Trial Outcomes & Findings for Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence (NCT NCT00113555)

NCT ID: NCT00113555

Last Updated: 2018-07-09

Results Overview

The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed. The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 221 participants
• Primary outcome timeframe: Baseline to 12 months
• Results posted on: 2018-07-09

Participant Flow

A total of 10 investigational sites in US and 2 in Canada which were clinics,University hospitals or Research centers implanted patients in this study from the period 2001-2006.A total of 221 patients have been enrolled(218 with enrollment data) and 163 of those patients underwent an implant procedure.

One patient was implanted and was considered a compassionate use patient that did not meet the enrollment criteria.This patient was not included in the efficacy and safety summaries and her adverse vents are recorded.Therefore the total number of implants for the analyses is 162.

Participant milestones

Measure	ACT Adjustable Continence Therapy for Women Open Label Study, patients implanted with ACT device for treatment of Stress Urinary Incontinence
Overall Study STARTED	221
Overall Study TREATED	162
Overall Study COMPLETED	142
Overall Study NOT COMPLETED	79

Reasons for withdrawal

Measure	ACT Adjustable Continence Therapy for Women Open Label Study, patients implanted with ACT device for treatment of Stress Urinary Incontinence
Overall Study Baseline Failure	59
Overall Study Permanently Explanted	7
Overall Study Death	1
Overall Study Missed Followup	4
Overall Study Lost to Follow-up	8

Baseline Characteristics

Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence

Baseline characteristics by cohort

Measure	Experimental n=162 Participants Open Label Study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	123 Participants n=5 Participants
Age, Continuous	67.6 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	162 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	137 participants n=5 Participants
Region of Enrollment Canada	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: Intent to Treat

The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed.

The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1.

Outcome measures

Measure	Experimental n=162 Participants Open Label Study
Change of Stamey Grade From Baseline to 12 Months.	-1.17 units on a scale Interval -1.33 to -1.01

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Intent to Treat

Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life.

Outcome measures

Measure	Experimental n=162 Participants Open Label Study
Incontinence Quality of Life (IQoL) Questionnaire	28.63 units on a scale Standard Deviation 29.69

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Intent to Treat

Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence.

Outcome measures

Measure	Experimental n=162 Participants Open Label Study
Incontinence Impact Questionnaire (IIQ-7)	-26.53 units on a scale Standard Deviation 33.07

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Intent to Treat

Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.

Outcome measures

Measure	Experimental n=162 Participants Open Label Study
Urinary Distress Inventory (UDI-6)	-22.66 units on a scale Standard Deviation 24.47

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Intent to Treat

Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.

Outcome measures

Measure	Experimental n=162 Participants Open Label Study
Number of Incontinence Episodes Per Day (Voiding Diary)	-2.76 units on a scale Standard Deviation 5.06

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Intent to Treat

Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.

Outcome measures

Measure	Experimental n=162 Participants Open Label Study
Number of Pads Changed Per Day (Voiding Diary)	-1.59 Number of Pads Changed per Day Standard Deviation 3.63

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: Intent to Treat

Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.

Outcome measures

Measure	Experimental n=162 Participants Open Label Study
Provocative Pad Weight	-31.03 gm Standard Deviation 55.27

Adverse Events

ACT Adjustable Continence Therapy for Women

Serious events: 2 serious events

Other events: 155 other events

Deaths: 0 deaths

Serious adverse events

Measure	ACT Adjustable Continence Therapy for Women n=163 participants at risk Open Label Study, Patients implanted with ACT device
Surgical and medical procedures port erosion	0.61% 1/163 • Number of events 1 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
Cardiac disorders Other (non-pelvic)	1.2% 2/163 • Number of events 2 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.

Other adverse events

Measure	ACT Adjustable Continence Therapy for Women n=163 participants at risk Open Label Study, Patients implanted with ACT device
General disorders Pain/Discomfort	31.3% 51/163 • Number of events 70 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
General disorders Balloon Migration	16.6% 27/163 • Number of events 32 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
General disorders Balloon Erosion	6.1% 10/163 • Number of events 11 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
General disorders Port Migration	4.3% 7/163 • Number of events 7 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
General disorders Port Erosion	12.9% 21/163 • Number of events 24 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
General disorders Perforation	8.6% 14/163 • Number of events 16 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
Renal and urinary disorders Worsening Incontinence	21.5% 35/163 • Number of events 37 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
Product Issues Device Failure	1.8% 3/163 • Number of events 4 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
General disorders Procedure Failure	3.1% 5/163 • Number of events 5 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
Infections and infestations Infected Device	0.61% 1/163 • Number of events 1 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
General disorders Other (Pelvic)	46.0% 75/163 • Number of events 118 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
General disorders Other (non-Pelvic)	68.7% 112/163 • Number of events 336 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
Renal and urinary disorders UTI	46.0% 75/163 • Number of events 165 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
Renal and urinary disorders Yeast Infection	12.9% 21/163 • Number of events 26 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.
Renal and urinary disorders Urinary Retention	14.7% 24/163 • Number of events 31 • Entire Study December 2001 to November 2010 at Study Closure All adverse events were collected. Overall, although there were a large number of adverse events on the study (883) the majority were unrelated to the device (75%) or the procedure (82%) and 75% resolved with no residual effects. Of the 883 events, 270 of those events (31%) were considered device and/or procedure related.

Additional Information

Timothy Plouffe

Uromedica

Phone: 763-999-7048

Email: tplouffe@uromedica-inc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place