Prospective US Radiofrequency SUI Trial

NCT04720352 | Unknown FDA Device

• 1 other identifier: VI-17-06
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 29

Brief Summary

PURSUIT: Prospective US Radiofrequency SUI Trial (VI-17-06) is a prospective, randomized, sham controlled, double blind study in premenopausal women with stress urinary incontinence. The study will be conducted in 390 subjects, randomized 2:1 with active or sham treatment. Study duration is 12 months post treatment. The primary objective is to evaluate the efficacy of the Viveve treatment, SUI protocol, in improving mild to moderate stress urinary incontinence (SUI), assessed using the 1-hour Pad Weight Test for up to 12 months post-treatment.

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (1)

• 1-hour pad weight test

  Standard test of incontinence

  12 months

Secondary Outcomes (6)

• 3-day diary

  3, 6, and 12 months

• 1-hour pad weight test

  3 and 6 months

• Patient Global Impression of Improvement (PGI-I)

  3, 6, 9, and 12 months

• Medical, Epidemiologic, and Social aspects of Aging (MESA) questionnaire

  3, 6, 9, and 12 months

• International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)

  3, 6, 9, and 12 months

Study Arms (2)

Sham Comparator

SHAM COMPARATOR

Sham delivers non therapeutic levels of radiofrequency and cryogen

Device: Sham

Active Arm

EXPERIMENTAL

Active arm delivers radiofrequency and cryogen

Device: Active treatment

Interventions

Active treatment DEVICE

Active treatment delivers radiofrequency and cryogen

Active Arm

Sham DEVICE

Sham delivers non therapeutic levels of radiofrequency and cryogen

Sham Comparator

Eligibility Criteria

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

You may qualify if:

• I.1 Able to understand and has voluntarily signed and dated the most current informed consent form (ICF) prior to initiation of any screening or study-specific procedures.
• I.2 Willing to comply with study requirements and instructions.
• I.3 Symptoms and diagnosis of stress urinary incontinence as determined by the following:
• If there are mixed symptoms there must be a predominant stress component as determined by the 3-day diary results and MESA questionnaire
• Patient-reported or history of SUI symptoms for \> 6 months prior to screening.
• Positive Bladder Stress Test at the Baseline Visit.
• Positive Q-tip test at the Baseline Visit (the observation of an angle that exceeds 30 degrees from horizontal in the opinion of the investigator or designee to denote hypermobility).
• hour pad weight at the Baseline Visit with a \>10 and \<50 g net increase from the pre-test pad weight.
• Subjects must complete 3 days in the 3-day voiding diary during 3 consecutive days in the 7 days prior to the Baseline Visit, and subjects must report a minimum of 1 incontinence episode per day or \> 4 incontinence episodes over the 3 days as reported in the 3-day voiding diary.
• For the Baseline 3-day diary, subjects must be compliant with recording events (i.e. void, leak or fluid intake) as determined through coordinator interview with the subject and review of voids and fluid intake reported in the diary compared to normal daily measurements.
• I.4 Pre-menopausal females, ≥18 years of age. Premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months or who is determined to be premenopausal by the PI or sub-investigator (e.g. premenopausal woman with hysterectomy).
• I.5 Body mass index (BMI) of ≤35 kg/m² at the Screening Visit. I.6 Normal, or abnormal but not clinically significant (i.e., mild atrophy with rugae present, low grade prolapse), physical, pelvic and neurologic exam at the Baseline Visit as determined by the investigator.
• I.7 Negative urine pregnancy test at the Baseline and Randomization Visits and subject agrees to not become pregnant during the study and uses an acceptable form of birth control started at least 3 months prior to screening (with the exception of double barrier contraception, where the 3-months required prior to screening does not apply).
• Examples of acceptable forms of birth control include: abstinence from heterosexual vaginal intercourse, hysterectomy, bilateral tubal ligation, vasectomy, double barrier contraception (note that condom and spermicide is not considered double barrier contraception), intrauterine device or hormonal contraceptive.
• Rhythm and withdrawal are not considered acceptable forms of contraception.

You may not qualify if:

• E.1 Currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.
• E.2 Undergone other stress urinary incontinence treatment(s), excluding behavioral modifications started \>3 months prior to screening (e.g., Kegel exercises).
• E.3 A MESA score of greater than 5 in sum on questions 10 - 12, or greater than 9 in sum on questions 10 - 15 at the screening visit (see appendix).
• E.4 A post void residual measurement of greater than 150 ml as measured with ultrasound or bladder scanner at the screening visit.
• E.5 Greater than 10 voids per day on average as measured with the 3-day diary at Baseline Visit.
• E.6 Greater than 1 nocturia episode per day on average as measured with the 3-day diary at Baseline Visit.
• E.7 Abnormal, clinically significant laboratory results at the Baseline Visit (as determined by the Investigator) that could impact the subject participation or evaluation for SUI. Retest is allowed with Sponsor approval.
• E.8 Greater than 100 ounces of fluid consumed per day on average as measured with the 3-day diary at baseline Visit.
• E.9 History of, or any current condition, illness, or surgery that might confound the results of urinary incontinence assessment, including, but not limited to:
• Prominent (i.e., greater than Stage II pelvic organ prolapse as determined by a POP-Q evaluation (at Baseline) e.g., cystocele, rectocele
• Neurological disorders (e.g., multiple sclerosis, Parkinson's disease, fibromyalgia)
• Recurrent Urinary Tract Infections (UTI)
• Current Urinary Tract Infection (UTI) as assessed by urine dipstick and associated urinary tract infection symptoms at the Baseline or Randomization Visit. If the subject has a UTI at the Baseline or Randomization Visit they may be treated with antibiotics, at the Investigator's discretion, and return within 7 days after UTI treatment completion.
• Vesicoureteral reflux
• Bladder stones

Sponsors & Collaborators

• Viveve Inc.: lead

Study Sites (29)

Coastal Clinical Research

Mobile, Alabama, 36608, United States

RECRUITING

Urological Associates of Southern Arizona, PC

Tucson, Arizona, 85715, United States

RECRUITING

Long Beach Clinical Trials Services, Inc.

Long Beach, California, 90806, United States

RECRUITING

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20011, United States

RECRUITING

IntimMedicine Specialists

Washington D.C., District of Columbia, 20036, United States

RECRUITING

Multi-Specialty Research Associates, Inc

Lake City, Florida, 32055, United States

RECRUITING

A Premier Medical Research of Florida

Orange City, Florida, 32763, United States

RECRUITING

Florida Urology Partners

Tampa, Florida, 33615, United States

RECRUITING

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

RECRUITING

Cypress Medical Research Center, LLC

Wichita, Kansas, 67226, United States

RECRUITING

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

RECRUITING

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

RECRUITING

Chesapeake Urology Research Associates

Owings Mills, Maryland, 21117, United States

RECRUITING

Minnesota Women's Care, P.A.

Maplewood, Minnesota, 55109, United States

RECRUITING

Boeson Research

Missoula, Montana, 59804, United States

RECRUITING

Adult and Pediatric Urology

Omaha, Nebraska, 68114, United States

ACTIVE NOT RECRUITING

AccuMed Research Associates

Garden City, New York, 11530, United States

RECRUITING

Circuit Clinical

West Seneca, New York, 14224, United States

RECRUITING

Unified Women's Health Care of Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

UWCR-Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Clinical Research Solutions

Middleburg Heights, Ohio, 44130, United States

ACTIVE NOT RECRUITING

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Venus Gynecology, LLC

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Advances In Health Research

Houston, Texas, 77030, United States

RECRUITING

Cedar Health Research

Irving, Texas, 75081, United States

RECRUITING

Maximos OB/GYN

League City, Texas, 77573, United States

RECRUITING

Urology San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Health Research of Hampton Roads, Inc

Newport News, Virginia, 23606, United States

RECRUITING

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 Officials

• Eric S Rovner, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Roger R Dmochowski, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Douglas M Massey, Ph.D.

CONTACT

720.696.8173; dmassey@viveve.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: January 11, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)