastique procedure, were included. Data regarding patient outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure rates, and adverse events were collected during follow-up. Uni- and multivariable analyses were performed to investigate outcomes. Multiple logistic regression was performed to identify factors involved in the risk of failure of the procedures or recurrence of SUI. RESULTS: In all, 85 women had the Macroplastique procedure. At the 3-year follow-up, all 85 (100%) patients were available for the evaluation. We did not find any significant change in the surgical outcomes during this time. At 3 years after surgery, 42 of 85 patients (49%) declared themselves cured (P = 0.67). Similarly, at the 3-year evaluation, 40 of 85 patients (47%) were objectively cured. There was no significant deterioration of objective cure rates over time (P = 0.3). A history of radical pelvic surgery and a low surgeon's skill were significantly associated with the risk of failure of Macroplastique. The multivariate analysis confirmed these findings; a previous history of radical pelvic surgery and a low surgeon's skill independently predicted the subjective and objective failure of Macroplastique. CONCLUSIONS: The 3-year results of this study showed that Macroplastique could be an acceptable alternative for the treatment of SUI with stable results over time and a negligible complication rate.

FRET in a Polymeric Nanocarrier: IR-780 and IR-780-PDMS.

We introduce a method to monitor the integrity of micellar nanocarriers using a novel fluorescent dye, IR-780-PDMS and Förster resonance energy transfer (FRET) as a readout. In addition, these dye-loaded nanocarriers can be used as a phototoxic agent in vitro. Mainly, a nanocarrier was designed, based on a previously described amphiphilic ABA-copolymer (Pip-PMOXA-PDMS-PMOXA-Pip) scaffold that incorporates the fluorescent FRET dye partners IR-780-PDMS (donor) and IR-780 (acceptor). The confirmation of FRET (that only occurs when donor and acceptor are in the required close proximity of less than ∼10 nm) in the nanocarriers is used to prove that the acceptor dye (IR-780) is still contained in its hydrophobic core. We measured such FRET signals of the nanocarriers also upon cellular uptake into HeLa cells using fluorescence-lifetime imaging microscopy (FLIM). Confocal laser scanning microscopy after incubation with nanocarriers demonstrated the intracellular uptake of the particles and their localization in an intracellular granular pattern. To demonstrate the intactness of the nanocarriers by detection of FRET we measured the fluorescence lifetime (FLIM) of the donor dye. FLIM showed that both types of lifetimes, that of the quenched donor, and that of the unquenched donor were present, in a granular pattern and homogeneously in the cytosol, respectively, indicating the presence of intracellular intact and disintegrated micellar nanocarriers. These data show that the herewith-described FRET method allows monitoring the intactness of nanocarriers while en route to the target, and also that the cargo is delivered and released within a potential target cell. In addition, near-infrared (NIR) irradiation of IR-780-loaded micellar nanocarriers leads to photocytotoxicity, which we demonstrated in in vitro experiments. Our findings open potential avenues in photodynamic therapy (PDT) of cancer.

Bulking for stress urinary incontinence in men: A systematic review.

AIMS: An updated literature review on outcomes in men treated with currently commercially available bulking agents was performed to determine whether this is a reasonable option in selected patients. METHODS: The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework of systematic reviews. A comprehensive search of PubMed, Medline, and Embase was undertaken. Abstracts were independently screened by two investigators to include men with stress urinary incontinence treated with a peri-urethral injection of bulking agents currently available in the market. RESULTS: Only eight original articles met the inclusion criteria. The bulking agents used were Macroplastique in five studies (total 123 patients), Opsys, Durasphere, and Urolastic in one study each (10, 7, and 2 patients, respectively). Only one study was randomized; Macroplastique vs AUS in men with mild or total incontinence. The included populations were heterogeneous and encompassed endoscopic, perineal, abdominal and laparoscopic prostate surgery as well as spinal cord injuries and urethral sphincter insufficiency. Significant dissimilarity was evident for the duration of incontinence (9-108 months), mean volume of bulking agent used (2.3-13.5 mL), number of cushions (1-5), depth and position of the cushions. The outcomes varied significantly, with reported dry rates between 0% and 83%. Outcomes were limited by relatively short follow-up in most studies. CONCLUSION: Following initial enthusiasm and then dismay with collagen-based compounds, sparse and heterogeneous literature data were produced on newer non-migrating and nonabsorbable bulking agents. Some studies have suggested encouraging, if short term outcomes, however, future studies are needed in this field to support recommendations for widespread use.

Interventions for primary vesicoureteric reflux.

BACKGROUND: Vesicoureteric reflux (VUR) results in urine passing retrograde up the ureter. Urinary tract infections (UTI) associated with VUR have been considered a cause of permanent renal parenchymal damage in children with VUR. Management has been directed at preventing UTI by antibiotic prophylaxis and/or surgical correction of VUR. This is an update of a review first published in 2004 and updated in 2007 and 2011. OBJECTIVES: The aim of this review was to evaluate the available evidence for both benefits and harms of the currently available treatment options for primary VUR: operative, non-operative or no intervention. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register to 3 May 2018 through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings, and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: RCTs in any language comparing any treatment of VUR and any combination of therapies. DATA COLLECTION AND ANALYSIS: Two authors independently determined study eligibility, assessed quality and extracted data. Dichotomous outcomes were expressed as risk ratios (RR) with 95% confidence intervals (CI) and continuous data as mean differences (MD) with 95% CI. Data were pooled using the random effects model. MAIN RESULTS: Thirty four studies involving 4001 children were included. Interventions included; long-term low-dose antibiotics, surgical reimplantation of ureters, endoscopic injection treatment, probiotics, cranberry products, circumcision, and oxybutynin. Interventions were used alone and in combinations. The quality of conduct and reporting of these studies was variable, with many studies omitting crucial methodological information used to assess the risk of bias. Only four of the 34 studies were considered at low risk of bias across all fields of study quality. The majority of studies had many areas of uncertainty in the risk of bias fields, reflecting missing detail rather than stated poor design.Low-dose antibiotic prophylaxis compared to no treatment/placebo may make little or no difference to the risk of repeat symptomatic UTI (9 studies, 1667 children: RR 0.77, 95% CI 0.54 to 1.09; low certainty evidence) and febrile UTI (RR 0.83, 95% CI 0.56 to 1.21; low certainty evidence) at one to two years. At one to three years, antibiotic prophylaxis made little or no difference to the risk of new or progressive renal damage on DMSA scan (8 studies, 1503 children: RR 0.73, 95% CI 0.33 to 1.61; low certainty evidence). Adverse events were reported in four studies with little or no difference between treatment groups (1056 children: RR 0.94, 95% CI 0.81 to 1.08; ), but antibiotics increased the likelihood of bacterial drug resistance threefold (187 UTIs: RR 2.97, 95% CI 1.54 to 5.74; moderate certainty evidence).Seven studies compared long-term antibiotic prophylaxis alone with surgical reimplantation of ureters plus antibiotics, but only two reported the outcome febrile UTI (429 children). Surgery plus antibiotic treatment may reduce the risk of repeat febrile UTI by 57% (RR 0.43, 95% CI 0.27 to 0.70; moderate certainty evidence). There was little or no difference in the risk of new kidney defects detected using intravenous pyelogram at 4 to 5 years (4 studies, 572 children, RR 1.09, 95% CI 0.79 to 1.49; moderate certainty evidence)Four studies compared endoscopic injection with antibiotics alone and three reported the outcome febrile UTI. This analysis showed little or no difference in the risk of febrile UTI with endoscopic injection compared to antibiotics (RR 0.74, 95% CI 0.31 to 1.78; low certainty evidence). Four studies involving 425 children compared two different materials for endoscopic injection under the ureters (polydimethylsiloxane (Macroplastique) versus dextranomer/hyaluronic acid polymer (Deflux), glutaraldehyde cross-linked (GAX) collagen (GAX) 35 versus GAX 65 and Deflux versus polyacrylate polyalcohol copolymer (VANTRIS)) but only one study (255 children, low certainty evidence) had the outcome of febrile UTI and it reported no difference between the materials. All four studies reported rates of resolution of VUR, and the two studies comparing Macroplastique with Deflux showed that Macroplastique was probably superior to dextranomer/hyaluronic acid polymer (3 months: RR 0.50, 95% CI 0.33 to 0.78; 12 months: RR 0.54 95% CI 0.35 to 0.83; low certainty evidence)Two studies compared probiotic treatment with antibiotics and showed little or no difference in risk of repeat symptomatic UTI (RR 0.82 95% CI 0.56 to 1.21; low certainty evidence)Single studies compared circumcision with antibiotics, cranberry products with no treatment, oxybutynin with placebo, two different surgical techniques and endoscopic injection with no treatment. AUTHORS' CONCLUSIONS: Compared with no treatment, the use of long-term, low-dose antibiotics may make little or no difference to the number of repeat symptomatic and febrile UTIs in children with VUR (low certainty evidence). Considerable variation in the study designs and subsequent findings prevented drawing firm conclusions on efficacy of antibiotic treatment.The added benefit of surgical or endoscopic correction of VUR over antibiotic treatment alone remains unclear since few studies comparing the same treatment and with relevant clinical outcomes were available for analysis.

High efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial.

BACKGROUND: Increasing resistance of head lice against neurotoxic agents and safety concerns have led to the search for treatment alternatives. Dimeticones with a physical mode of action are safe, and bear a reduced risk for the development of resistance. METHODS: We performed in vitro bioassays to assess pediculicidal and ovicidal activities of a new dimeticone-based product, and a randomized controlled clinical trial to assess efficacy, following 10 min application. Of 153 individuals screened, 100 participants with active head louse infestations were randomly assigned to treatment with either a dimeticone-based test product, or a 0.5% permethrin-based reference product (50 participants per group). Participants received two topical applications of either the test (10 min) or reference products (45 min) at days 0 and 7 or 8. Outcome measures included the efficacies of treatment and their safety, as well as global and local tolerability at baseline, and days 1, 7, and 10. RESULTS: After 10 min exposure, all lice treated with the dimeticone test product were classified as non-viable in the in vitro assay. Ovicidal activity after treatment of eggs with the dimeticone test product was 96.8%. In the clinical trial, 96 patients completed all study visits. In the full analysis set (FAS) population, on day 1 after one application, 98% of patients were cured in the test group, as compared to 84% cured in the reference group. All participants in both groups were free of head lice on day 10, following two applications (100% cure rate). In total, 42 adverse events (AEs) in 23 patients of both treatment groups were recorded, with the majority of AEs classified as mild. CONCLUSIONS: We have shown a high level of pediculicidal and ovicidal activity, and clinical efficacy and safety, of a brief application of a new dimeticone-based product. The short application time and reduced risk for the development of resistance are key drivers for improved patients' compliance. TRIAL REGISTRATION: EU Clinical Trials Register EudraCT  2016-004635-20 . Registered 14 November 2016.

A Comparison of Endoscopic Reduction for Medial Blowout Fractures Using a Bioresorbable Panel and Silastic Sheet.

BACKGROUND: The aim of the study was to compare the effectiveness of endoscopic endonasal reduction using a bioresorbable panel and silastic sheet packed with Merocel for blowout fractures of the medial orbital wall. DESIGN: Retrospective study. METHODS: The study group consisted of 147 patients who underwent endoscopic endonasal reduction of a blowout fracture of the medial orbital wall between January 2005 and December 2016. Fifty-seven fractures were repaired using a splint formed by a silastic sheet and Merocel (splint group), whereas 90 fractures were repaired using a bioresorbable panel for interposition (interposition group). Postoperative complications and surgical outcomes of the 2 groups were compared. RESULTS: Preoperative diplopia in both groups (n = 30) was resolved except 1 in interposition group after the reduction. Enophthalmos was resolved in 10 cases in the splint group and in 6 cases in the interposition group. In postoperative CT scans, 20 of the 57 cases in the splint group exhibited under- or overcorrection, compared with 9 of the 90 cases in the interposition group (P < 0.05). There were no sinus infections or implant-related side effects in the interposition group except for implant extrusion in 4 cases, whereas 7 cases developed sinusitis in the splint group (P < 0.05). CONCLUSIONS: Endonasal endoscopic reduction using a bioresorbable panel may be considered as a surgical alternative for the treatment of medial orbital blowout fractures.

Macroplastique for women with stress urinary incontinence secondary to intrinsic sphincter deficiency.

OBJECTIVE: To evaluate the subjective and objective outcomes of MacroplastiqueR (MPQ) in women with stress urinary incontinence (SUI) secondary to intrinsic sphincter deficiency (ISD). MATERIALS AND METHODS: Following Institutional Review Board (IRB) approval, charts of non-neurogenic women with SUI secondary to ISD who underwent MPQ injection and had 6 months minimum follow-up were reviewed from a prospectively maintained database. Patients were divided into 3 groups: Naive (Group I), Prior Anti-Incontinence Surgery (Group II), and combined Prior Bulking Agent and Anti-Incontinence Surgery (Group III). Data collected included SUI self-report, Urogenital Distress Inventory (UDI-6) Question 3, and VAS Quality of Life (QoL) Questionnaire scores at baseline and in follow-up. Three-dimensional ultrasound (3DUS) evaluated volume/confi guration of MPQ. Success was defi ned after the last MPQ injection as a UDI-6 Question 3 score of 0 (dry) or 1, and no reoperation for SUI. RESULTS: From 2011-2017, 106 of 142 women met study criteria. At a median follow-up of 20 months (mean=26 months; range: 6-71), success rate was 41% for Group I, 40% for Group II, and 65% for Group III (p = 0.22). QoL scores were signifi cantly improved over baseline in all groups. There was no signifi cant difference in clinical outcome between the asymmetrical and symmetrical group on 3DUS. The completely dry rate was highest in Group III at 29%, compared to 4% for Group I and 15% for Group II (p = 0.05). CONCLUSION: MacroplastiqueR improved subjective and objective outcome measures for SUI secondary to ISD as both a primary and secondary treatment option in women.

Results of an innovative bulking agent in patients with stress urinary incontinence who are not optimal candidates for mid-urethral sling surgery.

AIMS: To assess the efficacy and safety of peri-urethral bulking injections (PBI) with an innovative bulking material (PDMS-U) in women with stress-urinary incontinence (SUI) who are not optimal candidates for mid-urethral sling surgery. METHODS: A prospective study was performed in women with SUI who, for several reasons, have a relative contraindication for a mid-urethral sling procedure. These reasons include: (i) recurrent SUI after a prior SUI surgical procedure; (ii) a history of oncologic gynaecological surgery; (iii) a history of neurologic disease resulting in voiding problems; (iv) a maximal flow rate of less than 15 mL per second or; (v) women with a contraindication for surgery with general or regional anaesthesia. All women were treated with PBI consisting of PDMS-U, a bulking agent that polymerizes in situ. The primary outcome was subjective improvement, defined as "a little better" to "very much better" on the PGI-I. Secondary outcomes included objective cure, disease specific quality of life and adverse events. RESULTS: Subjective improvement was reported by 18 (90%) of the 20 included patients. The subjective cure rate was 56% and the objective cure rate was 65%. There was a statistically significant improvement of all domain scores of the UDI-6, IIQ-7, and PISQ-12 at 6 months follow up. Abnormal post voiding residual volume (>150 mL) was the most common adverse event (40%), but persisted in only one patient, based on the patient's preference for a catheter. CONCLUSIONS: PBI with PDMS-U is a viable treatment option in women with a relative contra-indication for mid-urethral sling surgery.

Urolastic®, a new bulking agent for treatment of stress urinary incontinence: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: The aim of the present systematic review and meta-analysis was to assess the effectiveness and safety of injections of the new bulking agent Urolastic® in the treatment of patients with stress urinary incontinence (SUI). METHODS: A systematic search was carried out to select observational and experimental studies on Urolastic® in female patients with SUI. Three different databases, Pubmed, the Cochrane Central Register of Controlled Trials, and Scopus, were used to retrieve scientific articles published from their inception to 31 January 2018. RESULTS: Eight full texts were evaluated but only five were selected for the qualitative and quantitative analyses. Duration of follow-up after Urolastic® injections was significantly heterogeneous, ranging from 6 to 24 months. Secondary injections were needed in 16.7%-35.0% of the treated patients. The pooled proportion of secondary injections was 20% (95% CI: 15%-24%; I2: 0%). Subjective improvement, measured by different means (i.e., patient global impression of improvement PGI-I score) was only assessed by 40% of the selected papers and was > 80% in two cohorts. The objective treatment success was evaluated by four (80.0%) papers and was achieved in all cohorts with a wide proportional range: from 32.7% (i.e., patients without objective SUI symptom cough tests and with a negative pad test) to 67.0%. Its pooled proportion was 57% (95% CI: 38%-75%; I2: 82.3%). CONCLUSIONS: Urolastic® showed effectiveness in patients with SUI during a follow-up period of 6-24 months.

The Effect of Dexpanthenol-Vitamin A (Nazalnem) on Silastic Splints After Nasal Septal Surgery.

OBJECTIVE: To investigate the effect of dexpanthenol-vitamin A (Nazalnem) ointment applied to the surface of silastic splints with an airway immediately after nasal septal surgery on postoperative complaints and nasal mucosa function. MATERIALS AND METHODS: The study enrolled 60 patients undergoing nasal septoplasty surgery. Group 1 (n = 30) received silastic splints with ointment containing dexpanthenol-vitamin A (Nazalnem), and Group 2 (n = 30), the control group, received silastic splints with vaseline. Of these patients, 2 patients from the Group 1 and 9 from the Group 2 were excluded.A thin layer of ointment was applied to the flat side of a silastic splint with an airway. The splints were removed on the second postoperative day. Patients were evaluated preoperatively and 1 and 2 weeks postoperatively using a visual analog scale and the Sino-Nasal Outcome test (SNOT-22). Mucociliary clearance (MCC) tests were performed at the same times. RESULTS: Visual analog scale for nasal crusting, nasal congestion, and foul odor was better in Group 1 than in Group 2 both at 1 week and at 2 weeks postoperatively (P < 0.05).The SNOT scores were significantly lower in Group 1 than in Group 2 at 1 week (P < 0.01), but did not differ at 2 weeks postoperatively (P > 0.05).Postoperatively, the MCC were insignificant between the groups and within the groups at 1 and 2 weeks (P > 0.05). CONCLUSION: Although Dexpanthenol-Vitamin A ointment had no direct effect on wound healing, it had significant effects on crusting, obstruction, and foul smell. However, silastic splints with dexpanthenol did not improve the MCC of the nose.

Techniques for Optimizing Surgical Scars, Part 2: Hypertrophic Scars and Keloids.

Surgical management of benign or malignant cutaneous tumors may result in noticeable scars that are of great concern to patients, regardless of sex, age, or ethnicity. Techniques to optimize surgical scars are discussed in this three-part review. Part 2 focuses on scar revision for hypertrophic and keloids scars. Scar revision options for hypertrophic and keloid scars include corticosteroids, bleomycin, fluorouracil, verapamil, avotermin, hydrogel scaffold, nonablative fractional lasers, ablative and fractional ablative lasers, pulsed dye laser (PDL), flurandrenolide tape, imiquimod, onion extract, silicone, and scar massage.

Safety and efficacy of a 100% dimethicone pediculocide in school-age children.

BACKGROUND: Head lice most commonly affect children, ages 3 to 11. Concerns exist about the safety and efficacy of pesticide-based treatments. Published studies suggest dimethicone is a potentially safe and effective non-toxic treatment, but have not evaluated 100% dimethicone in a pediatric population. The objectives were to evaluate the efficacy and safety of 100% dimethicone for the treatment of head lice in children, monitored by school nurses. METHODS: This was a multi-site, open-label study of a 100% dimethicone gel for the treatment of head lice in a pediatric population. Children (ages 3-12) suspected of infestation with head lice were evaluated by school nurses at six schools and daycare programs in New York and New Jersey. Inclusion criteria were presence of at least three live lice, or one live louse and 10 viable eggs (eggs found within 1.27 cm of the scalp) and no use of any head lice treatment within four weeks of enrollment. Counts of live lice and viable eggs found in 58 subjects were tracked at baseline (Day 0) and on Day 1, Day 7, and Day 14 after treatment. RESULTS: After 1 day of treatment with 100% dimethicone, 98.30% of subjects were free of live lice and 55.20% were free of viable eggs. On day 14, 96.50% were still free of live lice, and 80.70% were free of viable eggs. All subjects were monitored by the school nurse at baseline and throughout the study period for adverse effects, including scalp erythema, excoriation, flaking and edema. There was one adverse event of skin irritation lasting 10 min, and no serious adverse events reported. Overall, scalp conditions improved from the baseline: 10 subjects (17.5%) reported mild to moderate scalp erythema on day 1, compared with only one subject (1.7%) on day 14; 8 subjects (14.3%) reported mild scalp excoriation on day 1, with none reporting on day 14. CONCLUSIONS: 100% dimethicone was found to be a safe and highly effective treatment for pediatric head lice. Because dimethicone avoids pesticide exposure and resistance issues, dimethicone should be considered as a first-line treatment for head lice. TRIAL REGISTRATION: NCT02213055 Date of registration: August 8, 2014. STANDARDS OF REPORTING: The CONSORT 2010 Checklist was consulted during the review of this manuscript. Please note that sections pertaining specifically to randomized controlled trials (RCT's) were not applicable.

Polydimethylsiloxane for injection laryngoplasty: two cases necessitating tracheotomy.

The surgical treatment of glottic insufficiency due to lesions of the recurrent laryngeal nerve has become a routine procedure in the last few decades. In particular, injection laryngoplasty with polydimethylsiloxane (PDMS) has proved to be an easy, effective and safe method for vocal fold medialization. It is a biologically inert substance having almost ideal properties as a filler; complications related to its intralaryngeal use such as migration, or granuloma formation are extremely rare and allergic reactions have not been reported as yet. We discuss two cases representing the first description of acute severe complications after injection laryngoplasty with PDMS.

Steroid-sparing properties of emollients in dermatology.

Topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs) are very effective treatments in inflammatory dermatoses, but carry risks with long-term use. TCS are associated with cutaneous atrophy and tachyphylaxis and TCIs can be irritating and contain a black box warning of an increased risk of cancers including lymphoma and non-melanomatous skin cancers. Nevertheless, they are appropriate treatments for inflammatory conditions such as psoriasis and atopic dermatitis (AD) and should be used more often with disease flares and less as maintenance therapy. Given the associated risks of long-term continuous use with these pharmacologic agents, alternatives are needed with similar anti-inflammatory and barrier repair properties that can be used indefinitely without risk. Some over-the-counter (OTC) ingredients such as colloidal oatmeal and petrolatum, as well as anti-inflammatory prescription moisturizers (medical device creams), have demonstrated efficacy with little complications in skin barrier repair and symptom relief in steroid-responsive conditions. With regimented application, these non-drug options are safe and effective and can limit the longterm continuous use of TCS or TCIs.

Antibacterial activity of various root canal sealers and root-end filling materials in dentin blocks infected ex vivo with Enterococcus faecalis.

OBJECTIVE: The aim was to investigate the antibacterial activity of the root-end filling materials MTA and IRM, different endodontic sealers and calcium hydroxide [Ca(OH)2] in experimentally infected dentinal tubules. MATERIALS AND METHODS: Ninety-four human root segments were prepared and the root canals were enlarged to ISO size 90. After smear removal, the specimens were infected with Enterococcus faecalis for 3 weeks. The roots were divided into eight groups and filled either with MTA, IRM, Ca(OH)2, gutta-percha and EndoRez (ER)/GuttaFlow (GF)/AH Plus (AH+) or with Resilon and Epiphany (EpRe). One group of specimens was left unfilled for control. Half of the specimens were treated for 1 day and the other half for 7 days in humid conditions at 37°C. Dentin samples from each canal were collected by enlarging the canals to ISO size 150; thus a dentinal depth of 300 µm was sampled. The number of cultivable bacteria was determined for each specimen. Statistical significance was set to 5%. RESULTS: After 1-day or 7-days of treatment, compared to control, all materials (except ER and GF at day 7) significantly reduced the number of bacteria. At day 1 and day 7, no significant difference was found between ER and GF and between Ca(OH)2, AH+, EpRe, IRM and MTA. However, a significant difference was found between these two groups of materials (except between GF and EpRe at day 7). Significantly more bacteria were cultured in the ER, GF, EpRe and IRM groups at day 7 compared to day 1. CONCLUSIONS: All materials exerted varying degrees of antibacterial activity which generally tended to decrease with time. The most stable antibacterial effect throughout the 7-day period was for Ca(OH)2, AH+ and MTA.