Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis (ESTTFCP)

Chongqing Medical University

Status: Unknown

Conditions: Prostatitis

Treatments: Drug: tamsulosin; Drug: placebo; Drug: tolterodine

Study type: Interventional

Funder types: Other

Identifiers

NCT00913315

CQU023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

tolterodine + tamsulosin

Experimental group

Treatment:

Drug: tolterodine

Drug: tamsulosin

tamsulosin + placebo

Active Comparator group

Treatment:

Drug: tamsulosin

Drug: placebo