AzTrials
AzTrials

Stress Urinary IncontinenceNCT03066180

Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

A study testing Viveve SUI treatment in people with Stress Urinary Incontinence, run by Dr. Bruce B. Allan at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Stress Urinary Incontinence
What is being tested?
Viveve SUI treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteCanada
Study dates
29 May 2017to 30 Nov 2018
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

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Allan Centre

    Calgary, Alberta, T2J 6A5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Viveve SUI treatment
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.

  • Viveve SUI treatmentDevice

    Non-ablative radiofrequency treatment with surface cooling

Study groups in NCT03066180
Study groupRoleWhat they receive
Group 1ExperimentalSingle study treatment (Viveve SUI treatment) will be administered.
Receives: Device: Viveve SUI treatment
Group 2ExperimentalTwo study treatments (Viveve SUI treatments) will be administered approximately 6 weeks apart.
Receives: Device: Viveve SUI treatment

What is being measured

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

  1. reduction in pad weight vs. baseline

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

    Measured: baseline to 12 months post-treatment

Timeline

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

  1. First posted28 Feb 2017
  2. Study start29 May 2017
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03066180
Sponsor's protocol ID
VI-ERP-010
Status last verified
Dec 2018
First submitted
23 Feb 2017
Last updated
19 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 7780440

  • 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.

    PubMed 7841963

  • 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.

    PubMed 11483899

  • 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.

    PubMed 31464548

Questions about this trial

What is this clinical trial studying?

A study testing Viveve SUI treatment in people with Stress Urinary Incontinence, run by Dr. Bruce B. Allan at 1 site in Canada.

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 6 inclusion and 22 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: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

reduction in pad weight vs. baseline (time frame: baseline to 12 months post-treatment). 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 NCT03066180, which also lists 4 linked publications.

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 19 Dec 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in