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| [ Print-friendly version ] |
| Randomised trial of detrusor botulinum toxin injection compared to placebo in idiopathic detrusor overactivity |
| ISRCTN | ISRCTN26091555 |
| DOI | 10.1186/ISRCTN26091555 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Randomised trial of detrusor botulinum toxin injection compared to placebo in idiopathic detrusor overactivity |
| Scientific title | |
| Acronym | RELAX |
| Serial number at source | UHL 9735 and 2004-002981-39 |
| Study hypothesis |
The principal research objectives for this trial are:
1. To determine the efficacy of detrusor muscle botulinum toxin A (BOTOX®) injection at relieving symptoms of detrusor overactivity 2. To examine the side effects and complications of detrusor muscle BOTOX® injection 3. To collect basic cost effectiveness data including EuroQol 5D data to allow simple cost effectiveness calculations to be done |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Detrusor overactivity |
| Participants - 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 This point of the scale represents a reduction of incontinence episode frequency of around 50% (Slack, unpublished data).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. |
| Participants - 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 |
| Anticipated start date | 01/02/2006 |
| Anticipated end date | 31/10/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 240 |
| Interventions |
Prior to 16/03/10:
Women will be randomised to receive either a single treatment with 200 IU of botulinum toxin A (BOTOX®) into the detrusor muscle (10 units in 1 ml in 20 separate sites, sparing the trigone), or a single treatment of injection of normal saline (placebo) (20 separate injections of 1 ml) into the detrusor muscle. Modified 16/03/10: Women will be randomised to receive either a single treatment with 200 IU of botulinum toxin A (BOTOX®) into the detrusor muscle (10 units in 1 ml in 20 separate sites, sparing the trigone), or a single treatment of injection of placebo (injection vehicle) into the detrusor muscle. |
| Primary outcome measure(s) | 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 measure(s) |
a. Diary measures
1. Urgency episode frequency/24 hours at 3 and 6 months 2. Incontinence episode frequency at 3 and 6 months 3. Urgency severity assessed by IUSS26 at 3 and 6 months b. Questionnaire measures 1. International Consultation on Incontinence Questionnaire short form score (ICIQ-SF) 2. Incontinence Quality of Life (IQOL) questionnaire score c. Physical measures 1. Incidence of complications (including voiding dysfunction, urinary tract infection, haematuria, dysuria, reported muscle weakness) 2. Need for additional treatment during follow up, defined as a new prescription for drugs, or a new referral for other therapies 3. Interval between treatment and patient reported return of troublesome symptoms d. Health economics 1. EuroQol 5D data compared between baseline, 6 weeks and 6 months follow up 2. Estimated costs of each treatment, using reported health care contacts at 6 weeks and 6 months |
| Sources of funding |
1. Moulton Charitable Trust (UK)
2. Added 16./03/10: Wellbeing of Women (UK) |
| Trial website | |
| Publications |
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22236796
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23189940 |
| Contact name | Dr Douglas Tincello |
| Address |
Robert Kilpatrick Clinical Sciences Building
PO Box 65 Leicester Royal Infirmary |
| City/town | Leicester |
| Zip/Postcode | LE2 7LX |
| Country | United Kingdom |
| Tel | +44 (0)116 252 3165 |
| Fax | +44 (0)116 252 5850 |
| dgt4@le.ac.uk | |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Address |
Research and Development Office
Leicester General Hospital Gwendolen Road |
| City/town | Leicester |
| Zip/Postcode | LE5 4PW |
| Country | United Kingdom |
| Tel | +44 (0)116 249 0490 |
| Carolyn.maloney@uhl-tr.nhs.uk | |
| Date applied | 11/04/2005 |
| Last edited | 14/02/2013 |
| Date ISRCTN assigned | 26/05/2005 |
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| © 2013 ISRCTN unless otherwise stated. | |
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