Botulinum toxin-A in Sensory Urgency - BTXSENS

Phase 1

Conditions: Sensory Urinary Urgency. This is a condition where patients have urinary urgency (sudden desire to urinate which cannot be deferred) /- urge incontinence (urine leakage) and usually is accompanied by frequency (frequent passage of urine
usually > 8/day)
and nocturia (passing urine at night ie getting up from sleep). No abnormal bladder muscle overactivity, however, is present.
MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder

Registration Number: EUCTR2006-000129-76-GB

Lead Sponsor: Guy's & St Thomas' NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

Informed consent to participate
Male and females
18-80 years of age
Sensory urgency as defined by the investigators ie symptoms of overactive bladder with no evidence of detrusor overactivity on urodynamics
Refractory to anticholinergics

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy or planned pregnancy in the next year
Breast feeding
Painful bladder syndrome or interstitial cystitis
Evidence of significant outflow obstruction
Indwelling catheter
Previous bladder surgery eg augmentation cystoplasty
Previous urological use of botulinum toxin
Other bladder pathology eg tumours, active infection
Current anticoagulation treatment eg heparin, warfarin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can botulinum toxin-a effectively treat patients with sensory urgency - improving their symptoms by increasing their bladder capacity?;Secondary Objective: Can botulinum toxin-a reduce urinary frequency, urgency and incontinence episodes / 24 hours in sensory urgency patients?<br><br>Can botulinum toxin-a improve quality of life in patients with sensory urgency?;Primary end point(s): Maximum cystometric capacity.<br>3 day Bladder voiding diaries to assess <br>•urinary frequency, <br>•urgency and <br>•urge urinary incontinence episodes <br>on 3 non-consecutive days in the week prior to the follow-up visit<br><br>Validated quality of life questionnaires:<br>•King’s Health Questionnaire (KHQ)<br>•Incontinence Impact Questionnaire short form (IIQ-7)<br>•Urogenital Distress Inventory short form (UDI-6)<br>•Patient perception intensity urgency scale<br>•Bladder perception scale<br>•Urgency visual analogue scale<br><br>Other urodynamic parameters:<br>•Post void residual<br>

Secondary Outcome Measures