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Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence (TRANSFORM)

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TOPAS Treatment for Fecal Incontinence
Sponsored by
ASTORA Women's Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal incontinence, Accidental bowel leakage, Failure conservative therapy, Women, Class III medical device, Surgical mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Subject is/has:

  1. An adult (>/= 18 years) female.
  2. FI symptoms for a minimum of 6 months.
  3. Failed two modalities of conservative therapies such as Dietary Modification, Pharmacologic Intervention, or Pelvic Floor Muscle Training.
  4. <50 years old OR if >/= 50 years old, has had a negative cancer screening examination of the colon according screening guidelines (colonoscopy or barium enema + flexible sigmoidoscopy) within the past 3 years prior to informed consent date. (Note: if not done, the investigating physician must provide written justification for not having this exam and must be following the American Cancer Society Guidelines).
  5. FI episodes ≥ 4 in 14 day period.

Exclusion Criteria:

Subject is/has

  1. Unable or unwilling to sign Informed Consent Form or comply with study requirements.
  2. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by AMS.
  3. Allergic to polypropylene.
  4. Pregnant or planning a future pregnancy.
  5. Less than 12 months (365 days) postpartum.
  6. Pelvic prolapse >/=1 cm beyond the hymen (Stage III & IV)
  7. Had stress urinary incontinence (SUI) or anterior repair within 3 months (90 days) prior to TOPAS Sling System implantation.
  8. Had a hysterectomy, Sphincteroplasty, or Posterior surgery within 6 months (180 days) prior to TOPAS Sling System implantation.
  9. Had rectal surgery (such as rectopexy) within 12 months (365 days) of TOPAS Sling System implantation.
  10. Planning pelvic surgery within 12 months (365 days) post implant
  11. Current Grade III or IV hemorrhoids.
  12. Neurological or psychological condition as cause of FI such as MS, dementia, brain tumor.
  13. Diagnosed Inflammatory Bowel Disease (for example, ulcerative colitis or Crohn's disease).
  14. Chronic, watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence.
  15. Severe chronic constipation, including obstructive defecatory disorder.
  16. External full thickness rectal prolapse.
  17. A history of laxative abuse within the past 5 years.
  18. Had previous rectal resection.
  19. Active pelvic infection, perianal or recto-vaginal fistula.
  20. Congenital anorectal malformations or chronic 4th degree lacerations and cloacae.
  21. History of therapeutic radiation for cancers of the pelvis.
  22. Currently implanted with a sacral nerve stimulator.
  23. Contraindicated for surgery or having any condition that would compromise wound healing.

Sites / Locations

  • University of California SF - Mt Zion Medical Center
  • University of South Florida
  • Cleveland Clinic Foundation - Florida
  • Raybon OB-GYN
  • University of Michigan
  • Abbott Northwestern Hospital
  • Atlantic Health System
  • University of North Carolina - Chapel Hill
  • The Christ Hospital
  • Cleveland Clinic Foundation - Ohio
  • University of Oklahoma
  • St. Luke's Hospital
  • Womens Hospital of Texas
  • Sacred Heart Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TOPAS

Arm Description

TOPAS Treatment for Fecal Incontinence

Outcomes

Primary Outcome Measures

Percentage of Responders
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.

Secondary Outcome Measures

Change in Fecal Incontinence Episodes
Number of fecal incontinence episodes in a 14 day period
Change in Fecal Incontinence Days
Number of fecal incontinence days in a 14 day period
Change in Urge Fecal Incontinence Episodes
Number of urge fecal incontinence episodes in a 14 day period
Change in Wexner Symptom Severity Score
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
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
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
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)
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)
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.

Full Information

First Posted
March 19, 2010
Last Updated
August 25, 2016
Sponsor
ASTORA Women's Health
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1. Study Identification

Unique Protocol Identification Number
NCT01090739
Brief Title
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
Acronym
TRANSFORM
Official Title
An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ASTORA Women's Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal incontinence, Accidental bowel leakage, Failure conservative therapy, Women, Class III medical device, Surgical mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TOPAS
Arm Type
Experimental
Arm Description
TOPAS Treatment for Fecal Incontinence
Intervention Type
Device
Intervention Name(s)
TOPAS Treatment for Fecal Incontinence
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Responders
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Change in Fecal Incontinence Episodes
Description
Number of fecal incontinence episodes in a 14 day period
Time Frame
36 Month Follow-up Visit
Title
Change in Fecal Incontinence Days
Description
Number of fecal incontinence days in a 14 day period
Time Frame
36 Month Follow-up Visit
Title
Change in Urge Fecal Incontinence Episodes
Description
Number of urge fecal incontinence episodes in a 14 day period
Time Frame
36 Month Follow-up Visit
Title
Change in Wexner Symptom Severity Score
Description
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.
Time Frame
36 Month Follow-up Visit
Title
Change in Fecal Incontinence Quality of Life Score
Description
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.
Time Frame
36 Month Follow-up Visit
Title
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Description
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.
Time Frame
36 Month Follow-up Visit
Title
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Description
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.
Time Frame
36 Month Follow-up Visit
Title
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Description
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.
Time Frame
36 Month Follow-up Visit
Title
Change in Numeric Pelvic Pain Scale (NPPS)
Description
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.
Time Frame
12 Month Follow-up Visit
Other Pre-specified Outcome Measures:
Title
Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)
Description
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
Time Frame
36 Month Follow-up Visit
Title
Change in Health Resource Usage: # Pads Per Day Subject Took for FI
Description
Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI
Time Frame
36 Month Follow-up Visit
Title
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
Description
Change in health resource usage using sponsor-created questionnaire
Time Frame
36 Month Follow-up Visit
Title
Change in Health Resource Usage: # Physician Visits Due to FI
Description
Change in health resource usage using sponsor-created questionnaire
Time Frame
36 Month Follow-up Visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is/has: An adult (>/= 18 years) female. FI symptoms for a minimum of 6 months. Failed two modalities of conservative therapies such as Dietary Modification, Pharmacologic Intervention, or Pelvic Floor Muscle Training. <50 years old OR if >/= 50 years old, has had a negative cancer screening examination of the colon according screening guidelines (colonoscopy or barium enema + flexible sigmoidoscopy) within the past 3 years prior to informed consent date. (Note: if not done, the investigating physician must provide written justification for not having this exam and must be following the American Cancer Society Guidelines). FI episodes ≥ 4 in 14 day period. Exclusion Criteria: Subject is/has Unable or unwilling to sign Informed Consent Form or comply with study requirements. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by AMS. Allergic to polypropylene. Pregnant or planning a future pregnancy. Less than 12 months (365 days) postpartum. Pelvic prolapse >/=1 cm beyond the hymen (Stage III & IV) Had stress urinary incontinence (SUI) or anterior repair within 3 months (90 days) prior to TOPAS Sling System implantation. Had a hysterectomy, Sphincteroplasty, or Posterior surgery within 6 months (180 days) prior to TOPAS Sling System implantation. Had rectal surgery (such as rectopexy) within 12 months (365 days) of TOPAS Sling System implantation. Planning pelvic surgery within 12 months (365 days) post implant Current Grade III or IV hemorrhoids. Neurological or psychological condition as cause of FI such as MS, dementia, brain tumor. Diagnosed Inflammatory Bowel Disease (for example, ulcerative colitis or Crohn's disease). Chronic, watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. Severe chronic constipation, including obstructive defecatory disorder. External full thickness rectal prolapse. A history of laxative abuse within the past 5 years. Had previous rectal resection. Active pelvic infection, perianal or recto-vaginal fistula. Congenital anorectal malformations or chronic 4th degree lacerations and cloacae. History of therapeutic radiation for cancers of the pelvis. Currently implanted with a sacral nerve stimulator. Contraindicated for surgery or having any condition that would compromise wound healing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Mellgren, MD, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dee Fenner, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of California SF - Mt Zion Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33605
Country
United States
Facility Name
Cleveland Clinic Foundation - Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Raybon OB-GYN
City
Toccoa
State/Province
Georgia
ZIP/Postal Code
30577
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation - Ohio
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
76104
Country
United States
Facility Name
St. Luke's Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Womens Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Each site was provided with their individual participant data
Citations:
PubMed Identifier
26493933
Citation
Mellgren A, Zutshi M, Lucente VR, Culligan P, Fenner DE; TOPAS Study Group. A posterior anal sling for fecal incontinence: results of a 152-patient prospective multicenter study. Am J Obstet Gynecol. 2016 Mar;214(3):349.e1-8. doi: 10.1016/j.ajog.2015.10.013. Epub 2015 Oct 19.
Results Reference
result
Links:
URL
http://dx.doi.org/10.1016/j.ajog.2015.10.013
Description
Primary (1 Year) Results Manuscript

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Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence

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