Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation

General Committee of Teaching Hospitals and Institutes, Egypt

Status: Not yet enrolling

Conditions: Obstructed Defecation

Treatments: Procedure: Bilateral posterior tibial nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07390682

obesity and ODS

Details and patient eligibility

About

Obstructed defecation syndrome (ODS) is a common functional bowel disorder characterized by difficulty in stool evacuation. Bilateral posterior tibial nerve stimulation (BT PTNS) has emerged as a noninvasive, safe, and effective therapeutic option for functional ODS, improving symptom severity and quality of life.

Full description

Obesity is associated with altered pelvic floor mechanics, which may affect the response to neuromodulation therapy. However, the effect of obesity on BT PTNS outcomes in ODS has not been systematically evaluated. This study aims to fill this knowledge gap by comparing treatment efficacy between obese and non-obese patients.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of functional obstructed defecation (Rome IV criteria).
• Able to provide informed consent.
• BMI ≥30 kg/m² (obese group) or BMI <30 kg/m² (non-obese group).

Exclusion criteria

• Organic causes of constipation (e.g., colorectal cancer, inflammatory bowel disease).
• Previous pelvic floor surgery.
• Neurological disorders affecting bowel function.
• Pregnancy or lactation.
• Current use of other neuromodulation therapies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

obese with ODS

Active Comparator group

Description:

BT PTNS in obese patients with ODS

Treatment:

Procedure: Bilateral posterior tibial nerve stimulation

Non obese with ODS

Active Comparator group

Description:

BT PTNS in non-obese patients with ODS

Treatment:

Procedure: Bilateral posterior tibial nerve stimulation