Initial treatment of men with newly diagnosed lower urinary tract dysfunction in the Veterans Health Administration.

OBJECTIVE: To examine initial treatments given to men with newly diagnosed lower urinary tract dysfunction (LUTD) within a large integrated health care system in the United States. METHODS: We used data from 2003 to 2009 from the Veteran's Health Administration to identify newly diagnosed cases of LUTD using established ICD-9CM codes. Our primary outcome was initial LUTD treatment (3 months), categorized as watchful waiting (WW), medical therapy (MT), or surgical therapy (ST); our secondary outcome was pharmacotherapy class received. We used logistic regression models to examine patient, provider, and health system factors associated with receiving MT or ST when compared with WW. RESULTS: There were 393,901 incident cases of LUTD, of which 58.0% initially received WW, 41.8% MT, and 0.2% ST. Of the MT men, 79.8% received an alpha-blocker, 7.7% a 5-alpha reductase inhibitor, 3.3% an anticholinergic, and 7.3% combined therapy (alpha-blocker and 5-alpha reductase inhibitor). In our regression models, we found that age (higher), race (white/black), income (low), region (northeast/south), comorbidities (greater), prostate-specific antigen (lower), and provider (nonurologist) were associated with an increased odds of receiving MT. We found that age (higher), race (white), income (low), region (northeast/south), initial provider (urologist), and prostate-specific antigen (higher) increased the odds of receiving ST. CONCLUSION: Most men with newly diagnosed LUTD in the Veteran's Health Administration receive WW, and initial surgical treatment is rare. A large number of men receiving MT were treated with monotherapy, despite evidence that combination therapy is potentially more effective in the long-term, suggesting opportunities for improvement in initial LUTD management within this population.

Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.

CONTEXT: Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH); however, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg/d). OBJECTIVE: To determine the effect of saw palmetto extract (Serenoa repens, from saw palmetto berries) at up to 3 times the standard dose on lower urinary tract symptoms attributed to BPH. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, multicenter, placebo-controlled randomized trial at 11 North American clinical sites conducted between June 5, 2008, and October 10, 2010, of 369 men aged 45 years or older, with a peak urinary flow rate of at least 4 mL/s, an American Urological Association Symptom Index (AUASI) score of between 8 and 24 at 2 screening visits, and no exclusions. INTERVENTIONS: One, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks. MAIN OUTCOME MEASURES: Difference in AUASI score between baseline and 72 weeks. Secondary outcomes included measures of urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, participants' global assessments, and indices of sexual function, continence, sleep quality, and prostatitis symptoms. RESULTS: Between baseline and 72 weeks, mean AUASI scores decreased from 14.42 to 12.22 points (-2.20 points; 95% CI, -3.04 to -1.36) [corrected]with saw palmetto extract and from 14.69 to 11.70 points (-2.99 points; 95% CI, -3.81 to -2.17) with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo (upper bound of the 1-sided 95% CI most favorable to saw palmetto extract was 1.77 points, 1-sided P = .91). Saw palmetto extract was no more effective than placebo for any secondary outcome. No clearly attributable adverse effects were identified. CONCLUSION: Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00603304.

Long-term outcomes of urgency-frequency syndrome due to painful bladder syndrome treated with sacral neuromodulation and analysis of failures.

