Waking up at night to urinate in patients with benign prostatic enlargement and the effects of drug treatment for night urination
| ISRCTN | ISRCTN85509614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85509614 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/10/2018
- Registration date
- 12/11/2018
- Last edited
- 17/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Contact information
Scientific
No.2, anzhen Road, Chaoyang district
beijing
100029
China
| Phone | +861064412431 |
|---|---|
| jyg_doctor@sina.com |
Study information
| Study design | Interventional two-arm open randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study hypothesis | The improvement of nocturia in patients with α-adrenoceptor antagonist therapy will better than the placebo therapy. |
| Ethics approval(s) | The Ethics Committee of Beijing Huairou Hospital, 25/10/2014, Ref: BJHR20141020 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/11/2014 |
| Overall study end date | 01/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 88 |
| Participant inclusion criteria | 1. Aged at least 50 years 2. Diagnosed with benign prostatic hyperplasia 3. Male |
| 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
Study participating centre
beijing
101400
China
Sponsor information
Hospital/treatment centre
No.9, yongyai north street, huairou district
Beijing
101400
China
"ROR" |
https://ror.org/02jwb5s28 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/05/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/12/2018 | Yes | No |
Editorial Notes
17/12/2018: Publication reference added.
