Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00904969
Brief Summary:
The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.
Detailed Description:
A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected.
Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.
Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
Study:
NCT00904969
Study Brief:
Protocol Section:
NCT00904969