Minimal Device Encrustation on Vesair Intravesical Balloons in the Treatment of Stress Urinary Incontinence: Analysis of Balloons Removed from Women in the SOLECT Trial.

INTRODUCTION: Encrustation of urinary biomaterials is common; however, the incidence of surface deposition on the Vesair® intravesical pressure-attenuation balloon has not been previously reported. The purpose of this analysis is to determine the incidence and potential risk factors for encrustation of the Vesair intravesical balloon. METHODS: The SOLECT trial is a prospective randomized controlled trial conducted at several European centers to evaluate the safety and efficacy of the Vesair balloon for the treatment of female stress urinary incontinence (SUI). Women included in the study demonstrated SUI symptoms for more than 12 months without complicating factors, such as history of recurrent urinary tract infections or nephrolithiasis. All balloons removed from women enrolled in the SOLECT trial were analyzed for surface characteristics and encrustation. Surface deposition severity was quantified and composition analyzed with infrared spectroscopy and scanning electron microscopy. Incidence of surface deposition was tabulated and risk factors analyzed. RESULTS: One hundred and five balloons removed from 75 women were included in this analysis. Measurable stone deposition of less than 1.5 mm was found on four balloons (3.8%), surface granules were noted on 42 (40.0%), surface film on 11 (10.5%), and both granules and film on two (1.9%). Analysis identified calcium oxalate both in measurable encrustation deposits as well as those with surface granulation. Pooled analysis found that dwell time was a risk factor for calcium deposition. CONCLUSION: The rate of encrustation on the Vesair intravesical balloon is low and does not appear to increase the rate of adverse outcomes or reduce clinical efficacy. FUNDING: Solace Therapeutics, Inc.

Segmental testicular infarction: a case report.

BACKGROUND: Segmental testicular infarction is a very rare condition, which can mimic a testicular torsion or testicular cancer. Correct diagnosis is difficult but it is important to avoid unnecessary radical treatment. CASE PRESENTATION: We report a clinical case of a 36-year-old white man who presented at our emergency department with subacute testicular pain. A urine analysis, Doppler ultrasound, surgical exploration, blood analysis, and magnetic resonance imaging were performed to diagnose his condition, to exclude a testicular torsion, and to raise confidence in its non-malignancy. He was treated conservatively. At follow-up, a few months after the incident, he no longer had complaints. Ultrasonography showed remaining hypo-echogenicity of the left upper pole, indicating a sequel of ischemia. CONCLUSIONS: Segmental testicular infarction is a rare condition which can be easily confused with a testicular torsion or a testicular tumor. This case report can be helpful in recognizing and diagnosing this condition. Making the right diagnosis is important since it can prevent an unnecessary radical treatment.

A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females.

AIMS: Evaluate the efficacy, safety, and tolerability of a novel pressure-attenuation balloon for the treatment of female stress urinary incontinence (SUI) using a prospective, randomized, single-blind, multi-center design, evaluated at 3 months. METHODS: Sixty-three females with SUI were randomized 2:1 to treatment with a balloon (N = 41) or sham procedure (N = 22). The sham (control) entailed the same procedure without the deployment of a balloon. Endpoints were evaluated at 3 months and included a composite endpoint that required both ≥10 point increase in the 22-item Incontinence Quality of Life Survey (I-QOL) and ≥50% decrease in provocative pad weight. Additional endpoints included incontinence episode frequency, and PGII assessment. RESULTS: In an ITT analysis, 63% of women in the treatment group achieved the composite endpoint, compared to 31% in the Control Group (P = 0.0200). In a per protocol analysis, 81% of women in the treatment arm had a 50% decrease in pad weight test vs. 45% in the Control Group (P = 0.0143); 41.6% of the treatment patients were dry on pad weight test (≤1gram) vs. 0% in the Control Group (P < 0.001), and 58% of treated patients reported improvement on a PGII assessment versus 25% of women in the Control Group (P = 0.025). Adverse events in the treatment group included dysuria (14.6%), gross hematuria (9.8%), and UTI (7.3%). CONCLUSIONS: This minimally invasive treatment for female SUI with an intravesical pressure-attenuation balloon was safe and effective. The concept of pressure attenuation as a therapy for SUI is valid and feasible for those patients that can tolerate the balloon.

Tamoxifen to treat urge-incontinence from an isolated bladder metastasis of a primary breast cancer.

OBJECTIVES: Managing urge-incontinence after metastatic lobular carcinoma of the breast into the bladder. MATERIAL AND METHODS: Case report and review of the pertinent English language literature. RESULTS: Conservative management with tamoxifen resulted in clinical and partial radiological remission and the urge-incontinence disappeared. CONCLUSION: A conservative mode of treatment is possible for metastatic lobular carcinoma of the breast into the bladder.

Cabazitaxel for the treatment of prostate cancer.

INTRODUCTION: Prostate cancer is a frequently diagnosed male cancer. In men presenting locally advanced or metastatic disease, the mainstay of treatment is hormonal suppression. Despite the castrate levels of testosterone, with time, prostate cancer gradually evolves into a castration-refractory state. Chemotherapeutic agents are able to influence the natural history of metastatic castration-resistant prostate cancer. Docetaxel is a clinically relevant, FDA-approved taxane. Today, it is the first-line chemotherapeutic agent in castration-refractory prostate cancer (CRPC). There is no standard second-line chemotherapeutic regimen. AREAS COVERED: This review provides information on the efficacy of cabazitaxel as a second-line treatment for CRPC. The medline database was searched for clinical trials on chemotherapeutical treatment options of castration-resistant prostate cancer. All available data on the efficacy of cabazitaxel are summarized. EXPERT OPINION: New treatment strategies for castration-resistant prostate cancer should primarily focus on quality of life. In this view, vaccination therapy seems promising because of the acceptable level of toxicity. However, more research is needed to prove their efficacy in the treatment of castration-resistant prostate cancer. Cabazitaxel seems to be a promising second-line therapy in CRPC.

Comparison of the haemostatic properties of conventional monopolar and bipolar transurethral resection of the prostate in patients on oral anticoagulants.

INTRODUCTION: The aim of study is comparing the haemostatic properties of conventional monopolar resection (TURP) and bipolar transurethral resection in saline (TURIS) of the prostate in patients under chronic oral anticoagulants. MATERIAL AND METHODS: Out of a cohort group of 550 endoscopic resections for bladder outlet obstruction, 176 patients on chronic oral anticoagulant therapy required endoscopic resection either by monopolar TURP or bipolar TURIS technology. Changes in haemoglobin, blood transfusion, and clot retention were compared between both groups. RESULTS: Mean postoperative change in haemoglobin level was -1.21 ±0.92 mg/dl in the TURP group compared to -1.29 ±0.99 mg/dl in the TURIS group (p = 0.603). The need for blood transfusions and the mean numbers of units transfused did not significantly differ between the 2 groups. Clot retention appeared in 12 patients (15%) in the TURP group compared to 13 patients (13%) in the TURIS group (p = 0.828). CONCLUSIONS: Despite promising experimental results of better haemostasis and deeper coagulation depth, bipolar technology does not permit one to reduce the amount of blood loss when compared to patients treated by conventional monopolar technology in this study group of patients on oral anticoagulation therapy. Patients on oral anticoagulants suffer more incidents of clot retention, which sometimes results in re-hospitalisation.

Management of genital burns: a review.

We review the etiology and the management strategy of genital burns. The incidence of genital burns ranges from 2.8 to 13%. Most are part of larger injuries. Scald burns are typical for children, whereas flame and chemical burns happen more often in adults. For first and second-degree genital burns, a conservative approach with physiological dressings and topical antimicrobials is advised. Only third degree burns need to be treated with removal of necrotic tissue and grafting. Indwelling catheters or suprapubic drainage systems must be avoided whenever possible.

Urethral strictures and bipolar transurethral resection in saline of the prostate: fact or fiction?

PURPOSE: To compare the incidence of urethral strictures after monopolar transurethral resection of the prostate (TURP) and bipolar transurethral resection in saline (TURIS) for symptomatic benign prostatic hyperplasia. PATIENTS AND METHODS: Between January 2005 and January 2009, 518 patients with symptomatic benign prostate hyperplasia underwent either monopolar or bipolar resection. In a randomized trial, the incidence of urethral strictures after both treatment modalities was analyzed. RESULTS: Over 48 months, 255 patients were treated with conventional TURP and 263 patients with TURIS. Patient related, operation, and hospitalization characteristics were similar in both groups. After a mean follow-up of 32.1 months (range 50-7 months), the incidence of urethral strictures was 2.4% in the TURP group. After a comparable period of 31.4 months (range 50-7 months), the incidence in the TURIS group was 1.5%. No statistically significant difference was obtained (P = 0.539). These values were compared with the results of other randomized controlled trials with the same or other bipolar technology. No statistically significant difference in urethral structures was noticed between monopolar and bipolar resections (P = 0.739). CONCLUSIONS: With a stricture incidence of 1.5%, bipolar transurethral prostate resection has a low stricture rate, comparable with monopolar TURP (2.4%).

Bipolar transurethral resection in saline: the solution to avoid hyponatraemia and transurethral resection syndrome.

OBJECTIVE: To compare serum sodium changes and the incidence of transurethral resection (TUR) syndrome after monopolar transurethral resection of the prostate (TURP) and bipolar transurethral resection in saline (TURIS) for symptomatic benign prostatic hyperplasia. MATERIAL AND METHODS: Between January 2005 and August 2009, 550 consecutive patients with symptomatic benign prostate hyperplasia underwent TURP, by either a monopolar or bipolar technique. Preoperative and postoperative blood parameters were analysed to compare preoperative and postoperative electrolyte concentrations. RESULTS: Over 56 months, 265 patients underwent a conventional monopolar TURP and 285 patients had a bipolar TURIS (Olympus). Patient profiles regarding age, operation time, resection weight and resection speed were similar in both groups. A drop in sodium of 2.5 mmol/l was measured in the conventional monopolar resection group. The decline of 1.5 mmol/l in the bipolar group, although smaller, was still statistically significant (p = 0.001). With longer operation times (> 1 h) the difference between the groups became more important (p < 0.001). Two clinical TUR syndromes were observed in the monopolar group, while none occurred in the bipolar group. CONCLUSIONS: Bipolar TURP in saline is a safe technique and obviates the risk of TUR syndrome. Repeated serum analysis of electrolytes after TURIS can be omitted.

Bipolar versus monopolar technique for palliative transurethral prostate resection.

INTRODUCTION: The aim was to evaluate the postoperative morbidity and outcome of palliative endoscopic resections for relief of infravesical obstruction in prostate cancer patients with hormone deprivation therapy, and to investigate the added value of bipolar technology over conventional monopolar resections. MATERIAL AND METHODS: A retrospective study was performed on 70 patients with prostate cancer under hormone deprivation therapy undergoing 75 endoscopic procedures, by either monopolar or bipolar technology, between August 2005 and March 2009 at a single institution. The analysis used outpatient, inpatient, and operative records, and observations of electrolyte changes in the serum, postoperative morbidity, and the overall results of palliative endoscopic resections. Preoperative cancer stages and grades were compared with the pathological findings after surgery. Postoperative outcome and complications of conventional monopolar and bipolar technology were compared. RESULTS: Over a period of 44 months, 34 conventional monopolar resections were performed in 32 patients and 41 bipolar resections in 38 patients. Patients' profiles regarding age, initial cancer stage and grade, resection weight, resection speed, catheterization time, and hospital stay were similar in both groups. No statistically significant difference was observed in sodium drop (p = 0.802), clot retention (p = 0.565), or urinary retention (p = 0.292). The overall success rate in relieving obstruction leading to spontaneous voiding was 77%. While 38% of the patients had a high grade tumour at diagnosis, 79% were found to be high grade after the endoscopic resection (p < 0.0001). CONCLUSIONS: Palliative endoscopic transurethral resection is an acceptable and safe adjunctive surgical treatment for voiding disorders in prostate cancer patients. Bipolar technology offers no substantial benefit over conventional monopolar technology.

Bipolar transurethral resection in saline--an alternative surgical treatment for bladder outlet obstruction?

PURPOSE: The transurethral resection in saline system uses bipolar energy for transurethral prostate resection, thus, avoiding the need for glycine irrigation and its associated complications. We compared the clinical efficacy and safety of bipolar transurethral resection in saline and of monopolar transurethral prostate resection for symptomatic benign prostate hyperplasia. MATERIALS AND METHODS: From January 2005 to June 2006, 238 consecutive patients with symptomatic benign prostate hyperplasia were randomized into a prospective, controlled trial comparing the 2 treatment modalities. Patient demographics, operative time, hospital stay and complications were noted. Serum hemoglobin and electrolytes were determined in all patients immediately before and after the endoscopic procedure. RESULTS: During 18 months 120 patients were randomized to the conventional transurethral prostate resection group and 118 were randomized to the transurethral resection in saline group. Patient profiles, weight of resected prostatic tissue and duration of hospitalization were similar in the 2 groups. The decrease in serum sodium and serum chloride was statistically significantly greater in the transurethral prostate resection group than in the transurethral resection in saline group (each p = 0.05). The transurethral resection in saline procedure required significantly more time (mean 56 vs 44 minutes, p <0.01). There was 1 case (0.8%) of transurethral resection syndrome in the transurethral prostate resection group but none in the transurethral resection in saline group. Postoperative bleeding did not significantly differ between the 2 groups. Clot retention was observed in 6 (5%) and 4 patients (3%) in the transurethral prostate resection and transurethral resection in saline group, respectively. Two repeat interventions were required in the transurethral prostate resection group. CONCLUSIONS: The bipolar transurethral resection in saline system is as efficacious as monopolar transurethral prostate resection but it is safer than the latter because of the lesser decrease in postoperative hypernatremia and the smaller risk of transurethral resection syndrome. However, probably due to technical reasons, transurethral resection in saline operative time is significantly longer.