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Botulinum Toxin A Injections in Patients With Fowler's Syndrome

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ClinicalTrials.gov Identifier: NCT02428881
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief 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.


Condition or disease Intervention/treatment Phase
Urinary Retention Fowler's Syndrome Drug: onabotulinumtoxinA Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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 Injections of Botulinum Toxin A (BoNT-A)
Study Start Date : November 2009
Actual Primary Completion Date : July 2012


Arm Intervention/treatment
Experimental: Complete retention- onabotulinumtoxinA
Women in complete urinary retention receiving onabotulinumtoxinA
Drug: onabotulinumtoxinA
Patients received 100U onabotulinumtoxinA injection into the external urethral sphincter
Other Name: Botox

Experimental: Obstructed voiding- onabotulinumtoxinA
Women with obstructed voiding receiving onabotulinumtoxinA
Drug: onabotulinumtoxinA
Patients received 100U onabotulinumtoxinA injection into the external urethral sphincter
Other Name: Botox




Primary Outcome Measures :
  1. Improvement in urinary flow rates as assessed by uroflowmetry by more than 50% [ Time Frame: 10 weeks ]
    Improvement in urinary flow rates (as assessed by uroflowmetry and measured in mL/sec) by more than 50% after botulinum toxin compared to baseline in women with obstructed voiding

  2. Restoration of voiding for women in complete urinary retention [ Time Frame: 10 weeks ]
    Restoration of voiding (either yes or no) after botulinum toxin for women in complete urinary retention


Secondary Outcome Measures :
  1. Improvement of post void residual urine compared to baseline [ Time Frame: 10 weeks ]
    Improvement of post void residual urine (as assessed by bladder scan and measured in mL) compared to baseline after botulinum toxin. A reduction to less than 100mls would be considered clinically significant

  2. Improvement in lower urinary tract symptoms as assessed by an improvement in scores on the IPSS questionnaire [ Time Frame: 10 weeks ]
    Improvement in lower urinary tract symptoms as assessed by an improvement in scores on the IPSS (International Prostate Symptom score) questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Publications of Results:
Other Publications:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02428881    
Other Study ID Numbers: 08/0216
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015
Keywords provided by University College, London:
onabotulinumtoxin A
Additional relevant MeSH terms:
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Hydranencephaly
Urinary Retention
Syndrome
Disease
Pathologic Processes
Urination Disorders
Urologic Diseases
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents