Effect of Low Level Laser Therapy on Women With Obstructive Defecation Syndrome

NCT07771218 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-18

No results posted yet for this study

Summary

Obstructive defecation syndrome (ODS) is a condition in which a person has difficulty completely emptying the rectum during bowel movements. Women with ODS may experience excessive straining, a feeling of incomplete evacuation or blockage, abdominal discomfort, and the need to use manual assistance, laxatives, or enemas to facilitate defecation.

This randomized controlled trial will investigate the effect of adding low-level laser therapy (LLLT) to a conventional treatment program for women with ODS. Participants will be randomly assigned to one of two groups. The control group will receive nutritional modification and biofeedback training, while the study group will receive the same treatment in addition to low-level laser therapy applied to the lumbosacral region.

The study will evaluate whether adding low-level laser therapy can improve anorectal function, reduce the severity of ODS symptoms, and improve health-related quality of life compared with conventional treatment alone.

Conditions

  • Obstructive Defecation Syndrome

Interventions

OTHER

Nutritional Modification

Participants will receive nutritional modification throughout the intervention period. The program will include a fiber-rich diet containing both soluble and insoluble fiber to improve stool consistency and facilitate bowel movements. Participants will also be instructed to maintain adequate hydration by consuming approximately 6-8 glasses of water per day. The nutritional modification program will be applied to participants in both the control and study groups.

OTHER

Biofeedback Training

Participants will receive anorectal biofeedback training using a rectal biofeedback device that provides real-time visual or auditory feedback on pelvic floor muscle activity. During each session, participants will be trained to improve pelvic floor muscle coordination and relaxation during simulated defecation. They will be instructed to consciously relax and release the pelvic floor muscles, use deep abdominal breathing, and practice relaxation techniques while observing the biofeedback signals. Exercises will be repeated approximately 10-20 times per session according to participant tolerance and therapist assessment. The intervention will be administered twice weekly.

DEVICE

Low Level Laser Therapy

Participants in the study group will receive low-level laser therapy (LLLT) using a Scanner Laser PR 999 4W device with dual wavelengths (continuous 808 nm and pulsed 940 nm). LLLT will be applied to the lumbosacral region, targeting the lumbar (L2-L5) and sacral (S1-S5) areas. Participants will be positioned prone, and the laser scanner will be applied perpendicular to the skin at a 90° angle, approximately 1-2 inches above the treatment area. The scanner will be moved slowly to provide uniform coverage of the lumbosacral region. Each treatment session will last 30 minutes and will be administered twice weekly for 8 weeks. Both participants and therapists will wear appropriate protective eyewear during treatment.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohamed Ahmed Mohamed Awad, PhD · Professor, Cairo University

  • Doaa A. Osman, PhD · Ass. Professor, Cairo University

  • Hesham Mahmoud Salah El-Din, PhD · Professor, Cairo University

  • Radwa Ayad Mohamed, M. Sc · PhD Student, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2026-12-20
Completion
2026-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771218 on ClinicalTrials.gov