American Urological Association Symptom Index Score Research Articles

Prolieve Transurethral Thermodilatation for Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results from a Prospective Multicenter Trial.

Introduction and Objective: Prolieve® transurethral thermodilatation (TUTD) is the only third-generation transurethral microwave thermotherapy (TUMT) device that incorporates balloon dilation/compression of the prostatic urethra with cooled TUMT, at ≤50 W power. We evaluated its 5-year efficacy in the treatment of symptomatic benign prostatic hyperplasia (BPH) in an open-label prospective multicenter trial. Methods: Eligible patients with American Urological Association symptom index score (AUASS) ≥9, peak urine flow rate (Qmax) <12 mL/s, and prostate size 20-80 g without obstructing median lobe were enrolled. Prolieve TUTD was delivered in the office setting under local anesthesia. AUASS, quality of life (QOL), BPH impact index (BPHII), Qmax, and other measures were assessed at baseline, and at least annually thereafter to year 5. Adverse events (AEs) were recorded. Treatment success over time was analyzed using the Kaplan-Meier method while changes from baseline were evaluated using paired t-tests. Results: Intention to treat population was 225, of whom 220 with a mean (standard deviation) age of 65 (5.9) completed treatment. 187/220 (85%) did not require urethral catheterization. AUAS, QOL, and BPHII scores significantly improved from baseline in ≤3 months, with sustained improvements to year 5. Qmax also significantly improved from baseline at each annual follow-up evaluation. Cumulative 5-year surgical retreatment rate was 14.2% (95% confidence interval 9.5-20.8). Transient urinary urgency and dysuria were the most reported AEs. Conclusions: Prolieve TUTD is a safe and effective treatment option for BPH, with durable long-term improvements in voiding symptoms and urinary flow rates. It has a low catheterization rate and sexual side effects are rare. Clinical Trials.gov Registration Number: NCT02021032.

MP02-05 SYMPTOMS OF CENTRAL SENSITIZATION ARE ASSOCIATED WITH WORSE LOWER URINARY TRACT SYMPTOMS IN MEN

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Non-neurogenic Voiding Dysfunction I (MP02)1 Sep 2021MP02-05 SYMPTOMS OF CENTRAL SENSITIZATION ARE ASSOCIATED WITH WORSE LOWER URINARY TRACT SYMPTOMS IN MEN Angela Senders, Kamran Sajadi, Scott Bauer, Thu Le, Ryan Wexler, Yiyi Chen, Barry Oken, and Lynn Marshall Angela SendersAngela Senders More articles by this author , Kamran SajadiKamran Sajadi More articles by this author , Scott BauerScott Bauer More articles by this author , Thu LeThu Le More articles by this author , Ryan WexlerRyan Wexler More articles by this author , Yiyi ChenYiyi Chen More articles by this author , Barry OkenBarry Oken More articles by this author , and Lynn MarshallLynn Marshall More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001963.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Central sensitization (CS) is an impairment in the processing of sensory information that results in ongoing hypersensitivity to nociceptive and other somatic signals. CS has been examined as a possible mechanism of overactive bladder among women, but studies of CS and urinary symptoms among men are lacking. Our objective was to determine the association between CS symptoms and lower urinary tract symptoms (LUTS) among men. METHODS: We conducted a cross-sectional study using an electronic survey. From June-August 2020, we contacted 209 men, age 18 years or older, who had received urodynamic testing for LUTS in the past 3 years at our institution’s adult urology clinic. Of these, 75 did not respond, 43 declined, and 91 (44%) consented. We obtained demographics, history of diagnosed neurological conditions, chronic pain syndromes, current bladder or genital pain, the American Urological Association Symptom Index (AUASI) and the Central Sensitization Inventory (CSI). The CSI is a 25-item questionnaire quantifying symptoms commonly reported by people with CS, with the sum of items resulting in a total score of 0-100 points. A CSI score of ≥40 indicates moderate-to-severe CS-related symptoms. We used multivariable linear regression to model the association between moderate-to-severe CS and AUASI score. We estimated regression coefficients (β) and 95% confidence intervals (CI) adjusted first for age. The final model was adjusted for age, existing neurologic conditions (multiple sclerosis, Parkinson’s disease), chronic prostatitis (CP), chronic bladder or pelvic pain, and pain with urination or ejaculation in the past week. RESULTS: Among 90 men with complete data, the mean (standard deviation, sd) age was 66 (14) years, 76 (84%) were non-Hispanic white, 27 (30%) had CSI scores ≥ 40, and the mean (sd) AUASI score was 15 (9) points. Controlled for age, the AUASI score averaged 8 points greater among men with CS compared to men without CS (β=8.1, 95% CI: 4.3, 11.9). The positive association remained in the final model (β=7.6, 95% CI: 3.4, 11.7). When restricted to 53 men without neurologic conditions, CP, pain syndromes, or urination or ejaculation pain, the association remained (age-adjusted β=8.7, 95% CI: 2.5, 14.9). CONCLUSIONS: Symptoms suggestive of moderate-to-severe CS were common among men with a recent history of urodynamic testing for LUTS and associated with significantly greater AUASI scores. The association was independent of existing neurologic and chronic pain conditions including CP. Objective assessment for the presence of CS among men with LUTS is warranted. Source of Funding: Unfunded © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e13-e13 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Angela Senders More articles by this author Kamran Sajadi More articles by this author Scott Bauer More articles by this author Thu Le More articles by this author Ryan Wexler More articles by this author Yiyi Chen More articles by this author Barry Oken More articles by this author Lynn Marshall More articles by this author Expand All Advertisement Loading ...

MP28-04 THE 10-ITEM LURN SYMPTOM INDEX DETECTS ADDITIONAL SYMPTOMS AND SHOWS CONVERGENT VALIDITY WITH THE AUA-SI IN MEN WITH BENIGN PROSTATIC HYPERPLASIA

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Epidemiology & Evaluation (MP28)1 Sep 2021MP28-04 THE 10-ITEM LURN SYMPTOM INDEX DETECTS ADDITIONAL SYMPTOMS AND SHOWS CONVERGENT VALIDITY WITH THE AUA-SI IN MEN WITH BENIGN PROSTATIC HYPERPLASIA Clark Judge, Tanya Kristof, Richard Fantus, Brian Helfand, Abigail Smith, James Griffith, and Alexander Glaser Clark JudgeClark Judge More articles by this author , Tanya KristofTanya Kristof More articles by this author , Richard FantusRichard Fantus More articles by this author , Brian HelfandBrian Helfand More articles by this author , Abigail SmithAbigail Smith More articles by this author , James GriffithJames Griffith More articles by this author , and Alexander GlaserAlexander Glaser More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002025.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Lower Urinary Tract Dysfunction Research Network (LURN) developed a 10-item symptom index (LURN SI-10) designed for practical clinical use in both men and women for the assessment of lower urinary tract symptoms (LUTS). In this study, we compare the LURN SI-10 with the the widely used American Urological Association Symptom Index (AUA-SI) in men with benign prostatic hyperplasia (BPH)/LUTS to assess validity and determine how frequently the LURN SI-10 identifies symptoms missed by the AUA-SI. METHODS: LURN SI-10 and AUA-SI questionnaires were prospectively administered to men presenting with BPH/LUTS. Post void dribbling (PVD), bladder pain/discomfort, and urgency urinary incontinence (UUI) were considered present if the patient indicated occurrence of about half the time or more. Responses were tabulated and Pearson correlations between LURN SI-10 and AUA-SI scores were assessed. RESULTS: The LURN SI-10 and AUA-SI correlate strongly in men with BPH/LUTS (r=0.81; Figure). The bother item of the LURN-10 also correlates strongly with the quality of life (QoL) section of the AUA-SI (r=0.73). The LURN SI-10 identified PVD in 29% (26/91) of patients, bladder pain/discomfort in 13% (12/91) of patients, and UUI in 16% (15/91) of patients. CONCLUSIONS: The LURN SI-10 correlates strongly with the AUA-SI, a validated and widely used questionnaire for BPH in men. Additionally, the LURN SI-10 can help identify PVD, bladder pain/discomfort, and UUI in men with BPH, symptoms that are not identified by the AUA-SI. Further prospective study of the LURN SI-10 in men with BPH, including before and after medical and surgical treatment, is warranted. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e481-e482 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Clark Judge More articles by this author Tanya Kristof More articles by this author Richard Fantus More articles by this author Brian Helfand More articles by this author Abigail Smith More articles by this author James Griffith More articles by this author Alexander Glaser More articles by this author Expand All Advertisement Loading ...

Longitudinal Changes in Adiposity and Lower Urinary Tract Symptoms Among Older Men.

Adiposity increases risk for male lower urinary tract symptoms (LUTS), although longitudinal studies have produced conflicting results. No prior studies have evaluated longitudinal associations of changes in adiposity with concurrent LUTS severity among older men. We used repeated adiposity measurements from dual-energy x-ray absorptiometry (DXA), body mass index (BMI), and American Urological Association Symptom Index (AUASI) measured at 4 study visits over a 9-year period among 5 949 men enrolled in the Osteoporotic Fractures in Men (MrOS) study. Linear mixed effect models adjusted for age, health-related behaviors, and comorbidities were created to evaluate the association between baseline and change in visceral adipose tissue (VAT) area, total fat mass, and BMI with change in LUTS severity measured by the AUASI. A nonlinear association was observed between baseline VAT area and change in AUASI: men in baseline VAT tertile (T) 2 had a lower annual increase in AUASI score compared to men in T1 and T3 (T2 vs T1: β = -0.07; 95% CI -0.12, -0.03; p = .008; T3 vs T1: NS) but differences were small. No significant associations were observed between change in VAT area and change in AUASI score. Neither baseline tertiles nor change in total fat mass or BMI were associated with change in AUASI score. Changes in VAT area, total fat mass, and BMI were not associated with change in LUTS severity in this cohort. Thus, despite other health benefits, interventions targeting adiposity alone are unlikely to be effective for preventing or treating LUTS among older men.

A Retrospective Analysis of Surgical Outcomes and Risk Factors for Persistent Postoperative Symptoms Following Synthetic Mid Urethral Sling Revision.

The purpose of our study was to describe the symptom profile of patients who presented to a tertiary care hospital for sling revision, define the efficacy of sling removal/revision in alleviating symptoms and identify what factors, if any, contribute to favorable surgical outcomes. We retrospectively reviewed the records of patients who underwent revision of a synthetic mid urethral sling at our institution between 2004 and 2016. Patients with a history of vaginal mesh for pelvic organ prolapse were excluded from analysis. The outcomes assessed were the AUASI (American Urological Association Symptom Index) score, the M-ISI (Michigan Incontinence Symptom Index) score, pad use, post-void residual urine volume, examination findings and subjective improvement. A total of 430 patients met study inclusion criteria, of whom 182, 172 and 40 received a transobturator tape, a retropubic mid urethral sling and a mini-sling, respectively. Patients presented with 4 primary complaints, including mesh exposure or erosion, pain or dyspareunia, incontinence and/or bladder outlet obstruction. Of the patients 77% presented with at least 2 categories of symptoms. Average followup was 15 months. Postoperatively the AUASI score decreased from 19.0 to 14.7 (p <0.001) and the bother score decreased from 5.0 to 3.4 (p <0.001). The M-ISI also improved from total and bother scores of 15.7 and 4.4 to a postoperative average of 13.2 and 3.1 (p = 0.002 and <0.001, respectively). During this time approximately 40% of patients who presented with pain had persistent postoperative discomfort, in 20% with obstruction that condition failed to resolve and recurrent mesh complaints developed in 5% with mesh exposure or erosion. On multivariate analysis preoperative narcotic use was a significant risk factor for persistent postoperative pain (OR 6.9). Despite complex patient presentations subjective and objective urological symptom measures significantly improve following mid urethral sling revision.

Over-the-Counter Tamsulosin for Men with Urinary Symptoms: A Simulated Self-Selection Study.

We determined whether consumers who self-select to use tamsulosin for urinary symptoms can make appropriate decisions without health care provider guidance in a simulated over-the-counter setting. In a simulated retail setting eligible participants (18 years old or older) reviewed a mock-up of Flomax® over-the-counter packaging and determined whether it was right for them to use tamsulosin capsules (0.4 mg). Per an a priori mitigation procedure 3 urologists reviewed self-reported data, dipstick urinalysis results and AUA-SI (American Urological Association symptom index) scores of men who self-selected tamsulosin as appropriate to use despite information on the drug facts label instructing otherwise. Seemingly incorrect decisions were revised to "appropriate" if deemed well-informed and medically acceptable by 2 or 3 urologists. Overall 619 men and 38 women (mean age 60.9 and 51.6 years, respectively) were enrolled. Of the 470 (75.9%) men who self-selected to use tamsulosin 82 (17.4%) had low health literacy per the REALM (Rapid Estimate of Adult Literacy in Medicine) test and 365 (77.7%) reported seeing a physician at least once a year. Mean AUA-SI total score was 16.5 and 380 (80.9%) men reported urinary symptoms for 1 year or more. The proportions of men who made appropriate self-selection decisions in unmitigated and mitigated analyses were 92.8% (95% CI 90.0-94.9) and 97.9% (95% CI 96.1-99.0), respectively, and findings were similar regardless of health literacy level. Overall 36 of the 38 women (94.7%) made an appropriate decision not to use tamsulosin. These findings support the potential use of over-the-counter tamsulosin for male urinary symptoms.

Does Post-Void Residual Volume Predict Worsening Urological Symptoms in Patients with Multiple Sclerosis?

Our goal was to examine how post-void residual urine volume relates to urinary symptoms in patients with multiple sclerosis. We retrospectively reviewed the records of patients with multiple sclerosis who had lower urinary tract symptoms and presented to a tertiary neurourology clinic. Patients for whom post-void residual volume was recorded at the initial urological assessment were included in our analysis. Results of the AUA (American Urological Association) SI (Symptom Index) and the M-ISI (Michigan Incontinence Symptom Index) completed at this visit were analyzed to assess the severity of lower urinary tract symptoms and incontinence. A chart review was performed to obtain information on demographics and documented urinary tract infections. Between 2014 and 2017, 110 patients diagnosed with multiple sclerosis underwent post-void residual volume measurement at our clinic. Average post-void residual volume was 123.4 cc (range 0 to 650 cc). The mean AUA symptom score was 19.1 with an average bother score of 4.1. Analysis of post-void residual volume as a continuous variable did not show an association between increasing post-void residual volume and an increasing AUA SI or bother score (p= 0.53 and 0.44, respectively). When evaluated by post-void residual volume tertile, no relationship was found between post-void residual volume, and the AUA SI and the M-ISI (p = 0.54 and 0.57, respectively). No correlation was also found between increasing post-void residual volume and a recent history of recurrent urinary tract infections (p = 0.27). Post-void residual volume was not associated with worsening obstructive lower urinary tract symptoms as assessed by the AUA SI, worsening incontinence as measured by the M-ISI score or an increased risk of recurrent urinary tract infections in select patients with multiple sclerosis and lower urinary tract symptoms.

