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

niversity College London0 个研究点目标入组 10 人开始时间: 2008年11月27日最近更新: 2019年11月25日

试验速览

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•-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

•-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

发起方

niversity College London