Condition category
Urological and Genital Diseases
Date applied
19/07/2013
Date assigned
22/07/2013
Last edited
11/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 below 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 measures

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

30/06/2019

Reason abandoned

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

30/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Urological Institute
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

Trust Headquarters
Beckspool Road
Frenchay
Bristol
BS16 1JE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes