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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Prospective randomized clinical trial comparing two methods of intra-operative tensioning of retropubic midurethral slings for stress urinary incontinence. Primary outcome is rate of abnormal bladder function. Secondary outcomes include validated quality of life scores, physical exam findings, and rates of immediate post operative voiding dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Babcock tensioning technique | Active Comparator | Group for whom the retropubic mid-urethral sling was tensioned using a Babcock clamp. |
|
| Scissor spacer technique | Active Comparator | Group for whom the retropubic mid-urethral sling was tensioned using a surgical scissor as a spacer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retropubic Midurethral Sling | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Abnormal Bladder Function | Abnormal post-operative bladder function a composite outcome assessed at 12 months after surgery. It is one or more of the following: 1) significantly bothersome stress incontinence or over active bladder symptoms after surgery as measured by questions 1, 2, 3 of the Urogential Distress Inventory (UDI-6) 2) a positive cough stress test in the office, 3) re-treatment for stress urinary incontinence (repeat surgery or pessary use), 4) post-operative urinary retention (presence of self-catheterization at 6 weeks post-operatively or beyond, or therapeutic intervention for retention at any time during the 12 months after, such as pelvic floor physiotherapy, sling lysis, urethrolysis, or sacral nerve stimulation. | 1 year post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of discharge from hospital with on-going need for catheterization | 12 months | |
| Duration of catheterization after surgery | 12 months | |
| Questionnaire scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin A Brennand, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Hospital, University of Calgary | Calgary | Alberta | T2N 4J8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39352429 | Derived | Brennand EA, Chai J, Cummings S, Huang B, Hughes T, Edwards A, Ramirez AC; Calgary Women's Pelvic Health Research Group. Babcock versus Scissor Tensioning for Retropubic Mid-Urethral Slings: Comparing Two Intra-Operative Techniques Through 5 Years of Follow-Up. Int Urogynecol J. 2025 Feb;36(2):279-287. doi: 10.1007/s00192-024-05916-y. Epub 2024 Oct 1. | |
| 32769657 |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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standardized questionnaire scores (UDI-6, Incontinence Impact Questionnaire, International Consultation on Incontinence Modular Questionnaire) |
| 12 months |
| Pad test | Standardized 1 hour pad test values | 12 month |
| Uroflow parameters | Maximum urine flow rate, post void residual | 12 months |
| Brennand EA, Wu G, Houlihan S, Globerman D, Gagnon LH, Birch C, Hyakutake M, Carlson KV, Al-Shankiti H, Robert M, Lazare D, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):471-481. doi: 10.1097/AOG.0000000000004027. |
| 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 |