Vesair Continued Access Trial

NCT03082118 | Completed FDA Device

• 1 other identifier: CD1007
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 7

Brief Summary

Single arm study of the Vesair Balloon in postmenopausal women.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Improvement on patient-reported outcomes

  Improvement reported on questionnaires

  3-12 months

Secondary Outcomes (1)

• Reduction in leakage events

  3-12 months

Study Arms (1)

Vesair Arm

EXPERIMENTAL

Subjects treated with the Vesair Bladder Control System at enrollment.

Device: Vesair Bladder Control System

Interventions

Vesair Bladder Control System DEVICE

Intravesical balloon

Also known as: Vesair Balloon

Vesair Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women with SUI or stress predominant mixed incontinence
• Maximum score on IQOL of 60
• Positive cough test for leakage
• Willing to undergo procedures
• Free from infection
• Have previously tried (and failed) noninvasive treatment for SUI

You may not qualify if:

• SUI due to SUI
• Urge-predominant mixed incontinence
• Incontinence of neurogenic etiology
• or more UTIs in past year and 1 in past 3 months
• Surgery for SUI in the past 6 months
• taking medication that can be used to treat SUI
• taking medication that affects urinary symptoms for less than 3 months
• undergoing biofeedback
• Grade 3 or worse cystocele
• last menstrual period within 12 months
• oral progesterone or estrogen in the past 12 months
• BMI \> 40
• involuntary detrusor contractions or discomfort during bladder filling
• previous stage III or worse cancer
• previous cancer of the urinary tract

Sponsors & Collaborators

• Solace Therapeutics, Inc.: lead

Study Sites (7)

Kaiser Permanente Urology

Los Angeles, California, 90027, United States

Location

Kaiser Permanente Urogynecology

San Diego, California, 92110, United States

Location

Georgia Center for Women

Atlanta, Georgia, 30312, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Riddle Hospital, Main Line Health

Media, Pennsylvania, 19063, United States

Location

West Penn Hospital, Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All women enrolled are treated.

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: March 17, 2017
• Study Start: March 9, 2017
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)