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

NCT01090739 | Completed Results DMC

• 1 other identifier: WC0807
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 14

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.

Conditions

Fecal Incontinence

Keywords

Fecal incontinence; Accidental bowel leakage; Failure conservative therapy; Women; Class III medical device; Surgical mesh

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Months

Secondary Outcomes (9)

• Change in Fecal Incontinence Episodes

  36 Month Follow-up Visit

• Change in Fecal Incontinence Days

  36 Month Follow-up Visit

• Change in Urge Fecal Incontinence Episodes

  36 Month Follow-up Visit

• Change in Wexner Symptom Severity Score

  36 Month Follow-up Visit

• Change in Fecal Incontinence Quality of Life Score

  36 Month Follow-up Visit

Other Outcomes (4)

• Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)

  36 Month Follow-up Visit

• Change in Health Resource Usage: # Pads Per Day Subject Took for FI

  36 Month Follow-up Visit

• Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI

  36 Month Follow-up Visit

Study Arms (1)

TOPAS

EXPERIMENTAL

TOPAS Treatment for Fecal Incontinence

Device: TOPAS Treatment for Fecal Incontinence

Interventions

TOPAS Treatment for Fecal Incontinence DEVICE

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.

TOPAS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ASTORA Women's Health: lead

Study Sites (14)

University of California SF - Mt Zion Medical Center

San Francisco, California, 94115, United States

Location

University of South Florida

Tampa, Florida, 33605, United States

Location

Cleveland Clinic Foundation - Florida

Weston, Florida, 33331, United States

Location

Raybon OB-GYN

Toccoa, Georgia, 30577, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation - Ohio

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 76104, United States

Location

St. Luke's Hospital

Allentown, Pennsylvania, 18104, United States

Location

Womens Hospital of Texas

Houston, Texas, 77054, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 26493933 RESULT

Related Links

• Primary (1 Year) Results Manuscript

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

Study was a single arm trial with no control group. Study was done with a very specialized group of clinical investigators from two medical sub-specialties, Colorectal Surgeons and Urogynecologists. Study population was primarily Caucasian (90%).

Results Point of Contact

• Title: Dee Fenner, MD, Study Coordinating Investigator
• Organization: University of Michigan, Professor of Obstetrics and Gynecology

deef@med.umich.edu

734-647-5866

Study Officials

• Anders Mellgren, MD, PhD

  University of Illinois at Chicago

  STUDY CHAIR

• Dee Fenner, MD

  University of Michigan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 22, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2016
• Last Updated: August 26, 2016
• Results First Posted: August 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

US (14)