Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Prof Paul Abrams


Contact details

Bristol Urological Institute
Southmead Hospital
BS10 5NB
United Kingdom

Additional identifiers

EudraCT number 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)



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

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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Adult men with urodynamic stress incontinence after prostate surgery


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Bristol Urological Institute
BS10 5NB
United Kingdom

Sponsor information


North Bristol NHS Trust (UK)

Sponsor details

Trust Headquarters
Beckspool Road
BS16 1JE
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


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


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:

Publication citations

Additional files

Editorial Notes

09/10/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 30/06/2019 to 31/12/2017. 2. The overall trial end date was changed from 30/06/2019 to 01/06/2020. 3. Publication reference added.