1954 NOCTURIA: WHY DO PEOPLE VOID AT NIGHT?

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THE JOURNAL OF UROLOGY姞

nocturia status (group A; less than 50 years patients with nocturia, group B; 50 years or more patients with nocturia and group C; patients without nocturia ) and assessed the OSAS severity and other voiding status. Next, we evaluated the efficacy CPAP treatment for nocturia and identified the factor to improve the nocturia. RESULTS: The average number of awakenings to void before CPAP was 2.4 䉫 0.2 times at night (mean ⫾ SD) in group A, 2.9 ⫾ 0.1 times in group B and 0.4 u¨} 0.1 times in group C. At baseline, 16 patients (35.5%) had nocturia in the group A and 40 patients (76.9%) in the group B. The degree of OSAS was more severe in the patients with nocturia (group A and B) than in those without nocturia (AHI⫽52.0u¨}2.4 vs 44.7u¨}2.1, p⫽0.021). The highest AHI was in patients of group A, however baseline voiding symptom score (defined as AUA symptom score Q1⫹3⫹5⫹6) in the group A was significantly lower than the group B (0.7u¨}0.3 vs 5.4u¨}0.8, p⬍0.001). Of the 56 patients in group A and B, CPAP treatment reduced the number of awakenings in 12 patients (75%) of group A and in 36 patients (90%) of group B. There was significant differences in baseline OSAS severity between patients with improvement of noctuira and those without improvement of nocturia (AHI⫽53.7u¨}2.7 vs 42.4u¨}7.2, p⫽0.017) 3 months after CPAP treatment. CONCLUSIONS: These findings indicated that the severity of OSAS appeared to be associated with an increasing occurrence of awakenings to void before treatment. Nocturia in less than 50 years patients without other voiding symptom should be considered a diagnosis of OSAS. CPAP treatment in patients with severe OSAS might be more effective to reduce the nocturia. Source of Funding: None

1952 EFFECTS OF OBSTRUCTIVE SLEEP APNEA ON LOWER URINARY TRACT SYMPTOM Sangrak Bae*, Youngik Lee, Hyoungkeun Park, Hyeonggon Kim, Seoul, Korea, Republic of; Wonhee Park, Incheon, Korea, Republic of; Yongsoo Lho, Sunghyun Paick, Seoul, Korea, Republic of INTRODUCTION AND OBJECTIVES: To determine whether severity of obstructive sleep apnea affects on lower urinary tract symptom. METHODS: All patients who underwent full-night in-laboratory polysomnography were completed International Prostate symptom score (IPSS) and Overactive bladder symptom score (OABSS) questionnaires. Frequency of nocturia was assessed by questionnaire 7 in IPSS. Severity of OSA was evaluated according to the apnea-hypopnea-index (AHI) and patients were divided into four groups according to the severity of OSA; grade 0, grade 1, grade2, and grade 3 OSA group. Patients were also divided into mild OSA group (AHI⬍15) and severe OSA group. IPSS, OABSS and frequency of nocturia were compared between the groups. Correlation analysis between AHI between IPSS, OABSS and nocturia was performed. RESULTS: Data from 53 patients who underwent polysomnography was analyzed. Mean age was 43 years old and mean AHI score was 34 and. Mean value of IPSS and OABSS were 6.97 and 2.71 respectively. By increasing OSA grade, sum of OABSS and frequency of nocturia were increased. (p⫽0.004, 0.003). There is no relationship between OSA grade and IPSS. There is no difference in total IPSS score between mild OSA group and severe OSA groups, but total OABSS score (2.0ı´3⁄42.0 vs. 3.2ı´3⁄42.6, p⫽0.03) and mean number of nocturia (1.0ı´3⁄41.1 times vs. 1.8 ´ı3⁄41.5 times, p⫽0.04) had significant difference between the two groups. Correlation analysis showed that AHI was associated with increased frequency of nocturia (p⫽0.01) but not total IPSS and OABSS. OSA grade and AHI score significantly increased in severe nocturia group(ı´Ã2 per night) than mild nocturia group(ı´Â1 per night), (p⫽0.02, 0.01). CONCLUSIONS: Patients with more severe OSA symptom showed aggravated symptom of OAB and nocturia than those with mild OSA symptom. Clinicians should counsel about the presence of OSA to patients with OAB symptoms and nocturia. Source of Funding: None

Vol. 189, No. 4S, Supplement, Tuesday, May 7, 2013

1953 TREATMENT OF NOCTURIA IN WOMEN: RESULTS OF A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, 3-MONTH, PHASE III, SAFETY AND EFFICACY STUDY OF DESMOPRESSIN ORALLY DISINTEGRATING TABLET Roger R. Dmochowski*, Nashville, TN; Peter K. Sand, Evanston, IL; Egbert A. van der Meulen, Jens Peter Nørgaard, Copenhagen, Denmark INTRODUCTION AND OBJECTIVES: Nocturia interrupts sleep and is associated with multiple negative outcomes, especially when occurring ⱖ2 times/night. Desmopressin is the only medication that specifically targets nocturnal polyuria, which is the most common cause of nocturia. The objective of this study was to confirm the optimal dose of an orally disintegrating tablet (ODT) formulation in women with nocturia. METHODS: Randomized, controlled, double-blind, age-stratified, 3-month study at 39 centers, comparing 25 mcg desmopressin ODT vs. placebo in women with ⱖ2 voids/night and no evidence of severe daytime voiding dysfunction (e.g. ⬎8 daytime voids). Endpoints/ analyses were pre-defined and as per International Conference on Harmonisation (ICH) guidelines and FDA consultation. RESULTS: 261 women (age range 19-87 years) with an average of ⬃3 voids/night were included in the full analysis set. Baseline characteristics were comparable. 89% of randomized patients completed the study. 25 mcg desmopressin ODT: 1.Significantly reduced the mean number of nocturnal voids by -1.46 (treatment difference vs. placebo: -0.22; p ⫽ 0.028) and increased the odds of a ⱖ33% response vs. placebo by 85% (OR: 1.85; p ⫽ 0.006) during 3 months. The effect of desmopressin was rapid (week 1), sustained, and similar in those ⬍65 and ⱖ65 years. 2.Significantly increased the mean time to first nocturnal void by ⫹155 min (treatment difference vs. placebo: 49 min; p ⫽ 0.003) and reduced the nocturnal urine volume by 235 ml (difference: 83 ml; p ⫽ 0.003) at month 3. 3.Significantly improved health-related quality of life (N-QoL questionnaire; total and 2 sub-domain scores), sleep related visual analogue score for quality of sleep and feeling refreshed the next morning, and overall activity (Work Productivity and Activity Impairment questionnaire) at month 3. 4.Did not result in any serum sodium drops ⬍125 mmol/L or treatment withdrawal due to hyponatremia. Overall, the adverse event profile was comparable to placebo. CONCLUSIONS: The major new finding of this study is the confirmation of the efficacy of 25 mcg desmopressin orally disintegrating tablet for the treatment of nocturia in women of all ages combined with the absence of clinically significant reductions in sodium levels/ hyponatremia. The finding of improved quality of life and sleep quality further supports the value of desmopressin. This study supports recommendations for future gender-specific desmopressin doses for the treatment of nocturia. Source of Funding: This clinical trial was funded by Ferring Pharmaceuticals

1954 NOCTURIA: WHY DO PEOPLE VOID AT NIGHT? James M. Weinberger BS, New York, NY; Jeffrey P. Weiss MD*, Brooklyn, NY; Mahyar Kashan BA, Jerry G. Blaivas MD, New York, NY INTRODUCTION AND OBJECTIVES: There are two reasons why patients have nocturia -they are awakened by an urge to void or they awaken for some other reason and then void before going back to sleep. The aim of this study is to determine the relative contribution of each type of night void. METHODS: This is a retrospective review of consecutive patients who completed a validated 24 Hour Bladder Diary. Day and night-time voids were distinguished by bedtime and awake time as indicated on the bladder diary. Each nocturnal void was designated Primary or Secondary Nocturia based on the following scheme derived

Vol. 189, No. 4S, Supplement, Tuesday, May 7, 2013

from the Urge Perception Score (UPS): Primary Nocturia - was subdivided into Urgency Voids (severe urge or desperate urge - UPS ⫽ 3 or 4) and Non-Urgency Voids (mild urge or moderate urge - UPS ⫽ 1 or 2), Secondary Nocturia -(no urge -UPS ⫽ 0). RESULTS: Two Hundred and nineteen patients completed 219 bladder diaries. There were 95 female diaries and 124 male diaries. 2,184 voids were analyzed. Of these 2,184 voids, 545 (25%) were night-time voids. Four diaries were excluded for incompleteness. The data is summarized in the graph. CONCLUSIONS: It appears that eight percent of the time, men may be voiding at night due to insomnia or other sleep issues. Similarly, 10% of female night-time voids were secondary nocturia voids. Because patients designated that these voids were not accompanied by any urge and instead were “out of convenience,” we posit that secondary nocturia voids are unrelated to the bladder. It is likely that at the time of these voids, patients awoke for a reason other than urination and voided out of habit before returning to sleep. Conversely, urgency voids during the night-time are in fact related to the bladder. The great majority of night-time voids (54%) were primary nocturia non-urgency voids. While we can conclude that patients awoke to urinate for the urgency voids, we cannot definitively attribute waking up at night to the bladder for two thirds of all of the night-time voids. The etiology and treatment of the different types of voids is likely different, but requires further study.

THE JOURNAL OF UROLOGY姞

Index and AUA Symptom score were significantly higher in women than men. The most bothersome single symptom in men was pain in the pubic or bladder area (34%), perineal pain (23%), and urinary frequency (17%), while the most bothersome symptom in women was pain in the pubic or bladder area (59%) and urinary frequency (14%). CONCLUSIONS: Numerous studies have described symptoms of patients with either IC/BPS or CP/CPPS. However, this is the first study to prospectively recruit men and women with both urologic pain syndromes and to compare these syndromes using the same instruments. Our findings confirm the similarities between these syndromes. Additional information about the pathophysiology of these symptoms is needed to determine if these common urologic pain syndromes truly represent the same underlying condition. Baseline Characteristics of MAPP Participants By Gender Male Female Unadjusted Adjusted (n⫽186) (n⫽254) p-value p-value* Mean Age 46.9 41.1 (Range) (19-82) (19-78) ⬍ 0.001 Race/Ethnicity

Employment

White

166 (89.2%)

224 (88.2%)

Non-White

20 (10.8%)

30 (11.8%)

Employed

130 (69.9%)

150 (59.1%)

Unemployed

18 (9.7%)

40 (15.7%)

Retired

30 (16.1%)

14 (5.5%)

Full-time Homemaker

0

16 (6.3%)

Disabled

8 (4.3%)

33 (13.0%)

⬍ 0.001

0.491

0

1 (0.4%)

9 (4.8%)

32 (12.6%)

$10,001 to $25,000

12 (6.5%)

24 (9.4%)

$25,001 to $50,000

26 (14.0%)

47 (18.5%)

$50,001 to $100,000

59 (31.7%)

70 (27.6%)

More than $100,000

65 (34.9%)

55 (21.7%)

Missing

15 (8.1%)

26 (10.2%)

Duration of Symptoms (Years)

Mean (Range)

7.9 (0-54)

10.1 (0-52)

0.036

Pain (0-10)

Mean (Range)

4.8 (1-10)

5.3 (1-10)

0.015

0.563

Urgency (0-10)

Mean (Range)

4.7 (0-10)

5.3 (0-10)

0.018

0.068

Frequency (0-10)

Mean (Range)

4.7 (0-10)

5.1 (0-10)

0.101

0.345

Overall Symptom Severity (010)

Mean (Range)

5.0 (0-10)

5.5 (0-10)

0.028

0.459

Genitourinary Pain Index Total (0-45)

Mean (Range)

24.5 (6-44)

26.8 (0-43)

0.004

0.419

Genitourinary Pain Index Pain Subscale (0-23)

Mean (Range)

12.2 (2-23)

13.1 (0-22)

0.017

0.931

IC Symptom Index (0-20)

Mean (Range)

8.5 (0-20)

10.7 (0-20)

⬍ 0.001

⬍ 0.001

IC Problem Index (0-16)

Mean (Range)

7.3 (0-16)

9.5 (0-16)

⬍ 0.001

⬍ 0.001

AUA Symptom Score (0-35)

Mean (Range)

14.0 (0-33)

17.1 (1-35)

⬍ 0.001

0.005

1955

INTRODUCTION AND OBJECTIVES: The clinical features characteristic of interstitial cystitis/ bladder pain syndrome (IC/BPS) are similar to those of chronic prostatitis/ chronic pelvic pain syndrome (CP/CPPS). However, no studies have directly compared the clinical characteristics of these syndromes in men and women. The National Institutes of Health Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) network was established in part to apply novel phenotyping strategies to these conditions. To address one of the hypotheses of the network, that IC/BPS and CP/CPPS represent the same underlying condition, we compared baseline demographic and urologic symptoms in men and women. METHODS: A total of 186 men and 254 women with IC/BPS or CP/CPPS were recruited from six clinical centers across the United States. All subjects underwent an intensive in-person phenotyping evaluation that included demographic data and symptom characteristics and severity. RESULTS: After adjustment for age, income and symptom duration, most measures of symptom severity were similar across genders (Table). Mean scores for the IC Symptom Index, IC Problem

0.726

Missing

Source of Funding: Institute for Bladder and Prostate Research

J. Quentin Clemens*, Daniel J. Clauw, Ann Arbor, MI; Karl J. Kreder, Iowa City, IA; John N Krieger, Seattle, WA; John W Kusek, Bethesda, MD; H. Henry Lai, St. Louis, MO; Larissa V. Rodriguez, Los Angeles, CA; David Williams, Ann Arbor, MI; Xiaoling Hou, Alisa Stephens, J. Richard Landis, Philadelphia, PA

0.763

$10,000 or less

Income

COMPARISON OF BASELINE UROLOGIC SYMPTOMS IN MEN AND WOMEN WITH INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME OR CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME

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* Adjusted for age, income and symptom duration

Source of Funding: NIDDK

⬍ 0.001