Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOPAS | Experimental | TOPAS AMS Pelvic Floor Repair System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOPAS | Device | A mesh sling permanently implanted to increase pelvic floor support |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Anal Manometry: Maximum Resting Pressure | Baseline (pre-treatment), 6 Month post-treatment | |
| Anal Manometry: Maximum Squeeze Pressure | Baseline (pre-treatment), 6 Month post-treatment | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anders Mellgren, MD, PhD | Abbott Northwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Auburn Hospital | Cambridge | Massachusetts | 02138 | United States | ||
| University of Minnesota |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24763157 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TOPAS | TOPAS AMS Pelvic Floor Repair System TOPAS : A mesh sling permanently implanted to increase pelvic floor support |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Through 24 month post-treatment |
| 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. | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
| 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. | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
| 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. | Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
| 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. | Baseline (pre-treatment), 6 Week post-treatment |
| Intra- and Peri-Surgical Parameters: Length of Procedure | Duration of the device implant procedure |
| Intra- and Peri-Surgical Parameters: Length of Hospital Stay | Length of the hospital stay for the device implant procedure |
| Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure | Duration of the device implant procedure (an average of 23 minutes) |
| Anal Manometry: Rectal First Sensation |
| Baseline (pre-treatment), 6 Month post-treatment |
| Anal Manometry: Maximum Tolerable Volume | Baseline (pre-treatment), 6 Month post-treatment |
| Pudendal Nerve Terminal Motor Latency | Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both. | Baseline (pre-treatment), 6 Month post-treatment |
| Minneapolis |
| Minnesota |
| 55454 |
| United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| St. Lukes Hospital | Allentown | Pennsylvania | 97205 | United States |
| Sacred Heart Hospital | Spokane | Washington | 99204 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
20-30 subjects were targeted for enrollment. There was no sample size and power analysis performed for this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TOPAS | TOPAS AMS Pelvic Floor Repair System TOPAS : A mesh sling permanently implanted to increase pelvic floor support |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Body Mass Index | Body Mass Index is calculated as by the formula: weight (kg) / [height (m)]^2 | Mean | Standard Deviation | kg/[m]^2 |
| |||||||||||||||||||||
| Gravidity | Gravidity is defined as the number of times a female has been pregnant. | Mean | Standard Deviation | pregnancies |
| |||||||||||||||||||||
| Parity | Parity is defined as the number of times a female has given birth. | Mean | Standard Deviation | births |
| |||||||||||||||||||||
| Number Cesarean Births | Mean | Standard Deviation | deliveries |
| ||||||||||||||||||||||
| Number of Vaginal Births | Mean | Standard Deviation | deliveries |
| ||||||||||||||||||||||
| Menopausal Status | Number | participants |
| |||||||||||||||||||||||
| Fecal Incontinence Treatment History (failed modalities) | Participants can have multiple failed modalities | Number | participants |
| ||||||||||||||||||||||
| Etiology of Fecal Incontinence | Participants can have multiple etiologies | Number | participants |
| ||||||||||||||||||||||
| Colonoscopy within past 10 years | Number | participants |
| |||||||||||||||||||||||
| Colonoscopy Results | Number | participants |
| |||||||||||||||||||||||
| Digital Rectal Exam - Soft Tissue Scarring | Number | participants |
| |||||||||||||||||||||||
| Digital Rectal Exam - Hemorrhoids | Number | participants |
| |||||||||||||||||||||||
| Digital Rectal Exam - Anal Resting Tone | Number | participants |
| |||||||||||||||||||||||
| Endoanal Ultrasound or Magnetic Resonance Imaging Completed | Number | participants |
| |||||||||||||||||||||||
| Endoanal Ultrasound/Magnetic Resonance Imaging - Sphincter Defect | Number | participants |
| |||||||||||||||||||||||
| Endoanal Ultrasound/Magnetic Resonance Imaging - Extent of Sphincter Defect | Data from 10 subjects who had a sphincter defect. Defects are measured on 0-360 degree scale. | Mean | Standard Deviation | degrees |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The FI Bowel Diary was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=26, 3 Month: N=27, 6 Month: N=24, 12 Month: N=23, 24 Month: N=26 | Posted | Mean | Standard Deviation | Number of FI episodes/14 day period | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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) | Includes all subjects implanted with the TOPAS device | Posted | Number | events per 24 months/participant | Through 24 month post-treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Wexner Score was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23 | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Symptom Severity Scale in Fecal Incontinence was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23 | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Post-Hoc | Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline | Includes solid and liquid stools, as measured by a subject-reported bowel diary | Two subjects were enrolled who recorded no FI episodes at baseline and were excluded from this analysis. Missing data was not imputed and was considered a treatment failure. The Bowel Diary was completed by the number of subjects at each visit as follows: 6 Week: N=24, 3 Month: N=25, 6 Month: N=22, 12 Month: N=21, 24 Month: N=24 | Posted | Number | 90% Confidence Interval | percentage participants | 6 Weeks, 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Fecal Incontinence Quality of Life Assessment was completed by the number of subjects at each visit as follows: Baseline: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23 | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Pain Intensity Scale was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=29 | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-treatment), 6 Week post-treatment |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Intra- and Peri-Surgical Parameters: Length of Procedure | All enrolled/implanted subjects were included in this analysis | Posted | Mean | Standard Deviation | minutes | Duration of the device implant procedure |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Intra- and Peri-Surgical Parameters: Length of Hospital Stay | All enrolled/implanted subjects were included in this analysis | Posted | Mean | Standard Deviation | hours | Length of the hospital stay for the device implant procedure |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure | All enrolled/implanted subjects were included in this analysis | Posted | Mean | Standard Deviation | ml | Duration of the device implant procedure (an average of 23 minutes) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Anal Manometry: Maximum Resting Pressure | Posted | Mean | Standard Deviation | mmHg | Baseline (pre-treatment), 6 Month post-treatment |
|
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Anal Manometry: Maximum Squeeze Pressure | Posted | Mean | Standard Deviation | mmHg | Baseline (pre-treatment), 6 Month post-treatment |
|
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Anal Manometry: Rectal First Sensation | Posted | Mean | Standard Deviation | cc | Baseline (pre-treatment), 6 Month post-treatment |
|
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Anal Manometry: Maximum Tolerable Volume | Posted | Mean | Standard Deviation | cc | Baseline (pre-treatment), 6 Month post-treatment |
|
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pudendal Nerve Terminal Motor Latency | Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both. | Posted | Mean | Standard Deviation | msec | Baseline (pre-treatment), 6 Month post-treatment |
|
|
From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TOPAS | TOPAS AMS Pelvic Floor Repair System TOPAS : A mesh sling permanently implanted to increase pelvic floor support | 5 | 29 | 22 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Back Pain/Disk Herniation | Nervous system disorders | Systematic Assessment | Severe low back pain into legs. Admitted into hospital - MRI completed and indicated L2 - L3 disk herniated. Surgery for L2-L3 disk herniation. Related to procedure but not device. Onset = 3 days post implant. |
| |
| Blood Clot in Lungs | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Subject states that she had "2 blood clots in her lungs" that caused her to be hospitalized. Not related to device or procedure. Onset = 541 post implant. |
| |
| Right Leg Cellulitis | Infections and infestations | Systematic Assessment | Ruled out deep vein thrombosis. Hospital admit 5/9/09 and discharges 5/13/09. Treated with vancomycin and rocephin. Not related to device/procedure. Onset = 334 days post implant. |
| |
| Costochondoritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient was admitted to medical center for right wall chest pain. Negative for pulmonary embolism, electrocardiogram = normal sinus rhythm. Not related to device or procedure. Onset = 136 days post implant, |
| |
| Carpel Tunnel | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient had carpel tunnel requiring surgical release. Not related to device or procedure. Onset = 733 days from implant. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Incontinence (De Novo) | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspareunia (De Novo) | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Worsening Fecal Incontinence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infection (other than urinary tract infection) | Infections and infestations | Systematic Assessment |
| ||
| Abnormal Uterine Bleeding (De Novo) | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Worsening Vaginal Prolapse | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Worsening Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Leg Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Worsening Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Erosion (non-TOPAS Mesh Device) | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal Prolapse (De Novo) | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Persistent Vaginal Discharge | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Buttock Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Excessive Internal Fibrosis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Influenza | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Other (unclassified) | Investigations | Systematic Assessment |
|
This study was not powered to statistically evaluate device performance.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Rosenblatt, MD; Director of Urogynecology | Boston Urogynecology Associates | (617) 354-5452 | prosenbl@mah.harvard.edu |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Biofeedback |
|
| Pelvic surgery |
|
| Other |
|
| Obstetric trauma |
|
| Idiopathic/Unknown |
|
| Congenital abnormality |
|
| Other |
|
| Unknown |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| 6 Month (n = 24) |
|
| 12 Month (n = 23) |
|
| 24 Month (n = 26) |
|
|
|
|
|
|
|
| Denominators |
|---|
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
|
| 6 Month (n = 20) |
|
|
| 6 Month (n = 20) |
|
|
| 6 Month (n = 23) |
|
|
| 6 Month (n = 20) |
|
|