Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery
| ISRCTN | ISRCTN49212975 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49212975 |
| Secondary identifying numbers | HTA 11/106/01 |
- Submission date
- 19/07/2013
- Registration date
- 22/07/2013
- Last edited
- 17/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Paul Abrams
Scientific
Scientific
Bristol Urological Institute
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| paul.abrams@bui.ac.uk |
Study information
| Study design | Multicentre randomised controlled non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 acronym | MASTER |
| Study objectives | 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(s) | Currently being reviewed by National Research Ethics Service (NRES) Committee South West - Frenchay |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2013 |
| Completion date | 01/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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. |
| Total final enrolment | 480 |
| Key inclusion criteria | Adult men who have decided in discussion with their urologist to have surgery for urodynamic stress incontinence (USI) resulting from prostate surgery. |
| Key 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. |
| Date of first enrolment | 29/01/2014 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Urological Institute
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
North Bristol NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
Beckspool Road
Frenchay
Bristol
BS16 1JE
England
United Kingdom
"ROR" |
https://ror.org/036x6gt55 |
|---|
Funders
Funder type
Government
NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) - NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/106/01
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal - a 12-month safety outcome data paper has been submitted to a high impact journal (January 2020), the final report (24-month outcomes) will likely be submitted late 2020/early 2021. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/02/2018 | Yes | No | |
| Results article | 01/06/2021 | 02/06/2021 | Yes | No | |
| Results article | 01/08/2022 | 17/08/2022 | Yes | No |
Editorial Notes
17/08/2022: Publication reference added.
02/06/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/06/2020 to 01/07/2025.
2. Publication reference and total final enrolment added.
10/01/2020: The recruitment start date was changed from 01/07/2013 to 29/01/2014. The publication and dissemination plan and IPD sharing statement were added.
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.
