Clinical trial NCT00565136: Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fecal Incontinence
Keywords: Device study
Pelvic floor weakness
Fecal incontinence
Lead sponsor: ASTORA Women's Health
Sponsor class: INDUSTRY
First posted: 2007-11-29
Enrollment: 29
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
timeFrame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
Secondary outcomes:
measure: Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period
timeFrame: Through 24 month post-treatment
measure: Fecal Incontinence Symptoms as Measured by the Wexner Score
timeFrame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
measure: Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
timeFrame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
measure: Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
timeFrame: Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment
measure: Pain Intensity as Measured by the Pain Intensity Scale
timeFrame: Baseline (pre-treatment), 6 Week post-treatment
measure: Intra- and Peri-Surgical Parameters: Length of Procedure
timeFrame: Duration of the device implant procedure
measure: Intra- and Peri-Surgical Parameters: Length of Hospital Stay
timeFrame: Length of the hospital stay for the device implant procedure
measure: Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure
timeFrame: Duration of the device implant procedure (an average of 23 minutes)
Other outcomes:
measure: Anal Manometry: Maximum Resting Pressure
timeFrame: Baseline (pre-treatment), 6 Month post-treatment
measure: Anal Manometry: Maximum Squeeze Pressure
timeFrame: Baseline (pre-treatment), 6 Month post-treatment
measure: Anal Manometry: Rectal First Sensation
timeFrame: Baseline (pre-treatment), 6 Month post-treatment
measure: Anal Manometry: Maximum Tolerable Volume
timeFrame: Baseline (pre-treatment), 6 Month post-treatment
measure: Pudendal Nerve Terminal Motor Latency
timeFrame: Baseline (pre-treatment), 6 Month post-treatment
Locations:
city: Cambridge
country: United States
facility: Mount Auburn Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Allentown
country: United States
facility: St. Lukes Hospital
state: Pennsylvania
city: Spokane
country: United States
facility: Sacred Heart Hospital
state: Washington
Study officials:
affiliation: Abbott Northwestern Medical Center
name: Anders Mellgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.