Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence
NCT ID: NCT03066180
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2017-05-29
2018-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1
Single study treatment (Viveve SUI treatment) will be administered.
Viveve SUI treatment
Non-ablative radiofrequency treatment with surface cooling
Group 2
Two study treatments (Viveve SUI treatments) will be administered approximately 6 weeks apart.
Viveve SUI treatment
Non-ablative radiofrequency treatment with surface cooling
Interventions
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Viveve SUI treatment
Non-ablative radiofrequency treatment with surface cooling
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Dr. Bruce B. Allan
OTHER
Responsible Party
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Dr. Bruce B. Allan
Bruce B. Allan, PhD, MD, FRCSC
Principal Investigators
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Bruce B Allan, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Allan Centre
Calgary, Alberta, Canada
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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VI-ERP-010
Identifier Type: -
Identifier Source: org_study_id