Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof Paul Abrams
ORCID ID
Contact details
Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
-
paul.abrams@bui.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 11/106/01
Study information
Scientific title
Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery: Evaluation by Randomised controlled trial (MASTER)
Acronym
MASTER
Study hypothesis
The trial will investigate whether a male synthetic sling is non-inferior to implantation of an artificial urinary sphincter (AUS) for men who have urinary incontinence after prostate surgery (for cancer or benign disease).
More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1110601
Ethics approval
Currently being reviewed by National Research Ethics Service (NRES) Committee South West - Frenchay
Study design
Multicentre randomised controlled non-inferiority trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Adult men with urodynamic stress incontinence after prostate surgery
Intervention
Two surgical operations for male urinary incontinence, a synthetic male sling and an artificial urinary sphincter (AUS) implantation will be evaluated. All adult men who have decided in discussion with their urologist to have surgery for urodynamic stress incontinence (USI) resulting from prostate surgery and who consent to participate will be included in the study. If the treating urologist advises that either of the interventions are suitable for the patient and the man agrees to randomisation, he will be randomised to receive one of the two procedures. The patients who are not eligible for randomisation (if the urologist advises one particular type of surgery and/or the man is not willing to be randomised) will be invited to consent to be followed-up.
All men, whether in the randomised controlled trial or who are being followed-up, will complete questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months after surgery. Randomised men only will attend a review appointment with their urologist at 12 months following surgery to evaluate the results of surgery, including a 24 hour pad test.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Clinical effectiveness of implantation of the male sling compared with AUS in terms of self-reported incontinence at 12 months.
2. Cost effectiveness of a policy of primary implantation of the male sling compared with AUS, measured by incremental cost per quality-adjusted life-year (QALY) at 24 months.
Secondary outcome measures
1. Risks of each type of surgery
2. Costs of the benefits and risks of each treatment policy
3. Subsequent NHS services (including repeat surgery) needed for men with persistent or recurrent problems
4. The differential effects of the operations on other outcomes such as quality of life and general health
5. Satisfaction of the men with each procedure
Overall trial start date
01/07/2013
Overall trial end date
01/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult men who have decided in discussion with their urologist to have surgery for urodynamic stress incontinence (USI) resulting from prostate surgery.
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
360 randomised men and approximately a further 360 men who are not randomised but who have consented to follow-up.
Participant exclusion criteria
1. Men who have had previous male sling or AUS surgery.
2. Men with unresolved bladder neck contracture or urethral stricture after prostate surgery.
3. Men who do not consent to be randomised (these men will be asked to consent to follow up).
4. Men with insufficient manual dexterity to operate AUS device.
5. Men who are unable to give informed consent or complete trial documentation.
Recruitment start date
01/07/2013
Recruitment end date
31/12/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Urological Institute
Bristol
BS10 5NB
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) - NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/106/01
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
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29467024