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| Name | Class |
|---|---|
| Astellas Pharma Canada, Inc. | INDUSTRY |
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Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Other overactive bladder (OAB) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however, suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be alleviated by said procedure. It is our aim to investigate this relationship in our clinic.
As a prospective member of this study, you will be asked to complete five surveys. The first survey will be administered prior to your pubovaginal sling. This will be used to establish your baseline experience of OAB. Over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pubovaginal sling procedure | Experimental | Patients undergoing pubovaginal slings for stress urinary incontinence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pubovaginal sling procedure | Device | The procedure involves placing a band of sling material directly under the bladder neck (ie, proximal urethra) or mid-urethra, which acts as a physical support to prevent bladder neck and urethral descent during physical activity. The sling also may augment the resting urethral closure pressure with increases in intra-abdominal pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in OAB Symptoms Post Pubovaginal Sling Operation | Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test. | Baseline to final follow-up. |
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Inclusion Criteria.
Exclusion Criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph A Zadra, MD CM FRCSC | Barrie Urology Associates - The Male/Female Health and Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrie Urology Associates - The Male/Female Health and Research Centre | Barrie | Ontario | L4M 7G1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19002645 | Background | Toledo LG, Korkes F, Romero FR, Fernandes RC, Oliveira C, Perez MD. Bladder outlet obstruction after pubovaginal fascial sling. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):201-5. doi: 10.1007/s00192-008-0759-8. Epub 2008 Nov 12. | |
| 18520757 | Background | Koch YK, Zimmern P. A critical overview of the evidence base for the contemporary surgical management of stress incontinence. Curr Opin Urol. 2008 Jul;18(4):370-6. doi: 10.1097/MOU.0b013e3282fdf8d5. |
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No significant pres-assignment measures were taken.
Recruitment occurred over the course of one year (October 2010 - October 2011). Patients requiring pubovaginal sling procedures for stress incontinence were invited to participate if they possessed limited comorbidities.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pubovaginal Sling Procedure | Patients undergoing pubovaginal slings for stress urinary incontinence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pubovaginal Sling Procedure | Patients undergoing pubovaginal slings for stress urinary incontinence. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in OAB Symptoms Post Pubovaginal Sling Operation | Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test. | All patients enrolled in the study were analyzed, except for those currently being treated with antimuscarinic therapy. | Posted | Number | participants | Baseline to final follow-up. |
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Adverse event data was collected for the duration of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pubovaginal Sling Procedure | Patients undergoing pubovaginal slings for stress urinary incontinence. |
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The V8 questionnaire used for patient surveying has been validated, but forms of such a nature present potential over and under reporting of symptoms. Loss to follow-up presents an issue, although we anticipate those lost experienced improvements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph A Zadra, MD CM FRCSC | Barrie Urology Associates - The Male/Female Health and Research Centre | 705-727-0551 | joezadra@rogers.com |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053158 | Nocturia |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 17574730 | Background | Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, Mistry A, Wright DM, Bolodeoku J; STAR study group. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007 Oct;52(4):1195-203. doi: 10.1016/j.eururo.2007.05.027. Epub 2007 Jun 6. |
| 20339833 | Background | Toglia MR, Ostergard DR, Appell RA, Andoh M, Fakhoury A, Hussain IF. Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status. Int Urogynecol J. 2010 Jul;21(7):847-54. doi: 10.1007/s00192-010-1120-6. Epub 2010 Mar 26. |
| 18995887 | Background | Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 132 |
| 0 |
| 132 |
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| 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 |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |