Solace European Confirmatory Trial (SOLECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Solace Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01676662
First received: August 23, 2012
Last updated: January 7, 2014
Last verified: January 2014
  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: April 2016
Estimated Primary Completion Date: April 2014 (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)
Antwerp, Edegem, Belgium, 2650
UZ Brussel
Brussels, Belgium, B-1090
UZ Gent
Gent, Belgium
Italy
University of Naples (Università Degli Studi Di Napoli "Federico II" )
Naples (Napoli), Italy, 80131
Universita Campus Bio-medico di Roma
Rome, Italy
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
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: January 7, 2014
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 April 17, 2014