Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

January 9, 2016 updated by: Daniel Altman, Karolinska Institutet
A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized study to assess the use of Bulkamid for anal incontinence using three different transanal injection techniques .

Patients with anal incontinence severity Wexner score >7. Standardised injection treatment at baseline. Clinical status and subjective symptom evaluation (Wexner score and FIQL) at baseline, 2 months, 6 months and 1 year.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • informed consent, anal incontinence with Wexner score >10

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bulkamid injection treatment group 1
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
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
ACTIVE_COMPARATOR: Bulkamid injection treatment group 2
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
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
ACTIVE_COMPARATOR: Bulkamid injection treatment group 3
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wexner overall score
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 1 year
1 year
FIQL overall score
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Study Director: Daniel Altman, MD, PhD, Karolinska Institutet Danderyd Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

September 12, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (ESTIMATE)

September 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 9, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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