Urinary Stress IncontinenceNCT03301142
Study Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence
A study testing Laser and kinesiotherapy in people with Urinary Stress Incontinence, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Laser and kinesiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- Aug 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-menopausal women with stress urinary incontinence will be recruited for this study.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).
São Paulo, 05403-010
Lucilia C Fonseca, DR, 5511981839348, luciliacfonseca@gmail.com
FERNANDA BA GIARRETA
- Recruiting
Department of Gynecology and Obstetrics of the Clinicas Hospital of the (FMUSP).
São Paulo, 05403-010
Lucilia C Fonseca, DR, 5511981839348, luciliacfonseca@gmail.com
About this study
Official title: Randomized Trial Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence - a Pilot Study
The purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence
Read the detailed 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.
- Conditions
- Urinary Stress Incontinence
- Being tested
- Laser, kinesiotherapy
- Keywords
- urinary stress incontinence, urinary incontinence,stress, laser, physiotherapy, kinesiotherapy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserProcedure or surgery
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.
kinesiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Device laser | Experimental | treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20 Receives: Procedure: Laser |
| kinesiotherapy | Active comparator | with supervision twice a week for three months (n=20) Receives: Procedure: kinesiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of urinary loss
the urinary loss will be evaluated with the pad test
Measured: twelve months
Secondary outcomes (1)
improvement of pelvic floor strength
Functional evaluation of the pelvic floor with modified Oxford scale
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study startAug 2015
- Primary completionFeb 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucilia Carvalho da Fonseca, University of Sao Paulo General Hospital
- Investigators
- LUCILIA C FONSECA, Principal investigator, UNIVERSIDADE SÃO PAULO (USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301142
- Sponsor's protocol ID
- 13341
- Status last verified
- Nov 2017
- First submitted
- 10 Aug 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 3201169Subak 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.
PubMed 16582131Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47.
PubMed 16985862Herbison 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.
PubMed 23836411Gilpin 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.
PubMed 2923839Falconer C, Ekman G, Malmstrom A, Ulmsten U. Decreased collagen synthesis in stress-incontinent women. Obstet Gynecol. 1994 Oct;84(4):583-6.
PubMed 8090397Konstantinos 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.
PubMed 17136582Mouritsen L, Schiotz HA. Pro et contra pelvic floor exercises for female stress urinary incontinence. Acta Obstet Gynecol Scand. 2000 Dec;79(12):1043-5.
PubMed 11130084Fistonic 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.
PubMed 26861984Posten 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.
PubMed 15841638Bump 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.
PubMed 8694033Rodrigues 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.
PubMed 19347224Abrams 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.
PubMed 12559262Tamanini 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.
PubMed 12700842Souza 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.
PubMed 19506791
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence - a Pilot Study
- ClinicalTrials.gov ID
- NCT03301142
- Acronym / sponsor ID
- 13341
- Conditions
- Urinary Stress Incontinence
- Keywords
- urinary stress incontinence, urinary incontinence,stress, laser, physiotherapy, kinesiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device laser | Experimental | Procedure: Lasertreatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20 |
| kinesiotherapy | Active comparator | Procedure: kinesiotherapywith supervision twice a week for three months (n=20) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal women with stress urinary incontinence will be recruited for this study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserThe 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. | Procedure or surgery | Device laser |
| kinesiotherapyPatients 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. | Procedure or surgery | kinesiotherapy |
Primary outcome
Improvement of urinary loss
Time frame: twelve months
the urinary loss will be evaluated with the pad test
1 secondary outcome
improvement of pelvic floor strength
Time frame: twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Results publication: PubMed 3201169Abrams 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.
- Results publication: PubMed 16582131Subak 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.
- Results publication: PubMed 16985862Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47.
- Results publication: PubMed 23836411Herbison 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.
- Results publication: PubMed 2923839Gilpin 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.
- Results publication: PubMed 8090397Falconer C, Ekman G, Malmstrom A, Ulmsten U. Decreased collagen synthesis in stress-incontinent women. Obstet Gynecol. 1994 Oct;84(4):583-6.
- Results publication: PubMed 17136582Konstantinos 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.
- Results publication: PubMed 11130084Mouritsen L, Schiotz HA. Pro et contra pelvic floor exercises for female stress urinary incontinence. Acta Obstet Gynecol Scand. 2000 Dec;79(12):1043-5.
- Results publication: PubMed 26861984Fistonic 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.
- Results publication: PubMed 15841638Posten 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.
- Results publication: PubMed 8694033Bump 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.
- Results publication: PubMed 19347224Rodrigues 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LUCILIA C FONSECA principal investigator
UNIVERSIDADE SÃO PAULO (USP)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and kinesiotherapy in people with Urinary Stress Incontinence, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucilia C fonseca (5511981839348, LUCILIACFONSECA@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of urinary loss (time frame: twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03301142, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.