Validation study of the Self-Assessment Goal Achievement (SAGA) questionnaire for lower urinary tract symptoms.

BACKGROUND: Patients' treatment goals for overactive bladder (OAB) and other lower urinary tract symptoms (LUTS) may not be aligned with their healthcare provider's goals. Successful management of OAB symptoms is improved by individualised treatment plans with attainable treatment goals. Goal attainment setting may facilitate patient-provider interaction and the development of a personalised treatment plan based on realistic, individual goals, thereby increasing patient satisfaction and therapeutic outcomes. The purpose of this study was to validate the utility of the Self-Assessment Goal Achievement (SAGA) questionnaire for LUTS in helping patients identify and achieve realistic treatment goals. METHODS: The 2-module SAGA questionnaire consists of nine prespecified (fixed) items and five open-ended items for goal identification and ranking (baseline module) and goal achievement rating (follow-up module). Adult patients in the United States (n = 104) seeking treatment for LUTS, including symptoms of OAB, completed the SAGA baseline module, micturition diary, other patient-reported outcome measures (PROs), and discussed their urinary goals with a clinician at baseline. The SAGA follow-up module was completed 2-4 months later. SAGA was validated based on analyses of face, concurrent, known-groups, and convergent validity and item distribution. RESULTS: Among the nine fixed goals of SAGA, four were ranked as very important by > 50% of patients (i.e. reduce night-time frequency, daytime frequency, urine leakage, urgency). Most patients did not change the importance level of their goals after discussion with their healthcare provider. Pearson correlations between SAGA, diary variables and PRO scores were generally of low to moderate strength. The global mean (SD) follow-up SAGA T-score was 32.54 (12.54), indicating that overall goal attainment was not achieved after 3 months. The goal attainment score was significantly different between groups differing in symptom severity, health-related quality of life, bladder control and continence status. CONCLUSIONS: The results support the validity of SAGA as a measure of patients' goals and goal achievement for the treatment of LUTS, including symptoms of OAB. SAGA may improve healthcare provider-patient interactions and treatment outcomes in clinical practice.

Validation of a 3-item OAB awareness tool.

AIM: The purpose of this study was to validate a short awareness tool to assist patients in identifying if they have bothersome overactive bladder (OAB) symptoms. METHODS: This secondary analysis study utilised data from a cross-sectional study of adult patients presenting for primary care visits. Patients completed an 8-item OAB screener. The clinician probed for urinary frequency, urgency, nocturia and urgency urinary incontinence. If the patient screened positive or reported the presence of at least one OAB symptom, additional questions were asked regarding lifestyle and coping issues. The clinician then diagnosed the patient as having No OAB, Possible OAB, or Probable OAB. Multivariate logistic regressions were performed to assess the feasibility of deriving a shorter screener to raise awareness of OAB among primary care patients. RESULTS: The 1,260 patients in this study were 51.6±17.0 years old; 62% were women; and most (89%) were Caucasian. Clinicians diagnosed 12.1% of patients with Probable OAB, 19.7% with Possible OAB and 68.3% with No OAB. The logistic regression models were performed with OAB clinical diagnosis as the dependent variable comparing No OAB versus Probable OAB. Three items which included the symptoms of urinary frequency, urinary urgency and urine loss associated with a strong desire to urinate performed well as an awareness tool. A cut-point of four provided the most appropriate sensitivity (82%) and specificity (91%) when identifying Probable OAB and yielded adequate model fit. The final 3-item OAB Awareness Tool (OAB-V3) is gender neutral. CONCLUSION: The 3-item OAB Awareness Tool (OAB-V3) correctly identified patients with symptoms of OAB with high sensitivity and specificity and can be used as a conversation starter for patients with symptoms of OAB.

Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review.

Despite potential benefits, primary care clinicians may avoid using antimuscarinics in men with overactive bladder (OAB) symptoms because of safety concerns. To review the efficacy and safety of antimuscarinics, alone or in combination with an α-blocker, for the treatment of men with OAB symptoms, we conducted a systematic review of articles published before 22 July 2010, using PubMed. Data from 12-week, randomised, double-blind, placebo-controlled trials of tolterodine extended release (ER), oxybutynin and solifenacin show that combined antimuscarinic+α-blocker treatment is generally more effective than monotherapy or placebo in men with OAB symptoms. The efficacy and safety of tolterodine ER+α-blocker treatment was not affected by prostate size or prostate-specific antigen (PSA) level. In men meeting entry criteria for OAB and benign prostatic obstruction trials, tolterodine ER alone was effective selectively in men with prostate size or PSA level below study medians. Incidence of acute urinary retention (AUR) in men receiving antimuscarinics with or without an α-blocker was ≤3% in all of these trials; changes in postvoid residual volume and maximum flow rate did not appear clinically meaningful. Post hoc analyses from double-blind, placebo-controlled trials and prospective studies of fesoterodine, oxybutynin, propiverine, solifenacin and tolterodine also suggest that antimuscarinics are generally safe and efficacious in men. A retrospective database study found that risk of AUR in men was the highest in the first month of treatment and decreased considerably thereafter. Antimuscarinics, alone or with an α-blocker, appear to be efficacious and safe in many men with predominant OAB symptoms or persistent OAB symptoms despite α-blocker or 5-α-reductase inhibitor treatment. However, antimuscarinics are not approved for the treatment of benign prostatic hyperplasia. Monitoring men for AUR is recommended, especially those at increased risk, and particularly within 30 days after starting antimuscarinic treatment.

Ectopically draining dysplastic kidney associated with genuine stress urinary incontinence: unusual combined cause of incontinence.

A thirty-two-year-old Samoan woman was referred for evaluation of "unstable bladder" and a history of continuous life-long urinary incontinence. A comprehensive radiographic and urodynamic evaluation demonstrated the unusual combination of a vaginal ectopic ureter draining a dysplastic kidney and genuine stress urinary incontinence. Appropriate treatment based on the recognition of both abnormalities resulted in restoration of continence.

Bladder leiomyoma.

We herein present a case of leiomyoma of the urinary bladder discovered during evaluation for stress urinary incontinence. The histologic findings of this benign tumor and its urologic implications are reviewed.

Prostatodynia and interstitial cystitis: one and the same?

OBJECTIVES: To investigate further the observation that men with prostatodynia may represent a subset of patients with interstitial cystitis. METHODS: The charts of 20 patients with the diagnosis of nonbacterial prostatitis or prostatodynia who underwent cystoscopy and bladder hydrodistention were retrospectively reviewed. RESULTS: The primary complaint of all 20 patients was genital or rectal pain, or both. Ten patients reported irritative voiding symptoms. Twelve of the 20 patients developed petechial hemorrhages involving the bladder uroepithelium on hydrodistention. Bladder biopsies revealed no significant histopathologic abnormalities. Nine of the 12 patients who developed petechial hemorrhages reported symptomatic improvement at 2- to 3-week follow-ups compared with none of the 8 patients without petechial hemorrhages. CONCLUSIONS: These findings suggest that the diagnosis of interstitial cystitis should be considered in patients with nonbacterial prostatitis or prostatodynia.

Invasive adenocarcinoma of bladder response to cisplatinum, methotrexate, and vinblastine chemotherapy.

Primary invasive adenocarcinoma of the bladder was diagnosed in a fifty-two-year-old male with a two-month history of irritative voiding symptoms. He was treated with three courses of cisplatinum, methotrexate, and vinblastine with marked regression of tumor shown radiographically and cystoscopically. Subsequent prostatocystectomy and ileal loop diversion revealed invasive tumor through the bladder wall to regional lymph nodes. The patient had two postoperative courses of the same chemotherapeutic regimen and is without evidence of disease recurrence at one year.

Quality of life of persons with urinary incontinence: development of a new measure.

OBJECTIVES: Our objective was to develop a self-report quality of life measure specific to urinary incontinence (I-QOL) that could be used as an outcome measure in clinical trials and in patient care centers. METHODS: The I-QOL was developed from interviews of 20 individuals with urinary incontinence. Refining the questionnaire was accomplished by structured interviews of 17 individuals with urinary incontinence. Testing the I-QOL's psychometric properties involved two administrations (n = 62) along with measures of psychologic well-being and functional status. RESULTS: The rigorous development process ensured that the measure was complete and understandable. The I-QOL proved to be internally consistent (alpha 0.95) and highly reproducible (r = 0.93; 18 days; SD 4). For discriminant validity, severity of incontinence (P < 0.0001) and number of medical appointments in the past year to treat incontinence (P < 0.0001) significantly predicted I-QOL scores. Convergent validity analyses confirmed our predictions that the I-QOL scores were more closely related to overall well-being than bodily pain. CONCLUSIONS: The I-QOL proved to be valid and reproducible as a self-administered measure for assessing quality of life of patients with urinary incontinence.

Effectiveness of a urinary control insert in the management of stress urinary incontinence: early results of a multicenter study.

OBJECTIVES: The purpose of this study was to test the safety and effectiveness of a urethral insert for managing stress or mixed urinary incontinence. METHODS: We performed a prospective, multicenter study of 135 female patients who were treated for 4 months with the Reliance Urinary Control Insert. The effectiveness of the insert was measured objectively at the time of first use and after 4 months' use by standardized pad weight studies. Insert effectiveness was also measured by reports of symptom improvement during patient interviews and on patient diaries. Urine microscopy and culture were obtained monthly; cystoscopy and urodynamics were conducted at study entry and at 4 months. RESULTS: Significant improvement in involuntary urine loss was observed. Objective measurement of urine loss revealed that 80% of the patients were completely dry, and 95% of the patients achieved greater than an 80% decrease in urine loss. In addition, patients' perceptions of acceptability, incontinence symptom improvement, ease of learning, comfort, and time to habituation also showed improvements. Untoward events reported during the study included hematuria, bacteriuria, and bladder irritation. These events did not require significant medical intervention and did not result in any long-term clinical sequelae. CONCLUSIONS: These preliminary results indicate that the Reliance Urinary Control Insert may be a safe, effective, and well-tolerated alternative to other available methods for the management of stress or mixed incontinence in women. Additional long-term follow-up will be required to substantiate this conclusion.

Treatment with the Reliance urinary control insert: one-year experience.

The 1-year experience of 63 women using an intraurethral insert for the management of stress or mild mixed urinary incontinence is presented, emphasizing safety and efficacy. Objective criteria, including standardized pad weight tests and patient diaries, were employed to evaluate the device's effectiveness. At study outset, 82% of the patients were completely dry with the device in situ, with an additional 16% of patients significantly improved. At 12 months, 79% of the patients were completely dry, and 16% were significantly improved. This result is consistent with the significant improvement (P < 0.0001) in the number of urinary incontinence episodes reported in patient diaries. Women reported that the device significantly improved their ability to stay dry over a number of routine and physically demanding daily activities. The device was increasingly easy to use and more comfortable over time (P < 0.0001). The latter finding was confirmed by a decline in patient reports of "sensation of device presence" over the duration of the study (35% at 1 week v 7% at 12 months). Untoward events included gross hematuria (24%), device-related bladder mucosal irritation (9%), and symptomatic bacteriuria (30%). Such side effects were expected for this type of device, were easily managed without significant medical intervention, and did not result in any long-term clinical sequelae. The great reduction in the number of episodes of urinary incontinence, the low rate of significant problems associated with device use, and ease of use make the intraurethral insert a useful management alternative for women with stress urinary incontinence.

Sexual function and satisfaction in heterosexual couples when men are administered sildenafil citrate (Viagra) for erectile dysfunction: a multicentre, randomised, double-blind, placebo-controlled trial.

OBJECTIVE: To investigate the effect of improvement in erectile dysfunction (ED) on sexual function and satisfaction measures in heterosexual couples in which the woman reports that sexual intercourse is unsatisfactory at least half of the time. DESIGN: Multicentre, double-blind, placebo-controlled study. SETTING: Outpatient medical clinics. POPULATION: Hundred and eighty men with ED and their female partners in whom sexual intercourse was satisfactory about half the time or less (score of < or =3 on the Female Partner of ED Subject Questionnaire question 3 [FePEDS Q3]). METHODS: Men were randomised to flexible-dose sildenafil (25, 50, and 100 mg) or placebo as needed for 12 weeks. MAIN OUTCOME MEASURES: Primary: FePEDS Q3 ('Over the past four weeks, when you had sexual intercourse, how often was it satisfactory for you?') scored as 0 (no sexual activity) and 1 (almost never or never) to 5 (almost always or always). Secondary, partners: Sexual Function Questionnaire, Female Sexual Function Index (FSFI), and ED Inventory of Treatment Satisfaction (EDITS) partner version (EDITS-Partner). Secondary, men: International Index of Erectile Function (IIEF), General Efficacy Questions, event log data, Self-Esteem And Relationship questionnaire, and EDITS. Secondary, partners and men: Dyadic Adjustment Scale. RESULTS: The intention-to-treat population included 85 sildenafil recipients (mean age 59 +/- 12 years) and 91 placebo recipients (mean age 57 +/- 11 years). Most partners (aged 20-79 years; mean, 54 years) were postmenopausal. Sildenafil compared with placebo couples had greater improvement in the primary outcome (FePEDS Q3 [P < 0.0001]) and in sexual function, intercourse success rates, and secondary sexual satisfaction measures (FSFI satisfaction domain [P < 0.0001] and IIEF satisfaction domains [P < 0.001]) and had higher treatment satisfaction (EDITS and EDITS-Partner; P < 0.0001). Several predictors of improvement were identified, and improvement in one member of the couple correlated positively with improvement in the other member. CONCLUSIONS: The interdependence of sexual function and sexual satisfaction measures between members of couples consisting of men with ED and sexually healthy women reporting infrequent satisfactory sexual intercourse underscores the importance of including partners in ED treatment discussions.

Symptom-specific efficacy of tolterodine extended release in patients with overactive bladder: the IMPACT trial.

We evaluated the efficacy of tolterodine extended release (ER) for patients' most bothersome overactive bladder (OAB) symptom in a primary care setting. Patients with OAB symptoms for >or=3 months received tolterodine ER (4 mg q.d.) for 12 weeks. Among incontinent patients (n = 772), the most bothersome OAB symptoms were daytime frequency (28%), urgency urinary incontinence (UUI; 27%), nocturnal frequency (26%) and urgency (19%); among continent patients (n = 91), they were daytime frequency (47%), nocturnal frequency (42%) and urgency (10%). Sixty-nine per cent of patients had one or more comorbid conditions. By week 12, there were significant reductions in patients' most bothersome symptom: -80% for UUI, -78% for urgency episodes, -40% for nocturnal frequency and -30% for daytime frequency (p < 0.0001). The most common adverse events were dry mouth (10%) and constipation (4%). In primary care practice, bothersome OAB symptoms can be effectively and safely treated with tolterodine ER, even in patients with comorbid conditions.

Tolterodine extended release improves patient-reported outcomes in overactive bladder: results from the IMPACT trial.

We evaluated the effect of tolterodine extended release (ER) on patient- and clinician-reported outcomes in a primary care setting. Patients had overactive bladder (OAB) symptoms for >or=3 months and were at least moderately bothered by their most bothersome symptom, as indicated on the patient-completed OAB Bother Rating Scale. Patients completed the Overactive Bladder Questionnaire (OAB-q), American Urological Association Symptom Index (AUA-SI), and Patient Perception of Bladder Condition at each visit; investigators completed the Clinical Global Impression-Improvement at week 12. By week 12, there were statistically significant and clinically meaningful decreases on the OAB-q and AUA-SI total and subscale scores (p < 0.0001). Seventy-nine per cent of patients experienced some improvement in their overall bladder condition. Physicians reported that 68% of patients were 'much improved' or 'very much improved'. For symptom-defined conditions, patient-reported outcomes are a valuable means for determining responses to treatment.

Use of a urethral occlusion device for treatment of incontinence in a patient with heterotopic urinary diversion.

Incontinence is a frequent complication of continent cutaneous urinary diversion that usually requires surgical intervention for correction. We report a novel nonsurgical therapy for reservoir incontinence in a woman who underwent anterior pelvic exenteration with formation of an Indiana pouch urinary diversion for treatment of adenocarcinoma of the urethra. When she subsequently developed urinary incontinence that was only partially responsive to anticholinergic therapy, stomal continence was restored by using a disposable urethral occlusion device.

Bladder neck closure with continent augmentation or suprapubic catheter in patients with neurogenic bladders.

Twenty-four patients, with various combinations of non-healing decubitus ulcers, urethral fistulae, incontinence, and penile skin breakdown were candidates for proximal urinary diversion, having failed intermittent, external, and indwelling catheterization combined with pharmacologic therapy. Seventeen patients underwent bladder neck closure, including seven with multiple sclerosis and ten with spinal cord injury, and because they were unable or unwilling to do catheterization, had their urine diverted by suprapubic catheter. Seven patients, including four with spinal cord injury, underwent bladder neck closure and continent augmentation with formation of a catheterizable cutaneous stoma on the anterior abdominal wall, using right colon and right colon/ileum configurations. When ureteral reflux and obstruction are absent, the patient's bladder was used which spared the added risk of ureteral implantation and possible ureteral stricture while increasing total bladder capacity. In a select group of patients with intractable incontinence, perineal and penile skin breakdown, or urethral fistulae, bladder neck closure and urinary diversion by suprapubic catheter or continent augmentation has proven to be a reliable and effective alternative to an ileal conduit.

Inflammatory mediator profile in urine and bladder wash fluid of patients with interstitial cystitis.

Interstitial cystitis is a syndrome of urinary urgency, frequency and suprapubic pain. We investigated the role of inflammatory mediators in 96 patients with histories and symptoms consistent with interstitial cystitis, and 13 controls from The New York Hospital-Cornell Medical Center, University of Washington and University of California at San Diego. Patients were classified into either group A (meets all criteria of the National Institute of Arthritis, Diabetes, Digestive and Kidney Diseases for inclusion in research studies), group B (meets all of these criteria but without glomerulations) or an "other" group. A small number of group A patients had detectable interleukin-6 in the urine. Urinary concentrations of tumor necrosis factor, prostaglandins E2, D2 and F2 alpha, and thromboxane B2 were not different among either patient groups or controls. Urine specimens contained inhibitors of the bioactivity of interleukin-6 and tumor necrosis factors but no differences between patients or controls were found. No factors chemotactic for human neutrophils were detected in a small patient sample. Bladder wash fluid concentrations of prostaglandins E2, D2 and F2 alpha, and thromboxane were much lower than urinary levels. Bladder wash fluid interleukin-6 and tumor necrosis factor were not detectable. The results suggest that while a small subset of patients may have elevated levels of interleukin-6 the majority of patients do not appear to have elevated levels of inflammatory mediators in the urine or bladder wash fluid. Evaluation of patient bladder tissue may indicate changes not detectable in urine or bladder wash fluid. Alternatively, other etiologies must be considered in those patients.

Interstitial cystitis in children.

PURPOSE: Interstitial cystitis has been rarely reported in children. We present our experience with 16 children in whom clinical symptomatology and cystoscopic findings were consistent with the diagnosis of interstitial cystitis. MATERIALS AND METHODS: We retrospectively reviewed the charts of 20 children referred for chronic sensory urgency, frequency and bladder pain who underwent cystoscopy and hydrodistension. Four patients were excluded from study because of infection identified at cystoscopy or lack of cystoscopic changes with hydro-distension. RESULTS: Patient age at onset of first symptoms ranged from 2 to 11 years (median 4.5) and age at diagnosis ranged from 3 to 16 years (mean 8.2). Of the 16 children 14 (88%) presented with symptoms of urinary frequency and sensory urgency, and in 13 (81%) lower abdominal pain was relieved by voiding. None of the children had motor urgency. Urodynamic evaluation in 8 cases revealed early bladder sensation with no evidence of involuntary bladder contractions. Diffuse glomerulations and terminal hematuria were demonstrated in all patients after hydro-distension. Followup was available for 14 patients. Relief of symptoms occurred after hydro-distension in all children except 1. Seven children (50%) required repeat hydro-distension. CONCLUSIONS: Children with symptoms of bladder pain, urinary frequency and sensory urgency have bladder changes on cystoscopy consistent with interstitial cystitis. Although rare, this condition is recognizable and it should not be confused with dysfunctional voiding in which complaints are secondary to involuntary bladder contractions.