Advertisement

CO2 surgical laser for treatment of stress urinary incontinence in women: a randomized controlled trial

      Background

      Stress urinary incontinence is a common condition that can be treated conservatively and/or surgically. Given the risks of surgery, developing effective nonsurgical treatment options would be beneficial. Some studies have suggested that laser therapy may improve or cure stress urinary incontinence. However, there is a lack of sham-controlled randomized controlled trials to judge treatment efficacy.

      Objective

      This study aimed to compare the effects of CO2 vaginal laser vs sham therapy for treating stress urinary incontinence.

      Study Design

      This was a multicenter, participant-blinded, sham-controlled, parallel group (1:1) superiority randomized controlled trial performed in outpatient clinics in 2 hospitals. We included women aged 18 to 80 years with objective and subjective stress urinary incontinence. Participants had undertaken or declined supervised pelvic floor muscle training. Intervention was performed using a CO2 fractionated vaginal laser. Participants underwent 3 treatments, 4 weeks apart, with increasing energy and density settings. Sham treatment was performed using an identical technique with a deactivated pedal.
      The primary outcome was the subjective stress urinary incontinence rate (proportion with leak with cough, sneeze, or laughter) at 3 months after completion of treatment. Secondary outcomes included objective stress urinary incontinence, change in the disease-specific patient-reported outcomes, health-related quality of life, and adverse effects. Categorical outcomes were compared using the chi square test and continuous outcomes using analysis of covariance, adjusting for the baseline score.

      Results

      There were 52 participants who received laser and 49 who received sham treatment. One participant in each group withdrew from the study before the endpoint, and 2 participants in the laser group did not participate in the follow-up visits. Participant mean age was 53 (34–79) years. Mean body mass index was 26.1 (18.1–49.6); 90% were vaginally parous. At 3 months, there was no difference between the sham and active treatment arm in subjective stress urinary incontinence (46 [96%] vs 48 [98%]; relative risk, 0.98 [95% confidence interval, 0.91–1.05]; P=.55) or in objective stress urinary incontinence (37 [80%] vs 33 [80%]; relative risk, 0.99 [95% confidence interval, 0.81–1.23]; P=.995). Patient-reported outcomes and health-related quality of life were also comparable between the groups. Vaginal bleeding occurred in 3 participants after laser and 1 participant after sham treatment. Pain during treatment did not differ between laser and sham treatment.

      Conclusion

      We were unable to show an improvement in stress urinary incontinence after CO2 vaginal laser therapy compared with sham treatment.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Obstetrics & Gynecology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Milsom I.
        • Altman D.
        • Cartwright R.
        • et al.
        Epidemiology of urinary incontinence (UI) and other lower urinary tract symptoms (LUTS), pelvic organ prolapse (POP) and anal incontinence (AI).
        in: Abrams P. Cardozo L. Wagg A. Wein A. Incontinence 6th Edition. ICI-ICS. International Continence Society, Bristol, UK2017
        • Imamura M.
        • Williams K.
        • Wells M.
        • McGrother C.
        Lifestyle interventions for the treatment of urinary incontinence in adults.
        Cochrane Database Syst Rev. 2015; 12: CD003505
        • Dumoulin C.
        • Cacciari L.P.
        • Hay-Smith E.J.C.
        Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women.
        Cochrane Database Syst Rev. 2018; 10: CD005654
        • Ford A.A.
        • Rogerson L.
        • Cody J.D.
        • Aluko P.
        • Ogah J.A.
        Mid-urethral sling operations for stress urinary incontinence in women.
        Cochrane Database Syst Rev. 2017; 7: CD006375
        • Salvatore S.
        • Nappi R.E.
        • Zerbinati N.
        • et al.
        A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study.
        Climacteric. 2014; 17: 363-369
        • Robinson D.
        • Flint R.
        • Veit-Rubin N.
        • Araklitis G.
        • Cardozo L.
        Is there enough evidence to justify the use of laser and other thermal therapies in female lower urinary tract dysfunction? Report from the ICI-RS 2019.
        Neurourol Urodyn. 2020; 39: S140-S147
        • Krychman M.
        • Rowan C.G.
        • Allan B.B.
        • 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
        • Mackova K.
        • Mazzer A.M.
        • Mori Da Cunha M.
        • et al.
        Vaginal Er:YAG laser application in the menopausal ewe model: a randomised estrogen and sham-controlled trial.
        BJOG. 2021; 128: 1087-1096
        • Li F.G.
        • Maheux-Lacroix S.
        • Deans R.
        • et al.
        Effect of fractional carbon dioxide laser vs sham treatment on symptom severity in women with postmenopausal vaginal symptoms: a randomized clinical trial.
        JAMA. 2021; 326: 1381-1389
        • US Food and Drug Administration
        Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for ”vaginal rejuvenation”.
        (Available at:)
        • Lauterbach R.
        • Aharoni S.
        • Justman N.
        • Farago N.
        • Gruenwald I.
        • Lowenstein L.
        The efficacy and safety of a single maintenance laser treatment for stress urinary incontinence: a double-blinded randomized controlled trial.
        Int Urogynecol J. 2022; ([Epub ahead of print])
        • Seki A.S.
        • Bianchi-Ferraro A.M.H.M.
        • Fonseca E.S.M.
        • Sartori M.G.F.
        • Girão M.J.B.C.
        • Jarmy-Di Bella Z.I.K.
        CO 2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial.
        Int Urogynecol J. 2022; ([Epub ahead of print])
        • Alcalay M.
        • Ben Ami M.
        • Greenshpun A.
        • Hagay Z.
        • Schiff E.
        Fractional-pixel CO 2 laser treatment in patients with urodynamic stress urinary incontinence: 1-year follow-up.
        Lasers Surg Med. 2021; 53: 960-967
        • Behnia-Willison F.
        • Nguyen T.T.T.
        • Mohamadi B.
        • et al.
        Fractional CO 2 laser for treatment of stress urinary incontinence.
        Eur J Obstet Gynecol Reprod Biol X. 2019; 1100004
        • Fistonić N.
        • Fistonić I.
        • Lukanovič A.
        • Findri Guštek Š
        • Sorta Bilajac Turina I.
        • Franić D.
        First assessment of short-term efficacy of Er:YAG laser treatment on stress urinary incontinence in women: prospective cohort study.
        Climacteric. 2015; 18: 37-42
        • Kuszka A.
        • Gamper M.
        • Walser C.
        • Kociszewski J.
        • Viereck V.
        Erbium:YAG laser treatment of female stress urinary incontinence: midterm data.
        Int Urogynecol J. 2020; 31: 1859-1866
        • Okui N.
        Comparison between erbium-doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence.
        World J Urol. 2019; 37: 885-889
        • Reisenauer C.
        • Hartlieb S.
        • Schoenfisch B.
        • Brucker S.Y.
        • Neis F.
        Vaginal therapy of mild and moderate stress urinary incontinence using Er:YAG laser: a real treatment option.
        Arch Gynecol Obstet. 2019; 300: 1645-1650
        • Tien Y.W.
        • Hsiao S.M.
        • Lee C.N.
        • Lin H.H.
        Effects of laser procedure for female urodynamic stress incontinence on pad weight, urodynamics, and sexual function.
        Int Urogynecol J. 2017; 28: 469-476
        • Blaganje M.
        • Šćepanović D.
        • Žgur L.
        • Verdenik I.
        • Pajk F.
        • Lukanović A.
        Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: a randomized controlled trial.
        Eur J Obstet Gynecol Reprod Biol. 2018; 224: 153-158
        • Shobeiri S.A.
        • Kerkhof M.H.
        • Minassian V.A.
        • 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; 30: 371-376
        • Yalcin I.
        • Bump R.C.
        Validation of two global impression questionnaires for incontinence.
        Am J Obstet Gynecol. 2003; 189: 98-101
        • Avery K.
        • Donovan J.
        • Peters T.J.
        • 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
        • Jackson S.
        • Donovan J.
        • Brookes S.
        • Eckford S.
        • Swithinbank L.
        • Abrams P.
        The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing.
        Br J Urol. 1996; 77: 805-812
        • Uebersax J.S.
        • Wyman J.F.
        • Shumaker S.A.
        • McClish D.K.
        • Fantl J.A.
        Short forms to assess life quality and symptom distress for urinary incontinence in women: the incontinence impact questionnaire and the urogenital distress inventory. Continence Program for Women Research Group.
        Neurourol Urodyn. 1995; 14: 131-139
        • Rogers R.G.
        • Coates K.W.
        • Kammerer-Doak D.
        • Khalsa S.
        • Qualls C.
        A short form of the Pelvic Organ prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
        Int Urogynecol J Pelvic Floor Dysfunct. 2003; 14: 164-168
        • 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
        • 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. 2015; 34: 747-751
        • Skorupska K.
        • Grzybowska M.E.
        • Kubik-Komar A.
        • Rechberger T.
        • Miotla P.
        Identification of the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 cutoff scores in urinary incontinent women.
        Health Qual Life Outcomes. 2021; 19: 87
        • Savovic J.
        • Turner R.M.
        • Mawdsley D.
        • et al.
        Association between risk-of-bias assessments and results of randomized trials in Cochrane reviews: the ROBES meta-epidemiologic study.
        Am J Epidemiol. 2018; 187: 1113-1122
        • Tadir Y.
        • Gaspar A.
        • Lev-Sagie A.
        • et al.
        Light and energy based therapeutics for genitourinary syndrome of menopause: consensus and controversies.
        Lasers Surg Med. 2017; 49: 137-159
        • Franić D.
        • Fistonić I.
        • Franić-Ivanišević M.
        • Perdija Ž.
        • Križmarić M.
        Pixel CO 2 laser for the treatment of stress urinary incontinence: a prospective observational multicenter study.
        Lasers Surg Med. 2021; 53: 514-520
        • González Isaza P.
        • Jaguszewska K.
        • Cardona J.L.
        • Lukaszuk M.
        Long-term effect of thermoablative fractional CO 2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopause.
        Int Urogynecol J. 2018; 29: 211-215
        • Song S.
        • Budden A.
        • Short A.
        • Nesbitt-Hawes E.
        • Deans R.
        • Abbott J.
        The evidence for laser treatments to the vulvo-vagina: making sure we do not repeat past mistakes.
        Aust N Z J Obstet Gynaecol. 2018; 58: 148-162
        • Al-Badr A.
        • Alkhamis W.H.
        Laser vaginal tightening complications: report of three cases.
        Lasers Surg Med. 2019; 51: 757-759