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| A phase II, multi-centre, double-blind, placebo-controlled, 2-way cross-over study to evaluate efficacy, plasma concentrations and safety of 0.25 mL of 20 % w/w PSD503 for topical application in female volunteer patients with stress urinary incontinence |
| ISRCTN | ISRCTN39853232 |
| ClinicalTrials.gov identifier | |
| Public title | A phase II, multi-centre, double-blind, placebo-controlled, 2-way cross-over study to evaluate efficacy, plasma concentrations and safety of 0.25 mL of 20 % w/w PSD503 for topical application in female volunteer patients with stress urinary incontinence |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | PSD503-SUI-001 |
| Study hypothesis |
For many years alpha-adrenergic agonists have been used outside their approved use to treat SUI. As these medications are administered orally, the patients are subjected to systemic exposure so the applicability of these medications to certain patient groups e.g. those with cardiovascular disease, is limited due to the occurrence of sympathomimetic side-effects. Likewise systemic sympathetic side-effects may also limit patient compliance.
The purpose of the present study is to evaluate whether topical application of an alpha agonist on the anterior vaginal wall, over the site of the internal urethral sphincter and urethra can be efficacious in improving stress urinary incontinence (SUI), whilst minimising systemic exposure and hence adverse effects in the patient. |
| Lay summary | |
| Ethics approval | Guys Research Ethics Committee on 05/102005 (ref: 05/Q0704/136) |
| Study design | This is a phase II, multi-centre, double-blind, placebo-controlled, 2-way cross-over study with subjects receiving each treatment once. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stress Urinary Incontinence (SUI) |
| Participants - inclusion criteria |
1. Willing and able to provide written informed consent
2. Female and aged 18 - 75 years inclusive 3. SUI confirmed by a urinary (cough) stress test and urodynamic assessment within 36 months of Screening 4. SUI episode frequency >=7 and =<21 per week confirmed by a Frequency Volume Chart (FVC). If the subject has not completed a FVC prior to Screening, the subject will be asked to complete a FVC for a minimum of 3 days and to return this on Treatment Day 1 5. Normal filling cystometry conducted as part of a urodynamic assessment within 36 months of Screening (a bladder filling capacity of ≥300 mL and a first sensation of filling >100 mL) |
| Participants - exclusion criteria |
1. Has predominantly symptoms of urge urinary incontinence (>10 voids / 24 hours; >1 nocturia / night; urgency; urge incontinence) confirmed by a FVC. If the subject has not completed a FVC prior to Screening, the subject will be asked to complete a FVC for a minimum of 3 days and to return this on Treatment Day 1
2. Detrusor overactivity and / or a post-void residual volume >150 mL diagnosed by urodynamic examination within 36 months of screening 3. Unable to perform the physical exercises as required by the exercise stress pad test in the opinion of the Investigator 4. Current or past history of any cardiac abnormality or disease, or tachycardia, or any clinically significant abnormality in the opinion of the Investigator on electrocardiogram (ECG) at screening 5. Current or past history of hypertension (systolic blood pressure [SBP] ≥140 mmHg or a diastolic blood pressure [DBP] ≥90 mmHg). (If the subject has a SBP ≥140 mmHg or a DBP ≥90 mmHg on admission on any Treatment Day then they must be withdrawn) 6. Any significant medical history, including a current history of hyperthyroid disease, glaucoma, asthma or insulin dependent diabetes mellitus 7. Current or past history of (a) atherosclerotic disease including ischaemic heart disease, stroke, transient ischaemic attacks or with known aneurysm(s) or (b) vasospastic diseases e.g. Raynaud’s phenomenon and migraine 8. Known hypersensitivity to phenylephrine or any component in the preparation of PSD503 or has a known intolerance to sympathomimetics 9. Received within 4 weeks prior to screening or is continuing to receive any treatment which could: a. Interact with phenylephrine (antihypertensives, atropine, monoamine-oxidase inhibitors [MAOIs], tricyclic antidepressants, selective serotonin reuptake inhibitors [SSRIs], serotonin / noradrenaline reuptake inhibitors [SNRIs], cyclopropane, halothane, sympathomimetics, cardiac glycosides, quinidine, doxapram, oxytocin, ergotamine, methysergide, dopexamine and entacapone) b. Contain phenylephrine and related substances (e.g. Sudafed and Contac) c. Cause phenylephrine-like side-effects 10. Received or is continuing to receive any treatment for SUI in the 4 weeks prior to screening (Subjects who have consistently performed Kegel exercises for at least 4 weeks prior to Screening and are committed to continue to perform them regularly throughout the study may participate). 11. Urogenital prolapse >grade 1, cystocele, or has a previous history resulting in scarring in the pelvic region (e.g. surgery / radiotherapy) 12. History of recurring proven urinary infections (i.e. more than 2 in past year) or cystitis or is known to be suffering from any sexually transmitted disease 13. Lactating, or pregnant or at risk of pregnancy during the study. The subject must be either using secure contraceptive precautions, or have been surgically sterilised or be post-menopausal (defined as at least two years since the last menstrual period) 14. History of alcohol or drug abuse 15. Any clinically significant findings on urinalysis, chemical pathology, physical examination, vital signs or clinically significant concurrent illness at screening that in the opinion of the Investigator precludes inclusion / further participation in the study 16. Participated in a clinical trial within 30 days of screening 17. Unable to read and/or understand English 18. Unwilling or unable to abide by the protocol or in the opinion of the investigator, a subject who is not likely to complete the study for any reason |
| Anticipated start date | 31/10/2005 |
| Anticipated end date | 31/07/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Up to 40 subjects may be recruited to obtain data on 30 |
| Interventions | Single application of PSD503 gel containing an alpha-agonist or matching placebo. |
| Primary outcome measure(s) | To evaluate efficacy of treatment with PSD503 compared with placebo in female volunteer patients with SUI as measured by the change in pad weight gain following the exercise stress pad test at pre-dose compared to the pad weight gain following the exercise stress pad test post-dose administration. |
| Secondary outcome measure(s) |
1. To evaluate plasma concentrations of PSD503 in female volunteer patients with SUI at 1 and 3 hours after dose administration
2. To evaluate changes in blood pressure and pulse after treatment with PSD503 compared with placebo in female volunteer patients with SUI over 3 hours after dose administration 3. To evaluate safety and tolerability of PSD503 compared with placebo in female volunteer patients with SUI |
| Sources of funding | Plethora Solutions Limited (UK) |
| Trial website | |
| Publications | |
| Contact name | Miss Sheryl Caswell |
| Address |
Plethora Solutions
Lupus House 11-13 Macklin Street |
| City/town | London |
| Zip/Postcode | WC2B 5NH |
| Country | United Kingdom |
| Tel | +44 (0)207 269 8630 |
| sheryl.caswell@plethorasolutions.co.uk | |
| Sponsor | Plethora Solutions Ltd (UK) |
| Address |
Lupus House
11-13 Macklin Street |
| City/town | London |
| Zip/Postcode | WC2B 5NH |
| Country | United Kingdom |
| Tel | +44 (0)207 269 8630 |
| mail@plethorasolutions.co.uk | |
| Sponsor website: | http://www.plethorasolutions.co.uk/index.php |
| Date applied | 15/02/2007 |
| Last edited | 03/05/2011 |
| Date ISRCTN assigned | 20/04/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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