NCT00385892

Brief Summary

This safety study was carried out to investigate to what extent the use of an abdominal binder influences IAP. The study was designed as a comparative cross-over study measuring bladder pressure.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2005

Shorter than P25 for not_applicable healthy

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
Last Updated

October 11, 2006

Status Verified

October 1, 2006

First QC Date

October 9, 2006

Last Update Submit

October 10, 2006

Conditions

Healthy

Keywords

Healthy volonteersAbdominal binderIAPMAPAPP

Outcome Measures

Primary Outcomes (3)

  • Intra Abdominal Pressure (IAP)

  • Mean Arterial Pressure (MAP)

  • Abdominal Perfussion Pressure (APP)

Secondary Outcomes (2)

  • Comfort

  • Freedom of movement

Interventions

Abdominal binderDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum 18 years old
  • Healthy
  • Negative test of blood, nitrate or leucocytes in urinre
  • Waist line measurement 97-110 cm

You may not qualify if:

  • Pregnant
  • Known allergy
  • Know bladder disease
  • Tendency of/clinicla symptoms of urinay infection
  • Abdominal or urinary surgery
  • Medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lone M Poulsen, Consultant

    ITA 303 KAS-Gentofte Niels Andersensvej 65 2900 Hellerup DENMARK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 11, 2006

Study Start

August 1, 2005

Study Completion

October 1, 2005

Last Updated

October 11, 2006

Record last verified: 2006-10