Urinary Incontinence (UI)NCT07319247
Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence
A study testing PFME and Laser Therapy, Plasebo Laser and PFME in people with Urinary Incontinence (UI) and Laser Therapy, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence (UI), Laser Therapy, Stress Urinary Incontinence (SUI)
- What is being tested?
- PFME and Laser Therapy, Plasebo Laser and PFME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2025to 2 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-65,
- Women who are volunteers and committed to work,
- Women diagnosed with stress urinary incontinence,
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Physical Therapy Hospital
Meram, Konya, (507) 534-6142
About this study
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
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).
- Conditions
- Urinary Incontinence (UI), Laser Therapy, Stress Urinary Incontinence (SUI), Pelvic Floor Muscle Exercise
- Being tested
- PFME and Laser Therapy, Plasebo Laser, PFME
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFME and Laser TherapyBehavioural
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 LaserBehavioural
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).
PFMEBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| PFME | 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 12 week). Receives: Behavioral: PFME |
| PFME and Laser Therapy | Experimental | 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 12 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. Receives: Behavioral: PFME and Laser Therapy |
| Plasebo Laser | Placebo comparator | 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). Receives: Behavioral: Plasebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, post treatment (at 12 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.
Measured: baseline, post treatment (at 12 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.
Measured: baseline, post treatment (at 12 week)
Secondary outcomes (2)
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.
Measured: baseline, post treatment (at 12 week)
pelvic floor muscle function
Pelvic floor muscle function will be assessed with EMG biofeedback.
Measured: baseline, post treatment (at 12 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start9 Dec 2025
- Primary completion21 Feb 2026
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence (UI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanife dogan, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319247
- Sponsor's protocol ID
- hlaser
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No