Clinical trial NCT00421421: Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase IV Study to Evaluate the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Daily for 24 Weeks to Reduce The Risk of Acute Urinary Retention Relapse Following Successful Trial Without Catheter.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: Acute Urinary Retention
Benign Prostatic Hyperplasia
Trial Without Catheter
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-12
Enrollment: 276
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of dutasteride at reducing relapse rates of Acute Urinary Retention (AUR), including reduction in surgical intervention for benign prostatic hyperplasia (BPH), in patients who receive a 6 month treatment of dutasteride (0.5mg once daily) following a single episode of AUR followed by successful Trial Without Catheter compared with placebo.


Eligibility criteria: Inclusion Criteria:

* Able to read, write and understand instructions related to study procedures and able to give written informed consent
* Able to swallow and retain oral medication
* Had a single, spontaneous episode of AUR related to BPH with a drained volume of between 500 and 1500ml
* Had a successful TWOC (defined as successful if the patient returns to satisfactory voiding within the first 24 hours after catheter removal without re-catheterisation) following 2 - 3 days treatment with alpha blocker (preferably alfuzosin 10mg OD) pre TWOC followed by up to seven days treatment with alpha blocker (preferably alfuzosin 10mg OD) post TWOC.
* Able to be randomised within 7 days of successful TWOC

Exclusion Criteria:

* Prostate volume (PV) of less than 30cc and greater than 80cc measured via Trans Rectal Ultrasound (TRUS) either at time of hospitalisation or as part of the screening / randomisation visit
* Previous episode of AUR prior to the current episode
* AUR not related to BPH i.e. postoperative retention following major abdominal / pelvis surgery
* Previous prostate or urethral surgery
* Previous positive prostate biopsy
* Any cause other than BPH that may result in urinary symptoms or changes in flow rates.
* Any unstable co-existing medical condition
* Previous 5-ARI use
* Previous alpha blocker treatment other than the study mandated 2 - 3 days pre and up to 7 days post TWOC period with alpha blocker (preferably alfuzosin 10mg OD)
* Use of prohibited meds (e.g. 5ARI's, anabolic steroids including testosterone, drugs with antiandrogenic properties)
* Liver enzymes (ALT, AST, ALP) at time of hospitalisation / screening visit greater than 2 x ULN or bilirubin at time of hospitalisation / screening visit greater than 1.5 x ULN.
* Serum creatinine at time of hospitalisation / screening visit greater than 1.5 x ULN
* Treatment with any other investigational product within 30 days prior to the first dose of study medication
* History or current evidence of alcohol or drug abuse within the last 12 months
* Prostate Specific Antigen (PSA) greater than 20ng/ml
* Use of suprapubic catheterisation after failed urethral catheterisation
* Neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology
* Isolated bladder neck disease
* Acute or chronic prostatitis
* Confirmed or suspected urethral stricture
* Known bladder stones
* Clot retention secondary to haematuria of any cause
* Patient unwilling to use a condom during sexual intercourse

Primary outcomes:
measure: Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
timeFrame: 24 Weeks
Secondary outcomes:
measure: Benign prostatic hyperplasia (BPH) related surgical intervention rates during study IPSS score during study Relationship between length of time of catheter in situ and Intravesical prostatic protrusion measurements on relapse rates
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Barnet
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Bath
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Birmingham
country: United Kingdom
facility: GSK Clinical Trials Call Centre
city: Bradford
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Bristol
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Chester
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Colchester
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Crewe
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Derby
country: United Kingdom
facility: GSK Clinical Trials Call Centre
city: Edinburgh
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Glasgow
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Hull
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Leeds
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Leicester
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: London
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Newcastle Upon Tyne
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Nottingham
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Oldham
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Ormskirk
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Plymouth
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Stevenage
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Sunderland
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Sutton Coldfield
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Torquay
country: United Kingdom
facility: GSK Clinical Trials Call Center
city: Wakefield
country: United Kingdom
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, BSc MBBS
role: STUDY_DIRECTOR
References: