Obstructed DefecationNCT07390682
Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation
A study testing Bilateral posterior tibial nerve stimulation in people with Obstructed Defecation, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
Obstructed defecation syndrome (ODS) is a common functional bowel disorder characterized by difficulty in stool evacuation. Bilateral posterior tibial nerve stimulation (BT PTNS) has emerged as a noninvasive, safe, and effective therapeutic option for functional ODS, improving symptom severity and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructed Defecation
- What is being tested?
- Bilateral posterior tibial nerve stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2026to 28 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of functional obstructed defecation (Rome IV criteria).
- Able to provide informed consent.
- BMI ≥30 kg/m² (obese group) or BMI <30 kg/m² (non-obese group).
Who cannot join
- Organic causes of constipation (e.g., colorectal cancer, inflammatory bowel disease).
- Previous pelvic floor surgery.
- Neurological disorders affecting bowel function.
- Pregnancy or lactation.
- Current use of other neuromodulation therapies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, 21531
About this study
Official title: Impact of Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation in Obstructed Defecation
Obstructed defecation syndrome (ODS) is a common functional bowel disorder characterized by difficulty in stool evacuation. Bilateral posterior tibial nerve stimulation (BT PTNS) has emerged as a noninvasive, safe, and effective therapeutic option for functional ODS, improving symptom severity and quality of life.
Read the detailed description
Obesity is associated with altered pelvic floor mechanics, which may affect the response to neuromodulation therapy. However, the effect of obesity on BT PTNS outcomes in ODS has not been systematically evaluated. This study aims to fill this knowledge gap by comparing treatment efficacy between obese and non-obese patients.
- Conditions
- Obstructed Defecation
- Being tested
- Bilateral posterior tibial nerve stimulation
- Keywords
- Obesity, Bilateral Tibial Nerve Stimulation, Obstructed Defecation, ODS, BT PTNS
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral posterior tibial nerve stimulationProcedure or surgery
- Procedure: BT PTNS will be administered via transcutaneous electrodes placed bilaterally along the posterior tibial nerve at the medial malleolus.
- Frequency: 3 sessions per week for 6 weeks (total of 18 sessions).
- Duration per Session: 30 minutes.
- Monitoring: Patients will be monitored for adverse events during and after each session.
| Study group | Role | What they receive |
|---|---|---|
| obese with ODS | Active comparator | BT PTNS in obese patients with ODS Receives: Procedure: Bilateral posterior tibial nerve stimulation |
| Non obese with ODS | Active comparator | BT PTNS in non-obese patients with ODS Receives: Procedure: Bilateral posterior tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom severity measured by the Modified Obstructed Defecation Score (MODS).
Scale range: 0 to 24
Interpretation: Higher scores indicate more severe obstructed defecation symptoms
Unit of measure: Units on a validated symptom severity scale. No aggregation of different measurements into a single reported value is performed. Each scale is analyzed independently.
In response to the Advisory Issue, we have included the unabbreviated titles of the scales, their minimum and maximum values, and clarified whether higher scores represent better or worse outcomes for each outcome measure.
Measured: Within 6 weeks of treatment.
Change in quality of life measured by the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL).
Scale range: 0 to 96
Interpretation: Higher scores indicate worse constipation-related quality of life
Unit of measure: Mean score on a validated quality-of-life scale No aggregation of different measurements into a single reported value is performed. Each scale is analyzed independently.
In response to the Advisory Issue, we have included the unabbreviated titles of the scales, their minimum and maximum values, and clarified whether higher scores represent better or worse outcomes for each outcome measure.
Measured: Within 6 weeks of treatment.
Secondary outcomes (1)
Pelvic floor function
To assess the impact of obesity on pelvic floor function using electromyography (EMG).
Electromyograpghy (EMG) a diagnostic test that evaluates the electrical signals between your nerves and muscles to check for neuromuscular problems like nerve damage or muscle diseases. It usually involves two parts: a nerve conduction study (NCS) using surface electrodes to measure nerve signal speed, and a needle EMG where a tiny needle electrode is inserted into a muscle to record its activity at rest and during contraction, revealing abnormalities. To assess amplitude, number of turns and duration of pelvic floor muscle.
Measured: Within 6 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start15 Feb 2026
- Primary completion25 Mar 2026
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructed DefecationStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390682
- Sponsor's protocol ID
- obesity and ODS
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation in Obstructed Defecation
- ClinicalTrials.gov ID
- NCT07390682
- Acronym / sponsor ID
- obesity and ODS
- Conditions
- Obstructed Defecation
- Keywords
- Obesity, Bilateral Tibial Nerve Stimulation, Obstructed Defecation, ODS, BT PTNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 5 Feb 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.
Obstructed defecation syndrome (ODS) is a common functional bowel disorder characterized by difficulty in stool evacuation. Bilateral posterior tibial nerve stimulation (BT PTNS) has emerged as a noninvasive, safe, and effective therapeutic option for functional ODS, improving symptom severity and quality of life.
Detailed description
Obesity is associated with altered pelvic floor mechanics, which may affect the response to neuromodulation therapy. However, the effect of obesity on BT PTNS outcomes in ODS has not been systematically evaluated. This study aims to fill this knowledge gap by comparing treatment efficacy between obese and non-obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese with ODS | Active comparator | Procedure: Bilateral posterior tibial nerve stimulationBT PTNS in obese patients with ODS |
| Non obese with ODS | Active comparator | Procedure: Bilateral posterior tibial nerve stimulationBT PTNS in non-obese patients with ODS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of functional obstructed defecation (Rome IV criteria).
- Able to provide informed consent.
- BMI ≥30 kg/m² (obese group) or BMI <30 kg/m² (non-obese group).
Key exclusion criteria (5 listed)
- Organic causes of constipation (e.g., colorectal cancer, inflammatory bowel disease).
- Previous pelvic floor surgery.
- Neurological disorders affecting bowel function.
- Pregnancy or lactation.
- Current use of other neuromodulation therapies.
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 |
|---|---|---|
| Bilateral posterior tibial nerve stimulation* Procedure: BT PTNS will be administered via transcutaneous electrodes placed bilaterally along the posterior tibial nerve at the medial malleolus. * Frequency: 3 sessions per week for 6 weeks (total of 18 sessions). * Duration per Session: 30 minutes. * Monitoring: Patients will be monitored for adverse events during and after each session. | Procedure or surgery | Non obese with ODS, obese with ODS |
Primary outcome
Change in symptom severity measured by the Modified Obstructed Defecation Score (MODS).
Time frame: Within 6 weeks of treatment.
Scale range: 0 to 24 Interpretation: Higher scores indicate more severe obstructed defecation symptoms Unit of measure: Units on a validated symptom severity scale. No aggregation of different measurements into a single reported value is performed. Each scale is analyzed independently. In response to the Advisory Issue, we have included the unabbreviated titles of the scales, their minimum and maximum values, and clarified whether higher scores represent better or worse outcomes for each outcome measure.
Change in quality of life measured by the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL).
Time frame: Within 6 weeks of treatment.
Scale range: 0 to 96 Interpretation: Higher scores indicate worse constipation-related quality of life Unit of measure: Mean score on a validated quality-of-life scale No aggregation of different measurements into a single reported value is performed. Each scale is analyzed independently. In response to the Advisory Issue, we have included the unabbreviated titles of the scales, their minimum and maximum values, and clarified whether higher scores represent better or worse outcomes for each outcome measure.
1 secondary outcome
Pelvic floor function
Time frame: Within 6 weeks of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructed Defecation
Not yet recruiting
Clinical Evaluation of the Femiset Device for Perineal Descent in Women
Perineal Descent, Obstructed Defecation Syndrome (ODS)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral posterior tibial nerve stimulation in people with Obstructed Defecation, run by General Committee of Teaching Hospitals and Institutes, Egypt 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 29 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom severity measured by the Modified Obstructed Defecation Score (MODS). (time frame: Within 6 weeks of treatment.). The study lists 2 primary outcomes in all. 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 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.