Solace European Confirmatory Trial (SOLECT)
This study is currently recruiting participants.
Verified November 2012 by Solace Therapeutics, Inc.
Sponsor:
Solace Therapeutics, Inc.
Information provided by (Responsible Party):
Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01676662
First received: August 23, 2012
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stress Urinary Incontinence |
Device: Solace Bladder Control System Device: Solace Sham Treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence |
Resource links provided by NLM:
Further study details as provided by Solace Therapeutics, Inc.:
Primary Outcome Measures:
- Improvement in quality of life as assessed by pad weight tests assessments and questionnaires [ Time Frame: 3 Months ] [ Designated as safety issue: No ]Comparison of increases in pad weight test and patient reported outcomes on questionnaires.
Secondary Outcome Measures:
- Incidence of treatment-related adverse events [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]Site-reported adverse events designated as related to the treatment.
- Severity of treatment-related adverse events [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]Site-reported adverse events designated as related to the treatment.
Other Outcome Measures:
- Incidence of all adverse events [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]Rate of incidence of all adverse events for all patients
- Improvement in quality of life in all patients assessed with pad weight tests and questionnaires [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- Severity of all adverse events [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]Severity of all adverse events for all patients
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment on Day 0
Subjects who are treated with the Solace Bladder Control System upon entry into the trial.
|
Device: Solace Bladder Control System
Subjects may undergo treatment every 12 months until study completion.
|
|
Sham Comparator: Sham Treatment on Day 0
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.
|
Device: Solace Bladder Control System
Subjects may undergo treatment every 12 months until study completion.
Device: Solace Sham Treatment
Sham procedure that resembles treatment with the Solace Bladder Control System
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria (must answer NO):
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676662
Locations
| Belgium | |
| University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen) | Recruiting |
| Antwerp, Edegem, Belgium, 2650 | |
| Contact: Katleen Derickx +32 (0)800-78804 solect@meditech.nl | |
| Principal Investigator: Jean-Jacques Wyndaele, M.D. PhD | |
| Sub-Investigator: Stefan de Wachter, MD | |
| Italy | |
| University of Naples (Università Degli Studi Di Napoli "Federico II" ) | Recruiting |
| Naples (Napoli), Italy, 80131 | |
| Contact: Giovanni Tommaselli, M.D. (+39) 800-879-678 solect@meditech.nl | |
| Principal Investigator: Carmine Nappi, M.D. | |
| Sub-Investigator: Giovanni Tommaselli, M.D. | |
| Sub-Investigator: Carmen Formisano, MD | |
| Universita Campus Bio-medico di Roma | Recruiting |
| Rome, Italy | |
| Contact: Paolo Gennari, MD (+39) 800-879-678 solect@meditech.nl | |
| Principal Investigator: Roberto Angioli, MD PhD | |
| Sub-Investigator: Marzio A Zullo, MD | |
| Sub-Investigator: Roberto Montera, MD | |
| Sub-Investigator: Francesco Plotti, MD | |
| Netherlands | |
| Maastricht University Medical Center | Recruiting |
| Maastricht, Netherlands, 6229 HX | |
| Contact: Karin Weber +31 (0)43-3875255 k.weber@mumc.nl | |
| Principal Investigator: Gommert van Koevringe, MD | |
| Sub-Investigator: Marc Paffen, MD | |
Sponsors and Collaborators
Solace Therapeutics, Inc.
Investigators
| Principal Investigator: | Giovanni Tommaselli, M.D. | University of Naples |
More Information
No publications provided
| Responsible Party: | Solace Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01676662 History of Changes |
| Other Study ID Numbers: | CD 1004 |
| Study First Received: | August 23, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | Belgium: Ethics Committee Netherlands: Medical Ethics Review Committee (METC) Italy: Ethics Committee |
Keywords provided by Solace Therapeutics, Inc.:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013