Condition category
Urological and Genital Diseases
Date applied
30/10/2018
Date assigned
12/11/2018
Last edited
12/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nocturia - the need to get up in the middle of the night to urinate - is perceived as one of the most bothersome symptoms of all lower urinary tract symptoms by most men, especially older men. Frequent nocturia, can lead to a lack of sleep, a decline in energy and reduced quality of life. The causes of nocturia are varied, including urinary tract symtoms and benign prostatic enlargement, but also cardiovascular disease, diabetes, and other factors causing wakefulness and urination (such as anxiety and sleep disorder). This study aims to evaluate nocturia in patients with lower urinary tract symptoms and benign prostatic enlargement, along with looking at the effectiveness of drugs to treat nocturia.

Who can participate?
Men aged 50 or over with benign prostatic hyperplasia

What does the study involve?
Participants will be randomly allocated to receive either the study drug or a placebo (control). Those allocated to receive the study drug will receive 2 mg of tamsulosin to take once daily for 8 weeks, and participants in the control group will take the placebo once daily for 8 weeks.
All participants will be asked to complete various questionnaires and tests, including PSA tests, urinalysis and uroflowometry before and after taking the study drug or placebo.

What are the possible benefits and risks of participating?
Some patients with LUTS/BPH will benefit from the drug therapy as it may reduce nocturia and hence improve their quality of life.
There are no known risks to participants taking part in this study.

Where is the study run from?
Beijing Huairou Hospital (China)

When is the study starting and how long is it expected to run for?
November 2014 to February 2017

Who is funding the study?
Beijing Huairou Hospital (China)

Who is the main contact?
Prof. Yongguang Jiang
jyg_doctor@sina.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yongguang Jiang

ORCID ID

Contact details

No.2
anzhen Road
Chaoyang district
beijing
100029
China
+861064412431
jyg_doctor@sina.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

The improvement of nocturia in patients with α-adrenoceptor antagonist therapy will better than the placebo therapy.

Ethics approval

The Ethics Committee of Beijing Huairou Hospital, 25/10/2014, Ref: BJHR20141020

Study design

Interventional two-arm open randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Nocturia

Intervention

Participants will be randomly allocated to one of two groups. One group will receive an α-adrenoceptor antagonist (2 mg tamsulosin to be taken once daily orally) and the other will be the control group and will receive a placebo. Both groups will take their allocated drug for 8 weeks.
Participants will complete questionnaires relating to quality of life and prostate symptoms, along with frequency volume charts at the baseline and after taking the drug for 8 weeks. Participants will also complete PSA (prostate-specific antigen) tests, urinalysis, PV (prostate volume) test and uroflowometry at the baseline and after 8 weeks. Factors such as disease, disease treatment, operation, drinking habits and smoking habits will be recorded at the baseline.

Intervention type

Drug

Phase

Not Applicable

Drug names

Tamsulosin

Primary outcome measure

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

Secondary outcome measures

N/A

Overall trial start date

01/11/2014

Overall trial end date

01/02/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

88

Participant 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

Recruitment start date

01/01/2015

Recruitment end date

31/05/2016

Locations

Countries of recruitment

China

Trial participating centre

Bei Jing Huairou Hospital
No.9,yongyai north street,Huairou District
beijing
101400
China

Sponsor information

Organisation

Beijing Huairou Hospital

Sponsor details

No.9
yongyai north street
huairou district
Beijing
101400
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Beijing Huairou Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal

IPD sharing statement:
The dataset used and/or analysed during the currently reliability study is available from the corresponding author, Yongguang Jiang, jyg_doctor@sina.com, on reasonable request. All participants submitted a signed informed consent form that included information about the purpose of the study, its procedures, the participants’ rights and welfare, participants’ protections and the collection of data for publication. Individual data (age, comorbidities, evaluation data of nocturia, data comparison between therapeutic interventions), will be shared starting on 01/01/2019 upon previous communication and solicitation by responsible study contact personnel, as indicated.

Intention to publish date

01/05/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes