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

Urinary Stress Incontinence Clinical Trial

Official title:

Randomized Trial Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03301142
• Other study ID #: 13341
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2016
• Last updated: November 3, 2017
• Start date: August 2015
• Est. completion date: July 2018

Study information

• Verified date: November 2017
• Source: University of Sao Paulo General Hospital
• Contact: Lucilia C fonseca
• Phone: 5511981839348
• Email: LUCILIACFONSECA[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

the objective of this project is to compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence. A randomized controlled clinical trial is proposed involving 40 women diagnosed with stress urinary incontinence randomized into two groups: 1) treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20); 2) treatment with kinesiotherapy for three months with supervision twice a week (n=20). At baseline assessment, patients shall undergo anamnesis, general physical and gynecological exam, assessments of the pelvic floor based on the modified Oxford scale and of the presence of prolapse using the Pelvic Organ Prolapse Quantification (POP-Q) system. The following exams shall also be performed: Type 1 urine, urine culture, urodynamic study and 1-hour Pad test. Participants shall complete both the King's Health Questionnaire and Incontinence Quality of Life Questionnaire (IQOL). Post-treatment, patients will be assessed during follow-up visits at 1, 3, 6 and 12 months by physical exam and application of the questionnaires. The Pad test will be re-administered at 6 and 12 months. Data will be grouped and statistically assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Laser
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.
• kinesiotherapy
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.

Locations

Country	Name	City	State
Brazil	Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).	São Paulo
Brazil	Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (15)

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. — View Citation

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 — View Citation

Bump RC, Mattiasson A, Bø 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. — View Citation

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

Fistonic N, Fistonic I, Guštek ŠF, Turina IS, Marton I, Vižintin Z, Kažic 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 — View Citation

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. — View Citation

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

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. Epub 2006 Nov 29. Review. — View Citation

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

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. Review. — View Citation

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

Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3:S29-47. — View Citation

Souza CC, Rodrigues AM, Ferreira CE, Fonseca ES, di Bella ZI, Girão 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. do — View Citation

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. — View Citation

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. Epub 2003 Apr 4. Portuguese. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	impact in the quality of life	the impact in the quality of life will be evaluated with the quality of life questionnaires ( King's Health Questionnaire and IQOL quality of life questionnaires).	twelve months
Primary	Improvement of urinary loss	the urinary loss will be evaluated with the pad test	twelve months
Secondary	improvement of pelvic floor strength	Functional evaluation of the pelvic floor with modified Oxford scale	twelve months