Persistent Identifier
|
doi:10.7939/DVN/10962 |
Publication Date
|
2016-12-05 |
Title
| Single Incision Device (TVT Secur) Versus Retropubic Tension-free Vaginal Tape Device (TVT) for the Management of Stress Urinary Incontinence in Women: A Randomized Clinical Trial |
Alternative Title
| Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT |
Other Identifier
| ClinicalTrials.gov: NCT00685217 |
Author
| Ross, Sue (University of Alberta) - ORCID: 0000-0002-0600-4833
Tang, Selphee (University of Calgary)
Schulz, Jane (University of Alberta)
Murphy, Magnus (University of Calgary)
Goncalves, Jose (Penticton Regional Hospital)
Kaye, Stephen (Lions Gate Hospital)
Dederer, Lorel (University of Calgary)
Robert, Magali (University of Calgary) |
Point of Contact
|
Use email button above to contact.
Ross, Sue (University of Alberta) |
Description
| The objective of this Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, Gynecare TVT Secur, to the established predecate retropubic TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life. |
Subject
| Medicine, Health and Life Sciences |
Keyword
| single incision device
stress urinary incontinence
surgical treatment
effectiveness
randomized controlled trial (MeSH) https://www.nlm.nih.gov/mesh/ |
Related Publication
| Ross S, Tang S, Schulz J, et al. Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial. BMC Research Notes. 2014;7:941. doi: 10.1186/1756-0500-7-941 https://www.ncbi.nlm.nih.gov/pubmed/25532604 |
Producer
| Ross, Sue (University of Alberta)
Schulz, Jane (University of Alberta)
Robert, Magali (University of Calgary) |
Production Date
| 2008 |
Production Location
| Calgary, Alberta; Edmonton, Alberta; Penticton, British Columbia; Vancouver, British Columbia |
Funding Information
| Johnson & Johnson Medical Companies; Alberta Health Services; Women's and Children's Health Research Institute (WCHRI) |
Time Period
| Start Date: 2008-05 ; End Date: 2012-04 |
Date of Collection
| Start Date: 2008-05 ; End Date: 2011-03 |
Data Type
| Questionnaire data; Clinical data |
Software
| Microsoft Access
SAS, Version: 9.3 |
Related Material
| Ross S, Robert M, Ducey A. The short life cycle of a surgical device - literature analysis using McKinlay's 7-stage model. Health Policy Technol. 2015 Feb 23;4:168-188. |
Data Source
| Urogenital Distress Inventory (UDI-6); Incontinence Impact Questionnaire (IIQ-7); the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12, (PISQ-12); the 15D Instrument of Health-related Quality of Life (15D) was included for the proposed economic evaluation which was never done. |