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NCT Number: NCT07319247

Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

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).

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Key information

Conditions

Urinary Incontinence (UI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Laser Therapy Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Exercise Signs and Symptoms Stress Urinary Incontinence (SUI) Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PFME and 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 12.

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

Plasebo Laser

Behavioral

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).

PFME

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 12 week).

Primary outcomes

  1. Urinary incontinence severity

    Time frame: baseline, post treatment (at 12 week)

    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.

  2. The impact of urinary incontinence on quality of life

    Time frame: baseline, post treatment (at 12 week)

    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.

  3. pelvic floor dysfuntion severity

    Time frame: baseline, post treatment (at 12 week)

    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.

Secondary outcomes

  1. Sexually Dysfunction

    Time frame: baseline, post treatment (at 12 week)

    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.

  2. pelvic floor muscle function

    Time frame: baseline, post treatment (at 12 week)

    Pelvic floor muscle function will be assessed with EMG biofeedback.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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