Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence
NCT ID: NCT04636749
Last Updated: 2021-03-10
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-03-09
2022-10-22
Brief Summary
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Detailed Description
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Plenty of women suffer from SUI. It is a condition in which involuntary urine leakage occurs during exercise. This condition affects about 40% of all women and causes huge disturbance to daily life. There are plenty of risk factors, such as age, obesity and parity. We assume that the pathophysiology is related to hypermobility of the urethra due to damage to the surrounding tissue.
The treatment options vary from surgical interventional to conservative, each treatment has its own success rate and risk factors. An attempt to find effective treatment option has been made.
The use of laser for various gynecologic conditions are at rise. ERBIUM type laser works on the lamina propria layer and causes rejuvenation probably by strengthening collagen structures and creating new ones.
The efficacy and safety of vaginal laser therapy has been proven already, but in the field of SUI the numbers in each study were low and there was no control group.
In this study we desire to examine the effect of vaginal ERBIUM treatment on SUI in compare to placebo.
this is a randomized single blind control trial. 40 women will be included in the research group and 40 in the placebo group. Women will be assigned randomly to each group. They will be treated with vaginal laser probe, three treatments 4 weeks apart. Follow up visits will be performed 3, 6, and 12 months after the first treatment.
Effectiveness evaluation will be done by physical urodynamic examination before treatment and 6 month after finishing, by 24 hours pad test' cough test and by fulfilling questionnaires-
1. The Urogenital Distress inventory (UDI6)
2. The Female Sexual Function Index (FSFI)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Erbium laser
Treatment with Erbium laser
Erbium laser
Vaginal laser therapy
Sham laser
Treatment with sham laser
Sham laser
Sham laser therapy
Interventions
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Erbium laser
Vaginal laser therapy
Sham laser
Sham laser therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Vaginal operation in the previous year
3. Women with abnormal uterine bleeding
4. Women with diagnosed genital herpes infection
5. Any concurrent lower genital tract infection -
18 Years
70 Years
FEMALE
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Naama Farago MD
MD
Principal Investigators
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Naama Farago, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam Health Care Campus
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Cervigni M, Gambacciani M. Female urinary stress incontinence. Climacteric. 2015;18 Suppl 1:30-6. doi: 10.3109/13697137.2015.1090859.
Padmanabhan P, Dmochowski R. Urinary incontinence in women: a comprehensive review of the pathophysiology, diagnosis and treatment. Minerva Ginecol. 2014 Oct;66(5):469-78. Epub 2014 Jul 31.
Itkonen Freitas AM, Rahkola-Soisalo P, Mikkola TS, Mentula M. Current treatments for female primary stress urinary incontinence. Climacteric. 2019 Jun;22(3):263-269. doi: 10.1080/13697137.2019.1568404. Epub 2019 Feb 18.
Kobashi KC, Albo ME, Dmochowski RR, Ginsberg DA, Goldman HB, Gomelsky A, Kraus SR, Sandhu JS, Shepler T, Treadwell JR, Vasavada S, Lemack GE. Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. J Urol. 2017 Oct;198(4):875-883. doi: 10.1016/j.juro.2017.06.061. Epub 2017 Jun 15.
Dwyer PL, Karmakar D. Surgical management of urinary stress incontinence - Where are we now? Best Pract Res Clin Obstet Gynaecol. 2019 Jan;54:31-40. doi: 10.1016/j.bpobgyn.2018.10.003. Epub 2018 Oct 30.
Saraswat L, Rehman H, Omar MI, Cody JD, Aluko P, Glazener CM. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2020 Jan 28;1(1):CD001754. doi: 10.1002/14651858.CD001754.pub5.
Majaron B, Srinivas SM, Huang He, Nelson JS. Deep coagulation of dermal collagen with repetitive Er:YAG laser irradiation. Lasers Surg Med. 2000;26(2):215-22. doi: 10.1002/(sici)1096-9101(2000)26:23.0.co;2-o.
Greene D, Egbert BM, Utley DS, Koch RJ. In vivo model of histologic changes after treatment with the superpulsed CO(2) laser, erbium:YAG laser, and blended lasers: a 4- to 6-month prospective histologic and clinical study. Lasers Surg Med. 2000;27(4):362-72. doi: 10.1002/1096-9101(2000)27:43.0.co;2-h.
Vizintin Z, Lukac M, Kazic M, Tettamanti M. Erbium laser in gynecology. Climacteric. 2015;18 Suppl 1:4-8. doi: 10.3109/13697137.2015.1078668.
Okui N. Efficacy and safety of non-ablative vaginal erbium:YAG laser treatment as a novel surgical treatment for overactive bladder syndrome: comparison with anticholinergics and beta3-adrenoceptor agonists. World J Urol. 2019 Nov;37(11):2459-2466. doi: 10.1007/s00345-019-02644-7. Epub 2019 Jan 28.
Pergialiotis V, Prodromidou A, Perrea DN, Doumouchtsis SK. A systematic review on vaginal laser therapy for treating stress urinary incontinence: Do we have enough evidence? Int Urogynecol J. 2017 Oct;28(10):1445-1451. doi: 10.1007/s00192-017-3437-x. Epub 2017 Aug 2.
Shobeiri SA, Kerkhof MH, Minassian VA, Bazi T; IUGA Research and Development Committee. IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J. 2019 Mar;30(3):371-376. doi: 10.1007/s00192-018-3830-0. Epub 2018 Dec 6.
Fistonic I, Fistonic N. Baseline ICIQ-UI score, body mass index, age, average birth weight, and perineometry duration as promising predictors of the short-term efficacy of Er:YAG laser treatment in stress urinary incontinent women: A prospective cohort study. Lasers Surg Med. 2018 Jan 23. doi: 10.1002/lsm.22789. Online ahead of print.
Su CF, Chen GD, Tsai HJ. Preliminary outcome of non-ablative vaginal Erbium laser treatment for female stress and mixed urinary incontinence. Taiwan J Obstet Gynecol. 2019 Sep;58(5):610-613. doi: 10.1016/j.tjog.2019.07.006.
Ogrinc UB, Sencar S, Lenasi H. Novel minimally invasive laser treatment of urinary incontinence in women. Lasers Surg Med. 2015 Nov;47(9):689-97. doi: 10.1002/lsm.22416. Epub 2015 Sep 21.
Conte C, Jauffret T, Vieillefosse S, Hermieu JF, Deffieux X. Laser procedure for female urinary stress incontinence: A review of the literature. Prog Urol. 2017 Dec;27(17):1076-1083. doi: 10.1016/j.purol.2017.09.003. Epub 2017 Oct 21.
Lin KL, Chou SH, Long CY. Effect of Er:YAG Laser for Women with Stress Urinary Incontinence. Biomed Res Int. 2019 Jan 15;2019:7915813. doi: 10.1155/2019/7915813. eCollection 2019.
Gambacciani M, Torelli MG, Martella L, Bracco GL, Casagrande AG, Albertin E, Tabanelli S, Viglietta M, D'Ambrogio G, Garone G, Cervigni M. Rationale and design for the Vaginal Erbium Laser Academy Study (VELAS): an international multicenter observational study on genitourinary syndrome of menopause and stress urinary incontinence. Climacteric. 2015;18 Suppl 1:43-8. doi: 10.3109/13697137.2015.1071608.
Lin YH, Hsieh WC, Huang L, Liang CC. Effect of non-ablative laser treatment on overactive bladder symptoms, urinary incontinence and sexual function in women with urodynamic stress incontinence. Taiwan J Obstet Gynecol. 2017 Dec;56(6):815-820. doi: 10.1016/j.tjog.2017.10.020.
Lin HY, Tsai HW, Tsui KH, An YF, Lo CC, Lin ZH, Liou WS, Wang PH. The short-term outcome of laser in the management of female pelvic floor disorders: Focus on stress urine incontinence and sexual dysfunction. Taiwan J Obstet Gynecol. 2018 Dec;57(6):825-829. doi: 10.1016/j.tjog.2018.10.010.
Other Identifiers
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0379-20-RMB-CTIL
Identifier Type: -
Identifier Source: org_study_id
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