ProstatitisESTTFCPNCT00913315
Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis
A study testing tolterodine and tamsulosin in people with Prostatitis, run by Chongqing Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine whether tamsulosin and tolterodine are effective in the treatment of men with lower urinary tract symptoms and chronic prostatitis/chronic pelvic pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Prostatitis
- What is being tested?
- tolterodine and tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of CP/CPPS based on the classification of US National Institutes of Health, aged 18-45 years
- total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
- urinary score of at least 4 on the CPSI
- subjects who anticipate improving symptoms
Who cannot join
- previous treatment with any other alpha-adrenergic receptor blocker and antimuscarinic agents for symptoms of CP/CPPS or for any other reason
- those who had had previous urinary tract infection with the last year
- those who had been treat or were taking medication that could affect lower urinary tract function
- those who met the criteria for chronic bacterial prostatitis after lower urinary tract localization studies
- those who had other significant medical problems
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology, the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Xiaohou Wu, MD, 86-2389011122, 93404840@qq.com
About this study
Official title: Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms
The purpose of this study is to determine whether tamsulosin and tolterodine are effective in the treatment of men with lower urinary tract symptoms and chronic prostatitis/chronic pelvic pain syndrome.
Read the detailed description
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in urological clinics. Most of the clinically CP/CPPS are to some extent associated with storage (irritative) symptoms, such as increased frequency, urgency, and nocturia, namely many patients with CP/CPPS have overactive bladder symptoms. Alpha-blocker therapy has been advocated as a treatment modality for CP/CPPS. Some trials showed a statistically and likely clinically significant treatment effect, while other trials showed no benefit. Therefore, tamsulosin combination with tolterodine treatment for CP/CPPS may be more effective than tamsulosin single.
- Conditions
- Prostatitis
- Being tested
- tolterodine, tamsulosin, placebo
- Keywords
- prostatitis, Adrenergic alpha-Antagonists, tolterodine
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolterodineDrug
4 mg of tolterodine ER
tamsulosinDrug
0.4 mg of tamsulosin once a day for 8 weeks
placeboDrug
placebo once a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| tolterodine + tamsulosin | Experimental | Not described Receives: Drug: tolterodine; Drug: tamsulosin |
| tamsulosin + placebo | Active comparator | Not described Receives: Drug: tamsulosin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Chronic Prostatitis Symptom Index
Measured: 4 months
Secondary outcomes (2)
Peak urinary flow rate
Measured: 4 months
International Index of Erectile Function
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Fuling Central Hospital of Chongqing City
- Investigators
- Yong Chen, M.D., Principal investigator, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913315
- Sponsor's protocol ID
- CQU023
- Acronym
- ESTTFCP
- Status last verified
- Jun 2009
- First submitted
- 3 Jun 2009
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, Shoskes DA, Litwin MS, Alexander RB, White PC, Berger R, Nadler R, O'Leary M, Liong ML, Zeitlin S, Chuai S, Landis JR, Kusek JW, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008 Dec 18;359(25):2663-73. doi: 10.1056/NEJMoa0803240.
PubMed 19092152
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Tamsulosin and Tolterodine Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT00913315
- Acronym / sponsor ID
- ESTTFCP / CQU023
- Conditions
- Prostatitis
- Keywords
- prostatitis, Adrenergic alpha-Antagonists, tolterodine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Fuling Central Hospital of Chongqing City
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether tamsulosin and tolterodine are effective in the treatment of men with lower urinary tract symptoms and chronic prostatitis/chronic pelvic pain syndrome.
Detailed description
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in urological clinics. Most of the clinically CP/CPPS are to some extent associated with storage (irritative) symptoms, such as increased frequency, urgency, and nocturia, namely many patients with CP/CPPS have overactive bladder symptoms. Alpha-blocker therapy has been advocated as a treatment modality for CP/CPPS. Some trials showed a statistically and likely clinically significant treatment effect, while other trials showed no benefit. Therefore, tamsulosin combination with tolterodine treatment for CP/CPPS may be more effective than tamsulosin single.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tolterodine + tamsulosin | Experimental | Drug: tolterodine, Drug: tamsulosin |
| tamsulosin + placebo | Active comparator | Drug: tamsulosin, Drug: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of CP/CPPS based on the classification of US National Institutes of Health, aged 18-45 years
- total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
- urinary score of at least 4 on the CPSI
- subjects who anticipate improving symptoms
Key exclusion criteria (5 listed)
- previous treatment with any other alpha-adrenergic receptor blocker and antimuscarinic agents for symptoms of CP/CPPS or for any other reason
- those who had had previous urinary tract infection with the last year
- those who had been treat or were taking medication that could affect lower urinary tract function
- those who met the criteria for chronic bacterial prostatitis after lower urinary tract localization studies
- those who had other significant medical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tolterodine4 mg of tolterodine ER | Drug | tolterodine + tamsulosin |
| tamsulosin0.4 mg of tamsulosin once a day for 8 weeks | Drug | tamsulosin + placebo, tolterodine + tamsulosin |
| placeboplacebo once a day for 8 weeks | Drug | tamsulosin + placebo |
Primary outcome
National Institutes of Health Chronic Prostatitis Symptom Index
Time frame: 4 months
2 secondary outcomes
Peak urinary flow rate
Time frame: 4 months
International Index of Erectile Function
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
- Background: PubMed 19092152Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, Shoskes DA, Litwin MS, Alexander RB, White PC, Berger R, Nadler R, O'Leary M, Liong ML, Zeitlin S, Chuai S, Landis JR, Kusek JW, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008 Dec 18;359(25):2663-73. doi: 10.1056/NEJMoa0803240.
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Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Chen, M.D. principal investigator
Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tolterodine and tamsulosin in people with Prostatitis, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Chen, MD (86-23-89011122, cy0324@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Chronic Prostatitis Symptom Index (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2009.