Anal Incontinence
Conditions
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.
Interventions
PROCEDURETransanal 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
PROCEDURETransanal 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
PROCEDURETransanal 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
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wexner overall score | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| FIQL overall score | 1 year |
| Adverse events | 1 year |
Outcome results
None listed