The Virtue male sling study in Europe is designed to assess efficacy and safety of the Virtue® Male Sling.
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point of this study is to assess the efficacy and safety of the
surgical procedure based on improvement in 24-hour pad weight and adverse event
reporting in the Virtue® Male Sling European Study at 12 months post implant.
Secondary objectives will assess subject satisfaction, patient reported pad
use, and change in 24 hour pad weight through 36 months.
The primary end point will be based on the following endpoints after the 12
months follow-up is complete:
*Efficacy: 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 (including dry as defined as a pad weight of less than 1.3 grams
during the 12-month test).
*Safety: Safety of the device, including the implant procedure, will be
characterized by reporting adverse events including complications such as, but
not limited to perforation, erosion, and hematoma, at 12 months.
Secondary outcome
Secondary objectives will assess subject satisfaction, patient reported pad
use, and change in 24 hour pad weight through 36 months.
Secondary End Points:
The following secondary endpoints will be collected during the investigation.
As labeling claims will not be made on these endpoints, formal statistical
hypothesis tests are not specified and no adjustment of p-values for
multiplicity is required. Subjects will be stratified into the three groups
below by their 24 hour pad weight.
*24 Hour Pad Weight: 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. For this purpose, results
will be reported overall and by level of incontinence at baseline, divided into
these specific categories:
*Group 1 (< 100 g)
*Group 2 (100 * 400 g)
*Group 3 (> 400 g)
*Pad Use: Number and types of pads used will be collected at baseline,1, 3, 6,
12, 24 and 36 months and the difference reported. For this purpose, results
will be reported overall and by level of incontinence at baseline, divided into
these specific categories:
According to the number of pad:
*Group A (0 or 1 dry pad for security / prophylactic reason)
*Group B (1 or 2 pads per day)
*Group C (3 or 4 pads per day)
*Group D (5 or more pads per day or condom catheter)
*ICIQ-UI: The ICIQ patient questionnaire will be administered at baseline, 1,
3, 6, 12, 24 and 36 months and the difference reported.
*PGI-I: The PGI-I patient questionnaire will be administered at 1, 3, 6, 12, 24
and 36 months and the patient reported improvement in urinary incontinence
reported.
*USP questionnaire: The USP patient questionnaire will be administered at
baseline, 1, 3, 6, 12, 24 and 36 months and help to score the stress urinary
incontinence, bladder overactivity and dysuria
*Patient satisfaction score: The patient satisfaction will be evaluated at each
visit after Virtue implantation.
Background summary
Estimates suggest that approximately 3.4 million men (17%) in the U.S. over the
age of 60 have urinary incontinence (UI). Types of UI include urge
incontinence, iatrogenic incontinence, spinal-cord-related incontinence,
nocturnal enuresis, or other nonorganic causes. Although UI in men may occur
for several reasons, reports suggest that up to 30% of subjects who have a
radical prostatectomy have UI post-operatively to some extent.1 As the
population ages, radical prostatectomy is becoming a common procedure for
elderly males. There are approximately 74,200 radical prostatectomies performed
each year in the US yielding about 25,000 men who would be candidates for some
sort of incontinence treatment.2
The incidence of stress urinary incontinence (SUI) following radical
prostatectomy surgery varies throughout the literature ranging from 8-77%.3
More conservative estimates suggest that up to 34% of men report persistent SUI
following a radical prostatectomy.4 Inconsistencies in defining SUI contribute
to the vast range of incidence. Such inconsistencies include distinguishing
between *social* incontinence and SUI, and how to clinically diagnose SUI.
Although there is variance in defining incontinence and determining treatment
success, it is common across the literature that pad weight, pad use, quality
of life and patient satisfaction all contribute to both defining incontinence
and determining treatment success rates. Causes of male SUI can be due, but
not limited to:
* Prostate problems
* Neurologic or degenerative conditions
* Infection
* Aging
Currently, treatment for UI includes behavioral therapies, pharmaceuticals,
collagen implants, male slings, and artificial urinary sphincters (AUS).
Although behavioral therapy, including pelvic floor muscle exercises,
biofeedback, and bladder training, has been scientifically supported for the
treatment of women with SUI, efficacy of this therapy in men is not yet
ascertained. Treatment statistics using pharmaceuticals are positive for urge
incontinence and overactive bladder; however, they are not efficacious for the
treatment of SUI. When comparing slings to collagen injections, evidence
suggests that slings provide longer-term efficacy where as collagen injections
are more effective for short-term therapy.5 The AUS is considered the
gold-standard with efficacy rates reported up to 75% for the post radical
prostatectomy incontinence population, and patient satisfaction reported at
85-95%.6 Adverse event rates for the AUS range from six percent for mechanical
failure and 27% for revisions.7 The invasive nature of the procedure and
reported adverse events contribute to the AUS being used in more severely
incontinent males. The male sling therapies are currently marketed to those
subjects who are considered to be mild or moderately incontinent.8,9 However,
it is documented that if given a choice without physician input, 92% of
patients will choose to have a sling implanted rather than an AUS for the
treatment of incontinence.10
Male slings currently available on the market have perceived drawbacks such as
the presence of bone screws (which can lead to infection and pain), unclear
methods for changing and maintaining sling tension (which can lead to migration
and slippage), retropubic passage (which can lead to urethral or bladder
perforations), and dissection through the bulbous urethra.11-13The design of
Virtue® Male Sling is absent of bone screws and has four arms which may provide
elongated compression of the bulbous urethra, without having to expose the
urethra. The four arm design allows for compounded applied pressure to the
bulbous urethra intra-operatively as evidenced in cadaveric tissue.14
Study objective
The Virtue male sling study in Europe is designed to assess efficacy and safety
of the Virtue® Male Sling.
Study design
This study is a prospective, single arm, non-randomized, multi-center clinical
study that will be conducted at up to thirteen centers in Europe. 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.
Intervention
Surgical procedure: implantation of the Virtue male sling and creating tension
to support the bulbous urethra with the aid of the two prepubic arms and 2
transobturator arms of the sling. The surgical procedure takes place under
general aneasthesia or spinal anaesthesia.
Study burden and risks
Burden:
1. Pre-surgery visit and examination (does not differ from standard examination
for implants) and baseline examination
The Baseline Visit will occur once the decision has been taken to include the
patient in the Virtue study and after informed concent of the patient. This
visit will occur prior to implantation of the Virtue. The medical history that
relates to the urinary incontinence will be recorded. The patient is asked to
fill out 3 validated questionnaires (20 questions) about urine leakage, pad
use, and how urine leakage affects the daily life activities. Also, some tests
will be done to determine theseverity of incontinence and to ensure that the
patient has not a urinary tract infection. These tests are described below:
*Urodynamics
*Post Void Residual
*Uroflow Testing
*Urethro Cystoscopy
*24-hour pad weight; the patient performs this test 24 hours before the next
visit to the doctor
*Urinalysis
2. Implant Visit
The patient will be administered to the hospital 24 to 36 hours and the VirTue
male sling will be implanted while trhe patient is fully anesthetized.
3. Follow-up Visits
The patient has to visit the hospital 1, 3, 6, 12, 24 and 36 months after
implantation of the male sling. During thes follow up visits the patient has
to to complete three (20 questions) questionnaires. Some of the same tests
that were completed prior to the surgery will be completed at each follow-up
visit. These tests will be completed to see if any change has occurred in
relation to the patients incontinence.
The following tests will be completed at every follow-up visit:
*Post Void Residual
*Uroflow Testing
*24-hour pad weight: the patient performs this test 24 hours before the next
visit to the doctor
Potential risks (do not differ from other surgeries in the pelvic floor):
Procedure Related
*Delayed wound healing
*Bleeding/Hematoma
*Possible reaction from anesthesia
*Parasthesia (genital)
*Perineal pain
*Suprapubic pain
*Superficial wound infection
*Infection at implant site
*Bladder perforations
*Urethral perforations
*Vascular injury
*Nerve injury
*Urinary tract infection (with or without fever)
Device Related risks
*Erosion - sling enters the bladder or urethral lumen
*Urinary retention requiring a catheterization
*Foreign body reaction
*Device malfunction * sling does not improve subject*s stress urinary
incontinence and only if it causes patients symptoms beyond what they had.
Softwareweg 1
Amersfoort 3821 BN
NL
Softwareweg 1
Amersfoort 3821 BN
NL
Listed location countries
Age
Inclusion criteria
*the subject is male
*the suject is at least 18 years of age
*the subject has an estimated life expectancy of more than 5 years
*the subject has confirmed stress urinary incontinence (SUI) throug medical history, urodynamics and/or pysical 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
*the subject has compromised immune systems or any other conditions 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 TransUrethralResection 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 agensts are allowed)
*the subject has undergone radiation, cryosurgery or brachy therapy to treat prostate- or 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) equal to or more than 150 ml
*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 devise) 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39560.058.12 |