Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation

NCT07390682 | Completed DMC

• 1 other identifier: obesity and ODS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructed Defecation

Keywords

Obesity; Bilateral Tibial Nerve Stimulation; Obstructed Defecation; ODS; BT PTNS

Outcome Measures

Primary Outcomes (2)

• Change in symptom severity measured by the Modified Obstructed Defecation Score (MODS).

  Scale range: 0 to 24 Interpretation: Higher scores indicate more severe obstructed defecation symptoms Unit of measure: Units on a validated symptom severity scale. No aggregation of different measurements into a single reported value is performed. Each scale is analyzed independently. In response to the Advisory Issue, we have included the unabbreviated titles of the scales, their minimum and maximum values, and clarified whether higher scores represent better or worse outcomes for each outcome measure.

  Within 6 weeks of treatment.

• Change in quality of life measured by the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL).

  Scale range: 0 to 96 Interpretation: Higher scores indicate worse constipation-related quality of life Unit of measure: Mean score on a validated quality-of-life scale No aggregation of different measurements into a single reported value is performed. Each scale is analyzed independently. In response to the Advisory Issue, we have included the unabbreviated titles of the scales, their minimum and maximum values, and clarified whether higher scores represent better or worse outcomes for each outcome measure.

  Within 6 weeks of treatment.

Secondary Outcomes (1)

• Pelvic floor function

  Within 6 weeks of treatment.

Study Arms (2)

obese with ODS

ACTIVE COMPARATOR

BT PTNS in obese patients with ODS

Procedure: Bilateral posterior tibial nerve stimulation

Non obese with ODS

ACTIVE COMPARATOR

BT PTNS in non-obese patients with ODS

Procedure: Bilateral posterior tibial nerve stimulation

Interventions

Bilateral posterior tibial nerve stimulation PROCEDURE

* Procedure: BT PTNS will be administered via transcutaneous electrodes placed bilaterally along the posterior tibial nerve at the medial malleolus. * Frequency: 3 sessions per week for 6 weeks (total of 18 sessions). * Duration per Session: 30 minutes. * Monitoring: Patients will be monitored for adverse events during and after each session.

Non obese with ODS; obese with ODS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, 21531, Egypt

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: February 5, 2026
• Study Start: February 15, 2026
• Primary Completion: March 25, 2026
• Study Completion: March 28, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

EG (1)