Dyssynergic DefaecationNCT07488442
Efficacy of Cognitive Behavioral Therapy Administered in Patients With Dyssynergic Defecation
A study testing Pelvic floor rehabilitation and Pelvic floor rehabilitation+cognitive behavioral therapy in people with Dyssynergic Defaecation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effectiveness of cognitive-behavioral therapy when used in conjunction with lifestyle modifications and pelvic floor rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Dyssynergic Defaecation
- What is being tested?
- Pelvic floor rehabilitation and Pelvic floor rehabilitation+cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2026to 30 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A history of constipation lasting longer than one year
- Chronic constipation as defined by the Rome IV criteria
- Being between the ages of 18 and 55
- Findings consistent with dyssynergic defecation on anorectal manometry and balloon defecography
- Exclusion of organic and metabolic causes of chronic constipation
Who cannot join
- Active bowel disease
- Presence of an active anal fissure
- History of major abdominal surgery
- Presence of a neurological disorder
- Presence of a serious psychiatric disorder
- Use of medications that cause constipation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010
Ayse Naz Kalem Ozgen, Specialist, +90 0312 797 00 00, kalemnaz@gmail.com
About this study
Official title: An Evaluation of the Efficacy of Cognitive Behavioral Therapy Administered in Conjunction With Pelvic Floor Exercises in Patients With Dyssynergic Defecation
The aim of this study is to evaluate the effectiveness of cognitive-behavioral therapy when used in conjunction with lifestyle modifications and pelvic floor rehabilitation.
- Conditions
- Dyssynergic Defaecation
- Being tested
- Pelvic floor rehabilitation, Pelvic floor rehabilitation+cognitive behavioral therapy
- Keywords
- Dyssynergic Defecation, Cognitive Behavioral Therapy, Pelvic Floor Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor rehabilitationOther
Relaxation and kegel exercises and biofeedback therapy
Pelvic floor rehabilitation+cognitive behavioral therapyBehavioural
Relaxation and kegel exercises, biofeedback therapy and cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor rehabilitation | Active comparator | Patients in the first group will receive education on lifestyle changes, and a rehabilitation program consisting of 15 sessions of relaxation and Kegel exercises-held three days a week at the pelvic floor unit-will be planned. Receives: Other: Pelvic floor rehabilitation |
| Pelvic floor rehabilitation+cognitive behavioral therapy | Experimental | In addition to these treatments, patients in the second group will receive a total of five sessions of cognitive-behavioral therapy from a certified psychologist specializing in the field, focusing on their current gastrointestinal issues rather than their personal histories. Receives: Behavioral: Pelvic floor rehabilitation+cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wexner Constipation Score
Measured: first day of treatment and 5th week of treatment
Constipation Severity Scale
Measured: first day of treatment and 5th week of treatment
Secondary outcomes (2)
Bristol Stool Chart
Measured: first day of treatment and 5th week of treatment
Beck Depression Scale
Measured: first day of treatment and 5th week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start30 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyssynergic DefaecationStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Naz Kalem, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488442
- Sponsor's protocol ID
- AEŞH-EK-2025-314
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy of Cognitive Behavioral Therapy Administered in Conjunction With Pelvic Floor Exercises in Patients With Dyssynergic Defecation
- ClinicalTrials.gov ID
- NCT07488442
- Acronym / sponsor ID
- AEŞH-EK-2025-314
- Conditions
- Dyssynergic Defaecation
- Keywords
- Dyssynergic Defecation, Cognitive Behavioral Therapy, Pelvic Floor Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Mar 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.
The aim of this study is to evaluate the effectiveness of cognitive-behavioral therapy when used in conjunction with lifestyle modifications and pelvic floor rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor rehabilitation | Active comparator | Other: Pelvic floor rehabilitationPatients in the first group will receive education on lifestyle changes, and a rehabilitation program consisting of 15 sessions of relaxation and Kegel exercises-held three days a week at the pelvic floor unit-will be planned. |
| Pelvic floor rehabilitation+cognitive behavioral therapy | Experimental | Behavioral: Pelvic floor rehabilitation+cognitive behavioral therapyIn addition to these treatments, patients in the second group will receive a total of five sessions of cognitive-behavioral therapy from a certified psychologist specializing in the field, focusing on their current gastrointestinal issues rather than their personal histories. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A history of constipation lasting longer than one year
- Chronic constipation as defined by the Rome IV criteria
- Being between the ages of 18 and 55
- Findings consistent with dyssynergic defecation on anorectal manometry and balloon defecography
- Exclusion of organic and metabolic causes of chronic constipation
Key exclusion criteria (6 listed)
- Active bowel disease
- Presence of an active anal fissure
- History of major abdominal surgery
- Presence of a neurological disorder
- Presence of a serious psychiatric disorder
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 |
|---|---|---|
| Pelvic floor rehabilitationRelaxation and kegel exercises and biofeedback therapy | Other | Pelvic floor rehabilitation |
| Pelvic floor rehabilitation+cognitive behavioral therapyRelaxation and kegel exercises, biofeedback therapy and cognitive behavioral therapy | Behavioural | Pelvic floor rehabilitation+cognitive behavioral therapy |
Primary outcome
Wexner Constipation Score
Time frame: first day of treatment and 5th week of treatment
Constipation Severity Scale
Time frame: first day of treatment and 5th week of treatment
2 secondary outcomes
Bristol Stool Chart
Time frame: first day of treatment and 5th week of treatment
Beck Depression Scale
Time frame: first day of treatment and 5th week of treatment
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 30 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor rehabilitation and Pelvic floor rehabilitation+cognitive behavioral therapy in people with Dyssynergic Defaecation, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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: looking for participants now, as of the sponsor's last update on 30 Oct 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 Turkey (Türkiye). 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 Ayşe Naz Kalem Ozgen, specialist (+90 0312 797 00 00, kalemnaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wexner Constipation Score (time frame: first day of treatment and 5th week 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 30 Oct 2026.