NCT02067546

Brief Summary

Emptying disorders are of the most common causes of constipation. An adjustable toilet seat was designed by " Shva-Nach" Ltd company, and is designed to facilitate the angle sitting position. Its efficacy will be evaluated in the current study, on 50 volunteers who suffer from constipation and meet the Rome 3 criteria for constipation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

February 18, 2014

Last Update Submit

February 18, 2014

Conditions

Constipation

Keywords

constipation

Outcome Measures

Primary Outcomes (1)

  • Improvement in bowel movement frequency

    2 months

Secondary Outcomes (1)

  • Improvement in quality of life

    2 months

Study Arms (2)

Experimental toilet seat

EXPERIMENTAL

Experimental toilet seat for 1 month

Device: Experimental toilet seat

Standard toilet seat

SHAM COMPARATOR

Standard toilet seat for 1 month

Device: Standard toilet seat

Interventions

Experimental toilet seatDEVICE
Experimental toilet seat
Standard toilet seatDEVICE
Standard toilet seat

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from constipation and meet the criteria of Rome 3. No sub - distribution by emptying disorders or decreased stool frequency
  • Age group 18-80 years
  • Study population may include patients suffering from metabolic diseases such as diabetes mellitus, hypothyroidism and hypercalcemia.
  • Patients who understand the goals of the research and collaborate

You may not qualify if:

  • Patients who do not understand the goals of the research and / or unable to cooperate.
  • women with known pregnancy - second trimester and up
  • Patients with obesity - BMI\> 35 and / or weight over 120 kg
  • Neurological diseases - dementia, Parkinson's disease, CVA, multiple sclerosis, muscular dystrophy, spinal cord injury
  • Disabled patients on wheelchairs.
  • Patients with active anal fissure / fistula, active inflammation of the colon, patients after resection of the colon.
  • Minors and no judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423966, Israel

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yishai Ron, MD

CONTACT

97236974176yishayr@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 20, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

IL(1)