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Completed

NCT Number: NCT07390682

Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation

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.

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Key information

Conditions

Obstructed Defecation Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, 21531, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Within 6 weeks of treatment.

    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.

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

    Time frame: Within 6 weeks of treatment.

    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.

Secondary outcomes

  1. Pelvic floor function

    Time frame: Within 6 weeks of treatment.

    To assess the impact of obesity on pelvic floor function using electromyography (EMG).

    Electromyograpghy (EMG) a diagnostic test that evaluates the electrical signals between your nerves and muscles to check for neuromuscular problems like nerve damage or muscle diseases. It usually involves two parts: a nerve conduction study (NCS) using surface electrodes to measure nerve signal speed, and a needle EMG where a tiny needle electrode is inserted into a muscle to record its activity at rest and during contraction, revealing abnormalities. To assess amplitude, number of turns and duration of pelvic floor muscle.

Sponsors and collaborators

Lead sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Other Gov

Registry information

Official study title

Impact of Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation in Obstructed Defecation

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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