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Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

NCT02550899 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-01-12

No results posted yet for this study

Summary

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

Conditions

  • Anal Incontinence

Interventions

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

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

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

Sponsors & Collaborators

Principal Investigators

  • Daniel Altman, MD, PhD · Karolinska Institutet Danderyd Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02550899 on ClinicalTrials.gov