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Stress urinary incontinence is a significant potential source of morbidity after radical prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary sphincter remains the preferred therapeutic option. However, this technique is not free from complications. In an attempt to avoid such complications, male sling has been suggested for use in patients with mild degrees of stress incontinence.
This is a prospective collection of pre-defined parameters on the treatment of male stress urinary incontinence by male sling or artificial urinary sphincter.
This registry includes:
Surgery is performed with:
Device: Virtue® Device: Advance® and AdvanceXP® Device: Artificial urinary sphincter AMS-800® Device: Invance® Male Incontinence Sling
A prospective functional follow-up, with 24h-Pad Weight test and ICIQ-UI SF, is carried out 3-monthly for the first year and 6-monthly thereafter, parallel to the oncological follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial urinary sphincter AMS-800® | Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AMS-800® |
| |
| AdVance/AdvanceXP® | Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with AdVance/AdvanceXP® |
| |
| VIRTUE® | Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with VIRTUE® |
| |
| INVANCE® | Male patients with stress urinary incontinence after prostatectomy or radiotherapy treated with INVANCE® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMS-800 | Procedure | Artificial urianry sphincter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate | Cure is defined as no pad use | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Continence improvement | Assessed by means of the 24-Hour Pad Weight test | 15 years |
| Lower tract urinary symptoms modification after male surgery incontinence | Assessed with IPSS questionaires |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stress urianry incontinence undergoing male sling or artificial urinary sphincter after prostatectomy or radiation therapy for prostate cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Argimiro Collado, MD, PhD | Contact | 0034961114030 | 4030 | argicollado@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Argimiro Collado, MD,PhD | Fundación IVO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Argimiro Collado | Recruiting | Valencia | 46009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20065535 | Result | Collado A, Gomez-Ferrer A, Rubio-Briones J, Bonillo MA, Iborra I, Solsona E. [Which patients with stress urinary incontinence after radical prostatectomy benefit from the indication of an Invance?]. Arch Esp Urol. 2009 Dec;62(10):851-9. doi: 10.4321/s0004-06142009001000010. Spanish. | |
| 23465151 | Result | Collado Serra A, Resel Folkersma L, Dominguez-Escrig JL, Gomez-Ferrer A, Rubio-Briones J, Solsona Narbon E. AdVance/AdVance XP transobturator male slings: preoperative degree of incontinence as predictor of surgical outcome. Urology. 2013 May;81(5):1034-9. doi: 10.1016/j.urology.2013.01.007. Epub 2013 Mar 7. |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ADVANCE/ADVANCEXP |
| Procedure |
Male sling |
|
| VIRTUE | Procedure | Male sling |
|
| INVANCE | Procedure | Male sling |
|
| 15 years |
| Quality of Life in patients with male surgery incontinence | Assessed with "International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)" questionaires | 15 years |
| 27654121 | Result | Collado Serra A, Dominguez-Escrig J, Gomez-Ferrer A, Batista Miranda E, Rubio-Briones J, Solsona Narbon E. Prospective follow-up study of artificial urinary sphincter placement preserving the bulbospongiosus muscle. Neurourol Urodyn. 2017 Jun;36(5):1387-1394. doi: 10.1002/nau.23119. Epub 2016 Sep 21. |
| 29948042 | Result | Collado A, Dominguez-Escrig J, Ortiz Rodriguez IM, Ramirez-Backhaus M, Rodriguez Torreblanca C, Rubio-Briones J. Functional follow-up after Advance(R) and Advance XP(R) male sling surgery: assessment of predictive factors. World J Urol. 2019 Jan;37(1):195-200. doi: 10.1007/s00345-018-2357-9. Epub 2018 Jun 8. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |