Clinical trial NCT01090739: Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
Official title: An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: Fecal incontinence
Accidental bowel leakage
Failure conservative therapy
Women
Class III medical device
Surgical mesh
Lead sponsor: ASTORA Women's Health
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Percentage of Responders
timeFrame: 12 Months
Secondary outcomes:
measure: Change in Fecal Incontinence Episodes
timeFrame: 36 Month Follow-up Visit
measure: Change in Fecal Incontinence Days
timeFrame: 36 Month Follow-up Visit
measure: Change in Urge Fecal Incontinence Episodes
timeFrame: 36 Month Follow-up Visit
measure: Change in Wexner Symptom Severity Score
timeFrame: 36 Month Follow-up Visit
measure: Change in Fecal Incontinence Quality of Life Score
timeFrame: 36 Month Follow-up Visit
measure: Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
timeFrame: 36 Month Follow-up Visit
measure: Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
timeFrame: 36 Month Follow-up Visit
measure: Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
timeFrame: 36 Month Follow-up Visit
measure: Change in Numeric Pelvic Pain Scale (NPPS)
timeFrame: 12 Month Follow-up Visit
Other outcomes:
measure: Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)
timeFrame: 36 Month Follow-up Visit
measure: Change in Health Resource Usage: # Pads Per Day Subject Took for FI
timeFrame: 36 Month Follow-up Visit
measure: Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
timeFrame: 36 Month Follow-up Visit
measure: Change in Health Resource Usage: # Physician Visits Due to FI
timeFrame: 36 Month Follow-up Visit
Locations:
city: San Francisco
country: United States
facility: University of California SF - Mt Zion Medical Center
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Foundation - Florida
state: Florida
city: Toccoa
country: United States
facility: Raybon OB-GYN
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation - Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Allentown
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Womens Hospital of Texas
state: Texas
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
Study officials:
affiliation: University of Illinois at Chicago
name: Anders Mellgren, MD, PhD
role: STUDY_CHAIR
affiliation: University of Michigan
name: Dee Fenner, MD
role: STUDY_CHAIR
References:
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.