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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 χ 2  = 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) (χ 2  = 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.

Great endeavors have been dedicated to the development of wound dressing materials. However, there is still a demand for developing a wound dressing hydrogel that integrates natural macromolecules without requiring extra chemical modifications, so as to enable a facile transformation and practical application in wound healing. Herein, a composite hydrogel was prepared with water-soluble polysaccharides from Enteromorpha prolifera (PEP) cross-linked with boric acid and polyacrylamide cross-linked via polymerization (PAM) using a one-pot method. The dual-network of this hydrogel enabled it to have an ultratough mechanical strength. Moreover, interfacial characterizations reflected that the hydrogen bonds and dynamic hydroxyl-borate bonds contributed to the self-healing ability of the PEP-PAM hydrogel, and the surface groups on the hydrogel allowed for tissue adhesiveness and natural antioxidant properties. Additionally, human epidermal growth factor-loaded PEP-PAM hydrogel promoted cell proliferation and migration in vitro and significantly accelerated wound healing in vivo on model rats. These progresses suggested a prospect for the PEP-PAM hydrogel as an effective and easily available wound dressing material. Remarkably, this work showcases that a wound dressing hydrogel can be facially developed by using natural polysaccharides as a one component and offers a new route for the high-value utilization of disastrous marine blooming biomass by transforming it into a biomedical material.

Aims: Bulking agents are a minimally invasive treatment option for women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). The aim of this study was to evaluate long-term efficacy and safety following treatment with Bulkamid as a primary procedure for SUI or stress-predominant MUI., Methods: This was an Institutional Review Board-approved single-center retrospective study of female patients with SUI or stress-predominant MUI who had undergone injection with Bulkamid since 2005 and had completed 7 years of follow up. The primary endpoint was patient satisfaction measured on a four-point scale as cured, improved, unchanged, or worse. Secondary outcomes included the number of incontinence pads used, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF) scores, Visual Analog Scale Quality of Life (VAS QoL), reinjection rates, and perioperative and postoperative complications., Results: A total of 1,200 patients were treated with Bulkamid since 2005 and of these, 388 (32.3%) had completed 7 years of follow-up. A total of 67.1% of the patients reported feeling cured or improved if Bulkamid was a primary procedure, 11.1% reported no change, and 2.3% reported worsening of incontinence. A total of 19.5% of patients received a subsequent other incontinence procedure. The ICIQ-UI SF was reduced by 8.6 points. VAS QoL improved by a mean of 4.3 points. Postoperative complications were transient. Prolonged bladder emptying time was reported in 15.3% of patients and urinary tract infection in 3.5%., Conclusions: Bulkamid injections are an effective and safe first-line treatment option for women with SUI or stress-predominant MUI providing durable outcomes at 7 years., (© 2021 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)

Aims: The aim of the present work is to analyze the safety profile, effectiveness, and favorable and unfavorable predictors of clinical outcome in urethral bulking with Bulkamid, and to better identify the ideal candidate for the procedure., Methods: We included all consecutive female patients treated with urethral bulking with Bulkamid at our institution within 2 years. Patients were affected by stress urinary incontinence (SUI) or mixed incontinence. Incontinence severity was classified as "mild" (urinary leakage <50 g/die), "moderate" (50-200 g/die), or "severe" (>200 g/die) at 24-hours pad test. Clinical success was defined as "dry" (no pads); clinical failure included "partial improvement" (>50% 24-hours pad test reduction) and "no benefit" (<50% 24-hours pad test reduction). The χ 2 and Mann-Whitney tests were performed to assess the predictors of clinical outcome., Results: The success rate was 36.1% (n = 35). Forty-three patients (44.3%) reported continence improvement. Complications included eight urinary retention cases (8.2%). Statistically significant correlation was observed between incontinence severity and clinical outcome in thee χ 2 test (P = .008). No significant correlation was found between functional outcome and urodynamic incontinence features, postoperative urinary retention, previous pelvic surgery, age, and other physiological, pathological, and urodynamics characteristics. Urinary retention following the surgical procedure appeared to be related to clinical success with nonsignificant P value (P = .10)., Conclusions: Bulkamid procedure could be proposed with good results in elderly patients or in patients requiring a low-invasive procedure with low risk of complications, affected either by SUI or mixed incontinence and with mild to moderate incontinence. Previous training to clean intermittent self-catheterization maneuver should be performed., (© 2020 Wiley Periodicals LLC.)

Objective: The objective of this study was to review the literature to compare the efficacy and complications of polyacrylate-polyalcohol copolymer (PPC) and polyacrylamide hydrogel (PAHG) with the current standard of care, dextranomer/hyaluronic acid (Dx/HA), when used to treat VUR in the paediatric population., Methods: PubMed, Embase and Cochrane databases were searched. Keywords included Vesicoureteral reflux (VUR), endoscopic; endoscopic injection, endoscopic treatment, dulking material, dextranomer/hyaluronic acid copolymer, polyacrylate-polyalcohol copolymer, Deflux, Dexell, Vantris, Bulkamid, outcome, treatment and children. Prospective or retrospective studies comparing PAHG/PPC directly with Dx/HA were included for review., Results: Four studies were identified comparing PPC with Dx/HA. All studies showed superior efficacy (on micturating cystourethrogram (MCUG) at 3 months) of PPC over Dx/HA. However, 1 study identified a significantly higher rate of vesicoureteric junction obstruction (VUJO) in the PPC group. One study was identified comparing PAHG with Dx/HA which showed similar efficacy on 3-month MCUG., Conclusions: Current data suggest PPC confers a higher resolution rate of VUR and PAHG confers comparable resolution rates for VUR compared with Dx/HA in the paediatric population. However, the incidence of late-onset VUJO in one study is concerning, and high-quality randomised controlled trials with long-term follow-up are needed before making further recommendations., (Crown Copyright © 2019. Published by Elsevier Ltd. All rights reserved.)

Periurethral injection offers an alternative to the current main method for surgical treatment of stress incontinence in women, which is a polypropylene sling that is placed without tension below the mid-urethra. Injection therapy is a simple, gentle method that provides significant improvement in the degree of leakage and quality of life, but the results are not on a par with the polypropylene sling. Injection therapy may be relevant when the main method is not suitable or desired.

Purpose: This study was designed to investigate the applicability of carbomer 940 hydrogel on skin-burn wounds by focusing on its effects on the zone of stasis., Method: Fibroblast cells were used to assess the cytotoxicity of carbomer 940. Wound healing was monitored by laser Doppler flowmetry and histopathological analysis. Twenty adult male Wistar rats were randomly divided into two groups (N = 10 each). After shaving their dorsum, a 'burn comb' was contacted bilaterally on each side of the spine. Carbomer 940 hydrogel and TegaDerm were used as topical dressing, in the experimental group, while normal saline and TegaDerm were used as the control. The dressing was changed daily and the blood flow was measured until the animals were euthanized. The wound samples were collected at days 3 and 21 for histopathological studies. Cell viability study showed that the hydrogel was non-cytotoxic., Result: Our results revealed that skin blood perfusion in the zone of stasis was elevated at 24 hour post-burning, in the experimental group but not in the control group (p < .05) and this trend continued until the animals were euthanized. Histopathologically, there was statistically more epithelial tissue in the zone of stasis in the experimental group than in the control group, and the sebaceous glands and hair follicles remained viable in the group treated by hydrogel on day 3. There was significantly more collagen deposition and fibroplasia in the ischemic zones of the experimental group than in the control group at day 21., Conclusion: Our study has shown that carbomer 940 hydrogel is a nontoxic biomaterial, which improved tissue perfusion and decreased the area of necrotic tissue in burn wounds. Application of this biomaterial in treatment of burn injuries deserves further studies.

Introduction and Hypothesis: Mixed urinary incontinence (MUI), defined as mixed symptoms of stress urinary incontinence (SUI) and overactive bladder (OAB), is a difficult entity if conservative treatment has failed. Cure rates are low compared with SUI, particularly the OAB component, may deteriorate after sling insertion. Bulking agents pose an appealing alternative for the treatment of MUI. They have shown beneficial effect in small case studies, but larger series are lacking. The aim of this prospective study was an analysis of treatment efficacy and safety profile of the bulking agent, Bulkamid, in female patients with MUI., Methods: One hundred fifty-four women with MUI symptoms (components of SUI/OAB within the limits of 60-40% either way) received bulking therapy with polyacrylamide hydrogel (Bulkamid). Patients were followed-up 3 months postoperatively. Primary outcome was the domain Incontinence impact on the King's Health Questionnaire (KHQ). Secondary outcomes were the other KHQ domains, visual analog scale (VAS), and International Continence Society (ICS) standardized pad weight test as objective measurement of incontinence., Results: Statistically significant improvements were found for all KHQ domains, pad weight test, and the visual analog scale (VAS) before and after bulking. Overall complication rate was 13%., Conclusions: This study has shown improvement in MUI after bulking therapy according to both subjective and objective outcomes. We can advocate bulking therapy for treating MUI, as it is simple and safe and shows both objective and subjective improvement and relief. Long-term results (up to 1 year) are awaited.

Burn wound management is a complex process because the damage may extend as far as the dermis which has an acknowledged slow rate of regeneration. This study investigates the feasibility of using hydrogel microparticles composed of bacterial cellulose and polyacrylamide as a dressing material for coverage of partial-thickness burn wounds. The microparticulate carrier structure and surface morphology were investigated by Fourier transform infrared, X-ray diffraction, elemental analysis, and scanning electron microscopy. The cytotoxicity profile of the microparticles showed cytocompatibility with L929 cells. Dermal irritation test demonstrated that the hydrogel was non-irritant to the skin and had a significant effect on wound contraction compared to the untreated group. Moreover, histological examination of in vivo burn healing samples revealed that the hydrogel treatment enhanced epithelialization and accelerated fibroblast proliferation with wound repair and intact skin achieved by the end of the study. Both the in vitro and in vivo results proved the biocompatibility and efficacy of hydrogel microparticles as a wound dressing material.

Objective: The review article describes the possibilities of procedures for failed anti-incontinence surgery - sling procedure or "bulking agent"?, Design: Review article., Setting: Department of Obstetrics and Gynecology, General Faculty Hospital and 1st Medical Faculty, Charles University, Prague., Materials and Methods: The correct choice of procedure type to treat persistent SUI (Stress Urinary Incontinence) which persists or soon reoccurs after anti-incontinence surgery is often problematic. The procedures that treat SUI decrease excessive mobility of the urethra by partially compressing it. If the excessive mobility of the urethra and BN (bladder neck) persist and MUCP (Maximal Urethral Closure Pressure) is within normal range, then we choose a new sling operation to treat the persistent SUI. What type of sling procedure is preferable in this situatitons: transobturator, retropubic or possibly SISs (Single Incision Slings)? SISs are not adequately fixed to the surrounding structures after implantation and are often not of the correct size - especially regarding length - with poor compliance (elasticity). For mentioned reasons we do not use them in reoperations. In this cases we choose such a sling which is properly fixed to the surrounding structures, is of sufficient length, and of appropriate elasticity. When choosing the right type of procedure we also have to consider previous operations: for example, whether reconstructive surgery of pelvic floor defects using mesh has been carried out, where the mesh has been placed, and whether it might be an obstacle to the newly implanted sling. If there is a low urethral mobility after the unsuccessful incontinence operation and a low MUCP is observed on urodynamic examination, then we prefer either a retropubic sling or the application of a bulking agent. The decision of which method to choose also depends on other circumstances, such as whether the patient has undergone radiation treatment or more than on previous surgery to treat SUI. The results of urodynamic, ultrasound and other examinations are very important., Conclusions: The choice of the right type of surgery to treat SUI after a previous failed procedure depends on information and findings from complex examination of the patient. Case history, examination results, imaging and the experience of the surgeon in individual procedures are therefore most important.

Introduction and Hypothesis: Polyacrylamide hydrogel (PAHG, Bulkamid®) is one of several injectable agents currently used for the treatment of women with urinary stress incontinence. Although bulking agents appear to have lower efficacy rates compared to other surgical treatments, current evidence based on large prospective or comparative studies as well as systematic reviews is limited. The purpose of this study was to conduct a systematic review on the efficacy of PAHG in the treatment of female patients with stress urinary incontinence with regard to reproducibility, feasibility, safety and clinical outcome., Methods: We searched MEDLINE (1966-2015), Scopus (2004-2015), POPLINE (1974-2015) and ClinicalTrials.gov (2008-2015) along with reference lists of electronically retrieved studies. Observational studies, prospective, retrospective and randomized controlled studies were included. Two reviewers independently selected studies, assessed the risk of bias and tabulated data to structured forms., Results: We included 8 studies, which enrolled a total of 767 patients who received treatment with PAHG. We found that 186 of 767 women (24.3 %, range 12-35 %) required reinjection in order to achieve adequate efficacy. The most frequent adverse effects were pain at the site of injection (4-14 %) and urinary tract infections (3-7 %). Both the number of incontinence episodes/24 h and the number of ml/24 h were significantly reduced 1 year following treatment and the quality of life of patients was significantly improved., Conclusions: PAHG is a safe intervention for treating women with stress urinary incontinence, but repeat injections are often required. Further research is mandated in the field in order to compare its efficacy to other bulking agents.

Long-term results (>5 years) for synthetic substances used to repair facial lipoatrophy have not been published. We performed a cross-sectional study to evaluate the 10-year safety of polyacrylamide hydrogel (Aquamid) among the 751 patients from our unit who received facial infiltrations at least 10 years ago. Epidemiological and clinical data such as complications and patient satisfaction were collected. We also identified those patients who presented a facial infection at any time after infiltration. A total of 104 patients had received Aquamid at least 10 years ago. Before infiltrations, 24.0%, 41.3%, and 34.7% presented very severe, severe, and moderate facial lipoatrophy, respectively. After a mean (SD) of 10.3 (0.5) years since the infiltrations, 19.2%, 47.7%, and 31.7% of patients reported moderate, mild, and no signs of facial lipoatrophy. The values reported by physicians for the same categories were 1.9%, 10.6%, and 87.5%. Indurations were detected in 6.7% of patients and nodules in 3.8%. Five patients (4.8%) had a local infection. A further 15 patients with a shorter follow-up (less than 10 years) presented local infections (overall incidence considering the 751 patients who received infiltrations of Aquamid, 2.7%); the product had to be withdrawn in three cases. The majority of patients were highly satisfied (74.8%) or satisfied (23.4%) with the cosmetic results; among patients with severe or very severe lipoatrophy at baseline, 31.4% were satisfied and 65.7% were highly satisfied. Infiltrations with polyacrylamide hydrogel (Aquamid) are a safe strategy for the treatment of facial lipoatrophy in the long term. The rate of severe complications was low, and patient satisfaction with the cosmetic results was high. However, facial infections may appear in the long term. Therefore, HIV-infected patients who received synthetic substances should be carefully monitored over time.

Purpose: Bulkamid® is a new polyacrylamide hydrogel bulking agent for stress urinary incontinence that is injected in the urethral submucosa using a specifically designed device. We evaluated the safety and efficacy of Bulkamid vs Contigen® collagen gel for stress urinary incontinence or stress predominant mixed urinary incontinence., Materials and Methods: This was a single-blind, randomized, prospective, 33-center, 2-arm parallel study of hydrogel vs collagen gel with followup to 1 year. At baseline patients underwent physical examination and bladder testing, and completed quality of life questionnaires and bladder diaries. After randomization patients could receive up to 3 injections at 1-month intervals. Patients were assessed 3, 6, 9 and 12 months after bulking. They completed bladder diaries and quality of life questionnaires, and pad weight was tested. At the last visit Valsalva leak point pressure was measured. Subjective and objective incontinence outcomes and adverse events were compared., Results: Of the 345 women 229 were randomized to hydrogel and 116 were randomized to collagen gel. At 12 months a 50% or greater decrease in leakage and incontinence episodes was seen in 53.2% and 55.4% of patients who received hydrogel and collagen gel, respectively. At 12 months 47.2% of patients with hydrogel and 50% with collagen gel reported zero stress incontinence episodes, and 77.1% and 70%, respectively, considered themselves cured or improved. Major adverse events were rare in each group., Conclusions: Bulkamid is not inferior to Contigen. It has a favorable, persistent effect on stress urinary incontinence with a low risk of serious adverse events. Bulkamid is a new, simple, office based bulking system that shows promise as a treatment in women with stress urinary incontinence, particularly since Contigen is no longer commercially available., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to evaluate the cure effect of a transurethral injection (TUI) of Bulkamid(®) for female urodynamic stress (USI) and stress-predominant mixed urinary incontinence. The hypothesis was that the cure effect of Bulkamid(®) is positive in patients who have undergone previous unsuccessful anti-incontinence surgery and in patients with ISD (Intrinsic Sphincter Deficiency)., Study Design: This retrospective clinical study was performed on 52 patients for whom previous anti-incontinence surgery had failed (n=40) and on patients with ISD. Five patients had a reinjection of Bulkamid(®). The efficacy of TUI was evaluated an average of 22 months (minimum - 6 months, maximum - 50 months) after the procedure. Subjective assessment of the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF). Objective assessment of leakage of urine was assessed by the cough test. The cure effect of procedures was evaluated by VAS (Visual Analog Scale: VAS score 0-100; 100 - without leakage of urine, dry) and by using the five-point Likert scale. The statistics were calculated using the software STATISTICA 10-StatSoft. Inc software (Tulsa, USA)., Results: A retrospective study was performed on 52 women with urinary incontinence (stress 43, mixed 9), and 51 patients completed the study. One patient with SUI died during the study. Their mean age was 70 years, mean body mass index (BMI) was 28.65, and mean parity was 1.76. Objective assessment by cough test showed that 19.6% of patients had negative results for this test 22 months after the operation. Subjective assessment by the ICIQ-UI SF questionnaire showed that 15.7% of patients were completely dry, while 45.1% of patients were dry or improved. The mean VAS score was 51.3, and on the Likert scale the cure effect was evaluated as 5 or 4 ("cured" or "improved") in 54.9% of patients., Conclusions: The hypothesis that the cure effect of Bulkamid(®) is positive in patients who have undergone previous unsuccessful anti-incontinence surgery, and in patients with ISD, was confirmed. The procedure is an option for failed anti-incontinence surgery or for patients with ISD., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Introduction: This study was carried out to evaluate the efficacy of periurethral injection of polyacrylamide hydrogel (PAHG, Bulkamid(®), Ethicon) for the treatment of female stress urinary incontinence (SUI)., Methods: Single-center prospective study: periurethral injection of Bulkamid(®) was performed in 80 patients with severe urinary incontinence between June 2010 and October 2011. The evaluation of the impact on quality of life was carried out using the Patient Global Impression of Severity (PGI-S), the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and Patient Global Impression of Improvement (PGI-I) before and after treatment., Results: With a mean follow-up of 18.6 ± 5.3 months, 60% of patients had improved. For 30/74 (40%) there was no improvement and no patient had worsening of PGI-I after injection. Before surgery, 55.4% of patients considered their condition as severe (PGI-S). After injecting 21/74 (28%) and 11/74 (15%) considered it normal and severe (zero leakage). The ICIQ -SF score increased from 17 ± 2.84 before injection to 13 ± 5.52 after surgery, with a significant 30% decrease (P<0.00001). The reinjection rate was 29%. The complication rate was 16% (17/108): 11 cases of transient postoperative retention, 2 cases of cystitis, dysuria four episodes. No abscess or infection at the injection site, no specific complication to the product used., Conclusion: With an (PGI-I) improvement rate of 60 and 15% of patients without leakage (PGI-S/ICIQ), periurethral injection of Bulkamid(®) is an effective and safe treatment option for women with a severe urinary incontinence especially in therapeutic failure., Level of Proof: 4., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Introduction: To assess the effectiveness of polyacrylamide hydrogel (Bulkamid®) in injection therapy for urinary incontinence in women of 80 or more years., Materials and Methods: Twenty consecutive women mean age 84.5 (range 80-87) with stress or mixed urinary incontinence were enrolled in this prospective study. All subjects were evaluated at baseline and re-evaluated 7 days, 6,12,18 and 24 months after treatment. A detailed clinical evaluation, physical examination, daily pad count, urodynamic investigation and evaluation of urethral mobility by trans-labial ultrasound were performed., Results: A statistically significant decrease in the number of pads was observed in the follow-up (p = 0.0002 after 24 months). Physical examination showed a statistically significant lack or reduced lost of urine with stress test (p = 0.0163 after 24 months). Urodynamic findings showed an increase of Valsalva leak point pressure, maximum urethral closure pressure and functional length. Maximum flow and post void residual were respectively observed to be significantly reduced and increased only after 7 days from injection therapy. Quality of life (QoL) assessed with the Incontinence Impact questionnaire short form (IIQ-7) showed a statistically significant improvement (p = 0.0001 after 24 months). Patient satisfaction assessed with the Visual Analogue Scale and Patient Global Impression of Improvement questionnaire respectively produced evaluation of ″satisfied″ and "much improved" even after 24 months., Conclusions: Polyacrylamide hydrogel (Bulkamid®) is an effective treatment with low morbility in patients of 80 or more years.

Bulkamid is a periurethral bulking agent used to treat stress urinary incontinence (SUI). Manufacturers describe it as nontoxic, nonbiodegradable and biocompatible. Periurethral abscesses are one of the known complications of bulking agents. We present the first reported case of periurethral abscess following Bulkamid injection. The woman had previously had a transobturator tape (TOT) and total vaginal mesh repair. At 6 weeks after injection of the bulking agent, she reported 100 % cure of her SUI. Transperineal ultrasound was used to diagnose and monitor an abscess that developed anterior and lateral to the urethra and separate from the TOT. Magnetic resonance imaging was helpful in delineating the extent of the abscess into the retropubic space but was not able to identify the urethra or the TOT. Surgical drainage of the abscess was performed vaginally, resulting in successful resolution of pain but recurrence of incontinence.

Introduction and Hypothesis: Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence., Methods: Submucosal injection of PAHG was performed in 135 women with urinary incontinence, with subjective and objective assessment of the efficacy and safety 24 months postinjection., Results: At 24 months, the subjective responder rate was 64 % (a statistically non-significant reduction from 67 % at 12 months). The decreased number of incontinence episodes and urine leakage were maintained compared with the result from the 12-month evaluations, as were objective result rates and quality of life data. No safety issues occurred., Conclusions: PAHG is an effective and safe treatment option for women with stress-predominant mixed urinary incontinence, with maintained medium-term responder rates.

Objective: Studies have demonstrated the protective effects of biomaterials against myocardial infarction (MI), but the relationship between their physical characteristics and their function is incompletely understood. This study investigated such relationships for a hydrogel preparation., Methods: Two types of poly(N-isopropylacrylamide) (PNIPAAm) hydrogel with different degradation times (Gel A and Gel B) were synthesized. In vivo hydrogel formation and maintenance were observed and confirmed in mice. The solutions were also injected into the infarct area immediately after MI induction in rats., Results: PNIPAAm hydrogel exhibited a three-dimensional structure resembling native extracellular matrix (ECM). Compared with phosphate-buffered saline, Gel A and Gel B increased contractility of isolated infarcted myocardium, reduced collagen deposition, increased neovascularization, inhibited left ventricle expansion and improved cardiac function. Myocardial contractility was greater with Gel B than with Gel A., Conclusions: Intramyocardial injection of PNIPAAm hydrogel provides structural support and some functional repair of damaged ECM, suggesting that it might be useful for cardiac tissue engineering.

Background: Several treatments have been described for facial wasting rehabilitation in HIV-positive patients. In this article, we compare lipofilling and a nonabsorbable filler for facial wasting rehabilitation induced by antiretroviral therapy in HIV-positive patients., Methods: This study was conducted as a clinical prospective study. Twenty-three HIV-positive patients affected by facial wasting were treated for facial rehabilitation, between January 2007 and December 2008, at the Head and Neck Department of the II University of Naples. They were divided into 2 groups; the first group was treated with lipofilling (group A), and the second one with the injection of a nonabsorbable filler, Aquamid reconstruction (Contura International A/S, Soeborg, Denmark) (group B).All the patients were HIV-positive, they had been receiving antiretroviral therapy for several years (1.8-6.7 years, 3.2 years on average) and showed clinical signs of facial lipoatrophy. Group A was composed of 14 patients (9 men, 5 women; mean age, 43.7 years), all presenting facial wasting and lipohypertrophied areas of the body. Group B was composed of 9 male patients, 7 presenting only facial wasting, and 2 presenting lipohypertrophied areas of the body (mean age, 44.8 years). Clinical efficacy was assessed independently by the investigator and the patient, 3 months, 6 months, and 1 year after baseline. The main assessment was made by the investigator using the Global Aesthetic Improvement Scale (GAIS) 1 year after baseline; secondary assessment using the GAIS was made by the investigator and the patient 6 months after baseline., Results: There were no major complications. No infections or other complications were observed. According to GAIS ratings, group A (lipofilling) obtained significantly higher ratings than did group B (nonabsorbable filler) after baseline (P < 0.05)., Conclusions: We can treat HIV-related lipodistrophy more extensively with lipofilling because, after harvesting the fat graft, other body contouring procedures also can be performed; there is a better aesthetic outcome in facial rehabilitation performed with lipofilling, probably due to the possibility to fill deeper than with nonabsorbable fillers.

Introduction: Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence., Methods: Submucosal injection of Bulkamid® was performed in 135 women with urinary incontinence (stress, 67; mixed, 68) followed for 12 months. Forty-seven had a reinjection (35%)., Results: At 12 months, the subjective response rate was 66%. Incontinence episodes/24 h and urine leakage g/24 h decreased significantly (from 3.0 to 0.7 and 29 g to 4 g, respectively). Additionally, the median International Consultation on Incontinence Questionnaire score was reduced to approximately 50%, and the overall quality of life visual analogue scale score was decreased significantly (from 72 to 20). Efficacy was very similar between patients with stress and mixed incontinence. Thirty treatment-related adverse events were registered. The most frequent was urinary tract infection (n = 10). No polyacrylamide hydrogel-specific adverse events were seen., Conclusions: Bulkamid® is an effective and safe bulking agent in women with stress or mixed incontinence.

Infiltrations with synthetic substances are effective strategies for repairing facial lipoatrophy. However, few data are available on long-term safety. We describe the safety of polyacrylamide hydrogel in 145 patients who received facial infiltrations with Aquamid from September 2002 to April 2004. Epidemiological, clinical (mainly complications), and psychological data (patient satisfaction) were collected. We also recorded all patients who presented with a local infection at any time after receiving an infiltration. Sixty-two percent of patients presented with severe facial lipoatrophy before infiltration. The cumulative volume of Aquamid injected was 5.5 ml (4-18) per patient. During a mean (SD) of 50.2 (4.3) months after infiltration, only one patient presented with a local infection. Small palpable, nonvisible nodules or indurations were the most frequent complications (19.3% and 6.2%, respectively). If we include the remaining patients from our center (n = 294) who also received Aquamid (although less than 4 years ago), a further three patients presented with a local infection (incidence of 0.9%). Most patients (88.9%) were "satisfied" or "very satisfied" with the results; patients with mild to moderate baseline facial lipoatrophy were more satisfied than those with severe lipoatrophy ("very satisfied": 92.7% versus 86.5%, respectively). Only 17.4% reported mild impairment of lipoatrophy and only 9.2% required new infiltrations; however, 76% would have preferred more infiltrations. The high patient satisfaction and the low number of severe complications after at least 4 years of facial infiltrations with Aquamid reflect the long-term safety of this product for the repair of facial lipoatrophy. However, prolonged follow-up of these patients is recommended to detect unexpected long-term adverse reactions.

Background: Polyacrylamide (Aquamid) is a nonabsorbable soft-tissue filler. It consists of a polyacrylamide hydrogel. Safety and aesthetic results after injection of polyacrylamide hydrogel for facial soft-tissue enhancement were analyzed in a clinical trial., Methods: In a prospective multicenter study, 251 patients were enrolled for injection of polyacrylamide hydrogel (Aquamid). The results of the first year follow-up have been described previously. One hundred one of 251 initially enrolled patients could be recruited for follow-up 24 months after the first injection. Standardized photographs were taken, and blood and urine samples were collected before treatment and during follow-up visits. Common sites of injection were nasolabial folds, lips, glabella folds, and other sites. The amount of injected gel ranged from 0.2 to 12 ml., Results: A course of 24 months was followed in 101 patients. Results were judged to be good or very good by the investigators in 93 patients. Eighty-six patients judged the aesthetic outcome as satisfactory or very satisfactory. No severe side effects were observed during the 2-year follow-up period. Transient local reactions that resolved spontaneously were detected in several patients. In one case, burning sensations after lip augmentation were reported lasting up to the 24-month follow-up visit., Conclusions: Polyacrylamide hydrogel (Aquamid) yielded satisfying aesthetic results in more than 90 percent of patients. There was no difference in efficacy between 12 and 24 months' follow-up. No adverse soft-tissue reaction was observed. The study group may be biased, as patients with bad results may have refrained from further follow-up. Long-term follow-up is necessary.

