Richard C. Harkaway

Measurement characteristics of a voiding diary for use by men and women with overactive bladder

OBJECTIVESnTo examine the test-retest reliability and the validity of a voiding diary designed to assess the symptoms of frequency, urgency, and urge urinary incontinence (UI).nnnMETHODSnVoiding diaries serve as the primary tool to assess symptoms of overactive bladder in clinical settings and in clinical trials of treatment for overactive bladder. Despite the widespread use of these instruments, few studies have documented their measurement properties or investigated the number of days required to assess symptoms accurately. Study participants included 21 men and 133 women at least 20 years of age recruited from urogynecology and urology clinics. All had a history of urge incontinence or mixed incontinence with urge as the primary component. Participants completed a 7-day voiding diary on two occasions, separated by at least 1 week.nnnRESULTSnMen and women reported a daily average of approximately 10 micturitions, 7 occurrences of strong urge, and 2 episodes of urge urinary incontinence. The diary exhibited good to excellent reliability, with estimated intraclass correlation coefficients (ICCs) ranging from 0.81 to 0.86 for the symptoms of strong urge, diurnal and nocturnal micturitions, total incontinence, and urge incontinence episodes. Estimates did not differ appreciably between men and women. Moderate correlations with global questions on micturition frequency and UI episodes supported the validity of the diary. Diaries completed for 3 and 4 days were similar, with only slightly lower estimates of reliability (ICC 0.79 to 0.84).nnnCONCLUSIONSnThe voiding diary completed for 7 days, following detailed instruction, is reliable and appears to be valid for documenting the change in symptoms of overactive bladder in men and women with predominantly urge incontinence. Because of comparable reliability and reduced patient burden, diaries of shorter duration may also be acceptable to assess the symptoms of overactive bladder, depending on the degree of precision required.

A Clinical Study Of 22.5 mg. La-2550: A New Subcutaneous Depot Delivery System For Leuprolide Acetate For The Treatment Of Prostate Cancer

PURPOSEnThe safety, efficacy and pharmacokinetics of a unique 3-month subcutaneous depot of leuprolide acetate were investigated in patients with prostate cancer.nnnMATERIALS AND METHODSnThis open label, noncomparative, 6-month multicenter study enrolled 117 patients diagnosed with adenocarcinoma of the prostate. LA-2550 (22.5 mg. depot) (Atrix Laboratories, Fort Collins, Colorado) was administered subcutaneously once every 3 months. The primary efficacy parameter was serum testosterone 50 ng./dl. or less. Pharmacokinetics were analyzed in a subset of 22 patients.nnnRESULTSnOf the 117 enrolled patients 111 (98%) completed the 6-month study. Five patients withdrew for nontreatment related events and 1 was withdrawn because he received less than a full dose of the study drug. By day 28, 98% of patients had serum testosterone 50 ng./dl. or less and 84% had achieved 20 ng./dl. or less. By day 35 all patients had 50 ng./dl. or less testosterone. A patient with a breakthrough response after testosterone suppression on day 49 (112 ng./dl.) regained suppression (27 ng./dl.) 14 days after the second injection (day 98). At study completion all patients had 50 ng./dl. or less testosterone (mean plus or minus standard error of mean 10.1 +/- 0.07) and 104 of the 111 (94%) had 20 ng./dl. or less. From baseline to month 6 mean luteinizing hormone decreased from 9.2 +/- 1.1 to 0.08 +/- 0.01 mIU/ml. and mean prostate specific antigen decreased more than 98%. No flare reactions were observed and patient assessments of bone pain and urinary symptoms were unchanged. The most common treatment related adverse event was hot flashes, which were mild in 57% of cases, moderate in 12% and severe in 0%.nnnCONCLUSIONSnLA-2550 (22.5 mg. depot) produced and maintained safe and effective suppression of serum testosterone to well below the medical castrate level of 50 ng./dl. or less.

