Condition category
Urological and Genital Diseases
Date applied
11/04/2005
Date assigned
26/05/2005
Last edited
14/02/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Douglas Tincello

ORCID ID

Contact details

Robert Kilpatrick Clinical Sciences Building
PO Box 65
Leicester Royal Infirmary
Leicester
LE2 7LX
United Kingdom
+44 (0)116 252 3165
dgt4@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UHL 9735 and 2004-002981-39

Study information

Scientific title

Acronym

RELAX

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Detrusor overactivity

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Overall trial start date

01/02/2006

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

240

Participant 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

Recruitment start date

01/02/2006

Recruitment end date

31/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Robert Kilpatrick Clinical Sciences Building
Leicester
LE2 7LX
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Research and Development Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 249 0490
Carolyn.maloney@uhl-tr.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Moulton Charitable Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Added 16./03/10: Wellbeing of Women (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22236796
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23189940

Publication citations

  1. Results

    Tincello DG, Kenyon S, Abrams KR, Mayne C, Toozs-Hobson P, Taylor D, Slack M, Botulinum toxin a versus placebo for refractory detrusor overactivity in women: a randomised blinded placebo-controlled trial of 240 women (the RELAX study)., Eur. Urol., 2012, 62, 3, 507-514, doi: 10.1016/j.eururo.2011.12.056.

  2. Results

    Tincello DG, Owen RK, Slack MC, Abrams KR, Validation of the Patient Global Impression scales for use in detrusor overactivity: secondary analysis of the RELAX study., BJOG, 2013, 120, 2, 212-216, doi: 10.1111/1471-0528.12069.

Additional files

Editorial Notes