Phase II, multicentre, randomised, double blind, placebo conntrolled pilot study to determine proof of efficacy, safety, tolerablility and pharmacokinetics of intravesical PSD597 in the symptomatic management of interstital cystitis/painful bladder syndrome.

Completed

• Conditions: Interstitial cystitis/painful bladder syndrome; Urological and Genital Diseases

• Registration Number: ISRCTN56132730
• Lead Sponsor: Plethora Solutions Ltd. (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female patients aged between 18 and 75 years of age.
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. Symptoms of bladder pain/discomfort of more than four on a ten point Likert scale, described as suprapubic pain related to bladder filling accompanied by other symptoms including increased daytime and night-time frequency (more than eight or more than two respectively) in the absence of infection or other pathology, with or without the typical cystoscopic appearance of IC.
4. Symptoms of abnormal urinary frequency and bladder pain/discomfort must have been present for at least three months prior to study entry.
5. Anterior vaginal wall/bladder wall pain on bimanual examination.
6. Able to understand and complete a Likert Scale, Global Risk Assessment (GRA) and O’Leary Sant Interstitial Cystitis symptom and problem indexes.
7. Willing and able to provide written informed consent.

Exclusion Criteria

1. Known allergy to, or intolerance of, amide type local anaesthetics.
2. Currently receiving local anaesthetic analogue therapy.
3. Treatment for IC/PBS (e.g., Elmiron, dimethyl sulfoxide [DMSO] or intravesicular therapy) within four weeks prior to baseline visit.
4. History of cardiac arrhythmias, other cardiac conduction disturbances, and/or significant cardiovascular disease.
5. History of liver disease.
6. Inability to void spontaneously.
7. Severely debilitating or urgent concurrent medical condition.
8. History of pelvic radiation therapy, tuberculous cystitis, neurologic disease affecting bladder function, bladder cancer, or carcinoma in situ, or urethral cancer.
9. Presence of bladder, urethral, or ureteral calculi.
10. Clinical evidence of urethritis.
11. Presence of urethral diverticulum.
12. Unlikely to be compliant due to unmanaged medical or psychological problem, including neurological, psychological or speech/language problems that will interfere with ability to complete the study.
13. Substance abuse or dependency problem within the past two years for which treatment has not been received.
14. Imminent change in residence or other social factors that could compromise compliance with the protocol.
15. Clinically significant abnormal blood clinical chemistry or haematology.
16. Evidence of significant eletrocardiogram (ECG) abnormality such as prolonged QTc.
17. Previously failed therapy with alkalinised lidocaine.

Exclusion criteria for men only:
1. Current treatment for chronic bacterial prostatitis, as documented by a positive urine culture or prior history of recurrent bacterial urinary infections.
2. Unevaluated suspicious prostate examination.
3. History of any prostate cancer.

Exclusion criteria for women only:
1. Currently pregnant or breastfeeding.
2. Symptoms of bladder pain/discomfort and urinary frequency present only during menstruation.

Deferral Criteria: There are several conditions for which a participant will be deferred from entry into the study. Once it is formally ascertained that the condition is not present or has subsided according to the time frame identified, the participant will be reconsidered for entry into the trial. The following list identifies some of the conditions for deferment:
1. Positive urine culture at screening. Participant will be deferred until treated and the repeat urine culture is negative.
2. Gross haematuria. Participant will be deferred until they are without the condition.
3. Currently enrolled in another intervention study, or has received an investigational drug or device within three months prior to screening. Participant will be deferred until they have been off study for at least three months.
4. Active genital herpes, or history thereof, within the prior 12 weeks. Participant will be deferred until they have been without the condition for at least 12 weeks.

Deferral criteria for men only:
1. Recent Transurethral Resection of the Prostate (TURP), Transurethral Incision of the Prostate (TUIP), Transurethral Incision of the Bladder Neck (TUIBN), Transurethral Microwave Thermotherapy (TUMT), Transurethral Needle Ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment, such as cryotherapy or thermal therapy. He will be deferred until at least six months from the date of the procedure.

Deferral criteria for women only:
1. Active vaginitis. She will be deferred until she is free of the condition.
2. Recent v

Study & Design

• Study Type: Interventional
• Study Design: Not specified