Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    An Investigation of TReatment of FecAl IncontiNence using the TOPAS Sling
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01090739
Recruitment Status : Completed
First Posted : March 22, 2010
Results First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
ASTORA Women's Health

Tracking Information
First Submitted Date  ICMJE March 19, 2010
First Posted Date  ICMJE March 22, 2010
Results First Submitted Date  ICMJE April 19, 2016
Results First Posted Date  ICMJE August 26, 2016
Last Update Posted Date August 26, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2010)
Efficacy [ 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 success.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 25, 2016)
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
Official Title  ICMJE An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fecal Incontinence
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: TOPAS
TOPAS Treatment for Fecal Incontinence
Intervention: Device: TOPAS Treatment for Fecal Incontinence
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2016)
207
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2010)
152
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01090739
Other Study ID Numbers  ICMJE WC0807
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Each site was provided with their individual participant data
Responsible Party ASTORA Women's Health
Study Sponsor  ICMJE ASTORA Women's Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Anders Mellgren, MD, PhD University of Illinois at Chicago
Study Chair: Dee Fenner, MD University of Michigan
PRS Account ASTORA Women's Health
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP