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Effect of biofeedback with or without Electrical Stimulation in patients with anal incontinence: a randomized clinical trial

Effect of electromyographic biofeedback, with or without Transcutaneous Sacral Electrical Stimulation, in patients with anal incontinence: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10qk7nbp
Enrollment
60
Registered
2026-07-23
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pelvic Floor Fecal incontinence

Interventions

This is a two-arm, randomized controlled clinical trial employing simple random sampling
it is an open-label study (without masking), and the randomization process was carried out digitally. A pseudo-random algorithm via the Invertexto web tool was used to generate numbers corresponding t

Sponsors

Empresa Brasileira de Serviços Hospitalares
Lead Sponsor
Hospital das Clínicas da Universidade Federal de Goiás
Collaborator

Eligibility

Sex/Gender
Female
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Women; with symptoms of anal incontinence; aged between 40 and 80 years

Exclusion criteria

Exclusion criteria: Being pregnant; having given birth less than three months ago; having performed pelvic floor exercises in the past three months; and having a neurological disease that compromises cognitive function and/or the innervation of the pelvic floor

Design outcomes

Primary

MeasureTime frame
The treatment group is expected shows greater improvement in the reduction of fecal loss and in the gain of pelvic floor muscle strength

Secondary

MeasureTime frame
The treatment group is expected shows improvement in several domains of quality of life compared to the control group;To test whether physical therapy treatment promotes changes in resting pressures, voluntary contraction, capacity, and rectal sensitivity;To test whether physical therapy treatment promotes improvement in quality of life and the severity of anal incontinence;To identify whether there are sociodemographic, clinical, and lifestyle factors associated with anal incontinence;Identify the factors associated with anal incontinence;To describe the sociodemographic profile of patients with anal incontinence;To determine whether there is an association between quality of life and the severity of anal incontinence

Countries

BR

Contacts

Public ContactElicéia Batista

Hospital das Clínicas da Universidade Federal de Goiás

eliceiabatista@gmail.com+55 (62) 3644-8997

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026