Trial Outcomes & Findings for ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males (NCT NCT00277095)

NCT ID: NCT00277095

Last Updated: 2018-05-31

Results Overview

The percentage of participants with 50% reduction in pad weight.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 123 participants
• Primary outcome timeframe: 18 month follow-up
• Results posted on: 2018-05-31

Participant Flow

Participant milestones

Measure	Implantable Device ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.
Overall Study STARTED	124
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	Implantable Device ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.
Overall Study Death	2
Overall Study Explanted	7
Overall Study Lost to Follow-up	2
Overall Study Missed Follow-up	9
Overall Study Physician Decision	1

Baseline Characteristics

ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males

Baseline characteristics by cohort

Measure	ProACT n=124 Participants Implantable device
Age, Continuous	69.7 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants
Region of Enrollment United States	68 participants n=5 Participants
Region of Enrollment Canada	44 participants n=5 Participants
Region of Enrollment New Zealand	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 month follow-up

Population: As followed analysis of all patients who were treated and reached the 18 month follow-up visit

The percentage of participants with 50% reduction in pad weight.

Outcome measures

Measure	Urine Loss ( in Grams) n=99 Participants 24 hour pad weight(in grams) demonstrating 50% reduction in urine loss (in grams)over 18th month
Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.	60.6 percentage of patients Interval 50.0 to 70.0

Adverse Events

ProACT

Serious events: 4 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Measure	ProACT n=124 participants at risk Implantable device
Vascular disorders CVA	0.81% 1/124 • Number of events 1 • 18 Months
Cardiac disorders Low Heart Rate	0.81% 1/124 • Number of events 1 • 18 Months
Gastrointestinal disorders Ulcerative Colitis	0.81% 1/124 • Number of events 1 • 18 Months
Infections and infestations Sepsis	0.81% 1/124 • Number of events 1 • 18 Months

Other adverse events

Measure	ProACT n=124 participants at risk Implantable device
Renal and urinary disorders Other Genitourinary	37.1% 46/124 • Number of events 79 • 18 Months
General disorders Other Non Genitourinary	32.3% 40/124 • Number of events 54 • 18 Months
Renal and urinary disorders Pain Genitourinary	28.2% 35/124 • Number of events 47 • 18 Months
Renal and urinary disorders Worsening Incontinence	28.2% 35/124 • Number of events 37 • 18 Months
Investigations Balloon Migration	16.9% 21/124 • Number of events 30 • 18 Months
Renal and urinary disorders Infection, Urinary Tract	16.1% 20/124 • Number of events 23 • 18 Months
Renal and urinary disorders Retention	14.5% 18/124 • Number of events 23 • 18 Months
Investigations Perforation During Implant	13.7% 17/124 • Number of events 20 • 18 Months
Skin and subcutaneous tissue disorders Dermotologic	10.5% 13/124 • Number of events 15 • 18 Months
Gastrointestinal disorders Gastrointestinal Condition	10.5% 13/124 • Number of events 14 • 18 Months
Blood and lymphatic system disorders Oncological/hematologic Condition	10.5% 13/124 • Number of events 13 • 18 Months
Investigations Device Failure, Leakage	8.1% 10/124 • Number of events 10 • 18 Months
Infections and infestations Infection, Genitourinary	7.3% 9/124 • Number of events 11 • 18 Months
Investigations Balloon Erosion	6.5% 8/124 • Number of events 8 • 18 Months
General disorders Pain, nongenitourinary	6.5% 8/124 • Number of events 9 • 18 Months
Cardiac disorders Cardiac Condition	5.6% 7/124 • Number of events 8 • 18 Months
Investigations Device Failure, other	5.6% 7/124 • Number of events 8 • 18 Months

Additional Information

Sabitha R Shriram

Uromedica

Phone: 763-694-9880

Email: sshriram@uromedica-inc.com

Results disclosure agreements

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