Condition category
Surgery
Date applied
10/09/2013
Date assigned
10/09/2013
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively 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

Mr Antoine Kass-Iliyya

ORCID ID

Contact details

250 Euston Road
London
NW1 2PG
United Kingdom
-
antione.kass-iliyya@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14690

Study information

Scientific title

A comparison of the effectiveness of the Advance male sling and AMS 800 artificial urinary sphincter for mild to moderate post prostatectomy incontinence: a single-site, two-arm randomised controlled study

Acronym

Study hypothesis

A two-arm randomised comparison of the American Medical System (AMS) Advance male sling and AMS 800 artificial urinary sphincter for patients with mild and moderate post prostatectomy incontinence.

Ethics approval

11/0528

Study design

Randomised interventional treatment 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

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Surgery

Intervention

Advance Male Sling, Polypropylene mesh, retrourethral transobturator position.
Inserted using two needle passers and through a perineal incision.

Artificial Urinary Sphincter, A mechanical device made of silicon, has three components: cuff, pump and a baloon. Implanted through a perineal incision and inguinal incision.

Follow Up Length: 12 month(s)

Study Entry : Single Randomisation only

Intervention type

Procedure/Surgery

Phase

Phase II

Drug names

Primary outcome measures

Difference in 24 hour Pad weight; Timepoint(s): 3 months, 6 months, 12 months after surgery

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/02/2013

Overall trial end date

08/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Post prostatectomy men at least 6 months after surgery
2. Mild to moderate stress urinary incontinence (mild 50-200 ml 1-2 pads/day; moderate 200-400 ml 3-4 pads/day)
3. Able and willing to participate in the study for its duration
4. Able to comprehend and complete health outcomes questionnaires
5. Able to understand instructions related to study procedures and give written informed consent
6. Target Gender: Male; Upper Age Limit 80 years ; Lower Age Limit 40 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. Very mild incontinence (<50 ml/day; not approriate for artificial sphincter)
2. Severe incontinence (>400ml; 5 pads or more; not appropriate for male sling)
3. Previous radiotherapy for prostate cancer
4. Previous surgery for post prostatectomy incontinence or urethral stenosis
5. Urodynamics showing detrusor overactivity or compliance loss deemed a significant contributor to incontinence, or bladder outflow obstruction
6. Any unstable serious coexisting medical condition(s)) including but not limited to: myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, cerebrovascular accident or uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management within 6 months prior to Screening visit; which would preclude them from standard therapies as designated within the study design

Recruitment start date

08/02/2013

Recruitment end date

08/02/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Industry

Funder name

American Medical Systems

Alternative name(s)

AMS

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

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

06/09/2016: No publications found, verifying study status with principal investigator.