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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2008-004858-33-GB |
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Date of registration:
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27/11/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open label pilot study to treat women with chronic urinary retention or voiding dysfunction due to a primary disorder of sphincter relaxation (Fowler’s syndrome) with outpatient urethral sphincter injections of botulinum toxin A (BoNT-A) - Botulinum toxin A injections in patients with Fowler's syndrome
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Scientific title:
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Open label pilot study to treat women with chronic urinary retention or voiding dysfunction due to a primary disorder of sphincter relaxation (Fowler’s syndrome) with outpatient urethral sphincter injections of botulinum toxin A (BoNT-A) - Botulinum toxin A injections in patients with Fowler's syndrome |
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Date of first enrolment:
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09/01/2009 |
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Target sample size:
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10 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004858-33 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Inclusion criteria:
-Women 18 years old or over with diagnosed Fowler’s syndrome and abnormal sphincter function i.e. raised UPP {MUCP>(92 - patient age in years) cmH2O} (Edwards and Malvern 1974), increased sphincter volume (greater than 1.8 cm3) and if voiding, evidence of obstructed outflow. (Sphincter EMG will be recorded at the time of injection.)NB: Patients who are not sexually active will not have Sphincter volume measurements and those in full retention will not be able to have UPP and flow measurements, they must have a diagnosis of Fowler syndrom previously noted in their hospital notes.
-Willing to give written informed consent
-Willing to attend the necessary follow-up visits
-On effective contraception if sexually active: oral contraceptive pill (>3 months use), condoms, intrauterine contraceptive device, depot injection
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Exclusion criteria:
-Symptomatic Urinary Tract Infection with a Positive Urine Culture
-Previous urethral surgery (other than urethral dilatation)
-Neurological disease
-Pregnant or lactating women and those planning pregnancy
-Anticoagulant therapy at the time of inclusion*.
-On drugs that might interfere with neuromuscular transmission (e.g. aminoglycosides)
-Pain thought to originate from the urinary tract
-Unsuitable past medical history e.g. frequent epilepsy, uncontrolled hypertension, severe coronary artery disease.
- Symptomatic Urinary Tract Infection (As defined by a positive Urine culture and Symptoms)
-Participation in a clinical trial involving an investigational product in the last 3 months
-Patients who are unable to understand or speak English, as this is a pilot study involving very few patients.
* If taking aspirin, warfarin, clopidogrel or other anticoagulants which are contraindications to injection of sphincter BoNT-A unless these can be safely stopped prior to the injection
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Primary abnormality of the urethral sphincter or Fowlers Syndrome
MedDRA version: 9.1
Level: LLT
Classification code 10046456
Term: Urethral instrinsic sphincter deficiency
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Intervention(s)
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Product Name: Botox®
Product Code: NA
Pharmaceutical Form: Powder for solution for injection
CAS Number: 8000049323
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Primary end point(s): To investigate if voiding can be restored in those with complete retention or flow rates improved by more than 50% in those with incomplete bladder emptying using sphincter injections of botulinum toxin A.
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Main Objective: To investigate if urethral sphincter injections of botulinum toxin A can
A) restore voiding in those with complete retention (the inability to pass any urine from the bladder normally).
B) improve flow rates by more than 50% in those with incomplete bladder emptying
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Secondary Objective: To study the effect of urethral sphincter injections of botulinum toxin on
A) reducing post void residual (the amount of urine left in the bladder after normal voiding)
B) changing the score of the International Prostate Symptom Score validated questionnaire. (The IPSS contains 7 questions answered by the patient about their ability to pass urine and their frequency of passing urine).
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Secondary ID(s)
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Version 2.0 (03Nov2010)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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