Botulinum toxin A injections in patients with Fowler's syndrome

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  6073

• Sponsor organisation

  University College London

• Eudract number

  2008-004858-33

• ISRCTN Number

  NA

• Research summary

  Fowler??s syndrome (FS) is aprimary disorder of urethral sphincter (the muscle which controls the releaseof urine from the bladder) relaxation in women resulting in urinary retentionor incomplete emptying. The diagnosis is made by needle electromyography(EMG)(electrical recording of muscle activity by means of insertion of a fineneedle) of the urethral sphincter. Increased urethral pressure profile (UPP)(ameasurement of the pressures in the urethra) and enlarged urethral sphinctervolume (SV) are of additional diagnostic value. Women with FS have to rely onclean intermittent self-catheterisation. The only treatment found so far torestore voiding is sacral neuromodulation (placement of an electrode into thespine to stimulate the S3 nerve to normalize detrusor muscle [bladder muscle] andurethra function). This is an expensive and resource intensive surgicalintervention not widely available. Therefore, an alternative management optionwould be welcomed both by patients and healthcare professionals. The aim ofthis pilot study is to examine the effect of botulinum toxin A (BoNT-A)injections (100 units Botox©) in the urethral sphincter in women with FS. Thepatients will be followed up at 1, 4 and 10 weeks after treatment with urinaryflow measurements, post void residual and a validated questionnaire. Thestudies of urethral function performed prior to the study, urethral sphinctervolume measurement by transvaginal ultrasound and sphincter EMG will berepeated at 4 weeks. If there is evidence for a positive response the data willform the basis for a randomised, double-blind, placebo-controlled trial.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  08/H0716/82

• Date of REC Opinion

  11 Nov 2008

• REC opinion

  Favourable Opinion