Dyssynergic DefecationNCT07683390
Puborectalis Syndrome as a Phenotype of Dyssynergic Defecation in Chronic Constipation: a Comparative Study of Defecography,High-resolution Anorectal Manometry, and Pelvic Floor Ultrasound
An observational study of Dyssynergic Defecation and Puborectalis Syndrome, run by Third Military Medical University at 1 site in China.
Trial summary
Patients with suspected DD who met the Rome IV criteria were divided into the DD group and other types of constipation groups. The differences between the two groups were analyzed to explore the precise diagnostic scheme for DD. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Dyssynergic Defecation, Puborectalis Syndrome, Impaired Rectal Evacuation
- What is being tested?
- Analysis of inter-group differences
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2023to 31 May 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with suspected PRS-related DD
Who may be able to join
- Age ranges from 16 to 85 years old.
- Constipation patients should meet the Rome Ⅳ criteria for chronic constipation (must include two or more of the following: ① At least 25% of bowel movements are strenuous; ② At least 25% of bowel movements are lumpy or hard stools; ③ At least 25% of bowel movements are accompanied by a sense of incomplete evacuation; ④ At least 25% of bowel movements are associated with a feeling of anorectal obstruction or blockage; ⑤ At least 25% of bowel movements require manual assistance; ⑥ Fewer than 3 bowel movements per week). The healthy volunteer group has no above - mentioned constipation symptoms.
- Participants should be able to understand and complete relevant questionnaires.
- Participants should be willing to follow the research protocol and sign the informed consent form.
Who cannot join
- Pregnant women and lactating women
- Suffering from gastrointestinal and other malignant tumors
- Suffering from diseases such as diabetes and Parkinson's disease
- Currently participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, 400042
About this study
Patients with suspected DD who met the Rome IV criteria were divided into the DD group and other types of constipation groups. The differences between the two groups were analyzed to explore the precise diagnostic scheme for DD.
Read the detailed description
This study was conducted solely at the Army Specialized Medical Center and was a single-center, bidirectional cohort study. Patients with suspected dyssynergic defecation who visited the constipation specialty clinic of Daping Hospital were collected. After the patients signed the informed consent form, they were asked to fill out the questionnaire (general clinical data questionnaire, Wexner constipation rating scale, ODS rating scale, and constipation patient quality of life scale (PAC-QOL)). The baseline data of the patients (such as age, gender, symptoms, constipation scale scores, intestinal satisfaction scores, etc.) and the results of anorectal manometry, defecography, and perineal ultrasound were statistically analyzed. Patients meeting the Rome IV criteria were grouped through DFG, ARM, and pelvic floor ultrasound examination. The differences in clinical main symptoms, constipation scores, defecography, perineal ultrasound, etc. between the two groups were observed, and the roles and correlations of each parameter in diagnosis were analyzed.
- Being tested
- Analysis of inter-group differences
- Keywords
- Dyssynergic defecation, Puborectalis syndrome, Defecography, High-resolution anorectal manometry, Pelvic Floor Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of inter-group differencesOther
Analysis of inter-group differences
| Study group | Role | What they receive |
|---|---|---|
| patients with suspected PRS-related DD | Not described Receives: Other: Analysis of inter-group differences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectal emptying rate，（%）
Rectal emptying rate is defined as the reduction in rectal area from pre-evacuation to post-evacuation, expressed as a percentage of the pre-evacuation area, as assessed by defecography.
Measured: Baseline assessment
Secondary outcomes (21)
Obstructed Defecation Syndrome score，（ODS score）
the minimum value is 0,and maximum value is 31; a higher scores mean a worse outcome.
Measured: Baseline assessment
Cleveland Clinic Constipation Score,(CCCS)
the minimum value is 0,and maximum value is 30; a higher scores mean a worse outcome.
Measured: Baseline assessment
Patient Assessment of Constipation Quality of Life total score，（PAC-QOL score）
the minimum value is 0,and maximum value is 112; a higher scores mean a worse outcome.
Measured: Baseline assessment
Self-Rating Anxiety Scale score，（SAS score）
the minimum value is 25,and maximum value is 100; a higher scores mean a worse outcome.
Measured: Baseline assessment
Bristol Stool Form Scale score
the minimum value is 1,and maximum value is 7; a higher scores mean a worse outcome.
Measured: Baseline assessment
Body Mass Index
Measured: Baseline assessment
Disease duration,(year)
Measured: Baseline assessment
ARA change on DFG，(°)
changes in anorectal angle during defecography
Measured: Baseline assessment
Anal canal diameter on DFG，（mm）
anal canal diameter during straining on DFG
Measured: Baseline assessment
PRS on DFG
Puborectalis syndrome indicated by the defecography diagnostic report.
Measured: Baseline assessment
IRP on DFG
Internal rectal prolapse indicated by the defecography diagnostic report.
Measured: Baseline assessment
Rectocele on DFG
Rectocele indicated by the defecography diagnostic report.
Measured: Baseline assessment
Anal Resting Pressure，（mmHg）
Anal Resting Pressure measured by High-resolution Anorectal Manometry
Measured: Baseline assessment
Anal Squeeze Pressure,(mmHg)
Anal Squeeze Pressure measured by High-resolution Anorectal Manometry
Measured: Baseline assessment
Rectal propulsive pressure,(mmHg)
Rectal propulsive pressure measured by High-resolution Anorectal Manometry
Measured: Baseline assessment
Anal relaxation rate,(%)
Anal relaxation rate measured by High-resolution Anorectal Manometry during defecation
Measured: Baseline assessment
DD on HR-ARM
Dyssynergic defecation(DD) reported by high-resolution anorectal manometry parameters, with diagnostic criteria of rectal pressure during straining >45mmHg and anal canal relaxation rate <20%.
Measured: Baseline assessment
ARA change on TPUS,(°)
changes in anorectal angle during evacuation measured by Transperineal Ultrasound
Measured: Baseline assessment
Right PRM thickness change on TPUS,(mm)
Changes in right puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
Measured: Baseline assessment
Left PRM thickness change on TPUS,(mm)
Changes in left puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
Measured: Baseline assessment
PRS on TPUS
Puborectalis syndrome(PRS) indicated by the transperineal ultrasound diagnostic report
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start21 Jul 2023
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyssynergic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 164 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- Weidong Tong, MD, Study director, Army Medical Center (Daping Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683390
- Sponsor's protocol ID
- PRS202409
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puborectalis Syndrome as a Phenotype of Dyssynergic Defecation in Chronic Constipation: a Comparative Study of Defecography,High-resolution Anorectal Manometry, and Pelvic Floor Ultrasound
- ClinicalTrials.gov ID
- NCT07683390
- Acronym / sponsor ID
- PRS202409
- Keywords
- Dyssynergic defecation, Puborectalis syndrome, Defecography, High-resolution anorectal manometry, Pelvic Floor Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 6 Jul 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.
Patients with suspected DD who met the Rome IV criteria were divided into the DD group and other types of constipation groups. The differences between the two groups were analyzed to explore the precise diagnostic scheme for DD.
Detailed description
This study was conducted solely at the Army Specialized Medical Center and was a single-center, bidirectional cohort study. Patients with suspected dyssynergic defecation who visited the constipation specialty clinic of Daping Hospital were collected. After the patients signed the informed consent form, they were asked to fill out the questionnaire (general clinical data questionnaire, Wexner constipation rating scale, ODS rating scale, and constipation patient quality of life scale (PAC-QOL)). The baseline data of the patients (such as age, gender, symptoms, constipation scale scores, intestinal satisfaction scores, etc.) and the results of anorectal manometry, defecography, and perineal ultrasound were statistically analyzed. Patients meeting the Rome IV criteria were grouped through DFG, ARM, and pelvic floor ultrasound examination. The differences in clinical main symptoms, constipation scores, defecography, perineal ultrasound, etc. between the two groups were observed, and the roles and correlations of each parameter in diagnosis were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with suspected PRS-related DD | – | Other: Analysis of inter-group differences |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with suspected PRS-related DD
Key inclusion criteria (4 listed)
- Age ranges from 16 to 85 years old.
- Constipation patients should meet the Rome Ⅳ criteria for chronic constipation (must include two or more of the following: ① At least 25% of bowel movements are strenuous; ② At least 25% of bowel movements are lumpy or hard stools; ③ At least 25% of bowel movements are accompanied by a sense of incomplete evacuation; ④ At least 25% of bowel movements are associated with a feeling of anorectal obstruction or blockage; ⑤ At least 25% of bowel movements require manual assistance; ⑥ Fewer than 3 bowel movements per week). The healthy volunteer group has no above - mentioned constipation symptoms.
- Participants should be able to understand and complete relevant questionnaires.
- Participants should be willing to follow the research protocol and sign the informed consent form.
Key exclusion criteria (4 listed)
- Pregnant women and lactating women
- Suffering from gastrointestinal and other malignant tumors
- Suffering from diseases such as diabetes and Parkinson's disease
- Currently participating in other clinical trials
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 |
|---|---|---|
| Analysis of inter-group differencesAnalysis of inter-group differences | Other | patients with suspected PRS-related DD |
Primary outcome
Rectal emptying rate，（%）
Time frame: Baseline assessment
Rectal emptying rate is defined as the reduction in rectal area from pre-evacuation to post-evacuation, expressed as a percentage of the pre-evacuation area, as assessed by defecography.
21 secondary outcomes
Obstructed Defecation Syndrome score，（ODS score）
Time frame: Baseline assessment
Cleveland Clinic Constipation Score,(CCCS)
Time frame: Baseline assessment
Patient Assessment of Constipation Quality of Life total score，（PAC-QOL score）
Time frame: Baseline assessment
Self-Rating Anxiety Scale score，（SAS score）
Time frame: Baseline assessment
Bristol Stool Form Scale score
Time frame: Baseline assessment
Body Mass Index
Time frame: Baseline assessment
Disease duration,(year)
Time frame: Baseline assessment
ARA change on DFG，(°)
Time frame: Baseline assessment
Anal canal diameter on DFG，（mm）
Time frame: Baseline assessment
PRS on DFG
Time frame: Baseline assessment
IRP on DFG
Time frame: Baseline assessment
Rectocele on DFG
Time frame: Baseline assessment
Anal Resting Pressure，（mmHg）
Time frame: Baseline assessment
Anal Squeeze Pressure,(mmHg)
Time frame: Baseline assessment
Rectal propulsive pressure,(mmHg)
Time frame: Baseline assessment
Anal relaxation rate,(%)
Time frame: Baseline assessment
DD on HR-ARM
Time frame: Baseline assessment
ARA change on TPUS,(°)
Time frame: Baseline assessment
Right PRM thickness change on TPUS,(mm)
Time frame: Baseline assessment
Left PRM thickness change on TPUS,(mm)
Time frame: Baseline assessment
PRS on TPUS
Time frame: Baseline assessment
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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Weidong Tong, MD study director
Army Medical Center (Daping Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyssynergic Defecation and Puborectalis Syndrome, run by Third Military Medical University at 1 site in China.
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 4 inclusion and 4 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 6 Jul 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 China. 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?
Rectal emptying rate，（%） (time frame: Baseline assessment). 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 6 Jul 2026.