Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

The Effect of High-frequency Laser Therapy and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: A Plasebo Randomized Controlled Trial

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Laser Therapy; Pelvic Floor Muscle Exercise; Stress Urinary Incontinence (SUI); Urinary Incontinence (UI)
• Intervention / Treatment: Behavioral: PFME+Laser Therapy; Other: Plasebo Laser; Behavioral: PFMT Group

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konya
    • Meram, Konya, Turkey (Türkiye), (507) 534-6142
      • Physical Therapy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PFME Group; 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).	Behavioral: PFMT Group; 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).
Placebo Comparator: Plasebo Laser; 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).	Other: Plasebo Laser; The laser device will be held on 6 points in the perineal area for the same period of time without being plugged in.; Other Names: PFME; Laser+PFME
Active Comparator: PFME+Laser; 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.	Behavioral: PFME+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 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, in weeks 3-4, in weeks 5-6, in weeks 8-12, and in weeks 10. 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; Other Names: PFME; Plasebo Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary incontinence severity	The Incontinence Severity Index (ISI): This is a two-question questionnaire that helps calculate the severity of urinary incontinence in patients. It categorizes incontinence severity into three groups: mild, moderate, and severe. It is a useful method for monitoring and assessing incontinence severity.	baseline, post treatment (at 10 week)
The impact of urinary incontinence on quality of life	The Incontinence Quality of Life Scale (I-QOL) will be used to determine the impact of urinary incontinence on quality of life in women. It consists of questions under three headings: behavioral, psychological, and social impact. The questions will be asked of the participants and recorded.	baseline, post treatment (at 10 week)
pelvic floor dysfuntion severity	The Global Pelvic Floor Impact Questionnaire (GPTRA): This questionnaire consists of nine questions addressing pelvic floor dysfunction. A higher total score indicates a greater degree of symptoms. Participants were asked questions and recorded.	baseline, post treatment (at 10 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexually Dysfunction	The Female Sexual Function Index (FSFI): It consists of nineteen separate questions. It has six subscales: desire, arousal, lubrication, orgasm, general satisfaction, and pain. Questions 3-14 and 15-19 are scored on a 6-point Likert-type scale (0-5), while the remaining questions are scored on a 5-point Likert-type scale (1-5). The scale, which can be applied to those who have had sexual intercourse within the last month, is scored negatively, with higher scores interpreted as indicating no or low sexual dysfunction. The highest possible score is 36.0, and the lowest is 2.0. The cut-off score is 26.55. Scores of 26.55 and below are considered to indicate sexual dysfunction.	baseline, post treatment (at 10 week)
pelvic floor muscle function	Pelvic floor muscle function will be assessed with EMG biofeedback.	baseline, post treatment (at 10 week)

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Actual): February 21, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Incontinence, Stress; pentalenolactone F methyl ester
• Other Study ID Numbers: hlaser

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No