Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence - Randomized Single Blind Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636749
• Other study ID #: 0379-20-RMB-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: October 22, 2022

Study information

• Verified date: March 2021
• Source: Rambam Health Care Campus
• Contact: Naama Farago, MD
• Phone: 972-509267806
• Email: n_farago[@]rmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment.

Description:

Examine the efficacy of vaginal Erbium laser treatment for stress urinary incontinence (SUI) in compare to placebo.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 22, 2022
• Est. primary completion date: October 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

women above 18 with SUI -

Exclusion Criteria:

1. Recurrent pelvic inflammatory disease

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 -

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Erbium laser
Vaginal laser therapy
• Sham laser
Sham laser therapy

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (20)

Cervigni M, Gambacciani M. Female urinary stress incontinence. Climacteric. 2015;18 Suppl 1:30-6. doi: 10.3109/13697137.2015.1090859. — View Citation

Conté 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. Review. — View Citation

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. Review. — View Citation

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. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 ß3-adrenoceptor agonists. World J Urol. 2019 Nov;37(11):2459-2466. doi: 10.1007/s00345-019-02644-7. Epub 2019 Jan 28. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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:CD001754. doi: 10.1002/14651858.CD001754.pub5. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough test	Results of full bladder cough test	From enrollment up to 12 months post treatment
Primary	Pad test	Results of 24 hour pad weighing test	From enrollment up to 12 months post treatment
Secondary	Urinary distress index 6	Results of Urinary distress index 6 questionnaire	From enrollment up to 12 months post treatment
Secondary	Female sexual function	Results of female sexual function index questionnaire	From enrollment up to 12 months post treatment
Secondary	Urinary incontinence and sexuality	Results of urinary incontinence and sexuality questionnaire	From enrollment up to 12 months post treatment