NCT00971269

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2009

Typical duration for phase_1

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

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 3, 2009

Status Verified

September 1, 2009

Enrollment Period

1.9 years

First QC Date

September 2, 2009

Last Update Submit

September 2, 2009

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Change in fecal incontinence episodes

    Follow up during a four week period and after 6 and 12 months

Secondary Outcomes (1)

  • Side effects related to treatment

    12 months

Interventions

Solesta (Nasha/Dx)DEVICE

Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks

Also known as: Solesta

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, University Hospital

751 82 Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Wilhelm JR Graf, MD PhD

CONTACT

+46(0)18 611 46 06wilhelm.graf@akademiska.se

Study Design

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

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

September 3, 2009

Record last verified: 2009-09

Locations

SE(1)