NCT00011570

Brief Summary

The investigators will continue their work with implanted stimulators to improve bladder and bowel function. Electrical stimulation produces simultaneous contraction of sphincters with the target organs, making emptying difficult. By optimizing electrode placement, employing a new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to defecate with existing approaches. This is part of a multi-center study with multiple support sources, including Rehab R\&D, PVA and a commercial stimulator company.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 1998

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2001

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2001

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 28, 2008

Status Verified

April 1, 2008

Enrollment Period

7.5 years

First QC Date

February 22, 2001

Last Update Submit

April 25, 2008

Conditions

Spinal Cord Injury

Keywords

defecationelectrical stimulationpenile erectionSpinal cord injuryurology

Study Arms (1)

1

OTHER
Device: Bladder & Bowel Control

Interventions

Bladder & Bowel ControlDEVICE
1

Eligibility Criteria

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

You may qualify if:

  • Spinal cord injury with bowel \& bladder problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Donald Bodner, MD

    VA Medical Center-Cleveland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

February 22, 2001

First Posted

February 26, 2001

Study Start

April 1, 1998

Primary Completion

October 1, 2005

Study Completion

November 1, 2007

Last Updated

April 28, 2008

Record last verified: 2008-04

Locations

US(1)