Virtue® European Study

Stress Urinary Incontinence Clinical Trial

Official title:

Virtue® Male Sling European Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608789
• Other study ID #: SU012
• Status: Completed
• Phase: N/A
• Start date: August 27, 2012
• Est. completion date: June 11, 2018

Study information

• Verified date: June 2020
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.

Description:

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted at up to thirteen centers in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling. One hundred and twenty-one subjects, satisfying criteria for selection, will be implanted with no more than 15 implanted per site. The study's primary end point will be evaluated at 12 months with continued data collection through 36 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: June 11, 2018
• Est. primary completion date: June 28, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject has an estimated life expectancy of more than 5 years

• The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months

• The subject has intrinsic sphincter deficiency due to radical prostatectomy completed at least 1 year prior to implantation date

• The subject has a good bladder function

• The subject has failed non-invasive therapies, eg. Pelvic Floor/Kegel exercises, behavioral modification, or biofeedback, for at least 6 months

• The subject is willing to have the Virtue® Male Sling implanted

• The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol

Exclusion Criteria:

• The subject is unable or unwilling to comply with all follow-up requirements according to the study protocol

• The subject has an active urinary tract infection or active skin infection in region of surgery (temporary exclusion)

• The subject has compromised immune systems or any other conditions that affect healing

• The subject has serious bleeding disorders

• The subject has an urinary incontinence that is not mainly a stress urinary incontinence

• The subject has a stress urinary incontinence due to TransUrethral Resection or laser surgery of the Prostate (TURP)

• The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions

• The subject had a previous implant (male sling, Artificial Urinary Sphincter) to treat stress urinary incontinence (previous implanted bulking agents are allowed)

• The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months

• The subject is likely to undergo radiation therapy within the next 3 months

• The subject has a postvoid residual (PVR) > or = 150mL

• The subject has recently required transurethral instrumentation for urethral or urethro-vesical anatomosis stricture within the previous 6 months

• The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without the sponsors' approval

• The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by the attending physician

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Virtue® Male Sling
The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD).

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
France	Centre Hospitalier Universitaire Henri Mondor	Créteil
France	Groupe Hospitalo Universitaire Carémeau	Nîmes
France	Hôpital de la Pitié-Salpêtrière	Paris
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Heilig Geist Krankenhaus	Köln
Ireland	Mater Private Hospital	Dublin
Italy	Istituto europeo di Oncologia	Milan
Italy	Hospital Santa Maria della Misericordia	Udine
Netherlands	Leiden University Medical Center	Leiden
Spain	Fundacio Puigvert - Universitat Autonoma de Barcelona	Barcelona
Spain	Hospital Universitario Puerta del Mar	Cádiz
United Kingdom	Guy's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of urinary incontinence based on 24-hour pad test	The primary effectiveness end point will be improvement in pad weight defined as at least a 50% reduction in 24-hour pad weight from baseline to 12-months.	1 year
Primary	Safety of the device characterized by reported adverse events	Safety of the device, including the implant procedure.	1 year
Secondary	Improvement of urinary incontinence based on 24-hour pad test	24 hour pad weight tests will be administered at baseline, 1, 3, 6, 12, 24 and 36 months and the difference reported. Outcomes reported will include mean paired change from baseline as well as the proportion or patients improving by at least 50% from baseline	Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
Secondary	Improvement of urinary incontinence based on number of pad used	Number and types of pads used will be collected at baseline,1, 3, 6, 12, 24 and 36 months and the difference reported.	baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years
Secondary	Improvement of urinary incontinence based on PGI-I	Patient global Impression of improvement	1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Secondary	Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form	Base on International Consultation on Incontinence questionnaire-Urinary Incontinence short-form	baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years
Secondary	Patient satisfaction questionaire	the patient reported level of satisfaction in implantation sling procedure.	1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Secondary	Safety of the device characterized by reported adverse events	Safety of the device, including the implant procedure.	Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years