Suzette E. Sutherland

Does the size of the surgical margin in partial nephrectomy for renal cell cancer really matter

PURPOSE Although many groups recommend a surgical margin of 1 to 2 cm., to our knowledge the amount of normal renal parenchyma that must be excised during partial nephrectomy for stages T1-2N0M0 renal cell carcinoma to ensure a safe margin has never been critically evaluated. We investigated whether the size of the surgical margin has any effect on recurrence. MATERIALS AND METHODS All partial nephrectomies performed for localized renal cell carcinoma at our institution from 1988 to 1999 were retrospectively analyzed via a review of hospital records, pathology reports and histological slides. Parenchymal margin status was assessed and quantified by microscopy. Followup data were obtained via patient chart review and telephone interview. Average negative margin size and postoperative followup were determined, and renal cell carcinoma recurrence was assessed. RESULTS A total of 44 partial nephrectomies were performed with a mean followup of 49 months (range 8 to 153). Mean tumor size was 3.22 cm. (range 1.3 to 10). Surgical margins were negative for malignancy in 41 cases and positive in 3. All patients with negative margins were without local recurrence at followup except 1 with a recurrent mass adjacent to the kidney at a site distant from the original lesion. Mean and median size of the negative margins was 0.25 and 0.2 cm., respectively (range 0.05 to 0.7). In the 3 cases with positive margins there was no evidence of disease at 39 and 62 months of followup in 2, while multiple local and metastatic recurrences developed in 1. CONCLUSIONS No patient with negative parenchymal margins after nephron sparing surgery for stages T1-2N0M0 renal cell carcinoma had local recurrence at the resection site at a mean followup of 49 months. Margin size was irrelevant. Only a minimal margin of normal renal parenchyma of less than 5 mm. must be removed during partial nephrectomy for localized renal cell carcinoma.

The Adjustable Continence Therapy System for Recurrent Female Stress Urinary Incontinence: 1-Year Results of the North America Clinical Study Group

PURPOSE We determined the efficacy, safety, adjustability and technical feasibility of the adjustable continence therapy device (Uromedica, Plymouth, Minnesota) for the treatment of recurrent female stress urinary incontinence. MATERIALS AND METHODS Female patients with recurrent stress urinary incontinence were enrolled in the study and a defined set of exclusionary criteria were followed. Baseline and regular followup tests to determine eligibility, and to measure subjective and objective improvement were performed. A trocar was passed fluoroscopically and with digital vaginal guidance to the urethrovesical junction through small incisions between the labia majora and minora. The adjustable continence therapy device was delivered and the balloons were filled with isotonic contrast. The injection ports for balloon inflation were placed in a subcutaneous pocket in each labia majora. Device adjustments were performed percutaneously in the clinic postoperatively. An approved investigational device exemption Food and Drug Administration protocol was followed to record all adverse events. RESULTS A total of 162 subjects underwent implantation with 1 year of data available on 140. Mean Stamey score improved by 1 grade or more in 76.4% (107 of 140) of subjects. Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p <0.001). Reductions in mean Urogenital Distress Inventory (60.3 to 33.4) and Incontinence Impact Questionnaire (54.4 to 23.4) scores also occurred (p <0.001). Mean provocative pad weight decreased from 49.6 to 11.2 gm (p <0.001). Of the patients 52% (67 of 130) were dry at 1 year (less than 2 gm on provocative pad weight testing) and 80% (102 of 126) were improved (greater than 50% reduction on provocative pad weight testing). Complications occurred in 24.4% (38 of 156) of patients. Explantation was required in 18.3% (28 of 153) of the patients during 1 year. In terms of the complications 96.0% were considered to be mild or moderate. CONCLUSIONS The Uromedica adjustable continence therapy device is an effective, simple, safe and minimally invasive treatment for recurrent female stress urinary incontinence. It can be easily adjusted percutaneously to enhance efficacy and complications are usually easily manageable. Explantation does not preclude later repeat implantation.

