Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

NCT03066180 | Completed FDA Device

• 1 other identifier: VI-ERP-010
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, pilot clinical study involving two study groups. This study is designed to demonstrate that the study treatment meets primary efficacy and safety endpoints. The treatment involves radiofrequency treatment to address symptoms of stress urinary incontinence. After receiving the study treatment, subjects will be followed out to 12 months post-treatment. At the Screening Visit, and at each designated follow-up timepoint, subjects will be asked to complete a variety of questionnaires, provide a patient diary, and undergo an objective assessment for urine loss.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• reduction in pad weight vs. baseline

  pad weight tests to be completed at baseline and at designated study follow-up timepoints

  baseline to 12 months post-treatment

Study Arms (2)

Group 1

EXPERIMENTAL

Single study treatment (Viveve SUI treatment) will be administered.

Device: Viveve SUI treatment

Group 2

EXPERIMENTAL

Two study treatments (Viveve SUI treatments) will be administered approximately 6 weeks apart.

Device: Viveve SUI treatment

Interventions

Viveve SUI treatment DEVICE

Non-ablative radiofrequency treatment with surface cooling

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Able to understand and has voluntarily signed and dated the informed consent form (ICF) prior to initiation of any screening or study-specific procedures.
• Willing to comply with study requirements and instructions.
• Female, ≥ 18 years of age.
• Normal pelvic exam at Screening.
• Negative pregnancy test at Screening.
• Diagnosed with mild or moderate Stress Urinary Incontinence (SUI) by the 1-hour pad weight test ("mild" defined as 1 - 10 g; "moderate" defined as 11 - 50 g; and "severe" defined as \>50 g ) at Screening.

You may not qualify if:

• Subject is currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment.
• Any condition, illness, or surgery that might confound the results of urinary incontinence assessment, including, but not limited to:
• Categories of urinary incontinence other than the categories being investigated.
• Prominent (i.e., greater than stage II as defined by the International Continence Society) pelvic organ prolapse (e.g., cystocele, rectocele).
• Neurological disorders (e.g., multiple sclerosis, Parkinson's disease).
• Spastic bladder.
• Concurrent infections (e.g., urinary tract infection \[UTI\], cystitis, urethritis, active genital herpes flare-up, active genital/pelvic infection).
• Vesicoureteral reflux.
• Bladder stones.
• Bladder tumors.
• Morbid obesity.
• Any underlying condition that may pose unreasonable risks to the subject, such as:
• Coagulation abnormalities.
• Abnormal kidney function.
• Uncontrolled diabetes.

Sponsors & Collaborators

• Dr. Bruce B. Allan: lead

Study Sites (1)

Allan Centre

Calgary, Alberta, T2J 6A5, Canada

Location

Related Publications (4)

• Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.

  PMID: 7780440 BACKGROUND

• Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res. 1994 Oct;3(5):291-306. doi: 10.1007/BF00451721.

  PMID: 7841963 BACKGROUND

• Harvey MA, Kristjansson B, Griffith D, Versi E. The Incontinence Impact Questionnaire and the Urogenital Distress Inventory: a revisit of their validity in women without a urodynamic diagnosis. Am J Obstet Gynecol. 2001 Jul;185(1):25-31. doi: 10.1067/mob.2001.116369.

  PMID: 11483899 BACKGROUND

• Allan BB, Bell S, Husarek K. Early Feasibility Study to Evaluate the Viveve System for Female Stress Urinary Incontinence: Interim 6-Month Report. J Womens Health (Larchmt). 2020 Mar;29(3):383-389. doi: 10.1089/jwh.2018.7567. Epub 2019 Aug 29.

  PMID: 31464548 DERIVED

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

• Bruce B Allan, PhD, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Bruce B. Allan, PhD, MD, FRCSC

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: May 29, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)