Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Sheryl Caswell


Contact details

Plethora Solutions
Lupus House
11-13 Macklin Street
United Kingdom
+44 (0)20 7269 8630

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Symptoms of lower urinary tract dysfunction are associated with Bladder Outlet Obstruction (BOO) as a result of Benign Prostatic Enlargement (BPE). The symptoms experienced may be characteristic of OverActive Bladder (OAB) or secondary to Detrusor Overactivity (DO). OAB symptoms may be exacerbated by BOO that results from BPE. Treating the bothersome symptoms of OAB is therefore an important goal for the management of comorbid symptomatic DO and BOO. PSD506 is a novel antimuscarinic agent that is being studied for the treatment of OAB. This study aims to assess the safety of PSD506 in men with Lower Urinary Tract Symptoms (LUTS) and BPE/BOO and an International Prostatic Symptom Score (IPSS) of 8 -19, in line with American Urological Association recommendations.

Ethics approval

Northern and Yorkshire Multi-centre REC, 13/07/2006, ref: 06/MRE03/32

Study design

Multicentre multinational randomised double-blind placebo-controlled parallel-group study

Primary study design


Secondary study design


Trial setting

Not specified

Trial type


Patient information sheet


Men with LUTS and BPE/BOO


PSD506 20 mg or matching placebo once daily for 4 weeks, with a two- to four-week run-in period, if required.

Intervention type



Not Applicable

Drug names


Primary outcome measures

To demonstrate the similarity in safety profiles between PSD506 and placebo as assessed by a urodynamic measure of bladder outlet obstruction (BOO).

Secondary outcome measures

1. To measure the change in Post Void Residual volumes (PVR) and other urodynamic parameters
2. To obtain a preliminary assessment of efficacy by measuring the change in International Prostatic Symptom Score (IPSS) from baseline
3. To demonstrate the overall safety of PSD506 in this subject population

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Males aged 18 years and above
2. Symptoms of LUTS for ≥6 months prior to baseline
3. IPSS score of 8 - 19 at baseline
4. Maximum urine flow ≥5 ml/sec and ≤12 ml/sec on a minimum of 125 ml voided volume
5. Post-void residual volume <150 mL
6. Written informed consent
7. If male subject and partner are of childbearing potential, agree to use a secure form of contraception (e.g. oral or injectable contraceptive, condom)

Participant type


Age group




Target number of participants

Approximately 88 to ensure a total of 80 subjects

Participant exclusion criteria

1. Uncontrolled hypertension >160/95 mmHg (after sitting for 5 minutes)
2. Concomitant or recent medication for BPE: 5α-reductase inhibitors within 6 months prior to baseline or alpha-adrenergic receptor blockers within 3 months prior to baseline
3. Use of anticholinergics in the two weeks prior to baseline (four weeks for solifenacen)
4. Previous surgery for BOO
5. Acute urinary retention in the 12 months prior to baseline
6. Urinary tract infection within 6 weeks prior to baseline
7. History of significant hypotensive episodes or symptoms of fainting, dizziness or lightheadedness
8. Unstable cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart failure
9. Clinically significant central nervous system disease including: Parkinson’s disease, multiple sclerosis, transient ischemic attack, stroke, seizure disorder, depression, or behavioural disturbances
10. History of peripheral vascular or cerebrovascular disease
11. History of narrow angle glaucoma or increased ocular pressure
12. Clinically significant gastrointestinal disorder (e.g., gastroparesis, constipation, diarrhoea, colitis, gastrointestinal tract obstruction, hiatal hernia with reflux oesophagitis, cholestasis).
13. History of clinically significant liver disease, e.g., hepatitis B
14. Prohibited medications taken within two weeks prior to baseline
15. Concomitant use of any agent that has a significant interaction with CYP3A4 or P glycoprotein (Pgp)
16. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count [CBC], chemistry panel)
17. Participation in an investigational drug or device study within 30 days prior to screening
18. Concomitant urological disorders: bladder neck stenosis, urethral stricture, bladder stones, bladder diverticulum, recurrent urinary tract infections, neurogenic bladder
19. Diagnosed or suspected prostate cancer
20. Known hypersensitivity to anti-cholinergic agents
21. Unwillingness or inability to comply with the study protocol for any other reason
22. Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study; or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. This would include, but is not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
23. Any clinically significant abnormality on 12-lead ECG

Recruitment start date


Recruitment end date



Countries of recruitment

Germany, Ireland, United Kingdom

Trial participating centre

Plethora Solutions
United Kingdom

Sponsor information


Plethora Solutions Limited (UK)

Sponsor details

Lupus House
11-12 Macklin Street
United Kingdom

Sponsor type




Funder type


Funder name

Plethora Solutions Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes