Study Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence

NCT03301142 | Unknown DMC

• 1 other identifier: 13341
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence

Conditions

Urinary Stress Incontinence

Keywords

urinary stress incontinence; urinary incontinence,stress; laser; physiotherapy; kinesiotherapy

Outcome Measures

Primary Outcomes (1)

• Improvement of urinary loss

  the urinary loss will be evaluated with the pad test

  twelve months

Secondary Outcomes (1)

• improvement of pelvic floor strength

  twelve months

Other Outcomes (1)

• impact in the quality of life

  twelve months

Study Arms (2)

Device laser

EXPERIMENTAL

treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20

Procedure: Laser

kinesiotherapy

ACTIVE COMPARATOR

with supervision twice a week for three months (n=20)

Procedure: kinesiotherapy

Interventions

Laser PROCEDURE

The patients will be submitted to application of the Erbium Laser: YAG(yttrium aluminium garnet) 2940nm, SMOOTH mode developed by FOTONA.The vaginal canal will be accessed using a specific speculum. The 90 degree laser tip shall be used to perform 4 applications to the anterior and lateral vaginal wall at each of the 5 clock points (9,10:30,12,1:30,3 'o´-clock´), commencing at the back of the vagina, retracting in increments of 0.5cm, where 4 shots are made at each interval up to a distance 1cm short of the external opening of the urethra. After completion of this stage, the 90 degree tip shall be switched for the 360 degree tip, whereupon 4 additional applications shall be performed with 4 shots every 0.5 cm along the vaginal trajectory outlined above.

Device laser

kinesiotherapy PROCEDURE

Patients will be guided by the physiotherapist to perform exercises to strengthen the pelvic floor muscles at home on a daily basis in the supine position with an empty bladder. It will be performed 10 repetitions of five-second contractions, the 15 three-second contractions; 20 two seconds contractions; 20 contractions of a second; 5 repetitions of strong contractions while coughing; 10 repetitions of exercise "bridge" associated with pelvic floor contraction and relaxation up in descending.The level of difficulty in performing the exercises will be determined in accordance with the adopted position. In .changes position should be held every four sessions.

kinesiotherapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women with stress urinary incontinence will be recruited for this study.

You may not qualify if:

• Patients presenting detrusor hyperactivity,stress urinary incontinence with sphincter deficiency genital prolapse, stages 3 and 4 on the POP-Q system, genital cancer, history of painful bladder syndrome, previous history of radiotherapy, keloid, use of photosensitive drugs, uncontrolled diabetes mellitus, active vaginal infection (bacterial vaginosis and candidiasis), abnormal genital bleeding or vaginal stenosis shall be excluded.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).

São Paulo, 05403-010, Brazil

RECRUITING

Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).

São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (16)

• Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardisation of terminology of lower urinary tract function. The International Continence Society Committee on Standardisation of Terminology. Scand J Urol Nephrol Suppl. 1988;114:5-19. No abstract available.

  PMID: 3201169 RESULT

• Subak LL, Brown JS, Kraus SR, Brubaker L, Lin F, Richter HE, Bradley CS, Grady D; Diagnostic Aspects of Incontinence Study Group. The "costs" of urinary incontinence for women. Obstet Gynecol. 2006 Apr;107(4):908-16. doi: 10.1097/01.AOG.0000206213.48334.09.

  PMID: 16582131 RESULT

• Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47.

  PMID: 16985862 RESULT

• Herbison GP, Dean N. Weighted vaginal cones for urinary incontinence. Cochrane Database Syst Rev. 2013 Jul 8;2013(7):CD002114. doi: 10.1002/14651858.CD002114.pub2.

  PMID: 23836411 RESULT

• Gilpin SA, Gosling JA, Smith AR, Warrell DW. The pathogenesis of genitourinary prolapse and stress incontinence of urine. A histological and histochemical study. Br J Obstet Gynaecol. 1989 Jan;96(1):15-23. doi: 10.1111/j.1471-0528.1989.tb01570.x.

  PMID: 2923839 RESULT

• Falconer C, Ekman G, Malmstrom A, Ulmsten U. Decreased collagen synthesis in stress-incontinent women. Obstet Gynecol. 1994 Oct;84(4):583-6.

  PMID: 8090397 RESULT

• Konstantinos H, Eleni K, Dimitrios H. Dilemmas in the management of female stress incontinence: the role of pelvic floor muscle training. Int Urol Nephrol. 2006;38(3-4):513-25. doi: 10.1007/s11255-006-0085-3. Epub 2006 Nov 29.

  PMID: 17136582 RESULT

• Mouritsen L, Schiotz HA. Pro et contra pelvic floor exercises for female stress urinary incontinence. Acta Obstet Gynecol Scand. 2000 Dec;79(12):1043-5.

  PMID: 11130084 RESULT

• Fistonic N, Fistonic I, Gustek SF, Turina IS, Marton I, Vizintin Z, Kazic M, Hreljac I, Perhavec T, Lukac M. Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women--a pilot study. Lasers Med Sci. 2016 May;31(4):635-43. doi: 10.1007/s10103-016-1884-0. Epub 2016 Feb 9.

  PMID: 26861984 RESULT

• Posten W, Wrone DA, Dover JS, Arndt KA, Silapunt S, Alam M. Low-level laser therapy for wound healing: mechanism and efficacy. Dermatol Surg. 2005 Mar;31(3):334-40. doi: 10.1111/j.1524-4725.2005.31086.

  PMID: 15841638 RESULT

• Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.

  PMID: 8694033 RESULT

• Rodrigues AM, de Oliveira LM, Martins Kde F, Del Roy CA, Sartori MG, Girao MJ, Castro Rde A. [Risk factors for genital prolapse in a Brazilian population]. Rev Bras Ginecol Obstet. 2009 Jan;31(1):17-21. doi: 10.1590/s0100-72032009000100004. Portuguese.

  PMID: 19347224 RESULT

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.

  PMID: 12559262 RESULT

• Tamanini JT, D'Ancona CA, Botega NJ, Rodrigues Netto N Jr. [Validation of the Portuguese version of the King's Health Questionnaire for urinary incontinent women]. Rev Saude Publica. 2003 Apr;37(2):203-11. doi: 10.1590/s0034-89102003000200007. Epub 2003 Apr 4. Portuguese.

  PMID: 12700842 RESULT

• Souza CC, Rodrigues AM, Ferreira CE, Fonseca ES, di Bella ZI, Girao MJ, Sartori MG, Castro RA. Portuguese validation of the Urinary Incontinence-Specific Quality-of-Life Instrument: I-QOL. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1183-9. doi: 10.1007/s00192-009-0916-8. Epub 2009 Jun 9.

  PMID: 19506791 RESULT

• Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.

  PMID: 40709601 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Lasers

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• LUCILIA C FONSECA

  UNIVERSIDADE SÃO PAULO (USP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucilia C fonseca

CONTACT

5511981839348; LUCILIACFONSECA@GMAIL.COM

JORGE M HADDAD, PHD

CONTACT

5511930712843; JORGE_MILHEMH@UOL.COM.BR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: October 4, 2017
• Study Start: August 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)