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Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Primary Purpose

Anal Incontinence

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Transanal submucosal injection group 1

Transanal submucosal injection group 2

Transanal submucosal injection group 3

About this trial

This is an interventional treatment trial for Anal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Bulkamid injection treatment group 1

Bulkamid injection treatment group 2

Bulkamid injection treatment group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Wexner overall score

Secondary Outcome Measures

FIQL overall score

Adverse events

Full Information

NCT ID

NCT02550899

First Posted

September 12, 2015

Last Updated

January 9, 2016

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT02550899

Brief Title

Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Official Title

Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

Anal Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bulkamid injection treatment group 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Bulkamid injection treatment group 2

Arm Type

Active Comparator

Arm Description

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

Arm Title

Bulkamid injection treatment group 3

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Transanal submucosal injection group 1

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Transanal submucosal injection group 2

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Transanal submucosal injection group 3

Intervention Description

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

Primary Outcome Measure Information:

Title

Wexner overall score

Time Frame

1 year

Secondary Outcome Measure Information:

Title

FIQL overall score

Time Frame

1 year

Title

Adverse events

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Altman, MD, PhD

Organizational Affiliation

Karolinska Institutet Danderyd Hospital

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

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