Randomised trial of detrusor botulinum toxin injection compared to placebo in idiopathic detrusor overactivity

Completed

Conditions: Detrusor overactivity
Urological and Genital Diseases
Incontinence

Registration Number: ISRCTN26091555

Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 240

Inclusion Criteria

1. 8 weeks of continued treatment with oral anticholinergic medication, with a screening Patient Global Impression of Improvement (PGI-I) scale score of 'a little better' or 'worse'. This point of the scale represents a reduction of incontinence episode frequency of around 50% (Slack, unpublished data).
2. 8 weeks of continued treatment, with a verbal response that the treatment has not provided acceptable improvement
3. Treatment stopped because of side effects within 8 weeks
4. Previous treatments stopped because of lack of efficacy, and currently receiving no treatment

Additionally, patients will report at least 8 voids per 24 hours, with at least 2 urgency episodes per 24 hours. Urgency episodes will be defined as those rated as 'moderate' or higher on the Urgency severity scale, and urge incontinence episodes will be defined as recorded leakage in association with an urgency episode.

Exclusion Criteria

1. Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
2. Patients with pre-existing voiding dysfunction (flow rate less than 5th centile, or post void residual volume greater than 100 ml)
3. Patients fulfilling the exclusion criteria for the licensed indications of botulinum toxin (myasethenia gravis and Eaton Lambert syndrome, or allergy to constituents of BOTOX® injection)
4. Patients with co-existing urodynamic stress incontinence

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diary recorded urinary voiding frequency per 24 hours measured at 6 months. A minimum of two complete diary days will be accepted as valid data. A window of ?2 to +8 weeks around the 6 month follow up visit will be allowed.

Secondary Outcome Measures

Name	Time	Method
a. Diary measures<br>1. Urgency episode frequency/24 hours at 3 and 6 months<br>2. Incontinence episode frequency at 3 and 6 months<br>3. Urgency severity assessed by IUSS26 at 3 and 6 months<br><br>b. Questionnaire measures<br>1. International Consultation on Incontinence Questionnaire short form score (ICIQ-SF)<br>2. Incontinence Quality of Life (IQOL) questionnaire score<br><br>c. Physical measures<br>1. Incidence of complications (including voiding dysfunction, urinary tract infection, haematuria, dysuria, reported muscle weakness)<br>2. Need for additional treatment during follow up, defined as a new prescription for drugs, or a new referral for other therapies<br>3. Interval between treatment and patient reported return of troublesome symptoms<br><br>d. Health economics<br>1. EuroQol 5D data compared between baseline, 6 weeks and 6 months follow up<br>2. Estimated costs of each treatment, using reported health care contacts at 6 weeks and 6 months