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Urinary Incontinence, StressPURSUITNCT04720352

Prospective US Radiofrequency SUI Trial

A study testing Active treatment in people with Urinary Incontinence, Stress, run by Viveve Inc. at 29 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Urinary Incontinence, Stress
What is being tested?
Active treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
390 participants
Where
29 sitesUnited States
Study dates
11 Jan 2021to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).
  • 1-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.

Who cannot join

  • 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.
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  • 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
  • Bladder tumors
  • 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:
  • Uncontrolled cardiovascular, respiratory, neoplastic, infectious, and/or endocrinological condition that could impact the subject's ability to complete the trial.
  • Uncontrolled diabetes defined as hemoglobin A1c > 7%
  • 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].
  • 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.
  • 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.
  • 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.
  • Active genital/pelvic infection (e.g., herpes, gonorrhea, chlamydia) observed on physical or pelvic exam at Baseline.
  • 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.

Trial locations and contacts

29 sites in 1 country.

Douglas M Massey, Ph.D. contact

720.696.8173

dmassey@viveve.com

29 sites in 1 country

United States29 sites, 27 recruiting

  • AccuMed Research Associates

    Garden City, New York, 11530

    516-746-2190, Accumed@aol.com

    Mitchell Efros, MD

    Recruiting

  • Advances In Health Research

    Houston, Texas, 77030

    713-795-5964, AIH@advancesinhealthresearch.com

    Alfred Poindexter, MD

    Recruiting

  • Leavitt Clinical Research

    Idaho Falls, Idaho, 83404

    Rebecca Cortez, 208-502-3039, rebecca@drleavitt.net

    Glenn Leavitt, MD

    Recruiting

  • Cedar Health Research

    Irving, Texas, 75081

    214-253-8170, info@cedarresearch.com

    Jeff Livingston, MD

    Recruiting

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

    Alketa Dobi, 215-884-1700, clinicaltrialcenter@comcast.net

    Marvin Kalafer, MD

    Recruiting

  • Multi-Specialty Research Associates, Inc

    Lake City, Florida, 32055

    Robin Miller Sims, LPN, CRC, 386-438-8977, robbin@msrainc.com

    Miguel Tepedino, MD

    Recruiting

  • Maximos OB/GYN

    League City, Texas, 77573

    Jessica Orsak, 832-632-1333, jessica@maximosobgyn.com

    Bassem Maximos, MD

    Recruiting

  • Long Beach Clinical Trials Services, Inc.

    Long Beach, California, 90806

    Angela Rodriquez, 562-997-3869, longbeachtrials0812@gmail.com

    Suzanne Fussell, MD

    Recruiting

  • Minnesota Women's Care, P.A.

    Maplewood, Minnesota, 55109

    Lyndsey Gapinski, 651-600-3035 ext. 79, lgapinski@mnwcare.com

    Melvin Ashford, MD

    Recruiting

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

    Active, not recruiting

  • Boeson Research

    Missoula, Montana, 59804

    Ellie Bilyeu, 406-763-8833, ellie@boesonresearch.com

    Merlin Fausett, MD

    Recruiting

  • Coastal Clinical Research

    Mobile, Alabama, 36608

    Pam Rowe, 251-414-1984 ext. 125, pam.rowe@amrllc.com

    Charles F White, MD

    Recruiting

  • Venus Gynecology, LLC

    Myrtle Beach, South Carolina, 29572

    Tony Johnson, 843-449-0803, tjohnson@venusgyn.com

    Helena Kirkpatrick, MD

    Recruiting

  • Health Research of Hampton Roads, Inc

    Newport News, Virginia, 23606

    Mandie Fronzaglio, 757-591-8100, mfronz@hrhr-inc.com

    George Freeman, MD

    Recruiting

  • Adult and Pediatric Urology

    Omaha, Nebraska, 68114

    Active, not recruiting

  • A Premier Medical Research of Florida

    Orange City, Florida, 32763

    Norma Lyn, 386-960-7714, drnlyn@apmrofflorida.com

    Luis Pardo, MD

    Recruiting

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

    Jacque Nalley, 270-691-1829, jacquenalley@drvora.com

    Angela Dawson, MD

    Recruiting

  • Chesapeake Urology Research Associates

    Owings Mills, Maryland, 21117

    Rayna Bennett-Campbell, 443-231-1203, rbennett@chesuro.com

    Laura Giusto, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Zandra B Kennedy, 215-805-0410, zandra.kennedy@pennmedicine.upenn.edu

    Lilly Arya, MD

    Recruiting

  • Unified Women's Health Care of Raleigh

    Raleigh, North Carolina, 27607

    Monique Carignan, 919-788-4465, monique.carignan@unifiedhc.com

    Robert Littleton, MD

    Recruiting

  • Urology San Antonio

    San Antonio, Texas, 78229

    Sandra Salas, 210-617-4116, Sandra.salas@urologysa.com

    Kurt Meissner, MD

    Recruiting

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

    Kayla Telano, 318-683-0411, ktelano@regionalurology.com

    Kevin J Cline, MD

    Recruiting

  • Florida Urology Partners

    Tampa, Florida, 33615

    Linda Seibert, 239-223-4488, linda@gulfcoastcta.com

    Osvaldo Padron, MD

    Recruiting

  • Urological Associates of Southern Arizona, PC

    Tucson, Arizona, 85715

    520-351-5582, christinam@uasapc.com

    Susan Kalota, MD

    Recruiting

  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia, 20011

    Audrey Escobedo- Escotto, 202-239-0777 ext. 101, audrey@ecrinstitute.com

    Kristin McDay, MD

    Recruiting

  • IntimMedicine Specialists

    Washington D.C., District of Columbia, 20036

    Laura Barbee, 703-242-6362, lbarbee@intimmedicine.com

    James Simon, MD

    Recruiting

  • Circuit Clinical

    West Seneca, New York, 14224

    716-919-1130, recruitment@circuitclinical.com

    Jeffrey Constantine, MD

    Recruiting

  • Cypress Medical Research Center, LLC

    Wichita, Kansas, 67226

    Bryan S Baker, RN, MSM, 316-425-6333, bryan@cypressmrc.com

    Kevin Miller, MD

    Recruiting

  • UWCR-Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103

    Allie Deal, 336-397-3715, Alexandra.deal@unifiedhc.com

    Bradley Jacobs, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
Active treatment, Sham
Medical subject headings
Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active treatmentDevice

    Active treatment delivers radiofrequency and cryogen

  • ShamDevice

    Sham delivers non therapeutic levels of radiofrequency and cryogen

Study groups in NCT04720352
Study groupRoleWhat they receive
Sham ComparatorSham comparatorSham delivers non therapeutic levels of radiofrequency and cryogen
Receives: Device: Sham
Active ArmExperimentalActive arm delivers radiofrequency and cryogen
Receives: Device: Active treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-hour pad weight test

    Standard test of incontinence

    Measured: 12 months

Secondary outcomes (6)

  1. 3-day diary

    Voiding diary

    Measured: 3, 6, and 12 months

  2. 1-hour pad weight test

    Standard test of incontinence

    Measured: 3 and 6 months

  3. Patient Global Impression of Improvement (PGI-I)

    Single question patient assessment

    Measured: 3, 6, 9, and 12 months

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

    Questionnaire for stress and urge incontinence

    Measured: 3, 6, 9, and 12 months

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

    Incontinence severity, frequency QOL questionnaire

    Measured: 3, 6, 9, and 12 months

  6. Incontinence Quality of Life (I-QOL)

    QOL assessment

    Measured: 3, 6, 9, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start11 Jan 2021
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04720352
Sponsor's protocol ID
VI-17-06
Acronym
PURSUIT
Status last verified
Jul 2021
First submitted
18 Jan 2021
Last updated
26 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active treatment in people with Urinary Incontinence, Stress, run by Viveve Inc. at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Douglas M Massey, Ph.D. (720.696.8173, dmassey@viveve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-hour pad weight test (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04720352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.

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