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

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

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.

Keywords: Er:YAG laser; Minimally invasive SUI therapy; Stress urinary incontinence.

Figures

Fig 1
Fig 1
a Calculated temperature on the tissue surface following laser treatment with the PS03 handpiece for two different SMOOTH mode fluences (6 and 10 J/cm2) and with the R11 handpiece (fluence = 3 J/cm2), as a function of the number of consecutively delivered SMOOTH mode pulses. b Calculated normalized temperature change distribution in relation to depth below tissue surface following laser irradiation as a function of the number of consecutively delivered SMOOTH mode Er:YAG pulses using the handpiece PS03 at a SMOOTH mode pulse fluence of 10 J/cm2
Fig. 2
Fig. 2
a An example of the measured temperature development on the introitus mucous tissue during four consecutively delivered SMOOTH mode Er:YAG (Fotona Dynamis XS) laser pulses (PS03 handpiece, SMOOTH mode pulse fluence: 3 J/cm2, total fluence delivered: 4 × 3 J/cm2 = 12 J/cm2). b Measured temperature on the introitus mucosa following laser treatment with the PS03 handpiece for two different SMOOTH mode fluences (6 and 10 J/cm2) and with the R11 handpiece (fluence = 3 J/cm2), as a function of the number of consecutively delivered SMOOTH mode pulses
Fig. 3
Fig. 3
Mean scores from the ICIQ-UI questionnaire, which was the primary effectiveness endpoint, at baseline, and at 1, 2, and 6 months after treatment. Circles represent all patients that have participated in the measurement at each follow-up. * comparison test—***p < 0.001; **p < 0.01; *p < 0.05

References

    1. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21:167–178. doi: 10.1002/nau.10052.
    1. Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6(Suppl 3):S3–S9.
    1. Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6(Suppl 3):S29–S47.
    1. Holroyd-Leduc JM, Straus SE. Management of urinary incontinence in women. J Am Med Assoc. 2004;291:986–995. doi: 10.1001/jama.291.8.986.
    1. Ulmsten U, Falconer C, Johnson P, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:210–213. doi: 10.1007/BF01901606.
    1. Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol. 2004;45:203–207. doi: 10.1016/j.eururo.2003.12.001.
    1. Shaker H, Alokda A, Mahmoud H. The Twister laser fiber degradation and tissue ablation capability during 980-nm high-power diode laser ablation of the prostate. A randomized study versus the standard side-firing fiber. Lasers Med Sci. 2012;27:959–963. doi: 10.1007/s10103-011-1017-8.
    1. Chapple CR, Raz S, Brubaker L, Zimmern PE. Mesh sling in an era of uncertainty: lessons learned and the way forward. Eur Urol. 2013;64:525–529. doi: 10.1016/j.eururo.2013.06.045.
    1. Liu H, Dang Y, Wang Z, et al. Laser induced collagen remodeling: a comparative study in vivo on mouse model. Lasers Surg Med. 2008;40:13–19. doi: 10.1002/lsm.20587.
    1. El-Domyati M, Abd-El-Raheem T, Medhat W, et al. Multiple fractional erbium: yttrium-aluminum-garnet laser sessions for upper facial rejuvenation: clinical and histological implications and expectations. J Cosmet Dermatol. 2014;13:30–37. doi: 10.1111/jocd.12079.
    1. 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
    1. Rechberger T, Postawski K, Jakowicki JA, et al. Role of fascial collagen in stress urinary incontinence. Am J Obstet Gynecol. 1998;179:1511–1514. doi: 10.1016/S0002-9378(98)70017-1.
    1. Keane DP, Sims TJ, Abrams P, Bailey AJ. Analysis of collagen status in premenopausal nulliparous women with genuine stress incontinence. Br J Obstet Gynaecol. 1997;104:994–998. doi: 10.1111/j.1471-0528.1997.tb12055.x.
    1. Crivellaro S, Smith JJ. 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. 2009;9:466–478. doi: 10.1100/tsw.2009.53.
    1. Davila GW. Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durability. Adv Urol. 2011;2011:176498. doi: 10.1155/2011/176498.
    1. 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
    1. Elser DM, Mitchell GK, Miklos JR, et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol Urodyn. 2010;29:1424–1428. doi: 10.1002/nau.20875.
    1. 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
    1. Shori RK, Walston AA, Stafsudd OM, et al. Quantification and modeling of the dynamic changes in the absorption coefficient of water at λ = 2.94 μm. IEEE J Sel Top Quantum Electron. 2001;7:959–970. doi: 10.1109/2944.983300.
    1. Xu F, Lu TJ, Seffen KA. Biothermomechanical behavior of skin tissue. Acta Mech Sin. 2008;24:1–23. doi: 10.1007/s10409-007-0128-8.
    1. Patankar S. Numerical heat transfer and fluid flow. USA: CRC Press; 1980.
    1. Klovning A, Avery K, Sandvik H, Hunskaar S. Comparison of two questionnaires for assessing the severity of urinary incontinence: the ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn. 2009;28:411–415. doi: 10.1002/nau.20674.
    1. Wood VT, Pinfildi CE, Neves MAI, et al. Collagen changes and realignment induced by low-level laser therapy and low-intensity ultrasound in the calcaneal tendon. Lasers Surg Med. 2010;42:559–565. doi: 10.1002/lsm.20932.
    1. Lukac M, Perhavec T, Nemes K, Ahcan U. Ablation and thermal depths in VSP Er:YAG laser skin resurfacing. J Laser Health Acad. 2010;1:56–71.
    1. Kunzi-Rapp K, Dierickx CC, Cambier B, Drosner M. Minimally invasive skin rejuvenation with erbium: YAG laser used in thermal mode. Lasers Surg Med. 2006;38:899–907. doi: 10.1002/lsm.20380.
    1. Drnovsek-Olup B, Beltram M, Pizem J. Repetitive Er:YAG laser irradiation of human skin: a histological evaluation. Lasers Surg Med. 2004;35:146–151. doi: 10.1002/lsm.20080.
    1. Majaron B, Srinivas SM, Huang HL. Deep coagulation of dermal collagen with repetitive Er:YAG laser irradiation. Lasers Surg Med. 2000;26:215–222. doi: 10.1002/(SICI)1096-9101(2000)26:2<215::AID-LSM13>;2-O.
    1. Dierickx CC, Khatri KA, Tannous ZS, et al. Micro-fractional ablative skin resurfacing with two novel erbium laser systems. Lasers Surg Med. 2008;40:113–123. doi: 10.1002/lsm.20601.
    1. Trelles MA, Vélez M, Mordon S. 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. 2008;40:171–177. doi: 10.1002/lsm.20607.
    1. Nyström E, Sjöström M, Stenlund H, Samuelsson E. ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn. 2014
    1. Fistonic I, Findri-Gustek S, Fistonic N. Minimally invasive laser procedure for early stages of stress urinary incontinence (SUI) J Laser Health Acad. 2012;1:67–74.
    1. Vizintin Z, Rivera M, Fistonić I, et al. Novel minimally invasive VSP Er:YAG laser treatments in gynecology. J Laser Health Acad. 2012;1:46–58.
    1. Gaspar A, Addamo G, Brandi H. Vaginal fractional CO 2 laser: a minimally invasive option for vaginal rejuvenation. Am J Cosmet Surg. 2011;28:156–162. doi: 10.5992/0748-8068-28.3.156.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