Botulinum Toxin A Injections in Patients With Fowler's Syndrome

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Hypothesis / aims of study

Urinary retention is uncommon in young women, and one cause is a primary disorder of urethral sphincter relaxation, characterised by an elevated urethral pressure profile and specific findings in the urethral sphincter EMG (Fowler's Syndrome). Women may present with symptoms of obstructed voiding or complete urinary retention. Clean intermittent self-catheterisation is often painful to perform and currently, the only treatment to show benefit is sacral neuromodulation. This aim of this pilot study is to assess the efficacy of urethral sphincter injections of botulinum toxin, defined as improvement of flow rates by more than 50%, improvement in residual volume and scores on the IPSS questionnaire, and safety, in women with Fowler's Syndrome.

Study design, materials and methods In this open label pilot institutional review board approved study, ten women with a primary disorder of urethral sphincter relaxation (elevated urethral pressure profile (UPP), sphincter volume and abnormal EMG) presenting with obstructed voiding (n=5) or in complete urinary retention (n=5) are recruited from a single tertiary referral centre. Baseline symptoms are being assessed using the IPSS questionnaire, and urinary flow and post-void residual volume were measured. After 2% lidocaine injection, 100U of onabotulinumtoxintypeA is being injected into the striated urethral sphincter, divided on either side, under EMG guidance. Patients are being reviewed at weeks 1, 4 and 10 post-treatment and symptoms are reassessed using the IPSS questionnaire, and urinary flow and post-void residual volume are being measured. The UPP is being repeated at week 4.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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(if measured) (greater than 1.8 cm3) and if voiding, evidence of obstructed outflow. (Sphincter EMG will be recorded at the time of injection.)

• 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

Exclusion Criteria:

• 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 with a positive urine culture

• 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.