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Status unknownNCT00913315ESTTFCPUpdated Jun 5, 2009

Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis

An interventional study of tolterodine and tamsulosin in Prostatitis, sponsored by Chongqing Medical University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-06-05.

Sponsored by Chongqing Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Prostatitis

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Keywords

  • prostatitis
  • Adrenergic alpha-Antagonists
  • tolterodine
03

In context

Prostatitis

87 studies on the registry are indexed under Prostatitis; 9 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 69 interventional studies indexed under Prostatitis.

Browse Prostatitis studies →

Lead sponsor

Chongqing Medical University is the lead sponsor of 78 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. diagnosis of CP/CPPS based on the classification of US National Institutes of Health, aged 18-45 years
  2. total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
  3. urinary score of at least 4 on the CPSI
  4. subjects who anticipate improving symptoms

Exclusion criteria

Exclusion Criteria:

  1. previous treatment with any other alpha-adrenergic receptor blocker and antimuscarinic agents for symptoms of CP/CPPS or for any other reason
  2. those who had had previous urinary tract infection with the last year
  3. those who had been treat or were taking medication that could affect lower urinary tract function
  4. those who met the criteria for chronic bacterial prostatitis after lower urinary tract localization studies
  5. those who had other significant medical problems
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    tolterodine + tamsulosin

    Drug: tolterodine · Drug: tamsulosin

  • Active comparator
    tamsulosin + placebo

    Drug: tamsulosin · Drug: placebo

Interventions

  • Drugtolterodine

    4 mg of tolterodine ER

  • Drugtamsulosin

    0.4 mg of tamsulosin once a day for 8 weeks

  • Drugplacebo

    placebo once a day for 8 weeks

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What researchers measure

Primary outcomes

  1. National Institutes of Health Chronic Prostatitis Symptom Index

    Time frame: 4 months

Secondary outcomes

  1. Peak urinary flow rate

    Time frame: 4 months

  2. International Index of Erectile Function

    Time frame: 4 months

07

Study locations

1 site
  • Department of Urology, the First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality 400016, China
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2009, a primary completion of Oct 2009 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2009
First posted
Jun 4, 2009
Start
Aug 2009
Primary completionEst.
Oct 2009
CompletionEst.
Jan 2010
Last update
Jun 5, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00913315
Lead sponsor
Chongqing Medical University
Collaborators
Fuling Central Hospital of Chongqing City
First posted
Jun 4, 2009
Start date
Aug 2009
Primary completion
Oct 2009 (estimated)
Completion
Jan 2010 (estimated)
Last update
Jun 5, 2009

Study contacts

Yong Chen, MD
Contact
cy0324@yahoo.com.cn
86-23-89011122
Yong Chen, M.D.
principal investigator · Chongqing Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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