Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

Necmettin Erbakan University

Status: Invitation-only

Conditions: Pelvic Floor Muscle Exercise; Stress Urinary Incontinence (SUI); Laser Therapy; Urinary Incontinence (UI)

Treatments: Behavioral: PFME+Laser Therapy; Behavioral: PFMT Group; Other: Plasebo Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT07319247

hlaser

Details and patient eligibility

About

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 10 weeks under the supervision of a physiotherapist. PFMT will be administered with biofeedback. HFMT will be applied to six points in the perineal region (2 minutes per point). 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).

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups, including a placebo group

PFME Group

Active Comparator group

Description:

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 seconds, and then slowly relax them. One set of pelvic floor muscle exercises consists of 10 fast contractions and 10 slow contractions. According to this program, pelvic floor exercises are performed in weeks 1-2, 2 sets in weeks 3-4, 4 sets in weeks 5-6, 8 sets in weeks 7-8, and 10 sets in weeks 8-12. Assessments will be conducted twice, baseline and post treatment (at 10 week).

Treatment:

Behavioral: PFMT Group

PFME+Laser

Active Comparator group

Description:

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 then slowly relax them. One set of pelvic floor muscle exercises consists of 10 fast contractions and 10 slow contractions. Assessments will be conducted twice, baseline and post treatment (at 10 weeks). Laser was also applied to this group. Laser application is applied to 6 points in the perineal area. Continue and biostimulatory mode, intensity 6W, energy density 120J/cm2. Application time is 2 minutes for each point, and a total of 6 sessions are applied 3 time.

Treatment:

Behavioral: PFME+Laser Therapy

Plasebo Laser

Placebo Comparator group

Description:

This group will only receive placebo laser treatment. The sound will be turned up as if the laser is being applied, but no warning will be given. The laser device will be aimed at 6 points in the perineal area without being plugged in. Assessments will be conducted twice, baseline and post treatment (at 10 weeks).

Treatment:

Other: Plasebo Laser