Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ASTORA Women's Health
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.
Age
21–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
