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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-45
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutritional Modification

    Other intervention

    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.

  • Biofeedback Training

    Other intervention

    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

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Nutritional modification + Biofeedback muscle trainingActive comparator 2 interventions
Group B: Low level laser therapy + Nutritional modification + Biofeedback muscle trainingExperimental treatment 3 interventions

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

Anal Resting Pressure Assessed by Anorectal Manometry

Anal resting pressure will be assessed using anorectal manometry. After insertion of the anorectal manometry probe, the participant will be allowed to relax for approximately 3-5 minutes to allow anal sphincter tone to return to baseline. Basal anal pressure will then be recorded at rest over 60 seconds. The outcome will be expressed in mmHg.

Time frame
8 weeks
2

Anal Squeeze Pressure Assessed by Anorectal Manometry

Anal squeeze pressure will be assessed using anorectal manometry during voluntary contraction of the anal sphincter and pelvic floor muscles. Participants will perform three maximum voluntary squeezes, each maintained for approximately 5 seconds, with a 30-second recovery period between attempts. The average pressure obtained from the three attempts will be used for analysis and expressed in mmHg.

Time frame
8 weeks
3

Anal Strain Pressure Assessed by Anorectal Manometry

Anal strain pressure will be assessed using anorectal manometry during simulated defecation. Participants will be instructed to perform a bearing-down maneuver to simulate defecation. Three straining attempts will be performed, with each attempt lasting approximately 15 seconds and separated by a 30-second recovery interval. The average pressure obtained from the three attempts will be used for analysis and expressed in mmHg.

Time frame
8 weeks
4

Anal Sphincter Endurance Assessed by Anorectal Manometry

Anal sphincter endurance will be assessed using anorectal manometry during a sustained maximum voluntary contraction. Endurance will be defined as the length of time for which the participant can maintain pressure during the maximum voluntary contraction. The outcome will be recorded in seconds, with a longer duration indicating greater ability to sustain the contraction.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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