A randomized trial of urodynamic testing before stress-incontinence surgery.

BACKGROUND: Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS: We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS: A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS: For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Retropubic versus transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Treatment of urinary calculi in the combat zone.

Renal colic is a common condition among deployed soldiers in the Middle East. Eight percent of all admissions to the jump package of the 21st Combat Support Hospital in Mosul, Iraq, during Operation Iraqi Freedom involved patients with renal colic and urinary stones. The majority of patients were treated successfully with primary care measures. Fourteen percent of patients required urologic interventions; however, many of these soldiers were treated with ureteral stents and returned to duty. Aggressive management of urolithiasis resulted in 92% of soldiers remaining in the combat zone, preserving the fighting strength of supported units.

Ultrasonography in a forward-deployed military hospital.

Military medical units must be flexible and mobile to keep up with maneuver units on the modern battlefield. The requirements for unit mobility and maneuverability preclude bulky advanced radiologic imaging support, such as computed tomography or magnetic resonance imaging systems. Portable sonography is rapid, reliable, efficient, and user-friendly; it markedly expanded the diagnostic capability of our forward-deployed combat support hospital during Operation Iraqi Freedom. More than 400 ultrasound studies were performed during the first 6 months of hospital operations in Iraq. The use of this technology on the battlefield improved our ability to provide definitive, quality, medical care far forward and to preserve the fighting strength of supported units.

Fibrin sealant for the management of genitourinary injuries, fistulas and surgical complications.

PURPOSE: We report our preliminary experience with the use of fibrin sealant to manage iatrogenic urinary tract injuries, complex urinary fistulas, and urological surgical complications. MATERIALS AND METHODS: Topical fibrin sealant was used in 19 patients for iatrogenic urinary tract injury during gynecological or general surgical procedures (7), complex urinary fistulas (5) or urological surgical complications (7). RESULTS: Successful resolution of the injury, fistula or complication was attained after a single application of fibrin sealant in the 18 patients (94.7%) in whom a direct injection technique was used. The only failure (formation of a vesicovaginal fistula) occurred with the air driven sprayed sealant delivery technique after sutured closure of iatrogenic cystotomy during vaginal hysterectomy. CONCLUSIONS: Liquid fibrin sealant appears to be safe and prudent for use in urological "damage control" from trauma, fistulas or surgical complications. Direct injection over a sutured urinary anastomosis appears to be highly effective in preventing urinary drainage. Additional study is needed to define further the role and best use of tissue adhesives in urology.

Single dose levofloxacin prophylaxis for prostate biopsy in patients at low risk.

PURPOSE: We determine if a single 500 mg. oral tablet of levofloxacin represents adequate prophylaxis for patients at low risk who undergo transrectal prostate biopsy. MATERIALS AND METHODS: From April 2000 to May 2001 we prospectively evaluated 400 consecutive men who underwent transrectal needle biopsy of the prostate after a single 500 mg. oral dose of levofloxacin. Under an institutional review board approved protocol the drug was issued under a standing order by a clinic nurse 30 to 60 minutes before the procedure. Patients were issued 2 additional daily doses of levofloxacin if they were deemed at increased risk for infectious complications, that is if they had a large prostate more than 75 cc, diabetes mellitus, recent steroid use, severe voiding dysfunction or immune compromise. No patient received a cleansing enema before the procedure. Complications, the number of biopsy cores, prostate size and cancer detection rates were assessed. RESULTS: Only 1 of the 377 patients at low risk in whom biopsy was completed experienced a symptomatic urinary tract infection (0.27%). None of the 23 men at high risk who received additional doses of levofloxacin experienced a complication. Thus, the overall infection rate was 1 of 400 cases (0.25%) in this series. A mean of 7 biopsy cores (range 2 to 16) was obtained per patient and mean prostate volume was 49.75 cc (range 12 to 150). Prostate cancer was present in 93 patients (23%). CONCLUSIONS: A single 500 mg. dose of levofloxacin before transrectal needle biopsy of the prostate is effective and safe in patients at low risk. The administration of prophylaxis by a clinic nurse under a standing order optimizes patient compliance and physician efficiency. In patients at higher risk for infection additional antibiotic administration appears to provide adequate prophylaxis.

Central renal stab wounds: treatment with augmented fibrin sealant in a porcine model.

PURPOSE: We determined whether fibrin sealant augmented by an absorbable bolster could salvage kidneys with major, centrally located stab wounds. MATERIALS AND METHODS: A grade 4 renal injury was created in 16 commercial swine via a 1.5 cm sagittal, centrally located, through-and-through right renal laceration. Animals were randomized to 1 of 4 treatment arms, including control groups that received conventional renal capsule suture repair with an absorbable gelatin sponge bolster (3 in group 1) or a microfibrillar collagen sheet (3 in group 2) and experimental groups that received sutureless treatment entailing fibrin sealant instillation into the knife tract augmented by an external gelatin sponge (5 in group 3) or an external microfibrillar collagen sheet (5 in group 4). Arterial occlusion was not performed. Blood loss and time to hemostasis were recorded. Abdominal computerized tomography was performed at 1 week and necropsy was done at 6 weeks. RESULTS: Renal reconstruction with fibrin sealant resulted in significantly lower blood loss (62 vs 155 ml, p <0.05) and time to hemostasis (3.5 vs 6.5 minutes, p <0.05) than in the conventional suture groups. There was no radiographic or gross evidence of significant postoperative bleeding, urinoma formation or abnormal tissue healing in the recovery period. Gelatin sponge and collagen sheet demonstrated similar hemostatic efficacy. CONCLUSIONS: In this porcine renal trauma model fibrin sealant augmented by absorbable gelatin sponge or a microfibrillar collagen sheet effectively promoted hemostasis and renal salvage. Because of its safety, ease of use and efficiency, fibrin sealant appears to be an appropriate adjunct for managing challenging renal injuries.