Skip to main content
Top
Published in: Lasers in Medical Science 4/2016

Open Access 01-05-2016 | Original Article

Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women—a pilot study

Authors: Nikola Fistonić, Ivan Fistonić, Štefica Findri Guštek, Iva Sorta Bilajac Turina, Ingrid Marton, Zdenko Vižintin, Marko Kažič, Irena Hreljac, Tadej Perhavec, Matjaž Lukač

Published in: Lasers in Medical Science | Issue 4/2016

Login to get access

Abstract

The study presents an assessment of mechanism of action and a pilot clinical study of efficacy and safety of the Er:YAG laser for the treatment of stress urinary incontinence (SUI). The subject of this study is a treatment of SUI with a 2940 nm Er:YAG laser, operating in a special SMOOTH mode designed to increase temperature of the vaginal mucosa up to maximally 60–65 °C without ablating the epidermis. Numerical modelling of the temperature distribution within mucosa tissue following an irradiation with the SMOOTH mode Er:YAG laser was performed in order to determine the appropriate range of laser parameters. The laser treatment parameters were further confirmed by measuring in vivo temperatures of the vaginal mucosa using a thermal camera. To investigate the clinical efficacy and safety of the SMOOTH mode Er:YAG laser SUI treatment, a pilot clinical study was performed. The study recruited 31 female patients suffering from SUI. Follow-ups were scheduled at 1, 2, and 6 months post treatment. ICIQ-UI questionnaires were collected as a primary trial endpoint. Secondary endpoints included perineometry and residual urine volume measurements at baseline and all follow-ups. Thermal camera measurements have shown the optimal increase in temperature of the vaginal mucosa following treatment of SUI with a SMOOTH mode Er:YAG laser. Primary endpoint, the change in ICIQ-UI score, showed clinically relevant and statistically significant improvement after all follow-ups compared to baseline scores. There was also improvement in the secondary endpoints. Only mild and transient adverse events and no serious adverse events were reported. The results indicate that non-ablative Er:YAG laser therapy is a promising minimally invasive non-surgical option for treating women with SUI symptoms.
Literature
1.
go back to reference Abrams P, Cardozo L, Fall M et al (2002) The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 21:167–178CrossRefPubMed Abrams P, Cardozo L, Fall M et al (2002) The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 21:167–178CrossRefPubMed
2.
go back to reference Luber KM (2004) The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol 6(Suppl 3):S3–S9PubMedPubMedCentral Luber KM (2004) The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol 6(Suppl 3):S3–S9PubMedPubMedCentral
4.
go back to reference Holroyd-Leduc JM, Straus SE (2004) Management of urinary incontinence in women. J Am Med Assoc 291:986–995CrossRef Holroyd-Leduc JM, Straus SE (2004) Management of urinary incontinence in women. J Am Med Assoc 291:986–995CrossRef
5.
go back to reference Ulmsten U, Falconer C, Johnson P et al (1998) A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 9:210–213. doi:10.1007/BF01901606 CrossRefPubMed Ulmsten U, Falconer C, Johnson P et al (1998) A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 9:210–213. doi:10.​1007/​BF01901606 CrossRefPubMed
6.
go back to reference Delorme E, Droupy S, de Tayrac R, Delmas V (2004) Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol 45:203–207CrossRefPubMed Delorme E, Droupy S, de Tayrac R, Delmas V (2004) Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol 45:203–207CrossRefPubMed
7.
10.
go back to reference El-Domyati M, Abd-El-Raheem T, Medhat W et al (2014) Multiple fractional erbium: yttrium-aluminum-garnet laser sessions for upper facial rejuvenation: clinical and histological implications and expectations. J Cosmet Dermatol 13:30–37. doi:10.1111/jocd.12079 CrossRefPubMed El-Domyati M, Abd-El-Raheem T, Medhat W et al (2014) Multiple fractional erbium: yttrium-aluminum-garnet laser sessions for upper facial rejuvenation: clinical and histological implications and expectations. J Cosmet Dermatol 13:30–37. doi:10.​1111/​jocd.​12079 CrossRefPubMed
11.
go back to reference Dumoulin C, Hay-Smith J (2010) Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev CD005654. doi: 10.1002/14651858.CD005654.pub2 Dumoulin C, Hay-Smith J (2010) Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev CD005654. doi: 10.​1002/​14651858.​CD005654.​pub2
12.
go back to reference Rechberger T, Postawski K, Jakowicki JA et al (1998) Role of fascial collagen in stress urinary incontinence. Am J Obstet Gynecol 179:1511–1514CrossRefPubMed Rechberger T, Postawski K, Jakowicki JA et al (1998) Role of fascial collagen in stress urinary incontinence. Am J Obstet Gynecol 179:1511–1514CrossRefPubMed
13.
go back to reference Keane DP, Sims TJ, Abrams P, Bailey AJ (1997) Analysis of collagen status in premenopausal nulliparous women with genuine stress incontinence. Br J Obstet Gynaecol 104:994–998CrossRefPubMed Keane DP, Sims TJ, Abrams P, Bailey AJ (1997) Analysis of collagen status in premenopausal nulliparous women with genuine stress incontinence. Br J Obstet Gynaecol 104:994–998CrossRefPubMed
14.
go back to reference Crivellaro S, Smith JJ (2009) Minimally invasive therapies for female stress urinary incontinence: the current status of bioinjectables/new devices (adjustable continence therapy, urethral submucosal collagen denaturation by radiofrequency). ScientificWorldJournal 9:466–478. doi:10.1100/tsw.2009.53 CrossRefPubMed Crivellaro S, Smith JJ (2009) Minimally invasive therapies for female stress urinary incontinence: the current status of bioinjectables/new devices (adjustable continence therapy, urethral submucosal collagen denaturation by radiofrequency). ScientificWorldJournal 9:466–478. doi:10.​1100/​tsw.​2009.​53 CrossRefPubMed
16.
go back to reference Shamliyan TA, Kane RL, Wyman J, Wilt TJ (2008) Annals of Internal Medicine NIH Conference Systematic Review : randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. 148:1–15 Shamliyan TA, Kane RL, Wyman J, Wilt TJ (2008) Annals of Internal Medicine NIH Conference Systematic Review : randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. 148:1–15
17.
go back to reference Elser DM, Mitchell GK, Miklos JR et al (2010) Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol Urodyn 29:1424–1428. doi:10.1002/nau.20875 CrossRefPubMed Elser DM, Mitchell GK, Miklos JR et al (2010) Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol Urodyn 29:1424–1428. doi:10.​1002/​nau.​20875 CrossRefPubMed
18.
go back to reference Majaron B, Plestenjak P, Lukač M (1999) Thermo-mechanical laser ablation of soft biological tissue: modeling the micro-explosions. Appl Phys B Lasers Opt 69:71–80. doi:10.1007/s003400050772 Majaron B, Plestenjak P, Lukač M (1999) Thermo-mechanical laser ablation of soft biological tissue: modeling the micro-explosions. Appl Phys B Lasers Opt 69:71–80. doi:10.​1007/​s003400050772
19.
go back to reference Shori RK, Walston AA, Stafsudd OM et al (2001) Quantification and modeling of the dynamic changes in the absorption coefficient of water at λ = 2.94 μm. IEEE J Sel Top Quantum Electron 7:959–970. doi:10.1109/2944.983300 CrossRef Shori RK, Walston AA, Stafsudd OM et al (2001) Quantification and modeling of the dynamic changes in the absorption coefficient of water at λ = 2.94 μm. IEEE J Sel Top Quantum Electron 7:959–970. doi:10.​1109/​2944.​983300 CrossRef
21.
go back to reference Patankar S (1980) Numerical heat transfer and fluid flow. CRC Press, USA Patankar S (1980) Numerical heat transfer and fluid flow. CRC Press, USA
22.
go back to reference Klovning A, Avery K, Sandvik H, Hunskaar S (2009) Comparison of two questionnaires for assessing the severity of urinary incontinence: the ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn 28:411–415. doi:10.1002/nau.20674 CrossRefPubMed Klovning A, Avery K, Sandvik H, Hunskaar S (2009) Comparison of two questionnaires for assessing the severity of urinary incontinence: the ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn 28:411–415. doi:10.​1002/​nau.​20674 CrossRefPubMed
23.
go back to reference Wood VT, Pinfildi CE, Neves MAI et al (2010) Collagen changes and realignment induced by low-level laser therapy and low-intensity ultrasound in the calcaneal tendon. Lasers Surg Med 42:559–565. doi:10.1002/lsm.20932 CrossRefPubMed Wood VT, Pinfildi CE, Neves MAI et al (2010) Collagen changes and realignment induced by low-level laser therapy and low-intensity ultrasound in the calcaneal tendon. Lasers Surg Med 42:559–565. doi:10.​1002/​lsm.​20932 CrossRefPubMed
24.
go back to reference Lukac M, Perhavec T, Nemes K, Ahcan U (2010) Ablation and thermal depths in VSP Er:YAG laser skin resurfacing. J Laser Health Acad 1:56–71 Lukac M, Perhavec T, Nemes K, Ahcan U (2010) Ablation and thermal depths in VSP Er:YAG laser skin resurfacing. J Laser Health Acad 1:56–71
27.
go back to reference Majaron B, Srinivas SM, Huang HL (2000) Deep coagulation of dermal collagen with repetitive Er:YAG laser irradiation. Lasers Surg Med 26:215–222CrossRefPubMed Majaron B, Srinivas SM, Huang HL (2000) Deep coagulation of dermal collagen with repetitive Er:YAG laser irradiation. Lasers Surg Med 26:215–222CrossRefPubMed
29.
go back to reference Trelles MA, Vélez M, Mordon S (2008) Correlation of histological findings of single session Er:YAG skin fractional resurfacing with various passes and energies and the possible clinical implications. Lasers Surg Med 40:171–177. doi:10.1002/lsm.20607 CrossRefPubMed Trelles MA, Vélez M, Mordon S (2008) Correlation of histological findings of single session Er:YAG skin fractional resurfacing with various passes and energies and the possible clinical implications. Lasers Surg Med 40:171–177. doi:10.​1002/​lsm.​20607 CrossRefPubMed
30.
go back to reference Nyström E, Sjöström M, Stenlund H, Samuelsson E (2014) ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn. doi:10.1002/nau.22657 PubMed Nyström E, Sjöström M, Stenlund H, Samuelsson E (2014) ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn. doi:10.​1002/​nau.​22657 PubMed
31.
go back to reference Fistonic I, Findri-Gustek S, Fistonic N (2012) Minimally invasive laser procedure for early stages of stress urinary incontinence (SUI). J Laser Health Acad 1:67–74 Fistonic I, Findri-Gustek S, Fistonic N (2012) Minimally invasive laser procedure for early stages of stress urinary incontinence (SUI). J Laser Health Acad 1:67–74
32.
go back to reference Vizintin Z, Rivera M, Fistonić I et al (2012) Novel minimally invasive VSP Er:YAG laser treatments in gynecology. J Laser Health Acad 1:46–58 Vizintin Z, Rivera M, Fistonić I et al (2012) Novel minimally invasive VSP Er:YAG laser treatments in gynecology. J Laser Health Acad 1:46–58
Metadata
Title
Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women—a pilot study
Authors
Nikola Fistonić
Ivan Fistonić
Štefica Findri Guštek
Iva Sorta Bilajac Turina
Ingrid Marton
Zdenko Vižintin
Marko Kažič
Irena Hreljac
Tadej Perhavec
Matjaž Lukač
Publication date
01-05-2016
Publisher
Springer London
Published in
Lasers in Medical Science / Issue 4/2016
Print ISSN: 0268-8921
Electronic ISSN: 1435-604X
DOI
https://doi.org/10.1007/s10103-016-1884-0

Other articles of this Issue 4/2016

Lasers in Medical Science 4/2016 Go to the issue