PURPOSE: We present our long-term experience with sacral neuromodulation devices placed in patients with painful bladder syndrome to determine whether the benefit decreases over time. MATERIALS AND METHODS: Between January 2000 and July 2004, 32 women and 7 men with interstitial cystitis/painful bladder syndrome in whom previous conventional therapy failed underwent sacral neuromodulation test stimulation. Before 2003 a percutaneous test lead was placed in the clinic setting. After 2003 a quadripolar permanent lead was placed in the operating room. Permanent generators were implanted if the patient had more than 50% relief from the presenting complaint, which was defined as urinary or pelvic pain, urgency, or urinary frequency. Long-term outcomes included battery depletion, device malfunction, infection or loss of benefit as well as any change in need for medications. RESULTS: Of 39 patients 22 went from test stimulation to permanent generator implantation. There were significant differences in short-term but not long-term outcomes between the 2 methods of test stimulation. Of 33 patients undergoing percutaneous nerve evaluation 13 (39.4%) met the criteria for permanent generator implantation, while 9 of 11 (81.8%) evaluated with the quadripolar lead met these criteria (p = 0.015). Long-term success between the groups was similar at 92.3% (12 of 13) vs 77.8% (7 of 9) (p = 0.329) during an average followup of 59.9 months. Eleven (50.0%) devices required explantation. Of 22 patients 3 (13.6%) lost benefit over time. CONCLUSIONS: These patients appear to respond best to permanent quadripolar lead placement but long-term results do not appear to be independently affected by the method of test stimulation. Loss of benefit over time is not common.

Sacral neuromodulation in diabetic patients: success and complications in the treatment of voiding dysfunction.

AIMS: We compared success rates, subsequent complications, and possible indications for success of sacral neuromodulation (SNM) for urinary voiding dysfunction in diabetic and non-diabetic patients. METHODS: Thirty-two diabetic patients (mean age 61.8 years, range 27-83) with urge incontinence, urgency-frequency syndrome, and/or urinary retention refractory to non-surgical treatment were retrospectively evaluated along with 211 non-diabetic patients (mean age 54.1 years, range 20-86) with similar symptoms. All patients who experienced >or=50% reduction in urinary symptoms following a 7- to 21-day test period went on to permanent SNM device implantation. RESULTS: No significant difference was found with respect to successful conversion rates from the test period to permanent implantation between diabetic and non-diabetic patients. Long-term success rates at a mean followup of 29.3 months following permanent device implantation for diabetic patients were 69.2% of those with urge incontinence, 85.7% of those with urgency-frequency, and 66.7% of those with urinary retention. The non-diabetic cohort had success rates of 67.0% for urge incontinence, 67.8% for urgency/frequency, and 58.2% for urinary retention (P = 0.823, 0.157, and 0.631, respectively). No patient experienced intraoperative complications. Nine of 24 (37.5%) devices were explanted postoperatively in diabetic patients compared with 36 of 141 (25.5%) in non-diabetic patients (P = 0.224). The number of explants due to infection was higher in diabetic patients (16.7%) versus non-diabetic patients (4.3%; P = 0.018). CONCLUSIONS: No difference in long-term success rates was seen in diabetic patients when compared with similar, non-diabetic patients. Diabetic patients did, however, have a higher incidence of device explantation due to infection.

Efficacy of sacral neuromodulation for symptomatic treatment of refractory urinary urge incontinence.

OBJECTIVES: To determine the efficacy and complications of sacral neuromodulation as therapy for refractory urinary urge incontinence. METHODS: Forty-one patients (mean age 54.3 +/- 15.8 years) with urge incontinence refractory to conservative therapy (ie, pharmacologic, behavioral, biofeedback therapy) were retrospectively evaluated. The patients included those who received permanent one-staged or two-staged InterStim implants. Surgical implantation of the InterStim was performed in patients who experienced a greater than 50% reduction in urge incontinence symptoms, as documented by voiding diaries during a 3 to 7-day test stimulation period. RESULTS: Ninety percent of patients had 50% or greater improvement in presenting symptoms and quality-of-life parameters after InterStim implantation, with a median follow-up of 12 months (interquartile range 12 to 26.5) for single-stage and 4.5 months (interquartile range 1.5 to 12) for staged implants (P = 0.0003 Wilcoxon rank-sum test). Patients with urge incontinence had a significant reduction in mean leaking episodes (from 8.8 to 2.3 per day, P = 0.0001), with a significant decrease in the mean number of pads used (from 4.7 to 0.82 per day, P < 0.0001). No patient experienced operative complications, and postoperative complications were encountered in 29% of patients. CONCLUSIONS: Our results have demonstrated that sacral neuromodulation is a safe and effective approach for the treatment of urinary urge incontinence that is refractory to other more conservative forms of treatment.

