Interstitial cystitis/painful bladder syndrome Urological and Genital Diseases Interstitial cystitis/painful bladder syndrome
Conditions
Interventions
Eligible subjects will be randomly allocated (1:1) to receive blinded treatment with PSD597 or a placebo during the double-blind treatment phase of the study:
Group one: PSD597 treatment will consist
Sponsors
Plethora Solutions Ltd. (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the percentage of patients who respond to PSD597, assessed as 'moderately improved' or 'markedly improved' measured by a GRA, compared to placebo, at day 15 following a five consecutive day course of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess changes in GRA measured by a seven point scale. 2. To assess changes in bladder pain measured by ten point Likert scale. 3. To assess changes in frequency measured by a voiding log. 4. To assess changes in urgency measured by ten point Likert scale. 5. To assess changes in symptoms and problems associated with interstitial cystitis measured by the O’Leary Sant Interstitial Cystitis symptom and problem indexes. 6. To assess the safety and tolerability of PSD597 instilled into the bladder. 7. To characterise the pharmacokinetics of single and multiple doses of intravesical PSD597 in a sub-group of patients. | — |
Countries
United States of America
Outcome results
None listed