Effect of bulking agent on fecal incontinence

Study of efficacy of injectable bulking agent in low anal sphincter tonosity after surgical intervention for rectal prolapse

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015092124104N2

Enrollment

Registered

2015-11-05

Start date

2015-11-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fecal incontinence. fecal incontinence

Interventions

Intervention 1: case group: Exantia injected single dose, submucosally 5cc in anal canal. Intervention 2: control group: no treatment.

Treatment - Drugs

case group: Exantia injected single dose, submucosally 5cc in anal canal.

control group: no treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: inclusion criteria: history of surgical intervention for rectal prolapse; fecal incontinence; no response to medical treatment; low tone anal sphincter exclusion criteria: anorectal malignancy; concurrent perianal disease (abscess, fistula, sepsis); anal sphincter defect >90 degree; sphinctroplasty; IBD; radiation; psychological & cognitive problem

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Fecal incontinence. Timepoint: before , 1month ,6 months after injection. Method of measurement: wexner score.	—

Secondary

Measure	Time frame
Correction of anal sphincter. Timepoint: before intervention , 1 &6 mounth after. Method of measurement: observation of ultrasonic scan.;Pressure of anal sphincter. Timepoint: before intervention , 1 &6 mounth after. Method of measurement: anal manometery.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMirzaei Rezvan

Iran Uviversity of Medical Sciences

rezvan_mirzaei@yahoo.com+98 21 6650 9056

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026