Solace European Confirmatory Trial
SOLECT
An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
1 other identifier
interventional
80
3 countries
7
Brief Summary
The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2012
CompletedFirst Posted
Study publicly available on registry
August 31, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJune 23, 2017
June 1, 2017
1.7 years
August 23, 2012
June 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
Comparison of increases in pad weight test and patient reported outcomes on questionnaires.
3 Months
Secondary Outcomes (2)
Incidence of treatment-related adverse events
3 Months
Severity of treatment-related adverse events
3 Months
Other Outcomes (3)
Incidence of all adverse events
36 Months
Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
36 Months
Severity of all adverse events
36 Months
Study Arms (2)
Treatment on Day 0
EXPERIMENTALSubjects who are treated with the Solace Bladder Control System upon entry into the trial.
Sham Treatment on Day 0
SHAM COMPARATORPatients who undergo a sham procedure upon entry into the trial, with treatment with the Solace Bladder Control System at 3 months after the sham procedure.
Interventions
Subjects may undergo treatment every 12 months until study completion.
Sham procedure that resembles treatment with the Solace Bladder Control System
Eligibility Criteria
You may qualify if:
- Female 18 years of age or older with stress urinary incontinence (SUI)
- Experienced SUI for at least 12 months and attempted and failed prior noninvasive treatment
- Willing to undergo cystoscopic procedures required and 36 month follow-up
- On stable medication for a minimum of 3 months
- Free of local genital skin infection
- Positive Pad Weight Test
- Free of impassable urethral strictures, trauma or necrosis
You may not qualify if:
- Pregnant or planning to become pregnant during the study period
- Non-ambulatory or bedridden or physically unable to complete test exercises
- Morbidly obese (defined as BMI ≥ 40 kg/m2)
- Bladder infection (including bladder inflammation or edema) or UTI within 3 months
- History of recurrent urinary tract infections
- Prior surgical procedure for incontinence within the past 6 months
- Is taking medications for urinary incontinence other than anticholinergics
- History of kidney stones
- Has a prosthetic heart valve
- Unable to tolerate any form of antibiotic
- Taking anticoagulation therapy, other than aspirin
- Has urinary incontinence due to Intrinsic Sphincter Deficiency (ISD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)
Antwerp, Edegem, 2650, Belgium
UZ Brussel
Brussels, B-1090, Belgium
UZ Gent
Ghent, Belgium
University of Naples (Università Degli Studi Di Napoli "Federico II" )
Naples (Napoli), 80131, Italy
Universita Campus Bio-medico di Roma
Rome, Italy
Catharina Ziekenhuis
Eindhoven, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Related Publications (1)
Wyndaele JJ, De Wachter S, Tommaselli GA, Angioli R, de Wildt MJ, Everaert KC, Michielsen DP, Van Koeveringe GA. A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females. Neurourol Urodyn. 2016 Feb;35(2):252-9. doi: 10.1002/nau.22708. Epub 2015 Jan 16.
PMID: 25598453RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Tommaselli, M.D.
University of Naples
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2012
First Posted
August 31, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2014
Study Completion
January 1, 2017
Last Updated
June 23, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share
Pending publication of results