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The evaluation of nocturia in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and the analysis of the curative effect after medical or placebo therapy for nocturia: a randomized placebo-controlled study.
BMC Urol. 2018 Dec 13; 18(1):115.BU

Abstract

BACKGROUND

To study nocturia in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) after medical or placebo treatment.

METHODS

Patients with LUTS suggestive of BPH from several community clinics were included. Patients completed the International Prostate Symptom Score (I-PSS) questionnaire and a 3-day voiding diary. Urinalysis, prostate-specific antigen (PSA) measurement, and prostate ultrasonography were performed. Nocturnal polyuria (NP) was defined as a nocturnal urine fraction exceeding one third of the daily urine output in elderly men. A total of 148 outpatients were randomized to drug treatment (tamsulosin) or placebo treatment. After 8 weeks of treatment, they were re-evaluated using a 3-day voiding diary, PSA measurement, prostate volume (PV), I-PSS, etc. RESULTS: The average I-PSS score was 20.3, storage symptom score was 11.7, voiding symptom score was 8.6, quality of life (QoL) score was 3.7, PV was 40.4 ± 19.4 ml, and nocturnal urine volume (NUV) was 845.7 ± 339.0 ml. The mean frequency of nocturia was 2.3 ± 1.1 per day, and 94% of the patients had a nocturia frequency of more than two times per day. Of these patients, 76.5% had NP. A significant correlation was found between NUV and the amount of water intake at night and 4 h before sleep (r = 0.419,P = 0.002; r = 0.302,P = 0.031). Eighty patients were randomized to drug treatment (tamsulosin) and 68 patients were randomized to placebo treatment. The I-PSS score was 16.8 ± 4.9 to 19.3 ± 5.0 (p = 0.002), the storage symptom score was 10.3 ± 3.4 to 10.7 ± 3.4 (p = 0.007), and the voiding symptom score was 7.5 ± 2.4 to 8.6 ± 2.3 (p = 0.003). The frequency of daytime urination was 7.5 ± 2.6 to 8.1 ± 2.6 (p = 0.002), maximum urine volume (ml) was 372.8 ± 103.3 to 302.8 ± 119.3 (p = 0.007), and morning urine volume (ml) was 280.5 ± 111.7 to 259.5 ± 100.7 (p = 0.003). However, the frequency of nocturia score was 2.8 ± 0.7 to 3.0 ± 0.6 (p = 0.306) and the nocturnal urine volume (ml) was 800.7 ± 323.0 to 845.7 ± 303.5 (p = 0.056), which did not change significantly. There were significant differences between the NP and non-NP groups in the duration of LUTS, first voided urine volume, daytime urination frequency, and the amount of water intake at night and 4 h before sleep.

CONCLUSIONS

Among the symptoms of LUTS, the improvement rates for nocturia were the lowest after medical treatment for BPH. The α-blockers did not improve nocturia, which was a common symptom accompanying LUTS suggestive of BPH. Our results showed that the prevalence of NP was 76.5% and that NP was significantly related to the amount of water intake during the evening and before sleep.

TRIAL REGISTRATION

ISRCTN registry, Trial registration number (TRN): ISRCTN85509614 , Date of registration: 30/10/2018. This trial was registered retrospectively.

Authors+Show Affiliations

Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China. Department of Urology, Beijing Huairou Hospital, Beijing, 101400, China.Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China. jyg_doctor@sina.com.Department of Urology, Beijing Huairou Hospital, Beijing, 101400, China.Department of Urology, Beijing Huairou Hospital, Beijing, 101400, China.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30545338

Citation

Xue, Zhigang, et al. "The Evaluation of Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia and the Analysis of the Curative Effect After Medical or Placebo Therapy for Nocturia: a Randomized Placebo-controlled Study." BMC Urology, vol. 18, no. 1, 2018, p. 115.
Xue Z, Lin Y, Jiang Y, et al. The evaluation of nocturia in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and the analysis of the curative effect after medical or placebo therapy for nocturia: a randomized placebo-controlled study. BMC Urol. 2018;18(1):115.
Xue, Z., Lin, Y., Jiang, Y., Wei, N., & Bi, J. (2018). The evaluation of nocturia in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and the analysis of the curative effect after medical or placebo therapy for nocturia: a randomized placebo-controlled study. BMC Urology, 18(1), 115. https://doi.org/10.1186/s12894-018-0426-4
Xue Z, et al. The Evaluation of Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia and the Analysis of the Curative Effect After Medical or Placebo Therapy for Nocturia: a Randomized Placebo-controlled Study. BMC Urol. 2018 Dec 13;18(1):115. PubMed PMID: 30545338.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The evaluation of nocturia in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and the analysis of the curative effect after medical or placebo therapy for nocturia: a randomized placebo-controlled study. AU - Xue,Zhigang, AU - Lin,Yunhua, AU - Jiang,Yongguang, AU - Wei,Nengbao, AU - Bi,Jinwen, Y1 - 2018/12/13/ PY - 2018/08/27/received PY - 2018/11/26/accepted PY - 2018/12/15/entrez PY - 2018/12/14/pubmed PY - 2019/3/29/medline KW - Benign prostatic hyperplasia KW - Nocturia KW - Nocturnal polyuria KW - α-Adrenoceptor antagonists SP - 115 EP - 115 JF - BMC urology JO - BMC Urol VL - 18 IS - 1 N2 - BACKGROUND: To study nocturia in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) after medical or placebo treatment. METHODS: Patients with LUTS suggestive of BPH from several community clinics were included. Patients completed the International Prostate Symptom Score (I-PSS) questionnaire and a 3-day voiding diary. Urinalysis, prostate-specific antigen (PSA) measurement, and prostate ultrasonography were performed. Nocturnal polyuria (NP) was defined as a nocturnal urine fraction exceeding one third of the daily urine output in elderly men. A total of 148 outpatients were randomized to drug treatment (tamsulosin) or placebo treatment. After 8 weeks of treatment, they were re-evaluated using a 3-day voiding diary, PSA measurement, prostate volume (PV), I-PSS, etc. RESULTS: The average I-PSS score was 20.3, storage symptom score was 11.7, voiding symptom score was 8.6, quality of life (QoL) score was 3.7, PV was 40.4 ± 19.4 ml, and nocturnal urine volume (NUV) was 845.7 ± 339.0 ml. The mean frequency of nocturia was 2.3 ± 1.1 per day, and 94% of the patients had a nocturia frequency of more than two times per day. Of these patients, 76.5% had NP. A significant correlation was found between NUV and the amount of water intake at night and 4 h before sleep (r = 0.419,P = 0.002; r = 0.302,P = 0.031). Eighty patients were randomized to drug treatment (tamsulosin) and 68 patients were randomized to placebo treatment. The I-PSS score was 16.8 ± 4.9 to 19.3 ± 5.0 (p = 0.002), the storage symptom score was 10.3 ± 3.4 to 10.7 ± 3.4 (p = 0.007), and the voiding symptom score was 7.5 ± 2.4 to 8.6 ± 2.3 (p = 0.003). The frequency of daytime urination was 7.5 ± 2.6 to 8.1 ± 2.6 (p = 0.002), maximum urine volume (ml) was 372.8 ± 103.3 to 302.8 ± 119.3 (p = 0.007), and morning urine volume (ml) was 280.5 ± 111.7 to 259.5 ± 100.7 (p = 0.003). However, the frequency of nocturia score was 2.8 ± 0.7 to 3.0 ± 0.6 (p = 0.306) and the nocturnal urine volume (ml) was 800.7 ± 323.0 to 845.7 ± 303.5 (p = 0.056), which did not change significantly. There were significant differences between the NP and non-NP groups in the duration of LUTS, first voided urine volume, daytime urination frequency, and the amount of water intake at night and 4 h before sleep. CONCLUSIONS: Among the symptoms of LUTS, the improvement rates for nocturia were the lowest after medical treatment for BPH. The α-blockers did not improve nocturia, which was a common symptom accompanying LUTS suggestive of BPH. Our results showed that the prevalence of NP was 76.5% and that NP was significantly related to the amount of water intake during the evening and before sleep. TRIAL REGISTRATION: ISRCTN registry, Trial registration number (TRN): ISRCTN85509614 , Date of registration: 30/10/2018. This trial was registered retrospectively. SN - 1471-2490 UR - https://www.unboundmedicine.com/medline/citation/30545338/The_evaluation_of_nocturia_in_patients_with_lower_urinary_tract_symptoms_suggestive_of_benign_prostatic_hyperplasia_and_the_analysis_of_the_curative_effect_after_medical_or_placebo_therapy_for_nocturia:_a_randomized_placebo_controlled_study_ L2 - https://bmcurol.biomedcentral.com/articles/10.1186/s12894-018-0426-4 DB - PRIME DP - Unbound Medicine ER -