Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00277095




Registration number
NCT00277095
Ethics application status
Date submitted
11/01/2006
Date registered
13/01/2006
Date last updated
31/05/2018

Titles & IDs
Public title
ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males
Scientific title
Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence
Secondary ID [1] 0 0
UM02
Universal Trial Number (UTN)
Trial acronym
ProACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ProACT (Adjustable Continence Therapy)

Experimental: ProACT (Adjustable Continence Therapy) - Implantation with ProACT (Adjustable Continence Therapy), Single Arm


Treatment: Devices: ProACT (Adjustable Continence Therapy)
Implantable device to reduce urinary stress incontinence
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
18 month follow-up

Eligibility
Key inclusion criteria
- Undergone either a radical prostatectomy, transurethral resection of the prostate or
other prostate surgery at least 12 months prior without radiation therapy

- Demonstrate primary stress urinary incontinence

- Male subjects at least 45 years of age

- Willing and able to undergo surgical implantation of the ProACT devices

- Willing and able to comply with the follow-up requirements

- Willing and able to forego any other surgical urinary incontinence treatments while
participating in the study

- Willing and able to sign the informed consent

- Positive 24 hour pad weight tests (greater than or equal to 8 gram pad weight increase
demonstrated in two 24-hour pad weight tests)

- Experiences at least 3 incontinence episodes per day during two baseline voiding
diaries.

- Negative Urine culture

- No recurrent stricture at the anastamosis

- No known urogenital malignancy other than previously treated prostate cancer

- Physician determines subject to be suitable surgical candidate
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Primarily Urge incontinence

- Detrusor instability or over-activity

- Residual volume greater that 100 ml or greater than 25% of the total bladder capacity
after voiding.

- Subject has/had or is suspected of having bladder cancer

- History of recurrent bladder stones

- Neurogenic bladder that is atonic or has detrusor sphincter dyssynergia

- Known hemophilia or a bleeding disorder

- Abnormal PSA (Prostate Specific Antigen), according to sites laboratory standards,
unless further investigation confirms no underlying prostate malignancy.

- Known sever contrast solution allergy

- Has a genitourinary mechanical prosthesis other than previous sling procedure (e.g.,
Artificial Urinary sphincter, implantable penile prosthesis)

- Has a urethral stricture that prevents passage of an 18 F cystoscope or has had more
than one urethrotomy

- Undergone bulking procedure within 6 months of the baseline assessment

- Subject is currently enrolled or plans to enroll in another device or drug clinical
trial.

- Subject is currently using an indwelling catheter or condom catheter for treatment of
incontinence and is not willing to discontinue use at least 4 weeks prior to baseline
assessment.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
New Zealand
State/province [9] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Uromedica
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive
surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who
have stress urinary incontinence arising from intrinsic sphincter deficiency following an
operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two
adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress
incontinence.

The results will be analyzed to demonstrate the effects of the device as well as its
associated risks. Therapeutic success will be based on whether patients demonstrate at least
a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at
baseline.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00277095
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tim Cook, Ph.D
Address 0 0
Uromedica, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00277095