Early Feasibility Study to Evaluate the Viveve System for Female Stress Urinary Incontinence: Interim 6-Month Report

Bruce B Allan, Stacie Bell, Kathryn Husarek, Bruce B Allan, Stacie Bell, Kathryn Husarek

Abstract

Background: The purpose of this prospective, investigator-initiated feasibility study is to evaluate the efficacy and safety of nonablative, cryogen-cooled, monopolar radiofrequency (CMRF) treatment for stress urinary incontinence (SUI). Materials and Methods: Subjects meeting all the inclusion and exclusion criteria were enrolled and divided into two groups. Subjects in Group 1 received a single SUI treatment, and subjects in Group 2 received two SUI treatments ∼6 weeks apart. Follow-up visits are planned for 1, 4, 6, and 12 months post-treatment. At each study visit, subjects are asked to perform a 1-hour pad-weight test (PWT) and to complete the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) questionnaires. In addition, subjects completed 7-day bladder voiding diary and safety assessments. Results: Preliminary data indicate an improvement in SUI symptoms and quality of life for subjects, as determined by validated SUI-related patient-reported outcomes and the objective 1-hour PWT, with a >50% reduction in pad weight for 68.8% of the Group 1 subjects and 69.2% of the Group 2 subjects at 6 months. Initial review of the bladder voiding diaries suggests that subjects are having fewer urine leakage episodes per day. In addition to efficacy, the CMRF Viveve System was well tolerated and safe. Conclusions: The endpoints evaluated indicate an improvement in SUI symptoms and quality of life. The sustained benefit of the CMRF vaginal treatment at 6 months suggests potential use as a nonsurgical approach to treat SUI.

Trial registration: ClinicalTrials.gov NCT03066180.

Keywords: one-hour pad-weight test (1-hour PWT); radiofrequency (RF); stress urinary incontinence (SUI).

Conflict of interest statement

B.B.A. acquired support for the study from Viveve Investigator-sponsored Research Program, was a consultant to Viveve, Inc.; S.B. was an employee of Viveve, Inc., at the time of the study; and K.H. was an employee of Viveve, Inc.

Figures

FIG. 1.
FIG. 1.
CONSORT diagram. Note, the final follow-up visit is at 12 months, but this article only discusses the trial through 6-month follow-up visit.
FIG. 2.
FIG. 2.
Mean composite scores for SUI-related patient-reported outcomes. The gray bar in each graph denotes a published MCID from the literature. ICIQ-UI-SF, International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence-Short Form; IIQ-7, Incontinence Impact Questionnaire-Short Form; MCID, minimal clinical important difference; SUI, stress urinary incontinence; UDI-6, Urogenital Distress Inventory-6.

