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Prospective US Radiofrequency SUI Trial (PURSUIT)

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ClinicalTrials.gov Identifier: NCT04720352
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Viveve Inc.

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Device: Active treatment Device: Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PURSUIT: Prospective US Radiofrequency SUI Trial
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 1-hour pad weight test [ Time Frame: 12 months ]
    Standard test of incontinence


Secondary Outcome Measures :
  1. 3-day diary [ Time Frame: 3, 6, and 12 months ]
    Voiding diary

  2. 1-hour pad weight test [ Time Frame: 3 and 6 months ]
    Standard test of incontinence

  3. Patient Global Impression of Improvement (PGI-I) [ Time Frame: 3, 6, 9, and 12 months ]
    Single question patient assessment

  4. Medical, Epidemiologic, and Social aspects of Aging (MESA) questionnaire [ Time Frame: 3, 6, 9, and 12 months ]
    Questionnaire for stress and urge incontinence

  5. 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

  6. Incontinence Quality of Life (I-QOL) [ Time Frame: 3, 6, 9, and 12 months ]
    QOL assessment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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 Baseline.
  4. Positive Q-tip test at Baseline (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 Baseline 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 as reported in the 3-day voiding diary.
  7. For the Baseline 3-day diary, subjects must be at least 70% compliant with recording events (i.e. void, leak or fluid intake) within 3 hours of an event.

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.

  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 treatments, excluding behavioral modifications started >3 months prior to screening (e.g., Kegel exercises).

E.3 A MESA score of greater than 4 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 at the screening visit as measured with ultrasound.

E.5 Greater than 10 voids per day on average as measured with the 3-day diary at baseline.

E.6 Greater than 1 nocturia episode per day on average as measured with the 3-day diary at baseline.

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 Subject does not own/lease a smart phone, tablet or computer with internet access

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) 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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720352


Contacts
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Contact: Douglas M Massey, Ph.D. 720.696.8173 dmassey@viveve.com
Contact: Mark Robberson mrobberson@viveve.com

Locations
Show Show 21 study locations
Sponsors and Collaborators
Viveve Inc.
Investigators
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Principal Investigator: Eric S Rovner, MD Medical University of South Carolina
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Responsible Party: Viveve Inc.
ClinicalTrials.gov Identifier: NCT04720352    
Other Study ID Numbers: VI-17-06
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations