Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00277095