Prospective US Radiofrequency SUI Trial (PURSUIT)

July 19, 2021 updated by: Viveve Inc.

PURSUIT: Prospective US Radiofrequency SUI Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. Secondary endpoints include:

  • Percent of subjects who are responders in the 1-hour Pad Weight Test at 3- and 6-months post-treatment.
  • Change from Baseline (CFB) to 3, 6- and 12-months post-treatment in the number of incontinence episodes as assessed by the 3-day bladder voiding diary.
  • Percent of subjects with no incontinence episodes at 3, 6- and 12-months post-treatment as assessed by the 3-day bladder voiding diary.
  • CFB to 3, 6, 9- and 12-months post-treatment in the I-QOL, ICIQ-UI-SF, PGI-I and MESA questionnaires.
  • Percent CFB to 3, 6- and 12-months post-treatment in the 1-hour Pad Weight Test.

Study Type

Interventional

Enrollment (Anticipated)

390

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 Contact

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Coastal Clinical Research
        • Contact:
        • Principal Investigator:
          • Charles F White, MD
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Urological Associates of Southern Arizona, PC
        • Contact:
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • Long Beach Clinical Trials Services, Inc.
        • Contact:
        • Principal Investigator:
          • Suzanne Fussell, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Recruiting
        • Emerson Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • Kristin McDay, MD
      • Washington, District of Columbia, United States, 20036
        • Recruiting
        • IntimMedicine Specialists
        • Contact:
        • Principal Investigator:
          • James Simon, MD
    • Florida
      • Lake City, Florida, United States, 32055
        • Recruiting
        • Multi-Specialty Research Associates, Inc
        • Contact:
        • Principal Investigator:
          • Miguel Tepedino, MD
      • Orange City, Florida, United States, 32763
        • Recruiting
        • A Premier Medical Research of Florida
        • Contact:
        • Principal Investigator:
          • Luis Pardo, MD
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Florida Urology Partners
        • Contact:
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Leavitt Clinical Research
        • Contact:
        • Principal Investigator:
          • Glenn Leavitt, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cypress Medical Research Center, LLC
        • Principal Investigator:
          • Kevin Miller, MD
        • Contact:
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Recruiting
        • Research Integrity, LLC
        • Contact:
        • Principal Investigator:
          • Angela Dawson, MD
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Recruiting
        • Regional Urology, LLC
        • Contact:
        • Principal Investigator:
          • Kevin J Cline, MD
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Recruiting
        • Chesapeake Urology Research Associates
        • Contact:
        • Principal Investigator:
          • Laura Giusto, MD
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Women's Care, P.A.
        • Contact:
        • Principal Investigator:
          • Melvin Ashford, MD
    • Montana
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Boeson Research
        • Contact:
        • Principal Investigator:
          • Merlin Fausett, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Active, not recruiting
        • Adult and Pediatric Urology
    • New York
      • Garden City, New York, United States, 11530
        • Recruiting
        • AccuMed Research Associates
        • Contact:
        • Principal Investigator:
          • Mitchell Efros, MD
      • West Seneca, New York, United States, 14224
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Unified Women's Health Care of Raleigh
        • Contact:
        • Principal Investigator:
          • Robert Littleton, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • UWCR-Lyndhurst Clinical Research
        • Contact:
        • Principal Investigator:
          • Bradley Jacobs, MD
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Active, not recruiting
        • Clinical Research Solutions
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Recruiting
        • The Clinical Trial Center, LLC
        • Contact:
        • Principal Investigator:
          • Marvin Kalafer, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Lilly Arya, MD
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Venus Gynecology, LLC
        • Contact:
        • Principal Investigator:
          • Helena Kirkpatrick, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Advances In Health Research
        • Contact:
        • Principal Investigator:
          • Alfred Poindexter, MD
      • Irving, Texas, United States, 75081
        • Recruiting
        • Cedar Health Research
        • Contact:
        • Principal Investigator:
          • Jeff Livingston, MD
      • League City, Texas, United States, 77573
        • Recruiting
        • Maximos OB/GYN
        • Contact:
        • Principal Investigator:
          • Bassem Maximos, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Urology San Antonio
        • Contact:
        • Principal Investigator:
          • Kurt Meissner, MD
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Health Research of Hampton Roads, Inc
        • Contact:
        • Principal Investigator:
          • George Freeman, MD

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:

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:

  1. If there are mixed symptoms there must be a predominant stress component as determined by the 3-day diary results and MESA questionnaire
  2. Patient-reported or history of SUI symptoms for > 6 months prior to screening.
  3. Positive Bladder Stress Test at the Baseline Visit.
  4. 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).
  5. 1-hour pad weight at the Baseline Visit with a >10 and <50 g net increase from the pre-test pad weight.
  6. 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.
  7. 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).

  1. 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.
  2. Rhythm and withdrawal are not considered acceptable forms of contraception.

Exclusion Criteria:

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:

  1. Prominent (i.e., greater than Stage II pelvic organ prolapse as determined by a POP-Q evaluation (at Baseline) e.g., cystocele, rectocele
  2. Neurological disorders (e.g., multiple sclerosis, Parkinson's disease, fibromyalgia)
  3. Recurrent Urinary Tract Infections (UTI)
  4. 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.
  5. Vesicoureteral reflux
  6. Bladder stones
  7. Bladder tumors
  8. Interstitial cystitis E.10 Has any implantable electrical device [e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)].

E.11 A rectovaginal septum <2 cm. E.12 Planning on future pregnancies after the Viveve procedure.

E.13 Medical or immunological condition, including, but not limited to:

  1. Uncontrolled cardiovascular, respiratory, neoplastic, infectious, and/or endocrinological condition that could impact the subject's ability to complete the trial.
  2. Uncontrolled diabetes defined as hemoglobin A1c > 7%
  3. Untreated chronic abdominal/pelvic pain disorder [including, but not limited to, dyspareunia, vaginismus, endometriosis, significant vulvovaginal atrophy (VVA), genitourinary syndrome of menopause (GSM), irritable bowel syndrome, or Crohn's disease].
  4. Untreated medical condition or medication that, in investigator's opinion, may interfere with adequate wound healing response (e.g., congenital connective tissue disease) or the subject's ability to complete the clinical trial requirements.
  5. Untreated active malignancy (with the exception of basal cell carcinoma of the skin) or undergoing treatment (using chemotherapeutic agents, radiation therapy, and/or cytostatic medications) that may interfere with adequate wound healing response or the subject's ability to complete the trial.
  6. Untreated acute or chronic vaginal or vulvar disorder including, but not limited to, vulvovaginal atrophy/GSM; pain, including provoked/generalized vulvodynia, vulvar vestibulitis, dysesthetic vulvodynia, or vulvar dystrophy; current/chronic papulosquamous vulvar dermatoses (e.g., psoriasis, lichen planus, tinea cruris, lichen sclerosis, seborrheic dermatitis, contact/irritant dermatitis, lichen simplex, eczema); bullous dermatoses; systemic diseases with potential involvement of vulva; genital warts; past/current vaginal or vulvar radiotherapy or brachytherapy.
  7. Active genital/pelvic infection (e.g., herpes, gonorrhea, chlamydia) observed on physical or pelvic exam at Baseline.
  8. Active yeast infection. If the subject has an active vaginal yeast infection at the Baseline or Randomization Visit, they may be treated with an antifungal, at the Investigator's discretion, and return within 7 days after completion of vaginal yeast infection treatment.

E.14 Chronic use of anti-inflammatory drugs, including ibuprofen, aspirin, and oral steroids (excluding aspirin that is taken for cardiovascular prophylaxis).

E.15 Started taking any new medication, including herbal supplements and those taken in teas that potentially affects urination within 28 days prior to the Screening Visit, or had a change in the dosage of any medication that potentially affects urination within 28 days of the Screening Visit. Dosage should not change for the remainder of the study unless medically necessary.

E.16 Started or changed dose of local vaginal hormones <6 weeks before screening.

E.17 Undergone previous elective surgical or non-invasive procedure(s) in the vaginal canal (including previous treatment with the Viveve System or any other genital radiofrequency treatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancement procedure).

E.18 Participated in another clinical study within 6 months of screening or is not willing to abstain from participating in other clinical studies for duration of trial.

E.19 Employed by Viveve or participating investigative sites.

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Comparator
Sham delivers non therapeutic levels of radiofrequency and cryogen
Device: Sham
Sham delivers non therapeutic levels of radiofrequency and cryogen
Experimental: Active Arm
Active arm delivers radiofrequency and cryogen
Device: Active treatment
Active treatment delivers radiofrequency and cryogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-hour pad weight test
Time Frame: 12 months
Standard test of incontinence
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-day diary
Time Frame: 3, 6, and 12 months
Voiding diary
3, 6, and 12 months
1-hour pad weight test
Time Frame: 3 and 6 months
Standard test of incontinence
3 and 6 months
Patient Global Impression of Improvement (PGI-I)
Time Frame: 3, 6, 9, and 12 months
Single question patient assessment
3, 6, 9, and 12 months
Medical, Epidemiologic, and Social aspects of Aging (MESA) questionnaire
Time Frame: 3, 6, 9, and 12 months
Questionnaire for stress and urge incontinence
3, 6, 9, and 12 months
International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)
Time Frame: 3, 6, 9, and 12 months
Incontinence severity, frequency QOL questionnaire
3, 6, 9, and 12 months
Incontinence Quality of Life (I-QOL)
Time Frame: 3, 6, 9, and 12 months
QOL assessment
3, 6, 9, and 12 months

Collaborators and Investigators

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

Sponsor

Viveve Inc.

Investigators

  • Principal Investigator: Eric S Rovner, MD, Medical University of South Carolina
  • Study Director: Roger R Dmochowski, MD, Vanderbilt University Medical Center

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)

January 11, 2021

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VI-17-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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