Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence (TRANSFORM)

• ClinicalTrials.gov Identifier: NCT01090739
• Recruitment Status: Completed
• First Posted: March 22, 2010
• Results First Posted: August 26, 2016
• Last Update Posted: August 26, 2016
• Sponsor: ASTORA Women's Health
• Information provided by (Responsible Party): ASTORA Women's Health

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Fecal Incontinence
• Intervention: Device: TOPAS Treatment for Fecal Incontinence
• Enrollment: 207

Participant Flow

Recruitment Details	Subject recruitment occurred from July 2010 - December 2012.
Pre-assignment Details	Following enrollment (i.e., signing informed consent form), subjects underwent two screening visits to evaluate and confirm eligibility for the TOPAS implant procedures.

Arm/Group Title	TOPAS
Arm/Group Description	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Period Title: Enrollment
Started	207 [1]
Completed	152
Not Completed	55
Reason Not Completed
Withdrawal by Subject	24
Protocol Violation	14
Lost to Follow-up	5
Physician Decision	5
Sponsor termination of site	4
Study implant limit reached	2
Adverse Event	1
[1] Subject enrollment = signed informed consent form
Period Title: 12 Month Follow-up
Started	152
Completed	147
Not Completed	5
Reason Not Completed
Withdrawal by Subject	2
Lost to Follow-up	1
Physician Decision	1
Death	1
Period Title: 24 Month Follow-up
Started	147
Completed	138
Not Completed	9
Reason Not Completed
Withdrawal by Subject	7
Lost to Follow-up	1
Death	1
Period Title: 36 Month Follow-up
Started	138
Completed	115
Not Completed	23
Reason Not Completed
Withdrawal by Subject	6
Visit still pending	17

Baseline Characteristics

Arm/Group Title		TOPAS
Arm/Group Description		TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Baseline Participants		152
Baseline Analysis Population Description		All subjects who met the study inclusion/exclusion criteria and were implanted with the TOPAS device.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	152 participants
		59.6 (9.7)
Sex/Gender, Customized; Measure Type: Number; Unit of measure: Participants
Women	Number Analyzed	152 participants
		152
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
White/Caucasian		137
Black or African American		10
Asian		1
Hispanic/Latina		3
Other		1
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	152 participants
		152
Obstetric History - Gravidity [1]; Mean (Standard Deviation); Unit of measure: Number
	Number Analyzed	152 participants
		3.0 (1.8)
		[1] Measure Description: Number of times subjects have been pregnant
Obstetric History - Parity [1]; Mean (Standard Deviation); Unit of measure: Number
	Number Analyzed	152 participants
		2.6 (1.4)
		[1] Measure Description: Parity is defined as the number of pregnancies carried to gestation
Obstetric History - # of Vaginal Deliveries [1]; Mean (Standard Deviation); Unit of measure: Number
	Number Analyzed	152 participants
		2.4 (1.5)
		[1] Measure Description: The number of times a women delivered vaginally
Obstetric History - # of Caesarean deliveries [1]; Mean (Standard Deviation); Unit of measure: Number
	Number Analyzed	152 participants
		0.1 (0.5)
		[1] Measure Description: women delivering via a caesarean procedure
Menopausal Status; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Pre-menopausal		20
Peri-menopausal		6
Post-menopausal		126
Concomitant Use; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
# Smoked within past 6 months		8
# Caffeine use on a regular basis		102
# Rgular laxative use within past 5 years		18
Duration of Fecal Incontinence; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	152 participants
		110.0 (113.5)
Etiology of Fecal Incontinence [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Anorectal trauma		6
Obstetric trauma		87
Idiopathic/unknown		62
Other		4
		[1] Measure Description: Subjects can have multiple etiologies so total does not equal 152 (number of subjects)
Rectal soft tissue scarring; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Present		26
Absent		126
Baseline Medical History [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Previous hysterectomy / oophorectomy		74
Previous prolapse / UI repair		70
Gastrointestional reflux disease		65
Hypertension		60
Depressive disorder		56
Systemic pain		55
Hyperlipidemia		53
Pelvic area pain		52
Diverticulitis		41
Urinary incontinence		39
Hypothroid		38
Previous cholecystectomy		38
Hemorrhoids		36
Irritable bowel syndrome		31
Previous anal sphincter repair		31
Headaches		29
Vaginal atrophy		23
Diabetes		19
Vaginal prolapse		8
Rectal prolapse		6
Gallstones		2
		[1] Measure Description: Subjects can have multiple medical history items so the total does not equal 152 (number of subjects).
Baseline Fecal Incontinence Medication [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Opioid-receptor agents		30
Bulking agents		22
Osmotic laxatives		8
Anti-cholinergic agents		6
Other meds		5
Bile acid sequestrants		3
		[1] Measure Description: Subjects taking medications does not equal 152 (number of subjects).
Failed Fecal Incontinence Conservative Therapy [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Diet modification and medication		22
Diet modification and pelvic floor muscle training		49
Medication and pelvic floor muscle training		20
Diet, medication and pelvic floor training		61
		[1] Measure Description: Subjects had to fail at least two conservative therapies for their FI prior to entry into the study.
Hemorrhoids; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Present		34
Absent		118
Anal Resting Tone; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Present		141
Absent		11
Anorectal Manometry - Pressures; Mean (Standard Deviation); Unit of measure: mmHg	Number Analyzed	152 participants
Mean Maximum Resting Pressure		31.5 (21.9)
Mean Maximum Squeeze Pressure		60.1 (42.6)
Anorectal Manometry - Volumes; Mean (Standard Deviation); Unit of measure: Cc	Number Analyzed	152 participants
First sensation volume		43.1 (30.9)
Maximum tolerated volume		124.8 (61.9)
External Anal Sphincter Defects; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Present		79
Absent		73
Internal Anal Sphincter Defects; Measure Type: Number; Unit of measure: Participants	Number Analyzed	152 participants
Present		42
Absent		110
External Anal Sphincter Defect Extent; Mean (Standard Deviation); Unit of measure: Degrees
	Number Analyzed	152 participants
		95.3 (45.0)
Internal Anal Sphincter Defect Extent; Mean (Standard Deviation); Unit of measure: Degrees
	Number Analyzed	152 participants
		110.0 (53.7)

Outcome Measures

1. Primary Outcome

Title	Percentage of Responders
Description	The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of treatment responders
	69.1; (61.1 to 76.3)

2. Secondary Outcome

Title	Change in Fecal Incontinence Episodes
Description	Number of fecal incontinence episodes in a 14 day period
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Median (Full Range); Unit of Measure: fecal incontinent episodes/14 days
Baseline	18; (4 to 81)
3 Months	5; (0 to 94)
6 Months	5; (0 to 67)
12 Months	5; (0 to 80)
24 Months	5; (0 to 73)
36 Months	5; (0 to 52)

3. Secondary Outcome

Title	Change in Fecal Incontinence Days
Description	Number of fecal incontinence days in a 14 day period
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Median (Full Range); Unit of Measure: fecal incontinent days/14 days
Baseline	10; (3 to 14)
3 Months	4; (0 to 14)
6 Months	4; (0 to 14)
12 Months	4; (0 to 14)
24 Months	4; (0 to 14)
36 Months	4; (0 to 14)

4. Secondary Outcome

Title	Change in Urge Fecal Incontinence Episodes
Description	Number of urge fecal incontinence episodes in a 14 day period
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Median (Full Range); Unit of Measure: urge fecal incontinent episodes/14 days
Baseline	4; (0 to 52)
3 Months	0; (0 to 16)
6 Months	0; (0 to 18)
12 Months	0; (0 to 29)
24 Months	0; (0 to 39)
36 Months	0; (0 to 34)

5. Secondary Outcome

Title	Change in Wexner Symptom Severity Score
Description	Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	13.9 (2.7)
3 Months	9.4 (4.3)
6 Months	9.8 (4.4)
12 Months	9.6 (3.9)
24 Months	9.5 (4.2)
36 Months	9.4 (4.3)

6. Secondary Outcome

Title	Change in Fecal Incontinence Quality of Life Score
Description	Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Mean (Standard Deviation); Unit of Measure: units on a scale
Lifestyle - Baseline	2.6 (0.8)
Lifestyle - 3 Months	3.3 (0.7)
Lifestyle - 6 Months	3.3 (0.7)
Lifestyle - 12 Months	3.4 (0.7)
Lifestyle - 24 Months	3.4 (0.7)
Lifestyle - 36 Months	3.4 (0.7)
Coping - Baseline	1.7 (0.6)
Coping - 3 Months	2.6 (0.8)
Coping - 6 Months	2.6 (0.9)
Coping - 12 Months	2.7 (0.9)
Coping - 24 Months	2.7 (0.9)
Coping - 36 Months	2.7 (0.9)
Depression - Baseline	2.4 (0.6)
Depression - 3 Months	3.0 (0.7)
Depression - 6 Months	3.1 (0.7)
Depression - 12 Months	3.1 (0.7)
Depression - 24 Months	3.1 (0.7)
Depression - 36 Months	3.2 (0.7)
Embarrassment - Baseline	1.6 (0.6)
Embarrassment - 3 Months	2.5 (0.9)
Embarrassment - 6 Months	2.6 (1.0)
Embarrassment - 12 Months	2.7 (0.9)
Embarrassment - 24 Months	2.7 (0.9)
Embarrassment - 36 Months	2.7 (0.9)

7. Secondary Outcome

Title	Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Description	Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13). The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale.
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Mean (Standard Deviation); Unit of Measure: units on a scale
Total PFDI Score - Baseline	104.1 (47.4)
Total PFDI Score - 3 Months	69.7 (43.1)
Total PFDI Score - 6 Months	68.8 (45.9)
Total PFDI Score - 12 Months	66.7 (43.4)
Total PFDI Score - 24 Months	65.7 (43.9)
Total PFDI Score - 36 Months	70.3 (51.2)
Colorectal-Anal Subscale - Baseline	54.8 (16.2)
Colorectal-Anal Subscale - 3 Months	33.3 (17.7)
Colorectal-Anal Subscale - 6 Months	33.0 (19.8)
Colorectal-Anal Subscale - 12 Months	32.1 (19.2)
Colorectal-Anal Subscale - 24 Months	31.5 (19.7)
Colorectal-Anal Subscale - 36 Months	33.5 (21.0)
Urinary Subscale - Baseline	27.2 (25.1)
Urinary Subscale - 3 Months	21.4 (21.5)
Urinary Subscale - 6 Months	21.4 (22.7)
Urinary Subscale - 12 Months	21.5 (21.9)
Urinary Subscale - 24 Months	22.2 (22.1)
Urinary Subscale - 36 Months	22.6 (23.0)
POP Subscale - Baseline	21.9 (19.5)
POP Subscale - 3 Months	14.9 (15.6)
POP Subscale - 6 Months	14.2 (14.9)
POP Subscale - 12 Months	12.8 (13.9)
POP Subscale - 24 Months	12.1 (13.8)
POP Subscale - 36 Months	13.8 (16.9)

8. Secondary Outcome

Title	Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Description	Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13). The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score.
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Mean (Standard Deviation); Unit of Measure: units on a scale
Total PDFI Score - Baseline	79.6 (52.3)
Total PDFI Score - 3 Months	41.0 (43.5)
Total PDFI Score - 6 Months	39.6 (48.4)
Total PDFI Score - 12 Months	37.9 (43.5)
Total PDFI Score - 24 Months	35.2 (45.5)
Total PDFI Score - 36 Months	38.5 (48.5)
Colorectal-Anal Subscale - Baseline	51.7 (25.5)
Colorectal-Anal Subscale - 3 Months	23.1 (22.7)
Colorectal-Anal Subscale - 6 Months	23.3 (24.1)
Colorectal-Anal Subscale - 12 Months	21.7 (22.6)
Colorectal-Anal Subscale - 24 Months	20.4 (22.9)
Colorectal-Anal Subscale - 36 Months	20.9 (22.1)
Urinary Subscale - Baseline	18.5 (23.6)
Urinary Subscale - 3 Months	12.7 (19.8)
Urinary Subscale - 6 Months	10.8 (18.3)
Urinary Subscale - 12 Months	11.3 (18.1)
Urinary Subscale - 24 Months	10.4 (17.7)
Urinary Subscale - 36 Months	11.8 (19.6)
POP Subscale - Baseline	9.8 (19.5)
POP Subscale - 3 Months	5.2 (11.8)
POP Subscale - 6 Months	5.8 (16.3)
POP Subscale - 12 Months	4.8 (12.7)
POP Subscale - 24 Months	4.5 (13.9)
POP Subscale - 36 Months	5.8 (14.5)

9. Secondary Outcome

Title	Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Description	Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function.
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	32.2 (6.7)
3 Months	35.1 (6.1)
6 Months	35.0 (6.9)
12 Months	34.6 (7.1)
24 Months	33.9 (7.9)
36 Months	35.1 (7.8)

10. Secondary Outcome

Title	Change in Numeric Pelvic Pain Scale (NPPS)
Description	Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated.
Time Frame	12 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All subjects implanted at the time the NPPS was implemented in the study

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	103
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.8 (1.7)
Procedure	3.2 (2.5)
Acute Follow-up	1.0 (1.9)
3 Months	0.4 (1.1)
6 Months	0.7 (1.8)
12 Months	0.6 (1.6)

11. Other Pre-specified Outcome

Title	Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)
Description	The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All implanted subjects

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	86
Mean (Standard Deviation); Unit of Measure: units on a scale
	79.4 (22.1)

12. Other Pre-specified Outcome

Title	Change in Health Resource Usage: # Pads Per Day Subject Took for FI
Description	Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All implanted subjects

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Mean (Standard Deviation); Unit of Measure: pads per day
# pads per day subject took for FI - Baseline	2.4 (2.1)
# per day subject took for FI - 12 Months	1.4 (1.8)
# pads per day subject took for FI - 24 Months	1.1 (1.5)
# pads per day subject took for FI - 36 Months	1.2 (1.6)

13. Other Pre-specified Outcome

Title	Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
Description	Change in health resource usage using sponsor-created questionnaire
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All implanted subjects

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Mean (Standard Deviation); Unit of Measure: days
# days in hospital due to FI - Baseline	0.1 (0.6)
# days in hospital due to FI - 12 Months	0.1 (0.5)
# days in hospital due to FI - 24 Months	0.0 (0.1)
# days in hospital due to FI - 36 Months	0.0 (0.0)
# days took off work due to FI - Baseline	6.4 (34.0)
# days took off work due to FI - 12 Months	1.3 (9.9)
# days took off work due to FI - 24 Months	4.5 (35.4)
# days took off work due to FI - 36 Months	0.9 (9.5)
# days others took off work - Baseline	0.2 (1.3)
# days others took off work - 12 Months	0.0 (0.0)
# days others took off work - 24 Months	0.0 (0.3)
# days others took off work - 36 Months	0.0 (0.0)

14. Other Pre-specified Outcome

Title	Change in Health Resource Usage: # Physician Visits Due to FI
Description	Change in health resource usage using sponsor-created questionnaire
Time Frame	36 Month Follow-up Visit

Outcome Measure Data

Analysis Population Description

All implanted subjects

Arm/Group Title	TOPAS
Arm/Group Description:	TOPAS Treatment for Fecal Incontinence TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
Overall Number of Participants Analyzed	152
Mean (Standard Deviation); Unit of Measure: physician visits
# physician visits due to FI - Baseline	5.0 (7.6)
# physician visits due to FI - 12 Months	0.4 (1.4)
# physician visits due to FI - 24 Months	0.5 (1.8)
# physician visits due to FI - 36 Months	0.3 (1.1)

Adverse Events

Time Frame	AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
Adverse Event Reporting Description	An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
Arm/Group Title	TOPAS
Arm/Group Description	TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
All-Cause Mortality
	TOPAS
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	TOPAS
	Affected / at Risk (%)	# Events
Total	8/152 (5.26%)
Infections and infestations
Methicillin-resistant staphylococcus aureus infection † [1]	1/152 (0.66%)	1
Musculoskeletal and connective tissue disorders
Pain/discomfort - buttock † [2]	1/152 (0.66%)	1
Psychiatric disorders
Exacerbated post traumatic stress disorder †	1/152 (0.66%)	1
Reproductive system and breast disorders
Worsening Pelvic Organ Prolapse † [3]	1/152 (0.66%)	1
De novo pelvic organ prolapse † [4]	1/152 (0.66%)	1
De novo rectal prolapse † [5]	1/152 (0.66%)	1
Respiratory, thoracic and mediastinal disorders
Worsening chronic obstructive pulmonary disease †	1/152 (0.66%)	1
Vascular disorders
Deep vein thrombosis †	1/152 (0.66%)	1
† Indicates events were collected by systematic assessment; [1] Hospital acquired - Left hand; [2] Exacerbation of sciatic pain; [3] Recurrent rectal prolapse; [4] Mild cystocele / enterocele / rectocele; [5] Mucosal prolapse
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	TOPAS
	Affected / at Risk (%)	# Events
Total	72/152 (47.37%)
Gastrointestinal disorders
Defecatory problems † [1]	4/152 (2.63%)	4
Infections and infestations
Infection † [2]	22/152 (14.47%)	25
Injury, poisoning and procedural complications
Bleeding †	1/152 (0.66%)	1
Other † [3]	14/152 (9.21%)	14
Renal and urinary disorders
Urinary problems † [4]	8/152 (5.26%)	8
Reproductive system and breast disorders
Pelvic area pain † [5]	43/152 (28.29%)	50
Pelvic organ prolapse † [6]	9/152 (5.92%)	13
† Indicates events were collected by systematic assessment; [1] includes worsening fecal incontinence and constipation; [2] Includes incision site infection, abscess, UTIs, and fungal infections; [3] Includes Allergic Reaction / Hypersensitivity Reaction, Diarrhea, Headache, Deep Venous Thrombosis, COPD, Nausea, Post-Traumatic Stress Disorder, Rectal Discharge, Skin Irritation, and Wound Dehiscence; [4] Includes de novo and worsening urinary incontinence and retention; [5] Pain/discomfort in the general pelvic region including the buttocks, groin, pelvis, upper leg, urogenitals and abdomen.; [6] Includes de novo and worsening vaginal and rectal prolapse

Limitations and Caveats

Study was a single arm trial with no control group. Study was done with a very specialized group of clinical investigators from two medical sub-specialties, Colorectal Surgeons and Urogynecologists. Study population was primarily Caucasian (90%).

More Information

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.

After the primary or the combined data article has been published, an Investigator may publish the study experience from his/her site. However, the Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data.

All publications will be reviewed by the sponsor in order to assure that no confidential information is disclosed. Such confidential information is not allowed for publishing.

Results Point of Contact

• Name/Title: Dee Fenner, MD, Study Coordinating Investigator
• Organization: University of Michigan, Professor of Obstetrics and Gynecology
• Phone: 734-647-5866
• EMail: deef@med.umich.edu

Publications of Results:

Mellgren A, Zutshi M, Lucente VR, Culligan P, Fenner DE; TOPAS Study Group. A posterior anal sling for fecal incontinence: results of a 152-patient prospective multicenter study. Am J Obstet Gynecol. 2016 Mar;214(3):349.e1-8. doi: 10.1016/j.ajog.2015.10.013. Epub 2015 Oct 19.

• Responsible Party: ASTORA Women's Health
• ClinicalTrials.gov Identifier: NCT01090739
• Other Study ID Numbers: WC0807
• First Submitted: March 19, 2010
• First Posted: March 22, 2010
• Results First Submitted: April 19, 2016
• Results First Posted: August 26, 2016
• Last Update Posted: August 26, 2016