Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence (TRANSFORM)
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|ClinicalTrials.gov Identifier: NCT01090739|
Recruitment Status : Completed
First Posted : March 22, 2010
Results First Posted : August 26, 2016
Last Update Posted : August 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: TOPAS Treatment for Fecal Incontinence||Not Applicable|
This is a prospective, multi-center, single-arm, open-label, two- stage, adaptive study conducted to obtain data to demonstrate the safety and effectiveness of the TOPAS system for the treatment of FI in women who have failed conservative therapy. It was approved by the FDA for up to 152 implanted subjects at up to 15 investigational sites in the US. Eight study centers are led by a Colorectal Surgeon and seven centers are led by an Urogynecologist.
This study is being conducted in compliance with Title 21 CFR Parts 11, 50, 54, 56, and 812; the principles of GCP as set forth in the World Medical Association Declaration of Helsinki (2008); and the ISO standard 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||April 2016|
TOPAS Treatment for Fecal Incontinence
Device: TOPAS Treatment for Fecal Incontinence
The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
- Percentage of Responders [ Time Frame: 12 Months ]The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.
- Change in Fecal Incontinence Episodes [ Time Frame: 36 Month Follow-up Visit ]Number of fecal incontinence episodes in a 14 day period
- Change in Fecal Incontinence Days [ Time Frame: 36 Month Follow-up Visit ]Number of fecal incontinence days in a 14 day period
- Change in Urge Fecal Incontinence Episodes [ Time Frame: 36 Month Follow-up Visit ]Number of urge fecal incontinence episodes in a 14 day period
- Change in Wexner Symptom Severity Score [ Time Frame: 36 Month Follow-up Visit ]Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.
- Change in Fecal Incontinence Quality of Life Score [ Time Frame: 36 Month Follow-up Visit ]Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.
- Change in Pelvic Floor Distress Inventory (PFDI-20) Scores [ Time Frame: 36 Month Follow-up Visit ]
Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).
The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale.
- Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores [ Time Frame: 36 Month Follow-up Visit ]
Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).
The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score.
- Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [ Time Frame: 36 Month Follow-up Visit ]Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function.
- Change in Numeric Pelvic Pain Scale (NPPS) [ Time Frame: 12 Month Follow-up Visit ]Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated.
- Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8) [ Time Frame: 36 Month Follow-up Visit ]The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better
- Change in Health Resource Usage: # Pads Per Day Subject Took for FI [ Time Frame: 36 Month Follow-up Visit ]Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI
- Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI [ Time Frame: 36 Month Follow-up Visit ]Change in health resource usage using sponsor-created questionnaire
- Change in Health Resource Usage: # Physician Visits Due to FI [ Time Frame: 36 Month Follow-up Visit ]Change in health resource usage using sponsor-created questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090739
|United States, California|
|University of California SF - Mt Zion Medical Center|
|San Francisco, California, United States, 94115|
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33605|
|Cleveland Clinic Foundation - Florida|
|Weston, Florida, United States, 33331|
|United States, Georgia|
|Toccoa, Georgia, United States, 30577|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|United States, New Jersey|
|Atlantic Health System|
|Morristown, New Jersey, United States, 07960|
|United States, North Carolina|
|University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|The Christ Hospital|
|Cincinnati, Ohio, United States, 45219|
|Cleveland Clinic Foundation - Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 76104|
|United States, Pennsylvania|
|St. Luke's Hospital|
|Allentown, Pennsylvania, United States, 18104|
|United States, Texas|
|Womens Hospital of Texas|
|Houston, Texas, United States, 77054|
|United States, Washington|
|Sacred Heart Medical Center|
|Spokane, Washington, United States, 99204|
|Study Chair:||Anders Mellgren, MD, PhD||University of Illinois at Chicago|
|Study Chair:||Dee Fenner, MD||University of Michigan|