References

    1. Haylen BT, de Ridder D, Freeman RM, et al. . An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn 2010;29:4–20
    1. Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol 2011;186:589–593
    1. Tahtinen RM, Cartwright R, Tsui JF, et. al. Long-term impact of mode of delivery on stress urinary incontinence and urgency urinary incontinence: A systematic review and meta-analysis. Eur Urol 2016;70:148–158
    1. Saarni SI. The impact of 29 chronic conditions on health-related quality of life: A general population survey in Finland using 15D and EQ5D. Qual Life Res 2006;15:1403–1414
    1. Salonia A. Sexual dysfunction is common in women with lower urinary tract symptoms and urinary incontinence: Results of a cross-sectional study. Eur Urol 2004;45:642–648
    1. Yip SK. The impact of urodynamic stress incontinence and detrusor overactivity on marital relationship and sexual function. Am J Obstet Gynecol 2003;188:1244–1248
    1. Guralnick ML, Kelly H, Engelke H, Koduri S, O'Connor RC. InTone: A novel pelvic floor rehabilitation device for urinary incontinence. Int Urogynecol J 2015;26:99–106
    1. Beyar N, Groutz A: Pelvic floor muscle training for female stress urinary incontinence: Five years outcomes. Neurourol Urodyn 2015;36:132–135
    1. Norton PA, Zinner NR, Yalcin I, Bump RC. Duloxetine versus placebo in the treatment of stress urinary incontinence. Am J Obstet Gynecol 2002;187:40–48
    1. Toozs-Hobson P, Al-Singary W, Fynes M, Tegerstedt G, Lose G. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid(R)) for female stress and stress-predominant mixed incontinence. Int Urogynecol J 2012;23:1373–1378
    1. Kerr LA. Bulking agents in the treatment of stress urinary incontinence: History, outcomes, patient populations, and reimbursement profile. Rev Urol 2005;7:S3–S11
    1. Ford AA, Rogerson L, Cody JD, Ogah J. Midurethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev 2015;7:CD006375
    1. Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers 2017;3:17042.
    1. Berjano EJ, Ribera ENV, Gorris J, Alió JL. Radiofrequency heating of the cornea: An engineering review of electrodes and applicators. Open Biomed Eng J 2007;1:71–76
    1. Krychman M, Rowan CG, Allan BB, et al. . Effect of single-treatment, surface-cooled radiofrequency therapy on vaginal laxity and female sexual function: The VIVEVE I randomized controlled trial. J Sex Med 2017;14:215–225
    1. Lordelo P, Vilas Boas A, Sodre D, Lemos A, Tozetto S, Brasil C. New concept for treating female stress urinary incontinence with radiofrequency. Int Braz J Urol 2017;43:896–902
    1. Dmochowski R, Appell RA. Advancements in minimally invasive treatments for female stress urinary incontinence: Radiofrequency and bulking agents. Curr Urol Rep 2003;4:350–355
    1. Appell RA, Juma S, Wells WG, et al. . Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol Urodyn 2006;25:331–336
    1. Appell RA. Transurethral collagen denaturation for women with stress urinary incontinence. Curr Urol Rep 2008;9:373–379
    1. Krychman M, Rowan CG, Allan BB, Durbin S, Yacoubian A, Wilkerson D. Effect of single-session, cryogen-cooled monopolar radiofrequency therapy on sexual function in women with vaginal laxity: The VIVEVE I Trial. J Womens Health (Larchmt) 2018;27:297–304
    1. Krhut J, Zachoval R, Smith PP, et al. . Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn 2014;33:507–510
    1. Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Andrew Fantl J; and the Continence Program for Women Research Group: Short forms to assess life quality and symptom distress for urinary incontinence in women: The incontinence impact questionnaire and the urogenital distress inventory. Neurourol Urodyn 1995;14:131–139
    1. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: A brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn 2004;23:322–330
    1. Tubaro A, Artibani W, Bartram C, Delancey J, Khullar V, Vierhout M.. Imaging and other investigations. In: Abrams P, Cardozo L, Khoury S, Wein A eds. Incontinence, 4th Ed. Wiley Online, 2009.
    1. FDA Center for Devices and Radiological Health Office of Device Evaluation. Guidance for Industry and Food and Drug Administration Staff Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence 2011. Accessed March8, 2011
    1. Hróbjartsson A, Gøtzsche PC: Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001;344:1594–1602
    1. Vos JA, Ryan TP, Livengood RH, Jessop M, Coad JE. Non-ablative hyperthermic mesenchymal regeneration: A proposed mechanism of action based on the Vivev model. SPIE 2011;7901:790104-790101–790104-790108.
    1. Huber SA, Chinthakanan O, Hawkins S, Miklos JR, Moore RD. Laparoscopic Burch urethropexy at time of mesh sling removal: A cohort study evaluating functional outcomes and quality of life. World J Obstet Gynecol 2016;5:210–217
    1. Caruth J. Evaluation of the safety and efficacy of a novel radiofrequency device for vaginal treatment. Surg Technol Int 2018;32:145–149
    1. Lalji S, Lozanova P. Evaluation of the safety and efficacy of a monopolar nonablative radiofrequency device for the improvement of vulvo-vaginal laxity and urinary incontinence. J Cosmet Dermatol 2017;16:230–234
    1. Leibaschoff G, Izasa PG, Cardona JL, Miklos JR, Moore RD. Transcutaneous temperature controlled radiofrequency (TTCRF) for the treatment of menopausal vaginal/genitourinary symptoms. Surg Technol Int 2016;29:149–159
    1. Vicariotto F, Raichi M. Technological evolution in the radiofrequency treatment of vaginal laxity and menopausal vulvo-vaginal atrophy and other genitourinary symptoms: First experiences with a novel dynamic quadripolar device. Minerva Ginecol 2016;68:225–236
    1. Nystrom E, Sjostrom M, Stenlund H, Samuelsson E. ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn 2015;34:747–751
    1. Magon N, Alinsod R. ThermiVa: The revolutionary technology for vulvovaginal rejuvenation and noninvasive management of female SUI. J Obstet Gynaecol India 2016;66:300–302
    1. Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: Nonsurgical vaginal tightening. J Sex Med 2010;7:3088–3095
    1. Sekiguchi Y, Utsugisawa Y, Azekosi Y, et al. . Laxity of the vaginal introitus after childbirth: Nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy. J Womens Health (Larchmt) 2013;22:775–781

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit