Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PFME and Laser Therapy, Plasebo Laser, PFME.
- Who it may be relevant to
- Registry conditions: Urinary Incontinence (UI), Laser Therapy, Stress Urinary Incontinence (SUI), Pelvic Floor Muscle Exercise. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of High-frequency Laser Therapy and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: A Plasebo Randomized Controlled Trial
Overview
The aim of this study was to investigate the effects of Pelvic Floor Muscle Training (PFMT) in addition to high-intensity laser therapy (HILT) on pelvic floor dysfunction, sexual dysfunction, and quality of life in women with stress urinary incontinence. Women with SUI will be randomly assigned to PFMT (Group I), Laser + PFMT (Group II), and placebo laser (Group III). PFMT will be administered twice weekly for 12 weeks under the supervision of a physiotherapist. PFMT will be administered with biofeedback. HILT will be applied to six points in the perineal region . The intensity will be 6W, the energy density will be 120J/cm2, and three sessions will be administered weekly for a total of six sessions. Women included in the study will be evaluated twice, at the beginning and at the end of the treatment, with the Incontinence Quality of Life Scale (I-QOL), Incontinence Severity Index (ISI), Female Sexual Function Scale-(FSFI), and Global Pelvic Floor Impact Questionnaire (GPTRA).
Interventions
- Behavioral PFME and Laser Therapy
PFMT, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation. During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles. The image of "turning the faucet off and on" is used to help patients better understand this exercise. During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 seconds, and t - Behavioral Plasebo Laser
This group will only receive placebo laser treatment. The ND: YAG laser system was configured identically, except for the addition of a metal shielding plate to the hand tool to block energy, which had no therapeutic effect, during treatment. The laser device will be aimed at 6 points in the perineal area . Assessments will be conducted twice, baseline and post treatment (at 12 weeks). - Behavioral PFME
In this training, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation. During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles. The image of "turning the faucet off and on" is used to help patients better understand this exercise. During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 se
Primary outcome measures
- Urinary incontinence severity [Time frame: baseline, post treatment (at 12 week)]
- The impact of urinary incontinence on quality of life [Time frame: baseline, post treatment (at 12 week)]
- pelvic floor dysfuntion severity [Time frame: baseline, post treatment (at 12 week)]
Secondary outcome measures (2)
- Sexually Dysfunction [Time frame: baseline, post treatment (at 12 week)]
- pelvic floor muscle function [Time frame: baseline, post treatment (at 12 week)]
Eligibility criteria
Inclusion criteria
- Women aged 18-65,
- Women who are volunteers and committed to work,
- Women diagnosed with stress urinary incontinence,
Exclusion criteria
- Pregnancy,
- Previous surgery in the treatment area within 12 months,
- Active genital infection,
- Presence of malignancy,
- Systemic steroid use in the last 3 months,
- Use of vaginal lubricant within the last 7 days,
- Recurrent urinary tract or genital herpes,
- POP-Q score 3 or higher
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Physical Therapy Hospital — Meram
Identifiers
NCT: NCT07319247 · hlaser