AzTrials
AzTrials

Fecal IncontinencePhase 1/2TOPASNCT00565136

Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms

A Phase 1/2 study testing TOPAS in people with Fecal Incontinence, run by ASTORA Women's Health at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Fecal Incontinence
What is being tested?
TOPAS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesUnited States
Study dates
Sep 2007to Dec 2012
Phase
Phase 1/2
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 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females at least 21 years of age who have evidence of pelvic floor weakness
  • Females who attempted but not been satisfied with conservative therapies such as dietary changes, dietary bulking agents, biofeedback, etc.
  • Subjects, who have an external anal injury, must have some voluntary sphincter control

Who cannot join

  • Subjects who are unwilling or unable to sign an Informed Consent form
  • Subjects who are currently pregnant or considering future child-bearing
  • Subjects who are contraindicated for surgery
  • Subjects who are allergic to polypropylene mesh
  • Subjects who are enrolled in a concurrent clinical trial
  • Subjects with previous implantation of mesh or trauma to the pelvic area
Show all 18Show fewer
  • Subjects who engage in anal receptive intercourse
  • Subjects with a significant evacuation disorder such as chronic constipation
  • Subjects with Crohn's Disease, ulcerative colitis or chronic diarrhea as the primary cause for fecal incontinence
  • Subjects who had a hysterectomy within 6 months prior to enrollment
  • Subjects with vaginal prolapse that passes the hymen
  • Subjects with complete rectal prolapse
  • Subjects with a history of pelvic radiation that compromises the anal canal
  • Subjects who have psychiatric disturbance or debilitation as a possible cause for fecal incontinence
  • Subjects with a neurological disorder such as amyotrophic lateral sclerosis, multiple sclerosis, or brain tumor as a possible cause for fecal incontinence symptoms
  • Subjects with an active pelvic infection or a recto-vaginal fistula
  • Subjects who have not had a negative screening exam for colon cancer within 10 years of enrollment
  • Subjects who have other inappropriate conditions as determined by the physician

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • St. Lukes Hospital

    Allentown, Pennsylvania, 97205

  • Mount Auburn Hospital

    Cambridge, Massachusetts, 02138

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Minnesota

    Minneapolis, Minnesota, 55454

  • Sacred Heart Hospital

    Spokane, Washington, 99204

Other trials in United States

About this study

Official title: Evaluation of the Outcomes of Restoring Pelvic Floor Support Using TOPAS, AMS Pelvic Floor Support System, in Women With Moderate Fecal Incontinence Symptoms

The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence

Read the detailed description

This is a multi-center study under a common protocol. Approximately 20-30 patients will be enrolled across 5 sites in the U.S. The study population is females at least 21 years of age who have attempted but have not been satisfied with conservative therapy for their fecal incontinence symptoms. The study follow-up is two years.

Being tested
TOPAS
Keywords
Device study, Pelvic floor weakness, Fecal incontinence
Medical subject headings
Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TOPASDevice

    A mesh sling permanently implanted to increase pelvic floor support

Study groups in NCT00565136
Study groupRoleWhat they receive
TOPASExperimentalTOPAS AMS Pelvic Floor Repair System
Receives: Device: TOPAS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment

    Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.

    Measured: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment

Secondary outcomes (8)

  1. Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period

    Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29)

    Measured: Through 24 month post-treatment

  2. Fecal Incontinence Symptoms as Measured by the Wexner Score

    The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence.

    Measured: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment

  3. Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence

    The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1-6, 7-10, and 11-13 were categorized as mild, moderate, and severe fecal incontinence, respectively.

    Measured: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment

  4. Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life

    The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale.

    Measured: Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment

  5. Pain Intensity as Measured by the Pain Intensity Scale

    The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.

    Measured: Baseline (pre-treatment), 6 Week post-treatment

  6. Intra- and Peri-Surgical Parameters: Length of Procedure

    Measured: Duration of the device implant procedure

  7. Intra- and Peri-Surgical Parameters: Length of Hospital Stay

    Measured: Length of the hospital stay for the device implant procedure

  8. Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure

    Measured: Duration of the device implant procedure (an average of 23 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionDec 2010
  4. Study completionDec 2012

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00565136
Sponsor's protocol ID
WC0610
Acronym
TOPAS
Status last verified
Apr 2016
First submitted
27 Nov 2007
Last updated
23 May 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • Rosenblatt P, Schumacher J, Lucente V, McNevin S, Rafferty J, Mellgren A. A preliminary evaluation of the TOPAS system for the treatment of fecal incontinence in women. Female Pelvic Med Reconstr Surg. 2014 May-Jun;20(3):155-62. doi: 10.1097/SPV.0000000000000080.

    PubMed 24763157

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TOPAS in people with Fecal Incontinence, run by ASTORA Women's Health at 5 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 3 inclusion and 18 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 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2013). 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?

Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment (time frame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment). 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 NCT00565136, 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 23 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in