Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device laser | Experimental | treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20 |
|
| kinesiotherapy | Active Comparator | with supervision twice a week for three months (n=20) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of urinary loss | the urinary loss will be evaluated with the pad test | twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of pelvic floor strength | Functional evaluation of the pelvic floor with modified Oxford scale | twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucilia C fonseca | Contact | 5511981839348 | LUCILIACFONSECA@GMAIL.COM | |
| JORGE M HADDAD, PHD | Contact | 5511930712843 | JORGE_MILHEMH@UOL.COM.BR |
| Name | Affiliation | Role |
|---|---|---|
| LUCILIA C FONSECA | UNIVERSIDADE SÃO PAULO (USP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP). | Recruiting | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3201169 | Result | 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. | |
| 16582131 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP). | Recruiting | São Paulo | 05403-010 | Brazil |
|
| 16985862 | Result | Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47. |
| 23836411 | 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. |
| 2923839 | 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. |
| 8090397 | Result | Falconer C, Ekman G, Malmstrom A, Ulmsten U. Decreased collagen synthesis in stress-incontinent women. Obstet Gynecol. 1994 Oct;84(4):583-6. |
| 17136582 | 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. |
| 11130084 | 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. |
| 26861984 | 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. |
| 15841638 | 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. |
| 8694033 | 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. |
| 19347224 | 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. |
| 12559262 | 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. |
| 12700842 | 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. |
| 19506791 | 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. |
| 40709601 | Derived | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |