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Completed

NCT Number: NCT01676662

Solace European Confirmatory Trial

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Antwerp Hospital (Universitair Ziekenhuis Antwerpen), Antwerp, Edegem, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Solace Bladder Control System

Device

Subjects may undergo treatment every 12 months until study completion.

Solace Sham Treatment

Device

Sham procedure that resembles treatment with the Solace Bladder Control System

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of treatment-related adverse events

    Time frame: 3 Months

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

  2. Severity of treatment-related adverse events

    Time frame: 3 Months

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

Other outcomes

  1. Incidence of all adverse events

    Time frame: 36 Months

    Rate of incidence of all adverse events for all patients

  2. Improvement in quality of life in all patients assessed with pad weight tests and questionnaires

    Time frame: 36 Months

  3. Severity of all adverse events

    Time frame: 36 Months

    Severity of all adverse events for all patients

Sponsors and collaborators

Lead sponsor

Solace Therapeutics, Inc.

Industry

Registry information

Official study title

An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence

Acronym: SOLECT

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Aug 31, 2012
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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