Initial toxicity, quality-of-life outcomes, and dosimetric impact in a randomized phase 3 trial of hypofractionated versus standard fractionated proton therapy for low-risk prostate cancer

PurposeRandomized evidence for extreme hypofractionation in prostate cancer is lacking. We aimed to identify differences in toxicity and quality-of-life outcomes between standard fractionation and extreme hypofractionated radiation in a phase 3 randomized trial. Methods and materialsWe analyzed the results of the first 75 patients in our phase 3 trial, comparing 38 Gy relative biologic effectiveness (RBE) in 5 fractions (n = 46) versus 79.2 Gy RBE in 44 fractions (n = 29). Patients received proton radiation using fiducials and daily image guidance. We evaluated American Urological Association Symptom Index (AUASI), adverse events (AEs), and Expanded Prostate Index Composite (EPIC) domains. The primary endpoint of this interim analysis was the cumulative incidence of grade 2 (G2) or higher AEs. The randomized patient allocation scheme was a 2:1 ratio favoring the 38 Gy RBE arm. ResultsThe median follow-up was 36 months; 30% of patients reached 48-month follow-up. AUASI scores differed <5 points (4.4 vs 8.6; P = .002) at 1 year, favoring the 79.2 Gy arm. Differences in AUASI were not significant at ≥18 months. EPIC urinary symptoms favored the 79.2 Gy arm at 1 year (92.3 vs 84.5; P = .009) and 18 months (92.3 vs 85.3; P = .03); bother scores were not significant at other time points. Cumulative ≥G2 genitourinary toxicity was similar between the 79.2 Gy and 38 Gy arms (34.5% vs 30.4%; P = .80). We found no differences in the EPIC domains of bowel symptoms, sexual symptoms, or bowel ≥G2 toxicities. Bladder V80 (79.2 Gy arm; P = .04) and V39 (38 Gy arm; P = .05) were predictive for cumulative G2 genitourinary AEs. ConclusionsLow AE rates were seen in both study arms. Early temporary differences in genitourinary scores disappeared over time. Bladder constraints were associated with genitourinary AEs.

Characterizing Clinically Meaningful Changes in Lower Urinary Tract Symptoms Using the American Urological Association Symptom Index

To correlate patients' perception of changes in their lower urinary tract symptoms with changes in their American Urological Association Symptom Index (AUA-SI) scores with the goal of improving the ability of patients and clinicians to assess the clinical meaningfulness of changes in the AUA-SI score. Men were asked to complete an AUA-SI survey and answer a symmetrical response framework question to evaluate their global perception of change in lower urinary tract symptoms at each interval, namely, "Are your urinary symptoms much better, slightly better, the same, slightly worse, or much worse compared to your prior visit?" Median changes and interquartile ranges (IQRs) in the AUA-SI scores were compared with the global evaluation response for the entire cohort. Additionally, outcomes were stratified by baseline AUA-SI severity classification (mild, moderate, or severe). The median changes and IQRs in AUA-SI scores of patients rating themselves as much better, slightly better, the same, slightly worse, and much worse compared with their symptoms at the time of their last AUA-SI were -2 (IQR -6 to 0), -1 (IQR -5 to 1), 0 (IQR -2 to 2), 5 (IQR 0-9), and 11 (IQR 5-18), respectively. There was a significant difference in AUA-SI score change between each rating category (P <.001). These results demonstrate that the patients require only a small decrease in their AUA-SI scores to report they are slightly better or much better, whereas a larger increase in their AUA-SI scores is required for patients to report their symptoms are slightly worse or much worse.

Associations between lower urinary tract dysfunction and glycemic control in women with type 2 diabetes: A cross-sectional study

AimsPatients with diabetes are predisposed to develop a variety of complications, including lower urinary tract (LUT) dysfunction. We aimed to examine the associations between glycemic control and LUT dysfunction in women with type 2 diabetes (T2D). MethodsWe included 400 women with T2D (age range, 48–75 years) in this cross-sectional analysis. The participants were divided into tertiles according to glycosylated hemoglobin (HbA1c) measurements. The mean HbA1c levels for tertiles 1, 2, and 3 were 6.2% (N=132), 7.1% (N=132), and 8.4% (N=136), respectively. We evaluated LUT dysfunction with the American Urological Association Symptom Index (AUA-SI) questionnaire, uroflowmetry (UFM), and post-void residual (PVR). ResultsNo significant differences were found among HbA1c tertiles regarding storage, voiding and total AUA-SI scores, and prevalence of LUT symptoms. However, women in tertile 3 had higher prevalences of severe LUT symptoms (AUA-SI≥20) and clinically significant PVR (≥100mL) compared to women in the other tertiles. Multivariate analysis revealed that diabetic neuropathy, but not HbA1c, significantly predicted LUT symptoms in women with T2D after adjustment for age, body mass index (BMI) and hypertension. However, HbA1c was associated with an increased risk of developing clinically significant PVR. ConclusionsOur findings do not support significant associations between glycemic control and LUT symptoms in women with T2D. However, women with poor glycemic control are more likely to develop urinary retention than women with proper glycemic control. Clinicians should, therefore, be aware of and educate patients about the association between urinary retention and glycemic control.

MP71-17 LOWER URINARY TRACT SYMPTOMS AND RISK OF INCIDENT NON-SPINE FRACTURE AMONG OLDER US MEN

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Evaluation and Symptoms1 Apr 2015MP71-17 LOWER URINARY TRACT SYMPTOMS AND RISK OF INCIDENT NON-SPINE FRACTURE AMONG OLDER US MEN Lynn Marshall, Jodi Lapidus, Jack Wiedrick, Kathleen Holton, Elizabeth Barrett Connor, and J. Kellogg Parsons Lynn MarshallLynn Marshall More articles by this author , Jodi LapidusJodi Lapidus More articles by this author , Jack WiedrickJack Wiedrick More articles by this author , Kathleen HoltonKathleen Holton More articles by this author , Elizabeth Barrett ConnorElizabeth Barrett Connor More articles by this author , and J. Kellogg ParsonsJ. Kellogg Parsons More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2630AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Lower urinary tract symptoms (LUTS) are associated with an increased risk of falls in older men. Falls are a strong risk factor for fractures. Therefore, we assessed associations of LUTS severity with fracture risk in community dwelling U.S. men ages 65 years or older METHODS We conducted a prospective study in the Osteoporotic Fractures in Men (MrOS) cohort. The American Urological Association Symptom Index (AUA-SI), prescription medications for LUTS, hip bone mineral density (BMD), and other traditional fracture risk factors were recorded at baseline (2000-02) and every two years thereafter for a total of three assessments. LUTS severity was categorized from the AUA-SI as mild (0-7 points), moderate (8-19 points), or severe (>19 points). Men were followed from the date of their baseline visit to date of first non-spine fracture, death, voluntary withdrawal, or third study visit (2007-09), whichever occurred first. Associations of LUTS severity with fracture rate were estimated with hazard ratios (HR) and 95% confidence intervals (CI) from extended proportional hazards regression with age as the timescale. Models accounted for competing risks from death. RESULTS Among 5,989 men with baseline AUA-SI score and hip BMD measures, 576 incident non-spine fractures occurred during 35,947 person-years of follow-up. Crude fracture rates per 1000 person-years in each LUTS severity category did not differ statistically among men who used prescription LUTS medications and non-users (Figure 1). Adjusted for age and compared to mild LUTS, HR (95% CI) were 1.0 (0.9, 1.2) for moderate LUTS and 1.3 (1.0, 1.7) for severe LUTS, respectively. Further adjustment for hip BMD, falls in the past year, and prevalent fracture before baseline attenuated the HR to 0.9 (0.8, 1.1) for moderate and 1.1 (0.8, 1.4) for severe LUTS. CONCLUSIONS In this cohort of older US men, the association of severe LUTS with higher rate of incident non-spine fracture was explained by traditional fracture risk factors. Older men with LUTS may benefit from screening and counseling about their fracture risk factors. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e918-e919 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Lynn Marshall More articles by this author Jodi Lapidus More articles by this author Jack Wiedrick More articles by this author Kathleen Holton More articles by this author Elizabeth Barrett Connor More articles by this author J. Kellogg Parsons More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Efficacy and safety of a flaxseed hull extract in the symptomatic management of benign prostatic hyperplasia: a parallel, randomized, double-blind, placebo-controlled, pilot study.

This exploratory study was designed to assess the effectiveness of a lignan-rich extract of flaxseed hulls (LinumLife EXTRA(®)) in alleviating symptoms in subjects with benign prostatic hyperplasia (BPH) compared with placebo. Two dosages of extract were compared against placebo in a double-blinded, randomized, parallel, multicenter study. Newly diagnosed cases of BPH in patients aged 45-75 years with an American Urological Association Symptom Index (AUASI) score of ≥13 were included. Study treatment consisted of 500 or 1000 mg of extract containing 100 mg (low-dose active [LDA] group, n=26) or 200 mg (high-dose active [HDA] group, n=26) of secoisolariciresinol diglucoside (SDG), respectively. The placebo (P) group (n=28) received matching maltodextrin capsules. Sixty subjects (LDA [n=19], HDA [n=20], and P [n=21]) completed the study as per the protocol requirements. Change in the AUASI score within a period of 8 weeks, from baseline to end of treatment, was assessed. Significant improvement of obstructive symptoms and management of irritable BPH symptoms was achieved in all groups after treatment. Due to a strong placebo effect, there was no statistical difference between the groups that were treated with flaxseed hull extract as compared with the placebo group. Treatment with flaxseed hull extract did not lead to adverse effects compared with placebo. Supplementation with flaxseed hull extract was found to be safe and well-tolerated and may have improved the quality of life of individuals with BPH. The significant placebo effect as well as the number of subjects per treatment group and the relative short duration of the study may explain the lack of statistical significance between groups.

A study of bladder dysfunction in women with type 2 diabetes mellitus.

Introduction:Diabetes mellitus has been associated with an earlier onset and increased severity of urologic diseases that often result in debilitating urologic complications. Diabetic bladder dysfunction refers to a group of bladder symptoms occurring in patients with diabetes mellitus ranging from bladder over activity to impaired bladder contractility.Aim:Bladder dysfunction is an under evaluated issue in women with diabetes. Aim of our study was to investigate prevalence of bladder dysfunction and its relation with other chronic complications of diabetes in women with type 2 diabetes.Materials and Methods:In a hospital-based cross sectional study, a cohort of women with type 2 diabetes mellitus who had lower urinary tract symptoms (LUTS) were enrolled. We used the American Urological Association Symptom Index (AUA-SI) to assess the severity of LUTS and the Indevus Urgency Severity Scale (IUSS) to assess presence of overactive bladder (OAB). Age-BMI- matched controls that did not have diabetes but had lower urinary tract symptoms were also studied and compared with women with type 2 diabetes. Urodynamic evaluation was done in willing patients.Results:LUTS attributable to bladder dysfunction were reported in 67% of women with type 2 diabetes after exclusion of other causes. Out of them, 36% had moderate to severe LUTS (total AUA-SI score >7). Prevalence of OAB was 53%. Urodynamic evaluation revealed presence of stress urinary incontinence in 48% patients and changes of detrusor over activity and detrusor under activity in 23% and 11% patients, respectively. Among the chronic complications of diabetes, peripheral neuropathy, nephropathy, and presence of metabolic syndrome were significantly associated with moderate to severe LUTS and OAB.Conclusion:Bladder dysfunction is a highly prevalent complication in women with diabetes. Chronic complications of diabetes especially neuropathy, nephropathy, and presence of metabolic syndrome are important predictors of bladder dysfunction.

Treatment Status and Progression or Regression of Lower Urinary Tract Symptoms in a General Adult Population Sample

We report progression and regression of lower urinary tract symptoms in a population based cohort by race/ethnicity, gender, age and lower urinary tract symptom medication use. The BACH (Boston Area Community Health) Survey enrolled 5,502 participants 30 to 79 years old of black, Hispanic or white race/ethnicity. The 5-year followup interviews were completed by 1,610 men and 2,534 women for a conditional response rate of 80%. Population weighted estimates of lower urinary tract symptoms severity were assessed using the AUASI (American Urological Association symptom index) and analyzed using multivariate models. Symptom progression (increase in AUASI score of 3 or more points) was reported by 21% to 33% of participants and regression (decrease 3 or greater) by 30% to 44% of participants, most commonly women and Hispanic participants. Age and higher body mass index were associated with progression (p <0.01), but not with regression. Lower urinary tract symptom medication use at baseline only was associated with improved symptoms scores 5 years later (multivariate adjusted OR 3.10, 95% CI 1.28-7.51, compared to nonusers), whereas using medication at baseline and followup was associated with similar rates of progression and regression as observed among participants not using lower urinary tract symptom medication at either point. Lower urinary tract symptoms persisted at followup for approximately half of the population experiencing symptoms at baseline, including many men and women using lower urinary tract symptom medications. However, overall lower urinary tract symptom medication use and surgical treatment appeared beneficial for symptom control at 5-year followup. Age and body mass index were associated with symptom worsening, and Hispanic ethnicity was associated with greater symptom fluctuation. Clinicians should consider the higher likelihood of lower urinary tract symptom progression for older or heavier patients, and monitor responsiveness to lower urinary tract symptom medication.

1580 ARE LOWER URINARY TRACT SYMPTOMS IN WOMEN WITH TYPE 2 DIABETES AFFECTED BY GLYCEMIC CONTROL?

INTRODUCTION AND OBJECTIVES: It is well-known that intensive glycemic control defined as hemoglobin A1c (HbA1c) 6.5% is able to reduce diabetes-associated microvascular and macrovascular complications. However, it remains unclear whether glycemic control is associated with lower urinary tract symptoms (LUTS) and functions in women with type 2 diabetes. This study aimed to clarify this issue. METHODS: A total of 400 Taiwanese women with type 2 diabetes aged 48 to 75 years were included in this study. To examine the impact of HbA1c, patients were divided into tertiles according to the average of three consecutive HbA1c measurements in the past year. The lower urinary tract symptoms and functions were evaluated with the American Urological Association Symptom Index (AUA-SI) questionnaire and uroflowmetry (UFM) including voided volume (VV), peak urinary flow rate (Qmax) and the post void residual (PVR), respectively. RESULTS: The mean HbA1c was 6.2% (range, 5.6-6.7%, n 132) for tertile 1, 7.1% (6.8-7.4%, n 132) for tertile 2, and 8.4% (7.5-14.2%, n 136) for tertile 3. The overall prevalence of LUTS was 34% which defined as AUA-SI score more or equal than 8. However, no significant differences were found among tertiles 1, 2 and 3 regarding the patient’s age, storage, voiding and total AUA-SI scores. UFM parameters including VV and Qmax were also similar between groups. Of note, patients with the worst glycemic control had significantly higher PVR (p 0.01) and severe LUTS (Table1). Multivariate analysis revealed age, nephropathy and the presence of diabetic neuropathy were the independent factors to predict the presence of LUTS in women with type 2 diabetes. CONCLUSIONS: A significant higher PVR and severe LUTS were found among patients with the worst glycemic control. However, glycemic control in terms of HbA1c was not significantly associated with the development of LUTS.

1960 LOWER URINARY TRACT DYSFUNCTION AMONG ADULT WOMEN WITH DIABETIC MELLITUS

INTRODUCTION AND OBJECTIVES: Lower Urinary Tract Dysfunction (LUTD) is frequent among diabetic women. Our aim was to further evaluate LUTD in diabetic females, especially in regard to diabetic bladder dysfunction (DBD). METHODS: During three years study period, females with or without diabetic mellitus (DM) presenting to urology clinics were enrolled and evaluated by several validated instruments including American Urological Association Symptom Index (AUA-SI), Pelvic Floor Disorder Screening Questionnaire, Female Sexual Function Index, DM Screening Questionnaire, and uroflowmetry with postvoid residual urine volume measurement. Urinalysis and hemoglobin A1c (HbA1c) were also assessed. Overactive bladder (OAB) was defined as voiding frequency of 8 times/day. DBD was defined as a PVR 100 ml or a Qmax 12 ml/second or a bladder voiding efficiency 75% with a 50 PVR 100 ml. The data were reviewed and analyzed as to having various types of LUTD or DBD. Logistic regression model was also fitted with age, race, mean HbA1c, DM duration, UTI, total AUA-SI score, and pelvic floor disorders as the predictors of bladder dysfunction. RESULTS: 99 females with type I (23%) or II (77%) DM and 22 non-DM women were recruited. The mean age of patients with and without DM was 56.1 13.1 and 52.4 9.9 years, respectively. The mean duration of diabetes was 14.2 years and mean HbA1c was 7.9. Regarding LUTD, Mean total AUA-SI score of DM females was significantly higher than the controls (9.4 6.7 vs 5.7 4.9). Statistically significance difference was also achieved for the symptoms of incomplete emptying (p 0.03), weak stream (p 0.03), OAB (p 0.02) and sexual dysfunction (p 0.002) between DM and non-DM females. OAB was more frequently observed in type II than type I patients (43% vs 9%, p 0.05). Thirty-three (33.3%) patients were stratified as having DBD. These women had a significantly greater mean AUA-SI score (11.8 6.4 vs 8.1 6.5) than those without DBD. Further, a significantly greater percentage of DBD females had symptoms indicating urge incontinence (63.6% vs 39.4%, p 0.02), OAB (51.5% vs 27.3%, p 0.02) and fecal incontinence (33.3% vs 13.6%, p 0.02) compared to non-DBD patients. After adjustment for mentioned confounders, increasing in DM duration (OR: 1.1, 95% CI: 1.002-1.152) and having OAB (OR: 8.1, 95% CI: 1.07-6.45), were found to increase the risk of developing DBD. CONCLUSIONS: Our findings show that diabetic women have an increased risk of LUTD including OAB, weak urinary stream, incomplete bladder emptying and sexual dysfunction. Furthermore, DM duration and presence of OAB could be considered as risk factors for developing DBD.

Associations Between Improvements in Lower Urinary Tract Symptoms and Sleep Disturbance Over Time in the CAMUS Trial

We recently reported an association between the bother and severity of lower urinary tract symptoms secondary to benign prostatic hyperplasia and the severity of sleep disturbance. However, few studies have examined whether alterations in the severity of urinary symptoms influence the degree of sleep problems over time. The severity of lower urinary tract symptoms in men enrolled in CAMUS (Complementary and Alternative Medicine for Urological Symptoms), a clinical trial of saw palmetto (Serenoa repens), was evaluated using AUASI (American Urological Association symptom index) and quality of life scores. Sleep disturbance was evaluated by the Jenkins sleep scale at 0, 24, 48 and 72 weeks. Statistical analyses were used to assess the relationship(s) between changes in lower urinary tract symptoms and sleep disturbance. The baseline characteristics of the 339 men (172 placebo arm and 167 saw palmetto arm) enrolled in the CAMUS trial with assessment of sleep disturbance and urinary symptoms were similar. There were no differences between improvements in the severity of sleep disturbance or urinary symptoms between the 2 experimental arms. Combined analyses of the entire cohort revealed significant associations (p <0.001) between the AUASI score and sleep disturbance severity with time. Multivariate analyses demonstrated that improvements in lower urinary tract symptoms other than nocturia were the most significant predictors of improvements in sleep disturbance. Specific analyses adjusting for other baseline characteristics demonstrated that a 3-point improvement in AUASI score was associated with a 0.73-point improvement in the Jenkins sleep scale with time. Improvements in lower urinary tract symptoms correlate with changes in sleeping abilities with time in men with benign prostatic hyperplasia. While nocturia is significantly associated with sleep disturbance, other changes in overall lower urinary tract symptoms are better predictors of changes in sleep dysfunction.

Homoeopathic medicines in the management of benign prostatic hyperplasia: A multicentric prospective observational study

Objectives:The primary objective of this study was to determine the therapeutic usefulness of a group of predefined trial medicines in benign prostatic hyperplasia. The secondary objective was to check the progression of disease by evaluating changes in prostate volume (PV), post-void residual urine (PVRU) and peak urine flow rates (Qmax and Qavg in ml/sec). Methods:In a multi-centric observational study, 231 patients suffering from benign prostatic hyperplasia (BPH) having prostate volume > 20 mL and prostate specific antigen (PSA) ≤ 4 ng/mL were enrolled at 5 Institutes/Units under Central Council for Research in Homeopathy (CCRH). Symptoms were analyzed using the American Urological Association Symptom Index (AUASI). Parameters like PSA, Prostate volume, Post void residual urine, Qmax, Qavg were also analyzed. Twenty pre-defined homoeopathic medicines were short-listed for prescription after repertorizing the pathological symptoms of BPH. The appearance of any change (relief/worsening)/status quo was immediately followed by placebo/ change in potency/change in remedy. The follow-up period was for one year. The analysis was done as per intention to treat principle. Statistical analysis was done using SPSS version 16. Results:The data of 187 patients out of 231 enrolled was analyzed. The non-parametric Friedman test was applied to test for significant difference in AUASI score reported over 12 months (baseline, 3 months, 6 months and 12 months). There was a statistically significant reduction in AUASI score (median change of 13 points, p= 0.0001) on completion of one year of treatment. A total of 10 out of 20 pre-defined medicines were prescribed to 187 patients. The medicines found to be most useful in this study are: Thuja (27 out of 53; 51%), Sulphur (26 out 46; 56.5%), Pulsatilla (34 out of 46; 74%), Lycopodium.(7 out of 13; 54%).There was a mean reduction of 2.3 ml in prostate volume, which was significant satistically (p=0.005). Conclusion:Homoeopathic medicines significantly improved lower urinary tract symptoms in men with BPH. Placebo-controlled trials are needed to evaluate their efficacy and effectiveness.

Prostate cancer diagnosis is associated with an increased risk of erectile dysfunction after prostate biopsy

To evaluate prospectively the characteristics, erectile function and lower urinary tract symptoms (LUTS) of men undergoing prostate needle biopsy (PNBx). From 2008 to 2011, 134 men were prospectively administered the International Index of Erectile Function (IIEF), American Urological Association Symptom Index (AUA-SI), and quality-of-life (QoL) questionnaires before and after undergoing a single 12-core PNBx. Comparisons of IIEF and AUA-SI scores before and after PNBx, based upon baseline characteristics and prostate cancer (PCa) diagnosis, were performed. Univariable and multivariable logistic regression models were used to characterize predictors of change in IIEF scores. In the 85 men who fulfilled the inclusion criteria, there were no significant differences between the mean (sd) total pre-biopsy and the mean (sd) post-biopsy IIEF scores: 57.8 (12.9) vs 54.3 (17.2). Subgroup analysis showed that men who had biopsy-proven PCa had significantly greater changes in their post-biopsy IIEF scores compared with men without (-10.1 vs. 1.0; P < 0.001). After specific analyses of the IIEF domains in these groups we found significant decreases in every domain, including erectile function (P = 0.01). On multivariate analyses, only PCa diagnosis was associated with a significant change in IIEF (odds ratio 7.2; P = 0.003). There were no differences in AUA-SI or QoL scores in the overall population or in subgroups. Cancer diagnosis appears to have an adverse effect on the erectile function of men undergoing PNBx but no effect on LUTS. This study highlights a potential negative psychological confounder that may influence erectile function before the treatment of PCa. Additional prospective trials evaluating these relationships are warranted.

Effectiveness of medical and surgical therapies for lower urinary tract symptoms in the community setting

Study Type - Therapy (outcomes research) Level of Evidence 2c. What's known on the subject? and What does the study add? It is known that benign prostatic hyperplasia is a common condition affecting most men by the age of 80 years. There are multiple treatment options available, including both medical and surgical interventions. However, what is not known is how affective the different types of interventions are in the general population. Previous studies have focused on centre-specific data. What is unique about our study is that it is a prospective cross-section analysis of a community cohort of men. Through this study we were able to assess the outcomes in the general population as opposed to in a high-volume surgical centre. Our findings show that in this community medical management was poor at symptomatic improvement, whereas surgical intervention produced the best improvement. • To describe the use and symptomatic outcomes of different therapies for lower urinary tract symptoms (LUTS) in a community-based population of men followed for 17 years. • Data from a randomly selected cohort of 2184 men, aged 40-79 years in 1990, from Olmsted County, Minnesota, USA were included in the study. Participants completed a questionnaire similar to the American Urological Association Symptom Index (AUASI) and reported on incontinence. • Men were followed biennially through 2007 (median follow-up: 13.7 years; Q1, Q3: 8.8, 15.7). Medical and surgical treatments for LUTS were reported on biennial questionnaires and abstracted from community medical records. • Overall, 610 (28%) men received medical or surgical therapy for treatment of LUTS. Patients undergoing vaporization and transurethral resection of the prostate (TURP) had the highest pre-intervention AUASI scores (P < 0.001) and the most rapid increase in scores over time (P= 0.002) compared with those treated with medications or no therapy. After intervention, symptom progression slowed in all treatment groups. • However, the greatest improvement in AUASI score (median % change) was observed in the TURP group: -27.45%. The TURP group also reported a significant decrease in incontinence after surgery (% change): TURP: -22.58%. • All therapies were effective at slowing the progression of LUTS, but only TURP patients reported a significant decrease in both LUTS and incontinence after therapy.