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Pilot Study of NASHA/Dx Gel for Fecal Incontinence

Primary Purpose

Fecal Incontinence

Status
Unknown status
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Solesta (Nasha/Dx)
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Fecal incontinence with at least 2 episodes/week
  2. Symptom duration at least one year
  3. Failed attempt of conservative therapy
  4. Age 18-80
  5. Written informed consent
  6. Available for follow-up
  7. Fully compliant with protocol

Exclusion Criteria:

  1. Active inflammatory bowel disease
  2. Total external sphincter defect at ultrasound and clinical examination
  3. Bleeding diathesis or anticoagulant therapy
  4. Rectal prolapse or intussusceptions
  5. Present anal sepsis
  6. Anorectal implants
  7. Recent anorectal surgery (within 6 months)
  8. Rectal anastomosis
  9. Pregnancy, postpartum (one year) or breast feeding

Sites / Locations

  • Department of Surgery, University HospitalRecruiting

Outcomes

Primary Outcome Measures

Change in fecal incontinence episodes

Secondary Outcome Measures

Side effects related to treatment

Full Information

First Posted
September 2, 2009
Last Updated
September 2, 2009
Sponsor
Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00971269
Brief Title
Pilot Study of NASHA/Dx Gel for Fecal Incontinence
Official Title
A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Uppsala University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Solesta (Nasha/Dx)
Other Intervention Name(s)
Solesta
Intervention Description
Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks
Primary Outcome Measure Information:
Title
Change in fecal incontinence episodes
Time Frame
Follow up during a four week period and after 6 and 12 months
Secondary Outcome Measure Information:
Title
Side effects related to treatment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fecal incontinence with at least 2 episodes/week Symptom duration at least one year Failed attempt of conservative therapy Age 18-80 Written informed consent Available for follow-up Fully compliant with protocol Exclusion Criteria: Active inflammatory bowel disease Total external sphincter defect at ultrasound and clinical examination Bleeding diathesis or anticoagulant therapy Rectal prolapse or intussusceptions Present anal sepsis Anorectal implants Recent anorectal surgery (within 6 months) Rectal anastomosis Pregnancy, postpartum (one year) or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wilhelm JR Graf, MD PhD
Phone
+46(0)18 611 46 06
Email
wilhelm.graf@akademiska.se
Facility Information:
Facility Name
Department of Surgery, University Hospital
City
751 82 Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilhelm JR Graf, MD PhD

12. IPD Sharing Statement

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Pilot Study of NASHA/Dx Gel for Fecal Incontinence

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