Fecal IncontinenceTRANSFORMNCT01090739
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
A study testing TOPAS Treatment for Fecal Incontinence in people with Fecal Incontinence, run by ASTORA Women's Health at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- TOPAS Treatment for Fecal Incontinence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 2010to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
St. Luke's Hospital
Allentown, Pennsylvania, 18104
University of Michigan
Ann Arbor, Michigan, 48109
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation - Ohio
Cleveland, Ohio, 44195
Womens Hospital of Texas
Houston, Texas, 77054
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Atlantic Health System
Morristown, New Jersey, 07960
University of Oklahoma
Oklahoma City, Oklahoma, 76104
University of California SF - Mt Zion Medical Center
San Francisco, California, 94115
Sacred Heart Medical Center
Spokane, Washington, 99204
University of South Florida
Tampa, Florida, 33605
Raybon OB-GYN
Toccoa, Georgia, 30577
Cleveland Clinic Foundation - Florida
Weston, Florida, 33331
About this study
Official title: An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)
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.
Read the 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).
- Conditions
- Fecal Incontinence
- Being tested
- TOPAS Treatment for Fecal Incontinence
- Keywords
- Fecal incontinence, Accidental bowel leakage, Failure conservative therapy, Women, Class III medical device, Surgical mesh
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOPAS Treatment for Fecal IncontinenceDevice
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 group | Role | What they receive |
|---|---|---|
| TOPAS | Experimental | TOPAS Treatment for Fecal Incontinence Receives: Device: TOPAS Treatment for Fecal Incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (9)
Change in Fecal Incontinence Episodes
Number of fecal incontinence episodes in a 14 day period
Measured: 36 Month Follow-up Visit
Change in Fecal Incontinence Days
Number of fecal incontinence days in a 14 day period
Measured: 36 Month Follow-up Visit
Change in Urge Fecal Incontinence Episodes
Number of urge fecal incontinence episodes in a 14 day period
Measured: 36 Month Follow-up Visit
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.
Measured: 36 Month Follow-up Visit
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.
Measured: 36 Month Follow-up Visit
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.
Measured: 36 Month Follow-up Visit
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.
Measured: 36 Month Follow-up Visit
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.
Measured: 36 Month Follow-up Visit
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.
Measured: 12 Month Follow-up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2013
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASTORA Women's Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Mellgren, MD, PhD, Study chair, University of Illinois ChicagoDee Fenner, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090739
- Sponsor's protocol ID
- WC0807
- Acronym
- TRANSFORM
- Status last verified
- Aug 2016
- First submitted
- 19 Mar 2010
- Last updated
- 26 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Each site was provided with their individual participant data
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.
PubMed 26493933
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)
- ClinicalTrials.gov ID
- NCT01090739
- Acronym / sponsor ID
- TRANSFORM / WC0807
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, Accidental bowel leakage, Failure conservative therapy, Women, Class III medical device, Surgical mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- ASTORA Women's HealthIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Mar 2010 (estimated)
- Results
- Posted 26 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOPAS | Experimental | Device: TOPAS Treatment for Fecal IncontinenceTOPAS Treatment for Fecal Incontinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOPAS Treatment for Fecal IncontinenceThe 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. | Device | TOPAS |
Primary outcome
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.
9 secondary outcomes
Change in Fecal Incontinence Episodes
Time frame: 36 Month Follow-up Visit
Change in Fecal Incontinence Days
Time frame: 36 Month Follow-up Visit
Change in Urge Fecal Incontinence Episodes
Time frame: 36 Month Follow-up Visit
Change in Wexner Symptom Severity Score
Time frame: 36 Month Follow-up Visit
Change in Fecal Incontinence Quality of Life Score
Time frame: 36 Month Follow-up Visit
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Time frame: 36 Month Follow-up Visit
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Time frame: 36 Month Follow-up Visit
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Time frame: 36 Month Follow-up Visit
Change in Numeric Pelvic Pain Scale (NPPS)
Time frame: 12 Month Follow-up Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26493933Mellgren 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.
- Primary (1 Year) Results ManuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Each site was provided with their individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Mellgren, MD, PhD study chair
University of Illinois Chicago
Dee Fenner, MD study chair
University of Michigan
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOPAS Treatment for Fecal Incontinence in people with Fecal Incontinence, run by ASTORA Women's Health at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Responders (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.