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Solace European Confirmatory Trial (SOLECT)

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Solace Bladder Control System
Solace Sham Treatment
Sponsored by
Solace Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases, Urological Manifestations, Signs and Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)
  • UZ Brussel
  • UZ Gent
  • University of Naples (Università Degli Studi Di Napoli "Federico II" )
  • Universita Campus Bio-medico di Roma
  • Catharina Ziekenhuis
  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment on Day 0

Sham Treatment on Day 0

Arm Description

Subjects who are treated with the Solace Bladder Control System upon entry into the trial.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of treatment-related adverse events
Site-reported adverse events designated as related to the treatment.
Severity of treatment-related adverse events
Site-reported adverse events designated as related to the treatment.

Full Information

First Posted
August 23, 2012
Last Updated
June 22, 2017
Sponsor
Solace Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01676662
Brief Title
Solace European Confirmatory Trial
Acronym
SOLECT
Official Title
An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solace Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases, Urological Manifestations, Signs and Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment on Day 0
Arm Type
Experimental
Arm Description
Subjects who are treated with the Solace Bladder Control System upon entry into the trial.
Arm Title
Sham Treatment on Day 0
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Solace Bladder Control System
Intervention Description
Subjects may undergo treatment every 12 months until study completion.
Intervention Type
Device
Intervention Name(s)
Solace Sham Treatment
Intervention Description
Sham procedure that resembles treatment with the Solace Bladder Control System
Primary Outcome Measure Information:
Title
Improvement in quality of life as assessed by pad weight tests assessments and questionnaires
Description
Comparison of increases in pad weight test and patient reported outcomes on questionnaires.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Incidence of treatment-related adverse events
Description
Site-reported adverse events designated as related to the treatment.
Time Frame
3 Months
Title
Severity of treatment-related adverse events
Description
Site-reported adverse events designated as related to the treatment.
Time Frame
3 Months
Other Pre-specified Outcome Measures:
Title
Incidence of all adverse events
Description
Rate of incidence of all adverse events for all patients
Time Frame
36 Months
Title
Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
Time Frame
36 Months
Title
Severity of all adverse events
Description
Severity of all adverse events for all patients
Time Frame
36 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Tommaselli, M.D.
Organizational Affiliation
University of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)
City
Antwerp
State/Province
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
University of Naples (Università Degli Studi Di Napoli "Federico II" )
City
Naples (Napoli)
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universita Campus Bio-medico di Roma
City
Rome
Country
Italy
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pending publication of results
Citations:
PubMed Identifier
25598453
Citation
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.
Results Reference
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Solace European Confirmatory Trial

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