Stress Urinary Incontinence
Conditions
Keywords
Male sling, stress urinary incontinence, urinary incontinence
Brief summary
This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.
Interventions
DEVICEVirtue® Male Incontinence Sling
The VIRTUE® male sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years * Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam * Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant * Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date * Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol * Subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site
Exclusion criteria
* Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study * Subject has active urogenital infection or active skin infection in region of surgery * Subject has serious bleeding disorders * Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions * Subject has previous implant to treat SUI * Subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months * Subject has active urethral or bladder neck stricture disease requiring continued treatment * Subject has urge predominant incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) | 12 months post implant | Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: \>50% responding very much better or much better. |
| Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry). | 12 months | Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = \<12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: \>50% responding very much better or much better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function | Baseline | The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function. |
| Assess Change in Pad Use | Baseline | Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment. |
| Assess Change in Subject Satisfaction Through ICIQ | Baseline | The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity. |
| Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies | At implant | — |
| Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra | At implant | — |
| Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward | At implant | — |
| Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother | Baseline | The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Implanted With Virtue® Male Sling The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only. | 98 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Study deviation | 2 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Subjects Implanted With Virtue® Male Sling |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 54 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Continuous | 67.0 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment Canada | 36 participants |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 98 |
| serious Total, serious adverse events | 2 / 98 |
Outcome results
Primary
Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).
Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = \<12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: \>50% responding very much better or much better.
Time frame: 12 months
Population: The study was not fully enrolled and therefore underpowered for the planned analyses.~There are 71 subjects with outcome 2 (pad weight endpoint). Of the 74 with 12 months follow-up, 3 are missing the pad weight improvement assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry). | 62.0 % of subjects successful |
Primary
Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: \>50% responding very much better or much better.
Time frame: 12 months post implant
Population: The study was not fully enrolled and therefore underpowered for the planned analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) | 41.9 % of subjects successful |
Secondary
Assess Change in Pad Use
Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.
Time frame: Baseline
Population: There are 97 subjects with outcome 9 (baseline pad use). Of the 98 subjects implanted, one is missing the baseline assessment of pad use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in Pad Use | 4.1 pads/24 hours | Standard Deviation 3.6 |
Secondary
Assess Change in Pad Use
Time frame: 12 months post-implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in Pad Use | 2.4 pads/24 hours | Standard Deviation 2.1 |
Secondary
Assess Change in Subject Satisfaction Through ICIQ
The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.
Time frame: 12 months post implant
Population: There are 73 subjects with outcome 4 (ICIQ at 12 months). Of the 74 subjects with 12 months follow-up, 1 is missing the 12 month ICIQ assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in Subject Satisfaction Through ICIQ | 12.0 units on a scale - ICIQ Score | Standard Deviation 6.1 |
Secondary
Assess Change in Subject Satisfaction Through ICIQ
The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.
Time frame: Baseline
Population: There are 95 subjects with outcome 3 (ICIQ at baseline). Of the 98 subjects implanted, 3 are missing the baseline ICIQ assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in Subject Satisfaction Through ICIQ | 16.6 units on a scale - ICIQ Score | Standard Deviation 3.2 |
Secondary
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Time frame: Baseline
Population: There are 97 subjects with outcome 5 (Urinary bother at baseline). Of the 98 subjects implanted, 3 are missing the baseline Urinary Bother assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother | 13.7 units on a scale | Standard Deviation 20.7 |
Secondary
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Time frame: 12 months post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother | 36.5 units on a scale | Standard Deviation 34.9 |
Secondary
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Time frame: Baseline
Population: There are 97 subjects with outcome 7 (Urinary function at baseline). Of the 98 subjects implanted, 1 is missing the baseline Urinary Function assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function | 17.1 units on a scale | Standard Deviation 12.6 |
Secondary
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Time frame: 12 months post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function | 37.1 units on a scale | Standard Deviation 28.2 |
Secondary
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies
Time frame: At implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies | Strongly disagree | 3.1 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies | Somewhat disagree | 13.3 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies | Neutral | 10.2 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies | Somewhat agree | 9.2 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies | Strongly agree | 64.3 percentage of responses |
Secondary
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward
Time frame: At implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward | Strongly disagree | 4.1 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward | Somewhat disagree | 6.1 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward | Neutral | 3.1 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward | Somewhat agree | 24.5 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward | Strongly agree | 62.2 percentage of responses |
Secondary
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra
Time frame: At implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra | Strongly disagree | 3.1 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra | Somewhat disagree | 2.0 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra | Neutral | 3.1 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra | Somewhat agree | 30.6 percentage of responses |
| Subjects Implanted With Virtue® Male Sling | Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra | Strongly agree | 61.2 percentage of responses |