Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

December 18, 2018 updated by: Dr. Bruce B. Allan

Pilot Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, pilot clinical study involving two study groups. Subjects meeting the all the inclusion criteria and none of the exclusion criteria will be enrolled in the study. Subjects will receive a single SUI treatment; subjects in Group 2 will receive two SUI Treatments.

At the Screening Visit, and at each pre-designated study follow-up timepoint, subjects will be asked to complete several quality of life questionnaires related to the treated condition. In addition, subjects will provide a bladder voiding diary for review and data collection, and a pad weight test will be conducted and results collected.

Study Type

Interventional

Enrollment (Actual)

37

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 Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2J 6A5
        • Allan Centre

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:

  • 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.

Exclusion Criteria:

  • 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.
    • Has an implantable electrical device [e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)] that could potentially be affected by the use of radiofrequency.
  • Taking any new medication (< 3 months) that affects urination, or change in the dosage of any medication that affects urination within the past 3 months.
  • Medical history of keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of < 2 cm between the vaginal opening and the anal opening, as measured by a flexible tape measure); or history of fourth-degree laceration, hypertrophic scar formation, or mediolateral episiotomy.
  • Active malignancy or undergoing treatment (using chemotherapeutic agents, radiation therapy, and/or cytostatic medications) that may interfere with adequate wound healing response.
  • Previous vaginal, energy-based device treatment for vaginal laxity, urinary incontinence, or sexual function (e.g., radiofrequency treatment, cosmetic, laser, surgical, and/or genital enhancement procedure).
  • Chronic use of anti-inflammatory drugs, including ibuprofen, aspirin, and steroids.
  • Subject has been 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.

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
Single study treatment (Viveve SUI treatment) will be administered.
Device: Viveve SUI treatment
Non-ablative radiofrequency treatment with surface cooling
EXPERIMENTAL: Group 2
Two study treatments (Viveve SUI treatments) will be administered approximately 6 weeks apart.
Device: Viveve SUI treatment
Non-ablative radiofrequency treatment with surface cooling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in pad weight vs. baseline
Time Frame: baseline to 12 months post-treatment
pad weight tests to be completed at baseline and at designated study follow-up timepoints
baseline to 12 months post-treatment

Collaborators and Investigators

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

Sponsor

Dr. Bruce B. Allan

Investigators

  • Principal Investigator: Bruce B Allan, PhD, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 29, 2017

Primary Completion (ACTUAL)

November 30, 2018

Study Completion (ACTUAL)

November 30, 2018

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (ACTUAL)

February 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VI-ERP-010

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

product manufactured in and exported from the U.S.

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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