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Puborectalis Syndrome as a Phenotype of Dyssynergic Defecation in Chronic Constipation: a Comparative Study of Defecography,High-resolution Anorectal Manometry, and Pelvic Floor Ultrasound

Puborectalis Syndrome as a Phenotype of Dyssynergic Defecation in Chronic Constipation: a Comparative Study of Defecography,High-resolution Anorectal Manometry, and Pelvic Floor Ultrasound

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07683390
Enrollment
164
Registered
2026-07-06
Start date
2023-07-21
Completion date
2026-05-31
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyssynergic Defecation, Impaired Rectal Evacuation, Puborectalis Syndrome

Keywords

Dyssynergic defecation, Puborectalis syndrome, Defecography, High-resolution anorectal manometry, Pelvic Floor Ultrasound

Brief 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.

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.

Interventions

OTHERAnalysis of inter-group differences

Analysis of inter-group differences

Sponsors

Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
16 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Age ranges from 16 to 85 years old. 2. 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. 3. Participants should be able to understand and complete relevant questionnaires. 4. Participants should be willing to follow the research protocol and sign the informed consent form.

Exclusion criteria

1. Pregnant women and lactating women 2. Suffering from gastrointestinal and other malignant tumors 3. Suffering from diseases such as diabetes and Parkinson's disease 4. Currently participating in other clinical trials

Design outcomes

Primary

MeasureTime frameDescription
Rectal emptying rate,(%)Baseline assessmentRectal 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.

Secondary

MeasureTime frameDescription
Obstructed Defecation Syndrome score,(ODS score)Baseline assessmentthe minimum value is 0,and maximum value is 31; a higher scores mean a worse outcome.
Cleveland Clinic Constipation Score,(CCCS)Baseline assessmentthe minimum value is 0,and maximum value is 30; a higher scores mean a worse outcome.
Patient Assessment of Constipation Quality of Life total score,(PAC-QOL score)Baseline assessmentthe minimum value is 0,and maximum value is 112; a higher scores mean a worse outcome.
Self-Rating Anxiety Scale score,(SAS score)Baseline assessmentthe minimum value is 25,and maximum value is 100; a higher scores mean a worse outcome.
Bristol Stool Form Scale scoreBaseline assessmentthe minimum value is 1,and maximum value is 7; a higher scores mean a worse outcome.
Body Mass IndexBaseline assessment
Disease duration,(year)Baseline assessment
ARA change on DFG,(°)Baseline assessmentchanges in anorectal angle during defecography
Anal canal diameter on DFG,(mm)Baseline assessmentanal canal diameter during straining on DFG
PRS on DFGBaseline assessmentPuborectalis syndrome indicated by the defecography diagnostic report.
IRP on DFGBaseline assessmentInternal rectal prolapse indicated by the defecography diagnostic report.
Rectocele on DFGBaseline assessmentRectocele indicated by the defecography diagnostic report.
Anal Resting Pressure,(mmHg)Baseline assessmentAnal Resting Pressure measured by High-resolution Anorectal Manometry
Anal Squeeze Pressure,(mmHg)Baseline assessmentAnal Squeeze Pressure measured by High-resolution Anorectal Manometry
Rectal propulsive pressure,(mmHg)Baseline assessmentRectal propulsive pressure measured by High-resolution Anorectal Manometry
Anal relaxation rate,(%)Baseline assessmentAnal relaxation rate measured by High-resolution Anorectal Manometry during defecation
DD on HR-ARMBaseline assessmentDyssynergic defecation(DD) reported by high-resolution anorectal manometry parameters, with diagnostic criteria of rectal pressure during straining \>45mmHg and anal canal relaxation rate \<20%.
ARA change on TPUS,(°)Baseline assessmentchanges in anorectal angle during evacuation measured by Transperineal Ultrasound
Right PRM thickness change on TPUS,(mm)Baseline assessmentChanges in right puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
Left PRM thickness change on TPUS,(mm)Baseline assessmentChanges in left puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
PRS on TPUSBaseline assessmentPuborectalis syndrome(PRS) indicated by the transperineal ultrasound diagnostic report

Countries

China

Contacts

STUDY_DIRECTORWeidong Tong, MD

Army Medical Center (Daping Hospital)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026