Solace European Confirmatory Trial (SOLECT)

June 22, 2017 updated by: Solace Therapeutics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1090
        • UZ Brussel
      • Gent, Belgium
        • UZ Gent
    • Edegem
      • Antwerp, Edegem, Belgium, 2650
        • University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen)
  • Italy
      • Naples (Napoli), Italy, 80131
        • University of Naples (Università Degli Studi Di Napoli "Federico II" )
      • Rome, Italy
        • Università Campus Bio-Medico di Roma
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of treatment-related adverse events
Time Frame: 3 Months
Site-reported adverse events designated as related to the treatment.
3 Months
Incidence of treatment-related adverse events
Time Frame: 3 Months
Site-reported adverse events designated as related to the treatment.
3 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all adverse events
Time Frame: 36 Months
Rate of incidence of all adverse events for all patients
36 Months
Improvement in quality of life in all patients assessed with pad weight tests and questionnaires
Time Frame: 36 Months
36 Months
Severity of all adverse events
Time Frame: 36 Months
Severity of all adverse events for all patients
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solace Therapeutics, Inc.

Investigators

  • Principal Investigator: Giovanni Tommaselli, M.D., University of Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 31, 2012

Study Record Updates

Last Update Posted (Actual)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD 1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pending publication of results

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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