Obstructive Defecation SyndromeNCT07771218
Effect of Low Level Laser Therapy on Women With Obstructive Defecation Syndrome
A study testing Nutritional Modification, Biofeedback Training and Low Level Laser Therapy in people with Obstructive Defecation Syndrome, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Obstructive Defecation Syndrome
- What is being tested?
- Nutritional Modification, Biofeedback Training and Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Radwa Ayad Mohamed, M.Sc contact
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza
Doaa A. Osman, PhD, 01115792245, Doaa.osman@cu.edu.eg
Radwa Ayad Mohamed, M.Sc
About this study
Official title: Effect of Low Level Laser Therapy on Women With Obstructive Defecation Syndrome: A Randomized Controlled 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.
Read the detailed description
This study is a prospective, randomized, pre-posttest controlled trial designed to investigate the effect of low-level laser therapy (LLLT) as an adjunct to conventional treatment in women with obstructive defecation syndrome (ODS).
Women diagnosed with ODS will be randomly assigned to two groups. Participants in the control group will receive nutritional modification and biofeedback training. Nutritional modification will focus on dietary fiber intake, adequate hydration, and weight-management recommendations. Biofeedback training will provide real-time feedback to facilitate appropriate pelvic floor muscle control, relaxation, and coordination during defecation.
Participants in the study group will receive the same nutritional modification and biofeedback program in addition to low-level laser therapy. LLLT will be applied to the lumbosacral region, targeting the lumbar (L2-L5) and sacral (S1-S5) areas.
Participants will be assessed before and after the intervention. Anorectal manometry will be used to evaluate anorectal physiological parameters, including anal resting pressure, squeeze pressure, strain pressure, endurance, rectal sensitivity, and rectal compliance. The severity of obstructive defecation symptoms will be evaluated using the Renzi Obstructive Defecation Syndrome Score, and health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36).
The study aims to determine whether adding low-level laser therapy to nutritional modification and biofeedback training provides additional benefits in anorectal function, ODS symptom severity, and quality of life compared with nutritional modification and biofeedback training alone.
- Conditions
- Obstructive Defecation Syndrome
- Being tested
- Nutritional Modification, Biofeedback Training, Low Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional ModificationOther
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 TrainingOther
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Nutritional Modification; Other: Biofeedback Training; Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (7)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Rectal Sensitivity Assessed by Anorectal Manometry
Rectal sensitivity will be assessed using graded balloon distension during anorectal manometry. Participants will be instructed to report the first rectal sensation, desire or urgency to defecate, and maximum tolerated sensation during progressive balloon inflation. The corresponding balloon volumes will be recorded in milliliters (mL). Lower sensory threshold volumes indicate greater rectal sensitivity, whereas higher threshold volumes indicate reduced rectal sensitivity.
Measured: 8 weeks
Rectal Compliance Assessed by Anorectal Manometry
Rectal compliance will be assessed during anorectal manometry using controlled rectal balloon distension. Compliance will be determined from the relationship between changes in balloon volume and corresponding changes in steady-state intrarectal pressure (ΔV/ΔP). Higher values indicate greater rectal distensibility, whereas lower values indicate greater resistance to rectal distension.
Measured: 8 weeks
Health-Related Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
Health-related quality of life will be assessed using the 36-item Short Form Health Survey (SF-36). The questionnaire evaluates eight health domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each domain is scored from 0 to 100, with higher scores indicating a more favorable health status.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Defecation SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa A. Osman, Cairo University
- Investigators
- Mohamed Ahmed Mohamed Awad, PhD, Study chair, Professor, Cairo UniversityDoaa A. Osman, PhD, Study director, Ass. Professor, Cairo UniversityHesham Mahmoud Salah El-Din, PhD, Study director, Professor, Cairo UniversityRadwa Ayad Mohamed, M. Sc, Principal investigator, PhD Student, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771218
- Sponsor's protocol ID
- P.T.REC/012/006002
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy on Women With Obstructive Defecation Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07771218
- Acronym / sponsor ID
- P.T.REC/012/006002
- Conditions
- Obstructive Defecation Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, randomized, pre-posttest controlled trial designed to investigate the effect of low-level laser therapy (LLLT) as an adjunct to conventional treatment in women with obstructive defecation syndrome (ODS).
Women diagnosed with ODS will be randomly assigned to two groups. Participants in the control group will receive nutritional modification and biofeedback training. Nutritional modification will focus on dietary fiber intake, adequate hydration, and weight-management recommendations. Biofeedback training will provide real-time feedback to facilitate appropriate pelvic floor muscle control, relaxation, and coordination during defecation.
Participants in the study group will receive the same nutritional modification and biofeedback program in addition to low-level laser therapy. LLLT will be applied to the lumbosacral region, targeting the lumbar (L2-L5) and sacral (S1-S5) areas.
Participants will be assessed before and after the intervention. Anorectal manometry will be used to evaluate anorectal physiological parameters, including anal resting pressure, squeeze pressure, strain pressure, endurance, rectal sensitivity, and rectal compliance. The severity of obstructive defecation symptoms will be evaluated using the Renzi Obstructive Defecation Syndrome Score, and health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36).
The study aims to determine whether adding low-level laser therapy to nutritional modification and biofeedback training provides additional benefits in anorectal function, ODS symptom severity, and quality of life compared with nutritional modification and biofeedback training alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional modification + Biofeedback muscle training | Active comparator | Other: Nutritional Modification, Other: Biofeedback TrainingIt 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. |
| Low level laser therapy + Nutritional modification + Biofeedback muscle training | Experimental | Other: Nutritional Modification, Other: Biofeedback Training, Device: Low Level Laser TherapyIt 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. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional ModificationParticipants 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 | Low level laser therapy + Nutritional modification + Biofeedback muscle training, Nutritional modification + Biofeedback muscle training |
| Biofeedback TrainingParticipants 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. | Other | Low level laser therapy + Nutritional modification + Biofeedback muscle training, Nutritional modification + Biofeedback muscle training |
| Low Level Laser TherapyParticipants 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. | Device | Low level laser therapy + Nutritional modification + Biofeedback muscle training |
Primary outcome
Obstructive Defecation Syndrome Severity Assessed by the Renzi ODS Score
Time frame: 8 weeks
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.
7 secondary outcomes
Anal Resting Pressure Assessed by Anorectal Manometry
Time frame: 8 weeks
Anal Squeeze Pressure Assessed by Anorectal Manometry
Time frame: 8 weeks
Anal Strain Pressure Assessed by Anorectal Manometry
Time frame: 8 weeks
Anal Sphincter Endurance Assessed by Anorectal Manometry
Time frame: 8 weeks
Rectal Sensitivity Assessed by Anorectal Manometry
Time frame: 8 weeks
Rectal Compliance Assessed by Anorectal Manometry
Time frame: 8 weeks
Health-Related Quality of Life Assessed by the Short Form-36 Health Survey (SF-36)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Radwa Ayad Mohamed, M.Sc contact
Mohamed Ahmed Mohamed Awad, PhD study chair
Professor, Cairo University
Doaa A. Osman, PhD study director
Ass. Professor, Cairo University
Hesham Mahmoud Salah El-Din, PhD study director
Professor, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Modification, Biofeedback Training and Low Level Laser Therapy in people with Obstructive Defecation Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doaa A. Osman, PhD (01115792245, Doaa.osman@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive Defecation Syndrome Severity Assessed by the Renzi ODS Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.