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

NCT07771218 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Obstructive Defecation Syndrome Severity Assessed by the Renzi ODS Score

  The severity of obstructive defecation syndrome (ODS) will be assessed using the Renzi ODS Score. The scale consists of five items assessing excessive straining, incomplete rectal evacuation, use of enemas and/or laxatives, vaginal-anal-perineal digitations, and abdominal discomfort and/or pain. The total score ranges from 0 to 20, with higher scores indicating greater severity of ODS symptoms. A score of ≥9 is used to identify ODS.

  8 weeks

Secondary Outcomes (7)

• Anal Resting Pressure Assessed by Anorectal Manometry

  8 weeks

• Anal Squeeze Pressure Assessed by Anorectal Manometry

  8 weeks

• Anal Strain Pressure Assessed by Anorectal Manometry

  8 weeks

• Anal Sphincter Endurance Assessed by Anorectal Manometry

  8 weeks

• Rectal Sensitivity Assessed by Anorectal Manometry

  8 weeks

Study Arms (2)

Nutritional modification + Biofeedback muscle training

ACTIVE COMPARATOR

It will consist of 20 women with Obstructive Defecation Syndrome. They will be treated by nutritional modification and biofeedback muscle training, twice weekly for 8 weeks.

Other: Nutritional Modification; Other: Biofeedback Training

Low level laser therapy + Nutritional modification + Biofeedback muscle training

EXPERIMENTAL

It will consist of 20 women with Obstructive Defecation Syndrome. They will be treated by the same nutritional modification and biofeedback muscle training, in addition to low level laser therapy, twice weekly for 8 weeks.

Other: Nutritional Modification; Other: Biofeedback Training; Device: Low Level Laser Therapy

Interventions

Nutritional Modification OTHER

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.

Low level laser therapy + Nutritional modification + Biofeedback muscle training; Nutritional modification + Biofeedback muscle training

Biofeedback Training OTHER

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.

Low level laser therapy + Nutritional modification + Biofeedback muscle training; Nutritional modification + Biofeedback muscle training

Low Level Laser Therapy DEVICE

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.

Low level laser therapy + Nutritional modification + Biofeedback muscle training

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Woman diagnosed with ODS according to the Renzi ODS score (≥ 9).
• They suffer from difficult defecation for at least three months.
• Their ages will range from 30-45 years old.
• Their body mass index (BMI) will range from 25-30 kg/m2.
• Their parity number will be 2-3 times.

You may not qualify if:

• Any abnormalities around cancer colon, interstitial cystitis, or endometriosis.
• Enlarged rectal diameter and damaged mienteric plexus and abnormal motor function of rectum.
• Psychological or mental health problems.
• Pregnancy and lactation
• A history of previous pelvic surgery.
• A history of retinopathy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mohamed Ahmed Mohamed Awad, PhD

  Professor, Cairo University

  STUDY CHAIR

• Doaa A. Osman, PhD

  Ass. Professor, Cairo University

  STUDY DIRECTOR

• Hesham Mahmoud Salah El-Din, PhD

  Professor, Cairo University

  STUDY DIRECTOR

• Radwa Ayad Mohamed, M. Sc

  PhD Student, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doaa A. Osman, PhD

CONTACT

01115792245; Doaa.osman@cu.edu.eg

Radwa Ayad Mohamed, M.Sc

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy for Women's Health, Cairo University

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

EG (1)