NCT01380132

Brief Summary

The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_1

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

February 1, 2004

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

June 28, 2011

Status Verified

February 1, 2010

Enrollment Period

4.9 years

First QC Date

June 21, 2011

Last Update Submit

June 27, 2011

Conditions

Fecal Incontinence

Keywords

Fecal incontinenceTreatmentSurgery

Outcome Measures

Primary Outcomes (1)

  • Treatment response as measured by a 50% reduction in no of incontinence episodes.

    One year posttreatment

Secondary Outcomes (9)

  • Adverse events

    One year posttreatment

  • Global assessment

    One year posttreatment

  • Change in incontinence episodes

    One year posttreatment

  • Quality of life

    One year posttreatment

  • Adverse events

    Two years posttreatment

  • +4 more secondary outcomes

Study Arms (1)

Anal injection of Nasha Dx

EXPERIMENTAL
Procedure: Anal injection of Nasha Dx

Interventions

Anal injection of Nasha DxPROCEDURE

Submucous injection of Nasha Dx 5-10 mm above dentate line

Also known as: Solesta
Anal injection of Nasha Dx

Eligibility Criteria

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

You may qualify if:

  • Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
  • Age 18-80
  • Available for follow-up for the duration of the study
  • Written informed consent.

You may not qualify if:

  • Sphincter defect visible on anal ultrasound.
  • Pregnancy.
  • Rectal prolapse or inflammatory bowel disease.
  • Recent (within 6 months) anal surgery except for haemorrhoids.
  • Anorectal sepsis.
  • Anticoagulant medication or bleeding diathesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, University Hospital

751 82 Uppsala, Sweden

Location

Related Publications (1)

  • Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.

    PMID: 19581853RESULT

MeSH Terms

Conditions

Fecal Incontinence

Interventions

dextranomer-hyaluronic acid copolymer

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Wilhelm JR Graf, Prof.

    Inst of Surgical Sciences, Uppsala university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 27, 2011

Study Start

February 1, 2004

Primary Completion

January 1, 2009

Study Completion

May 1, 2009

Last Updated

June 28, 2011

Record last verified: 2010-02

Locations

SE(1)