NCT00219518

Brief Summary

We hypothesize that defecatory disorders can be described in mechanical terms which would allow a mechanistic description of disorders which would in turn allow better directed biofeedback mechanisms to treat disorders of defecation.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

5.2 years

First QC Date

September 14, 2005

Last Update Submit

May 23, 2018

Conditions

Constipation

Keywords

DefecographyPelvic floor dyssynergiaAnismus

Outcome Measures

Primary Outcomes (1)

  • change in shape of anorectum during changes in intraabdominal pressure and defecation

    measure change in dimension over time

    start of anorectal manometry procedure until procedure end

Interventions

defecographyPROCEDURE

insertion of catheter to record pressure. Insertion of barium to outline rectum and fluoroscopy to define change in rectal contour and expulsion of barium during the study.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with no defecatory dysfunctionl

You may qualify if:

  • Women
  • No defecatory problems
  • On no medication which affect bowel habits

You may not qualify if:

  • Pregnancy
  • Patients
  • Difficulty in defecation
  • Women
  • Pregnancy
  • Medication which can affect bowel movement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ann Ouyang, MD

    Penn State College of Medicine and Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

February 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 25, 2018

Record last verified: 2018-05

Locations

US(1)