NCT02550899

Brief Summary

A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

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

January 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

September 12, 2015

Last Update Submit

January 9, 2016

Conditions

Anal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Wexner overall score

    1 year

Secondary Outcomes (2)

  • FIQL overall score

    1 year

  • Adverse events

    1 year

Study Arms (3)

Bulkamid injection treatment group 1

ACTIVE COMPARATOR

Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide

Procedure: Transanal submucosal injection group 1

Bulkamid injection treatment group 2

ACTIVE COMPARATOR

injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide

Procedure: Transanal submucosal injection group 2

Bulkamid injection treatment group 3

ACTIVE COMPARATOR

injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide

Procedure: Transanal submucosal injection group 3

Interventions

Transanal submucosal injection group 1PROCEDURE

Transanal submucosal injection using an anoscope using four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide

Bulkamid injection treatment group 1
Transanal submucosal injection group 2PROCEDURE

Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide

Bulkamid injection treatment group 2
Transanal submucosal injection group 3PROCEDURE

Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide

Bulkamid injection treatment group 3

Eligibility Criteria

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

You may qualify if:

  • informed consent, anal incontinence with Wexner score \>10

You may not qualify if:

  • ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Daniel Altman, MD, PhD

    Karolinska Institutet Danderyd Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 12, 2015

First Posted

September 16, 2015

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 12, 2016

Record last verified: 2016-01