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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ASTORA Women's Health
ClinicalTrials.gov Identifier:
NCT01090739
First received: March 19, 2010
Last updated: August 25, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Fecal Incontinence
Device: TOPAS Treatment for Fecal Incontinence

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)

Resource links provided by NLM:


Further study details as provided by ASTORA Women's Health:

Primary Outcome Measures:
  • Percentage of Responders [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 Month Follow-up Visit ] [ Designated as safety issue: No ]
    Number of fecal incontinence episodes in a 14 day period

  • Change in Fecal Incontinence Days [ Time Frame: 36 Month Follow-up Visit ] [ Designated as safety issue: No ]
    Number of fecal incontinence days in a 14 day period

  • Change in Urge Fecal Incontinence Episodes [ Time Frame: 36 Month Follow-up Visit ] [ Designated as safety issue: No ]
    Number of urge fecal incontinence episodes in a 14 day period

  • Change in Wexner Symptom Severity Score [ Time Frame: 36 Month Follow-up Visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8) [ Time Frame: 36 Month Follow-up Visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in health resource usage using sponsor-created questionnaire


Enrollment: 207
Study Start Date: April 2010
Study Completion Date: April 2016
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOPAS
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090739

Locations
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
Raybon OB-GYN
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
Sponsors and Collaborators
ASTORA Women's Health
Investigators
Study Chair: Anders Mellgren, MD, PhD University of Illinois at Chicago
Study Chair: Dee Fenner, MD University of Michigan
  More Information

Additional Information:
Publications:
Responsible Party: ASTORA Women's Health
ClinicalTrials.gov Identifier: NCT01090739     History of Changes
Other Study ID Numbers: WC0807 
Study First Received: March 19, 2010
Results First Received: April 19, 2016
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Each site was provided with their individual participant data

Keywords provided by ASTORA Women's Health:
Fecal incontinence
Accidental bowel leakage
Failure conservative therapy
Women
Class III medical device
Surgical mesh

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 23, 2016