Botulinum Toxin A Injections in Patients With Fowler's Syndrome
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
University College, London
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA