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Self-fixating Mesh

TOPAS for Fecal Incontinence (TOPAS Trial)

Phase 1 & 2
Waitlist Available
Led By Anders Mellgren, MD, PhD
Research Sponsored by ASTORA Women's Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-treatment), 6 week, 3 month, 6 month, 12 month and 24 month post-treatment
Awards & highlights
No Placebo-Only Group

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

Eligible Conditions
  • Fecal Incontinence
  • Bowel Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-treatment), 6 week, 3 month, 6 month, 12 month and 24 month post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-treatment), 6 week, 3 month, 6 month, 12 month and 24 month post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
Secondary study objectives
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
Fecal Incontinence Symptoms as Measured by the Wexner Score
Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period
+2 more
Other study objectives
Pudendal Nerve Terminal Motor Latency

Side effects data

From 2012 Phase 1 & 2 trial • 29 Patients • NCT00565136
45%
Other (unclassified)
17%
Urinary Incontinence (De Novo)
14%
Urinary Tract Infection
10%
Infection (other than urinary tract infection)
10%
Worsening Fecal Incontinence
10%
Dyspareunia (De Novo)
7%
Worsening Depression
7%
Worsening Vaginal Prolapse
7%
Worsening Urinary Incontinence
7%
Leg Pain
3%
Costochondoritis
3%
Abnormal Uterine Bleeding (De Novo)
3%
Right Leg Cellulitis
3%
Vaginal Prolapse (De Novo)
3%
Carpel Tunnel
3%
Buttock Pain
3%
Pelvic Pain
3%
Urinary Retention
3%
Low Back Pain/Disk Herniation
3%
Blood Clot in Lungs
3%
Erosion (non-TOPAS Mesh Device)
3%
Excessive Internal Fibrosis
3%
Diarrhea
3%
Skin Irritation
3%
Persistent Vaginal Discharge
3%
Influenza
3%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
TOPAS

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TOPASExperimental Treatment1 Intervention
TOPAS AMS Pelvic Floor Repair System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TOPAS
2007
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

ASTORA Women's HealthLead Sponsor
6 Previous Clinical Trials
3,260 Total Patients Enrolled
1 Trials studying Fecal Incontinence
207 Patients Enrolled for Fecal Incontinence
Anders Mellgren, MD, PhDPrincipal InvestigatorAbbott Northwestern Medical Center
1 Previous Clinical Trials
207 Total Patients Enrolled
1 Trials studying Fecal Incontinence
207 Patients Enrolled for Fecal Incontinence
~2 spots leftby Dec 2025
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