Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Anal Incontinence Clinical Trial

Official title:

Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550899
• Other study ID #: KIDS
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2015
• Last updated: January 9, 2016
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wexner overall score		1 year	Yes
Secondary	FIQL overall score		1 year	No
Secondary	Adverse events		1 year	Yes