A trial study: the effect of low dose human chorionic gonadotropin on the symptoms of benign prostatic hyperplasia.

PURPOSE: Human chorionic gonadotropin (HCG) is a glycoprotein hormone with multiple physiological functions. It interferes with mammary tumorigenesis and modulates growth and tumorigenesis in prostate cancer cells. In addition, HCG receptor transcripts and protein have been demonstrated in normal and hyperplastic prostate glands. Functionally HCG has a growth modulating effect on androgen independent prostate cell lines. We investigated the possible clinical effects of HCG on the symptoms associated with benign prostatic hyperplasia (BPH) in this trial study. MATERIALS AND METHODS: We performed a multicenter, double-blind, placebo controlled, randomized pilot study evaluating the effects of low dose HCG vs placebo in 101 men (50 to 79 years old) with BPH. The primary efficacy measure was the American Urological Association total symptom index score. Secondary efficacy parameters included peak urinary flow and sexual self-efficacy questionnaire changes. RESULTS: Low dose HCG appeared to positively effect moderate to severe BPH symptoms according to American Urological Association scores and sexual function but not peak urinary flow. No HCG induced changes were noted in prostate specific antigen or prostate volume. CONCLUSIONS: These findings suggest that HCG may provide a well tolerated and beneficial therapy for BPH that will be investigated in subsequent studies.

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

OBJECTIVES: To 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). METHODS: Voiding 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. RESULTS: Men 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). CONCLUSIONS: The 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.

Storage (irritative) and voiding (obstructive) symptoms as predictors of benign prostatic hyperplasia progression and related outcomes.

OBJECTIVES: To assess the utility of voiding and filling symptom subscores in predicting features of benign prostatic hyperplasia (BPH) progression, including acute urinary retention (AUR) and prostate surgery. METHODS: The Proscar Long-term Efficacy and Safety Study (PLESS) was a 4-year study designed to evaluate the effects of finasteride versus placebo in men with lower urinary tract symptoms (LUTS), clinical evidence of BPH, and no evidence of prostate cancer. A self-administered questionnaire was employed to quantify LUTS at baseline. Receiver operating characteristics (ROC) curves were used to assess baseline characteristics from patients treated with placebo as predictors of outcomes. The characteristics assessed included the overall symptom score (Quasi-AUA SI), separate voiding and filling subscores, prostate volume (PV) and serum prostate-specific antigen (PSA) levels. RESULTS: PV and PSA were superior to the symptom scores at predicting episodes of spontaneous AUR and all types of AUR. The Quasi-AUA SI and the filling and voiding subscores were effective at predicting progression to surgery; however, PSA was more effective at predicting this outcome. To better evaluate symptoms as predictors of surgery, patients who experienced a preceding episode of AUR were excluded from the surgery analysis. In the absence of preceding AUR, the best predictors of future surgery were the Quasi-AUA SI and the filling subscore. CONCLUSIONS: Among men with LUTS, clinical BPH and no history of AUR, the overall symptom score and storage subscore are useful parameters to aid clinicians in identifying patients at risk for future prostate surgery. PV and PSA were the best predictors of AUR, while PSA was the best predictor of prostate surgery (for all indications).