Follicular Large Cell Lymphoma Localized to the Testis in Children

PURPOSE Primary follicular lymphoma of the testis in childhood is rare with only 6 cases previously reported. We present 3 additional cases. MATERIALS AND METHODS We extensively analyzed primary follicular lymphoma of the testis in 3 boys. Clinical data were obtained by reviewing patient charts. RESULTS The patients were 4, 5 and 11 years old, respectively. Two patients presented with painless unilateral testicular enlargement and 1 presented with unilateral hydrocele. Laboratory findings were within normal limits in all patients. Radical orchiectomy was done in all cases. The excised testes were partially or completely replaced by tumor. In all cases the features were those of follicular, large cell-type malignant lymphoma. Tumor cells in all cases were CD20 and CDw75 positive, focally CD23 positive and bcl-2 negative, while in 2 they were CD10 positive and bcl-6 positive. Surface Ig was absent in the 2 cases studied. Karyotyping in 1 case showed a normal karyotype. Staging revealed no evidence of extratesticular disease. All patients underwent combination chemotherapy and were in complete remission 7 to 59 months after therapy. CONCLUSIONS We present 3 cases of pediatric primary follicular lymphoma of the testis. Pathological findings and clinical features were similar to those in the 6 previously reported cases and suggest that primary pediatric testicular follicular lymphoma may represent unique subset of follicular lymphoma with a particularly good prognosis.

Elevate anterior/apical: 12-month data showing safety and efficacy in surgical treatment of pelvic organ prolapse.

Objective This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up. Methods This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal prolapse with or without apical descent (POP-Q ≥ stage II). Each patient received a single-incision transvaginal polypropylene mesh implantation anchored to the sacrospinous ligaments bilaterally. Primary outcome was treatment success defined as POP-Q less than or equal to stage I at 1 year using the Last Failure Carried Forward method. Secondary outcomes included validated quality-of-life measures. Fourteen subjects who received a concomitant posterior apical support procedure were excluded from the analysis. Results Of the 128 subjects, 112 (87.5%) completed the 12-months follow-up. The mean age was 64.7 years. The anatomic success rate was 87.7% (95% confidence interval, 80.3%–93.1%) for the anterior compartment and 95.9% (95% confidence interval, 88.5%–99.1%) for the apical compartment. POP-Q measurements (Aa, Ba, and C) improved significantly (P < 0.001) with no significant changes to TVL (P = 0.331). Related adverse events reported at greater than 2% were mesh exposure (8; 6.3%), urinary tract infection (7; 5.5%), transient buttock pain (5; 3.9%), de novo stress incontinence (5; 3.9%), retention (5; 3.9%), dyspareunia (3; 3.2%), and hematoma (3; 2.3%). All quality-of-life scores significantly improved from baseline (P < 0.001). Conclusions Twelve-month data show that Elevate Anterior/Apical support procedure completed through a single vaginal incision yields favorable objective and subjective outcomes.

Sacral neuromodulation: Therapy evolution

Objectives: Sacral neuromodulation has gained increased worldwide acceptance as the standard of care in patients with refractory overactive bladder (OAB) and non-obstructive urinary retention (NOUR). This review will detail the evolution of the technology. Materials and Methods: The mechanism of action and advances in treatment, including tined lead, fluoroscopic imaging, and smaller implantable pulse generator (IPG) are reviewed. This discussion also explores expanding indications and future advances including interstitial cystitis, chronic pelvic pain, neurogenic bladder, fecal incontinence, constipation, and dysfunctional elimination syndrome in children. Results: Sacral neuromodulation (SNM) exerts its influence by modulation of sacral afferent inflow on storage and emptying reflexes. The tined lead allows for placement and stimulation to be performed in the outpatient setting under local anesthesia with mild sedation. Lead migration has been minimal and efficacy improved. The use of fluoroscopy has improved accuracy of lead placement and has led to renewed interest in bilateral percutaneous nerve evaluation (PNE). Bilateral PNE can be performed in the office setting under local anesthesia, making a trial of therapy less expensive and more attractive to patients. A smaller IPG has not only improved cosmesis, but decreased local discomfort and need for revision. The role for SNM continues to expand as clinical research identifies other applications for this therapy. Conclusions: Our understanding of SNM, as well as technological advances in therapy delivery, expands the pool of patients for which this form of therapy may prove beneficial. Less invasive instrumentation may even make this form of therapy appealing to patients without refractory symptoms.

