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

Phase 1

• Conditions: Primary abnormality of the urethral sphincter or Fowlers Syndrome; MedDRA version: 9.1 Level: LLT Classification code 10046456 Term: Urethral instrinsic sphincter deficiency

• Registration Number: EUCTR2008-004858-33-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-27
• Study Completion: 2012-07-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified