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Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Study completion pushed from Aug 30, 2026 to Oct 2, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Study completion pushed from Jul 30, 2026 to Aug 30, 2026v15
  3. Study completion pushed from Jun 30, 2026 to Jul 30, 2026v14
  4. Interventions: PFME (Behavioral), PFME (Behavioral), Plasebo Laser (Behavioral) to PFME (Behavioral), PFME and Laser Therapy (Behavioral), Plasebo Laser (Behavioral)v13
  5. Interventions: PFME+Laser Therapy (Behavioral), PFMT Group (Behavioral), Plasebo Laser (Behavioral) to PFME (Behavioral), PFME (Behavioral), Plasebo Laser (Behavioral)v12
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  1. Interventions: PFME+Laser Therapy (Behavioral), PFMT Group (Behavioral), Plasebo Laser (Other) to PFME+Laser Therapy (Behavioral), PFMT Group (Behavioral), Plasebo Laser (Behavioral)v11
  2. Secondary endpoints: details revised at 2 of 2 entriesv10
  1. Study completion pushed from May 30, 2026 to Jun 30, 2026v9
  2. Study completion pushed from Apr 13, 2026 to May 30, 2026v8
  3. Study completion date: Mar 27, 2026 to Apr 13, 2026v7
  4. Study completion date: Feb 28, 2026 to Mar 27, 2026v6
  5. Primary completion date changed from estimate of Mar 10, 2026 to Feb 21, 2026
    • Study completion date: Mar 30, 2026 to Feb 28, 2026
    v5
  6. Trial status: Not Yet Recruiting to Enrolling by Invitationv4
  7. Interventions: PFME+Laser Therapy (Behavioral), Plasebo Laser (Other) to PFME+Laser Therapy (Behavioral), PFMT Group (Behavioral), Plasebo Laser (Other)v3
  8. Re-verified, no change to tracked fieldsv2
  9. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07319247
Lead Sponsor Necmettin Erbakan University
Conditions
(from sponsor)		 Urinary Incontinence (UI), Laser Therapy, Stress Urinary Incontinence (SUI), Pelvic Floor Muscle Exercise
Related terms Urinary Incontinence, Urinary Incontinence, Stress
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov