Impact of Obesity on the Efficacy of Bilateral Tibial Nerve Stimulation in Obstructed Defecation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in symptom severity measured by the Modified Obstructed Defecation Score (MODS).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
obese with ODS
BT PTNS in obese patients with ODS
干预措施: Bilateral posterior tibial nerve stimulation (Procedure)
Non obese with ODS
BT PTNS in non-obese patients with ODS
干预措施: Bilateral posterior tibial nerve stimulation (Procedure)
结局指标
主要结局
Change in symptom severity measured by the Modified Obstructed Defecation Score (MODS).
时间窗: 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.
Change in quality of life measured by the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL).
时间窗: 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.
次要结局
- Pelvic floor function(Within 6 weeks of treatment.)
研究者
Mohamed Hany Ashour
Professor of General surgery
General Committee of Teaching Hospitals and Institutes, Egypt