A new diagnostic algorithm for the evaluation of microscopic hematuria

OBJECTIVESnTo evaluate a new diagnostic algorithm for microscopic hematuria in which intravenous urography (IVU) is performed as a secondary radiographic study when microhematuria has persisted for 3 months after the initial workup with renal ultrasound (US) and cystoscopy was negative.nnnMETHODSnWe evaluated 372 consecutive patients who presented with microhematuria and negative urine cultures and cytologic findings at our institution. All patients underwent renal US scanning and cystoscopy as their initial evaluation. All patients underwent re-evaluation 3 months after the initial workup. Patients with persistent microhematuria with no apparent etiology were then evaluated with IVU.nnnRESULTSnThe initial evaluation was negative in 212 of 372 patients. Eighty-one of these patients had persistence of their microhematuria at the 3-month follow-up without a definitive diagnosis. Seventy-five of these patients underwent IVU. Abnormalities were found in 11 of the 75 patients. Six patients had renal stones, two had ureteral stones, two had ureteral tumors, and one had a tumor of the renal pelvis. Forty of the 131 patients with resolution of their microhematuria underwent IVU at their request. All those studies were normal.nnnCONCLUSIONSnThe combination of cystoscopy and renal US along with urinalysis, urine culture, and cytology is a good initial evaluation in patients with microhematuria. Those patients with persistent microhematuria after 3 months without definite etiology of the bleeding may still benefit from IVU.

Discontinuation of alpha-blockade after initial treatment with finasteride and doxazosin in men with lower urinary tract symptoms and clinical evidence of benign prostatic hyperplasia

OBJECTIVESnTo determine the effect of discontinuation of alpha-blockade and continuation of finasteride in men with lower urinary tract symptoms and enlarged prostates receiving combination treatment and to determine whether the alpha-blocker dose influences the ability to discontinue it.nnnMETHODSnWe treated 272 consecutive men with a prostate size greater than 40 g and American Urological Association symptom score greater than 20 with 5 mg finasteride and 2 mg doxazosin daily. Two hundred forty men reported a favorable response to therapy, defined as any reduction in symptom score and toleration of the medications. The dose was maintained at 2 mg doxazosin in 100 men and was titrated to 4 mg doxazosin in 80 patients and to 8 mg doxazosin in an additional 60 patients. We discontinued doxazosin at 3, 6, 9, or 12 months, while continuing finasteride, and then re-evaluated the patients 1 month later to determine whether any worsening of symptoms had resulted.nnnRESULTSnIn patients discontinuing doxazosin at 3 months, success (defined as no increase in symptom score and no desire to resume doxazosin) was reported by 20%, 15%, and 13% of those taking 2, 4, and 8 mg, respectively. In patients discontinuing doxazosin at 6 months, success was reported by 48%, 45%, and 40% of those taking 2, 4, and 8 mg, respectively. In patients discontinuing doxazosin at 9 months, success was reported by 84%, 80%, and 73% of those taking 2, 4, and 8 mg, respectively. In patients discontinuing doxazosin at 12 months, success was reported by 84%, 85%, and 87% of those taking 2, 4, and 8 mg, respectively.nnnCONCLUSIONSnPatients with lower urinary tract symptoms and moderately enlarged prostates initially receiving combination therapy using finasteride and an alpha-blocker are likely to experience no significant symptom deterioration after discontinuing the alpha-blocker after 9 to 12 months of combination therapy regardless of the dose of alpha-blocker chosen.

Estimated Blood Loss Underestimates Calculated Blood Loss during Radical Retropubic Prostatectomy

Objective: To compare the calculated blood loss for radical retropubic prostatectomy (RRP) with the anesthesiologist’s and operating surgeon’s estimates of operative blood loss. Methods: A retrospective review of 52 consecutive patients undergoing RRP between January 1999 and February 2000 was performed. Patient charts were reviewed for preoperative hemoglobin (Hgb_i), preoperative hematocrit (Hct_i), body weight (Wt), anesthesiologist’s and surgeon’s estimated blood loss (EBL_A and EBL_S), and postoperative day one morning hemoglobin (Hgb_f) and hematocrit (Hct_f). For each patient, the actual blood loss (ABL), i.e., the amount of blood that left the patient’s body, was calculated as the average ABL_n resulting from two computations of the following formula: ABL_n = (EBV × (H_i – H_f)) / ((H_i + H_f)/2) + (500 × T_u) where: (1) estimated blood volume (EBV) is assumed to be 70 cm³/kg; (2) H_i and H_f represent Hgb_iand Hgb_f for one computation and Hct_i and Hct_f for the second computation, and (3) T_u is the sum of autologous whole blood (AWB), packed red blood cells (PRBC), and cell saver (CS) units transfused. For each patient, ABL was compared with EBL_A and EBL_S. Descriptive statistics of the pooled data were calculated. Results: The mean (± SD) age was 60 ± 7.1 years. The mean ABL was 2,774 ± 1,014 cm³. Patients received an average of 1.96 U CS, 0.14 U PRBC, and 0.42 U AWB. Five patients (9.6%) were exposed to homologous blood. The average ABL_net (i.e. ABL reduced by the amount of CS returned) was 1,794 ± 806 cm³. EBL_A and EBL_S were 1,337 ± 676 and 1,300 ± 658 cm³, respectively. Conclusion: During radical retropubic prostatectomy, anesthesiologists and urologists both appear to underestimate blood loss as determined by standard calculation.

Minimal incision living donor nephrectomy: improvement in patient outcome

OBJECTIVESnTo analyze the minimal incision living donor (MILD) nephrectomy and compare it with the standard open donor (SOD) nephrectomy with respect to incision size, operative time, complication rate, length of hospital stay, and recipient creatinine.nnnMETHODSnForty-five consecutive patients who underwent MILD nephrectomy were compared with 13 patients who had previously undergone SOD nephrectomy. The MILD nephrectomy was performed through a minimally invasive incision using a modified, anterolateral, retroperitoneal approach without a rib resection. The incision length, operative time, complication rates, length of hospital stay, and recipient creatinine were analyzed.nnnRESULTSnThe average incision length in the MILD group was 8.6 cm compared with 21.8 cm in the SOD group (P >0.005.) The operative times (209 minutes in the MILD group versus 191 minutes in the SOD group) were not significantly different. Four postoperative complications were encountered in the SOD group and seven in the MILD group. The average hospital stay for the MILD patients was 2.5 days compared with 4.6 days in the SOD group, and as the procedure was refined, the length of stay was reduced to 1 day in 3 patients. The recipient creatinine at 1 and 6 months was 1.39 and 1.4 mg/dL in the MILD group, respectively.nnnCONCLUSIONSnThe MILD nephrectomy allows the patient to undergo a less morbid procedure with a more aesthetic incision. Patients have fewer complications, minimal anesthesia exposure, and short hospital stays.

Improved Continence after Radical Retropubic Prostatectomy Using Two Pubo-Urethral Suspension Stitches

Objectives: To determine if placement of urethral suspension stitches during radical retropubic prostatectomy improves postoperative urinary continence. Methods: Between January 1997 and January 1998 we performed radical retropubic prostatectomy on 50 men. The first 25 consecutive men had their surgery without urethral suspension stitches while the next 25 received placement of two anastomotic urethral suspension stitches anchored to the lower portion of the pubic bone. Patients were interviewed six months postoperatively and each underwent valsalva leak-point pressure measurement. Patients were categorized as either completely continent (requiring no pads and having no measurable valsalva leak point), socially continent (zero or one pad per day), or incontinent (two or more pads per day). Results: In the urethral suspension group, 8/25 (32%) patients were completely continent and did not have a measurable valsalva leak-point pressure while 3/25 (12%) without urethral suspension were completely continent. Of the remaining patients in the urethral suspension group, 13/17 (76%) patients were socially continent while 4/17 (24%) were incontinent. The mean valsalva leak-point pressure in the 17 patients with suspension stitches was 89.6 ± 21.6 cm H2O. In the patients without urethral suspension, there were 22 patients who had some degree of incontinence. Among non-stitch patients, 13/22 (59%) were socially continent while 9/22 (41%) were incontinent. The average valsalva leak-point pressure in these patients was 74.0 ± 16.7 cm H2O, which was significantly lower than those with the suspension (p = 0.015). Conclusion: Placement of anastomotic urethral suspension stitches during radical retropubic prostatectomy may increase the likelihood of complete postoperative urinary continence. The urethral suspension stitches also increase valsalva leak-point pressure, which may improve the percentage of patients with socially acceptable incontinence.

