Prospective US Radiofrequency SUI Trial

Urinary Incontinence, Stress Clinical Trial

— PURSUIT  

Official title:

PURSUIT: Prospective US Radiofrequency SUI Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720352
• Other study ID #: VI-17-06
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2021
• Source: Viveve Inc.
• Contact: Douglas M Massey, Ph.D.
• Phone: 720.696.8173
• Email: dmassey[@]viveve.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Active treatment
Active treatment delivers radiofrequency and cryogen
• Sham
Sham delivers non therapeutic levels of radiofrequency and cryogen

Locations

Country	Name	City	State
United States	AccuMed Research Associates	Garden City	New York
United States	Advances In Health Research	Houston	Texas
United States	Leavitt Clinical Research	Idaho Falls	Idaho
United States	Cedar Health Research	Irving	Texas
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	Multi-Specialty Research Associates, Inc	Lake City	Florida
United States	Maximos OB/GYN	League City	Texas
United States	Long Beach Clinical Trials Services, Inc.	Long Beach	California
United States	Minnesota Women's Care, P.A.	Maplewood	Minnesota
United States	Clinical Research Solutions	Middleburg Heights	Ohio
United States	Boeson Research	Missoula	Montana
United States	Coastal Clinical Research	Mobile	Alabama
United States	Venus Gynecology, LLC	Myrtle Beach	South Carolina
United States	Health Research of Hampton Roads, Inc	Newport News	Virginia
United States	Adult and Pediatric Urology	Omaha	Nebraska
United States	A Premier Medical Research of Florida	Orange City	Florida
United States	Research Integrity, LLC	Owensboro	Kentucky
United States	Chesapeake Urology Research Associates	Owings Mills	Maryland
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Unified Women's Health Care of Raleigh	Raleigh	North Carolina
United States	Urology San Antonio	San Antonio	Texas
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Florida Urology Partners	Tampa	Florida
United States	Urological Associates of Southern Arizona, PC	Tucson	Arizona
United States	Emerson Clinical Research Institute	Washington	District of Columbia
United States	IntimMedicine Specialists	Washington	District of Columbia
United States	Circuit Clinical	West Seneca	New York
United States	Cypress Medical Research Center, LLC	Wichita	Kansas
United States	UWCR-Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Viveve Inc.

Country where clinical trial is conducted

United States, 

Outcome

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