Evaluation of an experimental urodynamic platform to identify treatment effects: A randomized, placebo-controlled, crossover study in patients with overactive bladder†‡

To evaluate a urodynamic platform designed to identify treatment effects in small numbers of patients after a short duration of treatment using a medication with known efficacy in overactive bladder (OAB).

PD26-02 THE EFFECT OF SACRAL NEUROMODULATION ON COMPLETE CONTINENCE AT 5 YEARS FOR SUBJECTS WITH URINARY INCONTINENCE

compression. The buckling experiment showed different patterns of deformity (Figure 2). CONCLUSIONS: Data suggests that these prostheses exhibit significant physical differences. The clinical impact of these differences is poorly elucidated. These variations in the prostheses behaviors could be considered by the physician and the patient while objectively assessing the choice of the prosthesis. These findings could aid in objective patient counseling.

MP31-16 CONCOMITANT OVERACTIVE BLADDER MEDICATION USAGE AFTER SACRAL NEUROMODULATION IMPLANT

INTRODUCTION AND OBJECTIVES: This analysis aims to describe the use of concomitant overactive bladder (OAB) medications following implant of the sacral neuromodulation (SNM) InterStim system. Subjects with bothersome symptoms of OAB including urinary urge incontinence (UI) or urgency-frequency (UF), who had not exhausted all medication options (failed at least 1 anticholinergic medication and had at least 1 medication not tried) were included in the InSite study. METHODS: Subjects were restricted from taking OAB medications for the first 6 months post-implant. Concomitant use of OAB medications was allowed after 6 months. At each visit, data were collected on OAB medications used since previous visit. The number of implanted subjects who used any concomitant OAB medication postimplant is summarized by medication type. Baseline characteristics were compared between implanted subjects with and without concomitant OAB medication use during any time between implant and 5-years follow-up. Logistic regression was used to assess the effect of concomitant OAB medication use on 5-year therapeutic success in UI and UF subjects respectively. RESULTS: Of 272 subjects that were implanted, 91% were female and the mean age was 57 years. A total of 73 subjects used any concomitant OAB medications between 6 months and 5 years post implant; the most commonly used medications were mirabegron, oxybutynin, and solifenacin. At baseline, subjects qualified more frequently as both UI and UF in the group with concomitant OAB medication use vs. the group with no concomitant OAB medication (54% vs. 44%, p1⁄40.0479), and subjects with concomitant OAB medication use were older (mean age of 60.5 vs 55.6, p1⁄40.0163). When assessing the effect of concomitant OAB medications use on therapeutic response with baseline characteristics and test stimulation response adjusted, UI subjects were less likely to have 5-year therapeutic success if they had concomitant OAB medication use compared to those who didn’t (Odds Ratio1⁄40.28, 95% Confidence Interval 0.10-0.80, p1⁄40.0171). No relationship between concomitant OAB medication use and UF therapeutic response was observed. CONCLUSIONS: This result shows that a small portion of subjects implanted with InterStim use concomitant OAB medications post implant. However, the presence of OAB medications after implant does not improve long term therapeutic success. In UI subjects, the association between concomitant OAB medication use and poorer long term therapeutic success might indicate that a subset of subjects with symptoms remain refractory even with addition of OAB medications.