Role of Urologic Evaluation in the Adult Spina bifida Patient

Objective: To evaluate a population of adult spina bifida patients performing clean intermittent catheterization (CIC) and determine the indications for urologic consultation and intervention. Methods: We evaluated 52 adults (ages 18–37 years) with a history of lumbar myelomeningocele, all of whom performed CIC and were dry between catheterizations. We excluded 12 patients with conditions potentially predisposing to renal insufficiency (staghorn calculus, n = 3; multiple admissions for pyelonephritis, n = 5; history of vesicoureteral reflux, n = 2, and renal scarring on ultrasound, n = 2), leaving 40 patients evaluable. Each patient kept a catheterization diary for 2 weeks from which an average catheterized volume was recorded. Results: In patients with normal ultrasound and normal serum creatinine (<1.5 mg/dl), there were no individuals (0/20) whose average catheterized volume corresponded to a bladder pressure of >40 cm H2O on cystometry. However, in the patients with hydronephrosis and/or elevated creatinine, 30% (6/20) had average catheterized volumes corresponding to a bladder pressure of >40 cm H2O, and are therefore theoretically at risk for upper tract deterioration. Conclusion: Many spina bifida patients receive urologic care only as children, and those without urinary calculi or urinary incontinence are assumed to be urologically stable. However, certain patients have urodynamic parameters which put them at risk for renal deterioration even if they appear to be problem-free. We recommend a yearly renal ultrasound and serum creatinine determination in all adult spina bifida patients with immediate urologic consultation and urodynamics if either is abnormal.

Minimal incision living donor nephrectomy compared to the hand-assisted laparoscopic living donor nephrectomy

Background. There has been a surge of minimally invasive procedures for living donor nephrectomy. We compared our minimal incision living donor (MILD) nephrectomy to hand-assisted laparoscopic (HAL) living donor nephrectomynn Methods. We conducted a Medline search and compared our first 45 MILD nephrectomies to the data from the University of Michigan (UM), Tulane University (TU), and the University of Chicago (UC).nn Results. The MILD incision was smaller than the cumulative incisions in the UM and UC groups (8.6, 11 and 10.4xa0cm, respectively). The operating times were similar in the UM and UC groups (209, 246, and 215xa0xa0min, respectively). The UM and TU lengths of hospital stay (1.8 and 2.2xa0days) were shorter than those of the MILD and UC groups (2.5 and 2.8xa0days).nn Conclusions. MILD nephrectomy has results similar to those of HAL living donor nephrectomy. It allows the surgeon with a traditionally trained background to perform a safe, minimally invasive operation without laparoscopic technology.

Discontinuation of Alpha-Blockade after Initial Treatment with Finasteride and Doxazosin for Bladder Outlet Obstruction

Objectives: Patients with symptomatic bladder outlet obstruction and moderately enlarged prostates can receive durable relief from finasteride. However, the delayed onset of action has led many clinicians to prescribe an α-blocker in addition to finasteride early in therapy for more rapid symptom relief. Our goal was to determine when to discontinue the α-blocker in this group of patients. Methods: We enrolled 100 consecutive men with an estimated prostate size of >40 g and an AUA symptom score of ≧20, who reported an initially favorable response to combination therapy with 5 mg finasteride and 2 mg doxazosin daily. The average symptom score reduction at 1 month was 3.3. We discontinued the doxazosin at 3, 6, 9, or 12 months, while continuing finasteride, then reevaluated patients 1 month later to determine if the patients reported any worsening of symptoms. Results: Twenty-five patients discontinued doxazosin at 3 months. Five (20%) were successfully discontinued, reporting no change in symptom score. Twenty reported worsening symptoms. Twenty-five patients discontinued doxazosin at 6 months. Twelve (48%) were successfully discontinued, reporting no change in symptom scores. Thirteen (52%) reported worsening symptoms. Twenty-five patients discontinued doxazosin at 9 months. Twenty-one (84%) were successfully discontinued, reporting no change in symptom scores. Four (16%) reported worsening symptoms. Twenty-five patients discontinued doxazosin at 12 months. Twenty-one (84%) were successfully discontinued, reporting no change in symptom scores. Four (16%) reported worsening symptoms. Conclusion: Patients with symptomatic bladder outlet obstruction and moderately enlarged prostates who are placed initially on combination therapy using finasteride and an α-blocker are likely to tolerate discontinuation of the α-blocker after 9 months of combination therapy.