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Comparative study between Laser therapy versus Pelvic Muscle Training in women with Stress Urinary Incontinence

CO2 Laser Therapy versus Urogynecology Physiotherapy in SUI : prospective randomized non inferiority study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4ckch8
Enrollment
Unknown
Registered
2020-01-07
Start date
2020-01-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Urinary Incontinence

Interventions

Ninety four women will be submitted to a urogynecology physical exam and will be paralell randomized controll open study into two groups of stress urinary incontinence treatment: 47 for urogynecol
E02.594

Sponsors

Faculdade de Ciência Médicas da Universidade Estadual de Campinas
Lead Sponsor
Clínica Condé
Collaborator
Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Women with 18 years old or over; with sintoms of Stress Urinary Incontinence - SUI; with positive effort test or valsalva manouver and/or urodynamics findings of Stress Urinary Incontinence - SUI and residual volume less than 100 ml or 20 % of voided volume superior 300ml; in case of women with a negative stress test with anamnesis suggesting Stress Urinary Incontinence , women with a positive urodynamic study for Stress Urinary Incontinence will be included

Exclusion criteria

Exclusion criteria: Women with overactive bladder; or urodynamic finding of detrusor overactivity; women with repetitive Urinary Tract Infection; woman with previous urogynecology surgeries; with previous treatment of radioterapy or Pelvic Organ Prolapse (POP) more than 2 years; women with previous and recently history of bladder stone; urinary fistula or divertíiculum

Design outcomes

Primary

MeasureTime frame
Primary outcome was the mean difference of ICIQ-SF(International Consultation on Incontinence Questionnaire - Short Form ) which allows us to qualify and quantify the urinary loss and to investigate its impact on the quality of life between laser and PFMT groups after 3 and 6 months.Improvement of stress urinary incontinence is expected through 3 sessions of vaginal laser theraphy application over a 12 week treatment period

Secondary

MeasureTime frame
Clinically evaluate through questionaires the main secondary outcomes were pelvic floor symptoms measured by the Pelvic Floor Impact Questionnaire (PFIQ) – 7;Evaluate the clinical conditions of women related to sexual activity, as well as female sexual function, through the validated Female Sexual Function Index (FSFI) questionnaire;Evaluate subjective post-intervention improvement using the Patient Global Impression of Improvement (PGI-I) questionnaire

Countries

Brazil

Contacts

Public ContactSamantha Rangel

Faculdade de Ciência Médicas da Universidade Estadual de Campinas

samanthaconderocha@gmail.com+5521 999346331

Outcome results

None listed

Source: REBEC (via WHO ICTRP)