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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00565136
First received: November 27, 2007
Last updated: June 9, 2014
Last verified: June 2014
Results First Received: May 1, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fecal Incontinence
Intervention: Device: TOPAS

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects enrolled at 5 U.S. study centers (medical clinics) from September 2007 to August 2008. The maximum allowed enrollment number from one site is 12.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After signing informed consent and prior to implant, subjects completed a 3-week bowel diary to describe the FI episodes, Fecal Incontinence Quality of Life scale, Wexner Score, Symptom Severity Scale in Fecal Incontinence, pain intensity scale, and dynamic MRI or defecography.

Reporting Groups
  Description
TOPAS

TOPAS AMS Pelvic Floor Repair System

TOPAS : A mesh sling permanently implanted to increase pelvic floor support


Participant Flow:   Overall Study
    TOPAS  
STARTED     29  
COMPLETED     26  
NOT COMPLETED     3  
Lost to Follow-up                 1  
Withdrawal by Subject                 1  
Protocol Violation                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
20-30 subjects were targeted for enrollment. There was no sample size and power analysis performed for this study.

Reporting Groups
  Description
TOPAS

TOPAS AMS Pelvic Floor Repair System

TOPAS : A mesh sling permanently implanted to increase pelvic floor support


Baseline Measures
    TOPAS  
Number of Participants  
[units: participants]
  29  
Age  
[units: years]
Mean ± Standard Deviation
  60.6  ± 13.9  
Gender  
[units: participants]
 
Female     29  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
White / Caucasian     28  
Other     1  
Height  
[units: cm]
Mean ± Standard Deviation
  164.8  ± 5.9  
Weight  
[units: kg]
Mean ± Standard Deviation
  76.3  ± 19.6  
Body Mass Index [1]
[units: kg/[m]^2]
Mean ± Standard Deviation
  28.1  ± 7.1  
Gravidity [2]
[units: pregnancies]
Mean ± Standard Deviation
  3.6  ± 2.1  
Parity [3]
[units: births]
Mean ± Standard Deviation
  2.9  ± 1.1  
Number Cesarean Births  
[units: deliveries]
Mean ± Standard Deviation
  0.1  ± 0.3  
Number of Vaginal Births  
[units: deliveries]
Mean ± Standard Deviation
  2.8  ± 1.1  
Menopausal Status  
[units: participants]
 
Pre-menopausal     7  
Post-menopausal     22  
Fecal Incontinence Treatment History (failed modalities) [4]
[units: participants]
 
Diet modification     25  
FI medication     9  
Biofeedback     11  
Pelvic surgery     3  
Other     6  
Etiology of Fecal Incontinence [5]
[units: participants]
 
Neurological     2  
Anorectal trauma     4  
Obstetric trauma     10  
Idiopathic/Unknown     15  
Congenital abnormality     0  
Other     0  
Colonoscopy within past 10 years  
[units: participants]
 
Yes     24  
No     5  
Colonoscopy Results  
[units: participants]
 
Normal     15  
Abnormal     8  
Unknown     6  
Other     0  
Digital Rectal Exam - Soft Tissue Scarring  
[units: participants]
 
Yes     5  
No     24  
Digital Rectal Exam - Hemorrhoids  
[units: participants]
 
Yes     2  
No     27  
Digital Rectal Exam - Anal Resting Tone  
[units: participants]
 
Yes     27  
No     2  
Endoanal Ultrasound or Magnetic Resonance Imaging Completed  
[units: participants]
 
Endoanal Ultrasound     23  
MRI     6  
Endoanal Ultrasound/Magnetic Resonance Imaging - Sphincter Defect  
[units: participants]
 
Yes     10  
No     19  
Endoanal Ultrasound/Magnetic Resonance Imaging - Extent of Sphincter Defect [6]
[units: degrees]
Mean ± Standard Deviation
  95.0  ± 50.2  
[1] Body Mass Index is calculated as by the formula: weight (kg) / [height (m)]^2
[2] Gravidity is defined as the number of times a female has been pregnant.
[3] Parity is defined as the number of times a female has given birth.
[4] Participants can have multiple failed modalities
[5] Participants can have multiple etiologies
[6] Data from 10 subjects who had a sphincter defect. Defects are measured on 0-360 degree scale.



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period   [ Time Frame: Through 24 month post-treatment ]

3.  Secondary:   Fecal Incontinence Symptoms as Measured by the Wexner Score   [ Time Frame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment ]

4.  Secondary:   Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence   [ Time Frame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment ]

5.  Secondary:   Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life   [ Time Frame: Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment ]

6.  Secondary:   Pain Intensity as Measured by the Pain Intensity Scale   [ Time Frame: Baseline (pre-treatment), 6 Week post-treatment ]

7.  Secondary:   Intra- and Peri-Surgical Parameters: Length of Procedure   [ Time Frame: Duration of the device implant procedure ]

8.  Secondary:   Intra- and Peri-Surgical Parameters: Length of Hospital Stay   [ Time Frame: Length of the hospital stay for the device implant procedure ]

9.  Secondary:   Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure   [ Time Frame: Duration of the device implant procedure (an average of 23 minutes) ]

10.  Post-Hoc:   Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline   [ Time Frame: 6 Weeks, 3 Month, 6 Month, 12 Month and 24 Month post-treatment ]

11.  Other Pre-specified:   Anal Manometry: Maximum Resting Pressure   [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]

12.  Other Pre-specified:   Anal Manometry: Maximum Squeeze Pressure   [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]

13.  Other Pre-specified:   Anal Manometry: Rectal First Sensation   [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]

14.  Other Pre-specified:   Anal Manometry: Maximum Tolerable Volume   [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]

15.  Other Pre-specified:   Pudendal Nerve Terminal Motor Latency   [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was not powered to statistically evaluate device performance.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul Below, Clinical Trial Manager
Organization: American Medical Systems
phone: 952-930-6089
e-mail: paul.below@ammd.com


Publications of Results:

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT00565136     History of Changes
Other Study ID Numbers: WC0610
Study First Received: November 27, 2007
Results First Received: May 1, 2013
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board