Primary abnormality of the urethral sphincter or Fowlers Syndrome MedDRA version: 9.1 Level: LLT Classification code 10046456 Term: Urethral instrinsic sphincter deficiency
Conditions
Interventions
Product Name: Botox®
Product Code: NA
Pharmaceutical Form: Powder for solution for injection
CAS Number: 8000049323
Other descriptive na
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ; 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). ;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. | — |
Countries
United Kingdom
Outcome results
None listed