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

NCT07683390 | Completed DMC

• 1 other identifier: PRS202409
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyssynergic Defecation; Impaired Rectal Evacuation; Puborectalis Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline assessment

Secondary Outcomes (21)

• Obstructed Defecation Syndrome score，（ODS score）

  Baseline assessment

• Cleveland Clinic Constipation Score,(CCCS)

  Baseline assessment

• Patient Assessment of Constipation Quality of Life total score，（PAC-QOL score）

  Baseline assessment

• Self-Rating Anxiety Scale score，（SAS score）

  Baseline assessment

• Bristol Stool Form Scale score

  Baseline assessment

Study Arms (1)

patients with suspected PRS-related DD

Other: Analysis of inter-group differences

Interventions

Analysis of inter-group differences OTHER

Analysis of inter-group differences

patients with suspected PRS-related DD

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with suspected PRS-related DD

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Army Medical Center (Daping Hospital)

Yuzhong, Chongqing Municipality, 400042, China

Location

Study Officials

• Weidong Tong, MD

  Army Medical Center (Daping Hospital)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 6, 2026
• Study Start: July 21, 2023
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: July 6, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)