Stress Urinary IncontinenceSOLECTNCT01676662
Solace European Confirmatory Trial
A study of Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Sep 2012to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Belgium3 sites
University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)
Antwerp, Edegem, 2650
UZ Brussel
Brussels, B-1090
UZ Gent
Ghent
Italy2 sites
University of Naples (Università Degli Studi Di Napoli "Federico II" )
Naples (Napoli), 80131
Universita Campus Bio-medico di Roma
Rome
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven
Maastricht University Medical Center
Maastricht, 6229 HX
About this study
Official title: An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
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.
Read the detailed description
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months.
All patients undergoing sham treatment are treated at 3 months.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Solace Bladder Control System, Solace Sham Treatment
- Keywords
- Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases, Urological Manifestations, Signs and Symptoms
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urination Disorders, Urologic Diseases, Urological Manifestations, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solace Bladder Control SystemDevice
Subjects may undergo treatment every 12 months until study completion.
Solace Sham TreatmentDevice
Sham procedure that resembles treatment with the Solace Bladder Control System
| Study group | Role | What they receive |
|---|---|---|
| Treatment on Day 0 | Experimental | Subjects who are treated with the Solace Bladder Control System upon entry into the trial. Receives: Device: Solace Bladder Control System |
| Sham Treatment on Day 0 | Sham comparator | Patients 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. Receives: Device: Solace Bladder Control System; Device: Solace Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Secondary outcomes (2)
Incidence of treatment-related adverse events
Site-reported adverse events designated as related to the treatment.
Measured: 3 Months
Severity of treatment-related adverse events
Site-reported adverse events designated as related to the treatment.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solace Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Tommaselli, M.D., Principal investigator, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676662
- Sponsor's protocol ID
- CD 1004
- Acronym
- SOLECT
- Status last verified
- Jun 2017
- First submitted
- 23 Aug 2012
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pending publication of results
Publications
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.
PubMed 25598453
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01676662
- Acronym / sponsor ID
- SOLECT / CD 1004
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases, Urological Manifestations, Signs and Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Solace Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months.
All patients undergoing sham treatment are treated at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment on Day 0 | Experimental | Device: Solace Bladder Control SystemSubjects who are treated with the Solace Bladder Control System upon entry into the trial. |
| Sham Treatment on Day 0 | Sham comparator | Device: Solace Bladder Control System, Device: Solace Sham TreatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solace Bladder Control SystemSubjects may undergo treatment every 12 months until study completion. | Device | Sham Treatment on Day 0, Treatment on Day 0 |
| Solace Sham TreatmentSham procedure that resembles treatment with the Solace Bladder Control System | Device | Sham Treatment on Day 0 |
Primary outcome
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
Time frame: 3 Months
Comparison of increases in pad weight test and patient reported outcomes on questionnaires.
2 secondary outcomes
Incidence of treatment-related adverse events
Time frame: 3 Months
Severity of treatment-related adverse events
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Results publication: PubMed 25598453Wyndaele 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.
- Individual participant dataSharing planned: No. Pending publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Tommaselli, M.D. principal investigator
University of Naples
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01676662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017; AzTrials last refreshed its copy on 26 Oct 2026.