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Sacral nerve stimulation in treatment of fecal incontinence due to rectal hyposensitivity

Sacral nerve stimulation in treatment of adult patients with fecal incontinence due to rectal hyposensitivity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000099729
Enrollment
22
Registered
2013-01-25
Start date
2013-02-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Patients with fecal incontinence due to rectal hyposensitivity will have S3 or S2 sacral nerve stimuation. They will be randomized to either continous stimulation or intermittent stimulation. Score of continence, power of discrimination of flatus and feces and quality of life will be assessed

Interventions

Patients with rectal hyposensitivity usually complain of fecal incontinence. Sacral nerve stimulation might help to increase the sensitivity of rectal mucosa, power of discrimination and continence. Sacral nerve stimulation will be done as a continuous stimulation . Temporary stimulation was performed with unilateral percutaneous nerve evaluation performed by insertion of a stimulating electrode (3065USC; Medtronic, Minneapolis, MN) into the S3 sacral foramen under local anesthesia and/or intrav

Patients with rectal hyposensitivity usually complain of fecal incontinence. Sacral nerve stimulation might help to increase the sensitivity of rectal mucosa, power of discrimination and continence. Sacral nerve stimulation will be done as a continuous stimulation . Temporary stimulation was performed with unilateral percutaneous nerve evaluation performed by insertion of a stimulating electrode (3065USC; Medtronic, Minneapolis, MN) into the S3 sacral foramen under local anesthesia and/or intravenous sedation. Default stimulation parameters were set at 210 microsecond pulse width, 15 Hz frequency, and a subsensory amplitude ranging between 0.5 and 10 V. Stimulation was done for 4 weeks followed by one week OFF. Successful percutaneous nerve evaluation (on basis of clinical improvement as judged by physician and patient) was followed by the offer of permanent stimulation.

Sponsors

Health Insurance Institute
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Adult male or female Fecal incontinence (wexner score < 12) Rectal hyposensitivity (balloon volume to elicit first constant sensation (FCS), defecatory desire volume (DDV), and maximum tolerated volume(MTV). more than normal by 30% or more

Exclusion criteria

Injured anal sphincters Injured pudendal nerve

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026