Background: Polyacrylamide is a nonabsorbable soft-tissue filler that has been used for body contouring for more than 10 years. Aquamid is a soft-tissue filler containing polyacrylamide hydrogel. Safety and aesthetic results after injection of polyacrylamide hydrogel for facial soft-tissue enhancement were assessed at a 1-year follow-up., Methods: In a prospective, multicenter study, 251 patients were enrolled and assigned for injection of polyacrylamide hydrogel (Aquamid) as a means of facial augmentation and enhancement of facial contours. Subjects with facial contour deformities or soft-tissue deficiencies caused by aging, acne, trauma, surgery, or other causes were included. Persons presenting with connective tissue disorders, skin disorders affecting the face, uncontrolled diabetes mellitus, compromised immune functions or acute inflammatory diseases, known substance abuse, or mental disorders were excluded from participation in the study, as were those who had experienced treatment with any nonabsorbable filler within 6 months before the start of the study. To assess the safety and efficacy of the treatment, follow-up visits were scheduled for day 7, day 28, and 3 months, 6 months, and 12 months after the first injection. Standardized photographs were taken before treatment and during month-3 and month-12 visits. Blood and urine samples were collected and analyzed before injection and at 6 and 12 months after injection. The most common sites of injection were the nasolabial folds (48 percent) and lips (25 percent) followed by glabella folds (8 percent) and other sites. The amount of injected gel ranged from 0.2 to 12 ml., Results: Two hundred twenty-eight patients were followed for 12 months after treatment. In 93 percent, results were judged to be good or very good by the investigators and satisfactory or very satisfactory by the patients. Adverse events that could be ascribed to the treatment were observed in 37 cases, most commonly presenting as transient swelling, hematoma, redness, and pain or itching. In one case, a slight change of skin color at the site of injection was reported. No severe adverse events related to the gel were observed. In one case, neutropenia was detected in month-12 blood samples. The other values were within the normal ranges., Conclusions: Aquamid is an easy-to-use soft-tissue filler. The effect of tissue enhancement lasted over the entire study period. Transient local tissue reactions observed were attributable to the injection procedure rather than the chemical properties of the gel. During the first year after treatment, no permanent soft-tissue reaction was observed. Long-term results need to be evaluated in the future.

Polyacrylamides have been used in tissue augmentation since 1980. AQUAMID injections amounting to 40,000 have been done for facial and body corrections in cosmetic and reconstructive medicine and surgery. Possible neurotoxic and carcinologic effects of acrylamide and their stability are reported. The most important complications are infection, granuloma, and migration. All actual studies and results are reported. Main indications are lips, nasolabial fold, and malar area.

Hydrogels present an attractive alternative to nanoscale block copolymer aggregates and microscale resin beads as potential asystemic serum cholesterol reduction materials. Not only would the oral delivery of these materials be more pleasant than the sand-like bile salt anion sequestrant beads but also the hydrogel preparation is much simpler than the copolymer aggregate analogues [Cameron, N. S.; Eisenberg, A.; Brown, G. R. Biomacromolecules 2002, 3, 116-123. Cameron, N. S.; Eisenberg, A.; Brown, G. R. Biomacromolecules 2002, 3, 124-132]. Our goal was to explore these materials building on our experience with bulk resins and self-assembled copolymers. In this paper, following a brief introduction to hydrogels and their application to hypercholesterolemia, the synthesis, characterization, and preliminary glycocholate binding properties of poly(N,N,N-trimethylammoniumalkyl acrylamide chloride)gel are presented [Cameron, N. S.; Eisenberg, A.; Brown, G. R. Polym. Preprints 2002, 43, 771-772].

Aquamid represents a new generation of soft-tissue fillers thanks to the lack of particles and a very high concentration of water. Aquamid is the result of a new, patented production method called "In line Cross-Linking Technology" (ILX Technology). The Aquamid gel contains 2.5% polyacrylamide (PAAG) and 97.5% water. It is homogenous, perfectly stable and nonbiodegradable and has optimum viscosity and elasticity. Aquamid has been authorized for sale in Europe since March 2001 as a new medical device (CE-mark 0543). This pilot study presents our experiences with Aquamid based on 59 subjects treated with 77 doses mainly used for aesthetic correction but even on medical indication. Lip augmentation was the most frequent procedure (72%), dominated by the age groups from 20 to 25 and from 50 to 60 years. Cheekbone enlargement was carried out in 13% of the cases. The rest concerned augmentation of deep naso-labial fold, glabella, and chin with 5% representation of each. The patient satisfaction was almost 100% with the aesthetic results and either short time or long time side effect reported during a follow-up period of 9 months (range: 2 to 16 months). Aquamid is easy to use without any pretest. Considering its long-lasting effect and the need for sterile conditions with use, only qualified and experienced staff, preferably physicians, should administrate the gel. Adequate indication, correct handling, and thoughtful following of the recommendations/cautions are of vital importance. Given that, aquamid seems to be a promising long-lasting soft tissue filler.