Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Aaron Berger


Contact details

3822 Summit Street
Kansas City
United States of America
+1 816 421 6400 ext 2184

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


PSD597 Bladder Biopsy

Study hypothesis

Cystoscopies are often performed in the physician office using local anaesthesia in the form of 2% lidocaine gel which is squeezed through the urethra prior to insertion of the cystoscope. This results in anaesthesia of the urethra allowing passage of the cystoscope to be generally well tolerated. However, additional procedures beyond a visual diagnosis may not be possible as the local anaesthetic effect is limited to the urethra. Patients who are able to tolerate it do have bladder biopsies performed without anaesthesia but this procedure, though bearable, is painful. If a technique was available that allowed the anaesthetic effect to be extended beyond the urethral mucosa to the bladder mucosa and sub-mucosal space, it would be possible to carry out many more procedures in the office with a resulting reduction in cost and an increase in convenience and comfort to the patient.

Ethics approval

1. Ethical Review Committee, Inc. (USA), approval gained 17 August 2006.
2. The Queen’s University and Affiliated Teaching Hospitals, Health Sciences Human Research Ethics Board (REB) (Canada), review information pending

Study design

This is a phase II, multicentre, randomised, double-blind, placebo-controlled, parallel group, pilot study.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Persons scheduled to undergo a bladder biopsy


This is a phase II, multicentre, randomised, double-blind, placebo-controlled, parallel group, pilot study to determine proof of efficacy, safety, tolerability and pharmacokinetics of intravesical PSD597 in reducing the pain of bladder biopsy in the conscious patient receiving no sedation or other analgesia or anaesthesia except urethral anaesthesia with 2% lidocaine gel.

1. A single dose of PSD597 or placebo will be instilled via urinary catheter and remain in the bladder for 15 minutes before being drained through the cystocope sheath. PSD597 consists of 200 mg lidocaine (as 5ml of 4% lidocaine) instilled into an empty bladder via a urinary catheter followed by 5 ml 8.4% sodium bicarbonate solution.

2. Placebo consists of 10 ml normal saline instilled as two 5 ml instillates via a urinary catheter.

Standard treatment if discontinued from study.

Intervention type



Phase II

Drug names

PSD597 (consists of 200 mg lidocaine as 5ml of 4% lidocaine)

Primary outcome measure

To assess the change in bladder pain between baseline and immediately after the first bladder biopsy achieved by PSD597 versus placebo.

Secondary outcome measures

1. To assess the change in bladder pain between baseline and different aspects of the procedure following treatment with PSD597 versus placebo.
2. To assess the safety and tolerability of PSD597 dosed intravesically prior to bladder biopsy.
3. To measure systemic exposure to lidocaine following intravesical PSD597 in patients undergoing bladder biopsy.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Males or Female aged over 18 years
2. Women of child bearing potential or men with partners of child bearing potential willing to commit to the use of a reliable form of contraception during the course of the study (e.g. contraceptive pill or condoms)
3. Able to understand and complete the Visual Analogue Pain Score (VAPS) form
4. Provide written informed consent

Participant type


Age group




Target number of participants

40, to ensure 30 patients complete the study.

Participant exclusion criteria

1. Receipt of another investigational product within one month prior to screening
2. Known hypersensitivity to amide-type local anaesthetics
3. Requirement for amide local anaesthetics pre-operatively other than 2% lidocaine for urethral anaesthesia prior to insertion of the cystocope
4. Clinically relevant abnormality on Electrocardiogram (ECG), such as prolonged QTc
5. History of alcohol or drug abuse within the past two years for which treatment has not been received
6. Clinically significant abnormal blood biochemistry or haematology
7. History of psychiatric illness, from vulnerable groups, or have learning difficulties
8. Female subjects who are pregnant or lactating
9. Presence of bladder, urethral, or ureteral calculi
10. Have taken an analgesic prior to the procedure (within specified time limits)
11. Known liver disease, known renal disease or heart-failure
12. Clinical evidence of urethritis
13. Urinary infection that has not resolved by Day one

Recruitment start date


Recruitment end date



Countries of recruitment

Canada, United States of America

Trial participating centre

3822 Summit Street
Kansas City, Missouri
United States of America

Sponsor information


Plethora Solutions Ltd (UK)

Sponsor details

c/o Sheryl Caswell
11-13 Macklin Street
Covent Garden
United Kingdom

Sponsor type




Funder type


Funder name

Plethora Solutions Ltd (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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes