Waking up at night to urinate in patients with benign prostatic enlargement and the effects of drug treatment for night urination

An evaluation of nocturia in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia, and analysis of the curative effect after medical or placebo therapy for nocturia: a randomised placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85509614

Enrollment

Registered

2018-11-12

Start date

2015-01-01

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia Urological and Genital Diseases Nocturia

Interventions

Participants will be randomly allocated to one of two groups. One group will receive an a-adrenoceptor antagonist (2 mg tamsulosin to be taken once daily orally) and the other will be the control grou

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Aged at least 50 years 2. Diagnosed with benign prostatic hyperplasia 3. Male

Exclusion criteria

Exclusion criteria: 1. Prostate cancer 2. PSA >10 ng/ml 3. Urinary tract infection 4. Disease of the nervous system 5. Urolithiasis 6. Medical therapy that could affect the function of urination 7. Prostatic surgery 8. Pelvic surgery

Design outcomes

Primary

Measure	Time frame
The following are assessed at the baseline and after 8 weeks: 1. Symptoms of benign prostatic hyperplasia, assessed using the International Prostate Symptom Score (I-PSS) 2. Serum PSA levels, assessed using a serum PSA test 3. Prostate volume, assessed using a prostate ultrasound 4. A 3-day bladder diary is used to assess the following: 4.1. Nocturnal urine volume 4.2. Frequency of nocturia 4.3. Drinking water volume 4.4. Drinking water volume 4 hours before bedtime 4.5. Maximum urination volume 4.6. Morning urine volume	—

Measure

Time frame

The following are assessed at the baseline and after 8 weeks: 1. Symptoms of benign prostatic hyperplasia, assessed using the International Prostate Symptom Score (I-PSS) 2. Serum PSA levels, assessed using a serum PSA test 3. Prostate volume, assessed using a prostate ultrasound 4. A 3-day bladder diary is used to assess the following: 4.1. Nocturnal urine volume 4.2. Frequency of nocturia 4.3. Drinking water volume 4.4. Drinking water volume 4 hours before bedtime 4.5. Maximum urination volume 4.6. Morning urine volume

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Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026