Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

NCT07319247 | Enrolling By Invitation DMC

• 1 other identifier: hlaser
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Sexually Dysfunction

  baseline, post treatment (at 10 week)

• pelvic floor muscle function

  baseline, post treatment (at 10 week)

Study Arms (3)

PFME Group

ACTIVE COMPARATOR

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

PFME+Laser

ACTIVE COMPARATOR

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

Plasebo Laser

PLACEBO COMPARATOR

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

Interventions

Plasebo Laser OTHER

The laser device will be held on 6 points in the perineal area for the same period of time without being plugged in.

Plasebo Laser

PFMT Group BEHAVIORAL

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).

PFME Group

PFME+Laser Therapy BEHAVIORAL

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

PFME+Laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-65,
• Women who are volunteers and committed to work,
• Women diagnosed with stress urinary incontinence,

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Physical Therapy Hospital

Meram, Konya, (507) 534-6142, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physıcal Therapy and Rehabilitation

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 6, 2026
• Study Start: December 9, 2025
• Primary Completion: February 21, 2026
• Study Completion: May 30, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)