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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
* 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.
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, Egypt
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.
Time frame: 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.
Time frame: Within 6 weeks of treatment.
Pelvic floor function
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.
Time frame: Within 6 weeks of treatment.
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