A multicentre, randomised clinical trial to evaluate the efficacy of oral ciprofloxacin, oral tamsulosin, and the combination of oral ciprofloxacin and oral tamsulosin for the treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

ISRCTN	ISRCTN85291415
DOI	https://doi.org/10.1186/ISRCTN85291415
Secondary identifying numbers	N/A

Submission date: 30/06/2004
Registration date: 11/11/2004
Last edited: 25/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kathleen Propert
Scientific

University of Pennsylvania School of Medicine
Blockley Hall 6th Floor
423 Guardian Drive
Philadelphia, PA
19104-6021
United States of America

Study information

Study design	Multicentre randomised double blind placebo controlled 2x2 factorial trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS)
Intervention	A 2x2 factorial design assessing four interventions: ciprofloxacin alone, tamsulosin alone, the combination of ciprofloxacin and tamsulosin, and placebo. All treatments were provided for six weeks. Please note that as of 25/08/09 the start and end dates of this trial have been updated. The initial dates, 01/04/2002 to 30/04/2004, were generated at the time of registration.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ciprofloxacin, tamsulosin
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2001
Completion date	30/09/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	184 (196 final [added 25/08/09])
Key inclusion criteria	Approximately 184 participants, 46 per arm, were treated and followed for a total of 12 weeks. These participants were male, had symptoms of discomfort or pain in the pelvic region for at least a 3 month period within the last 6 months, and had a overall score of equal to or greater than 15 out of 43 points on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/07/2001
Date of final enrolment	30/09/2002

Locations

Countries of recruitment

United States of America

Study participating centre

University of Pennsylvania School of Medicine

Philadelphia, PA
19104-6021
United States of America

Sponsor information

National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (NIDDK, NIH) (USA)
Research organisation

Dr John W. Kusek
2 Democracy Plaza
Room 617
6707 Democracy Boulevard
Bethesda, MD
20892-5458
United States of America

Website	http://www.niddk.nih.gov
"ROR"	https://ror.org/00adh9b73

Funders

Funder type

Government

National Institutes of Health (NIH) (USA) - cooperative agreements U01 DK53572, U01 DK53730, U01 DK53736, U01 DK53734, U01 DK53732, U01 DK53746, and U01 DK53738.

No information available

Boehringer Ingelheim (USA) - provided tamsulosin and matching placebo

No information available

Bayer Corporation (USA) - provided ciprofloxacin and matching placebo.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/10/2004		Yes	No