Evaluation and management of malfunctioning sacral neuromodulator.

OBJECTIVES: To describe a strategy for revising the malfunctioning InterStim device and to provide an algorithm for evaluation and management. METHODS: We retrospectively reviewed 82 patients who had undergone InterStim placement. Ten patients (eight women and two men) experienced complications and subsequently underwent revision of their device between October 2001 and October 2003. Five patients had originally received a permanent implant after a successful percutaneous test stimulation trial, and five had undergone a test stimulation using the tined lead. Indications for revision included gradual onset of recurrent voiding dysfunction (n = 2), lead migration (n = 5), generator malfunction (n = 1), generator site pain and infection (n = 1), and genital/rectal pain with stimulation (sensory discomfort; n = 1). RESULTS: Of the 10 patients who underwent revision, 7 experienced complete resolution of their problem. Eight patients had lead site changes and two had generator replacements. No intraoperative or postoperative complications occurred in the revision cases. CONCLUSIONS: In our experience, 70% of patients who undergo revision of the malfunctioning InterStim can expect success. In this study, no difference in success appeared to be related to the original cause of malfunction. In the management of malfunctioning sacral neuromodulators, we recommend an attempt at revision before permanent explantation.

Conservative strategies for the treatment of stress urinary incontinence.

The conservative treatment of stress urinary incontinence for women has many facets. Each intervention may have value and patients may benefit from simple, reversible recommendations and techniques versus invasive surgery. Starting with a thorough history, lifestyle modifications may lead to decreased incontinence. Depending on the patient's goals and clinical situation, they may benefit from a pessary or anti-incontinence device. Finally, the use of pelvic floor muscle exercises has been shown to benefit a significant number of patients. Regardless of the degree of stress urinary incontinence, conservative strategies should be considered a fundamental part of the treatment plan.

Cost-effectiveness of tamsulosin, doxazosin, and terazosin in the treatment of benign prostatic hyperplasia.

OBJECTIVE: To evaluate the cost-effectiveness of tamsulosin, doxazosin, or terazosin as initial treatments for moderate benign prostatic hyperplasia (BPH) over a 3-year time horizon from a health-system-payer perspective. METHODS: A decision-analytic model is used to project the course of treatment at 6-month intervals over 3 years following initiation of therapy with tamsulosin, doxazosin, or terazosin. Treatment failure is defined as failure to attain and maintain a 25% improvement in the American Urological Association (AUA) symptom score from baseline. In the model, finasteride is added for patients who fail on their initial therapy and, in the event of finasteride treatment failure, patients progress to transurethral resection of the prostate (TURP) and, if needed, a second TURP. The ranges of values for treatment failure rates and clinical event cost parameters used in the decision model are derived from the literature. Only direct medical costs related to BPH and its treatment are included. Since 2 comparators are available generically (doxazosin and terazosin) drug acquisition costs are defined by the list prices at Drugstore.com. All costs are discounted by 3% per year. Effectiveness is measured as successful medical treatment without surgery over 3 years. RESULTS: For base-case model parameters, discounted BPH-related total direct medical costs over 3 years are 4084 dollars, 4323 dollars, and 4695 dollars for generic terazosin, generic doxazosin, and tamsulosin, respectively. The model estimates a medical treatment success rate (no TURP) at 3 years of 72.3% for tamsulosin, compared with 68.2% for both terazosin and doxazosin. The incremental cost for tamsulosin versus terazosin is 610 dollars over 3 years, which yields an incremental cost-effectiveness ratio of 14,609 dollars per success. Generic doxazosin is dominated (higher cost but equal effectiveness compared with terazosin). Higher rates of twice-daily (or 2 units per day) dosing are associated with higher incremental cost-effectiveness ratios. The decision-model results also are sensitive to the estimated costs of TURP and hypotensive adverse events. CONCLUSION: As an initial medical therapy for moderate BPH, tamsulosin is more effective than generic terazosin or doxazosin, with an incremental cost of about 203 dollars per year (or about 17 dollars per month) over 3 years.