Sexual Dysfunction, Quality of Life and Visceral Hyperalgesia in Women With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Change on barostat study during menstrual cycle
研究概览
简要总结
This study aims to compare visceral rectal sensitivity and quality of life of 40 Irritable Bowel Syndrome women, with (20) and without sexual dysfunction (20). Both Irritable Bowel Syndrome (IBS) and sexual dysfunction (SD), decrease quality of life (QOL) separately, and only recently we have shown that quality of life decreases even more with both diseases. Thus, there is clinical evidence to search for a biological marker that explains this cumulative effect. Investigators will determine IBS using the Rome IV criteria, SD through the Female Sexual Function Index (FSFI) while and QOL through the Short Form-36 and the IBS-QOL. Visceral sensitivity will be evaluated by a barostat study: A small bag connected to a computer is placed in the rectum. This computer will insufflate air increasing the volume and simultaneously record the pressure inside the rectum; therefore investigators can simulate what happens when the stool reaches the rectum. The patient reports the first sensation, gas sensation, need to defecate and even pain. For patient protection the pressure will never exceed 50 mmHg and/or if any amount of pain is reported. To assess the effect of food on this visceral sensitivity, it is performed in 2 stages, fasting and 30 minutes after a standardized meal. The protocol will be carried out through 3 visits. First patients will be recruited; the diagnosis of IBS, SD, quality of life will be established and basic laboratory tests will be schedule before next visit. Second visit will be on day 7 of the menstrual cycle when investigators will carry out the barostat study and determination of blood´s sex hormones. The last visit is for the second barostat study on day 21 of the menstrual cycle with sex hormones measurement. This protocol will compare: Rectal pressure and volume for tone, first sensation, gas sensation, desire to defecate and pain, measure during fasting and postprandial periods in day 7 and 21 (estrogenic and progesterone phase) of the menstrual cycle. Other variables include (age, marital status, disease history, SF-36, IBS-QOL, etc.). This study aims to find a biological marker to explain the low QOL observed in daily clinical practice. This approach will allow us a more effective diagnosis and perhaps the creation of more effective therapeutic approaches to treat these patients. In the long term, we expect to establish the foundations of a patient-centered medicine with shared decision more effective in the gut brain axis disorders.
详细描述
Irritable bowel syndrome (IBS) is characterized by chronic abdominal pain related to alterations in defecation. Although the diagnostic criteria used in various consensuses may mask its true prevalence and incidence, it is known that it suffers between 5 and 15% of the population and it is more than two times more frequent in women. Only 10% of patients seek medical attention and even so it represents between 25 and 50% of gastroenterological visits in the United States. In Mexico the frequency is similar to that reported in the world.
IBS does not have a specific biological marker, but it is known that there are multiple factors involved in its pathophysiology. However, alterations in the gut-brain (GBA) are considered the main mechanism in the generation of symptoms.
The GBA regulates homeostatic functions through a set of organs that form a bidirectional network that links both elements. The neural portion includes peripheral elements (enteric nervous system, ENS), related elements (pairs of spinal and cranial nerves) and central (superior brain nuclei).
The ENS (neurons in the intestinal wall, epithelial and endocrine elements, associated neurotransmitters, and visceral smooth muscle) is the third division of the autonomic nervous system.
Once sensory information is captured in peripheral receptors, the information travels by intrinsic innervation to generate local reflexes in the viscera (absorption, secretion, motility and sensitivity) or by extrinsic innervations of the vagus nerve and thoracolumbar sympathetic afferent pathways towards the spinal medulla.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 Years And Older,
- •Meet The Diagnostic Criteria Of Roma Iv For Ibs ,
- •Agreeing To Participate In The Study And Sign Informed Consent
排除标准
- •Patient With Non-Ibs-Related Visceral Neuropathy
- •Prokinetic And/Or Antidepressant Treatment Within 3 Months
- •Patients With Gastrointestinal Or Ibs-Related Disease
- •Patients With Severe Heart, Kidney And/Or Systemic Diseases
- •Pregnant Or Nursing Patients
结局指标
主要结局
Change on barostat study during menstrual cycle
时间窗: Second and third visit: Day 7 and day 21 of the menstrual cycle
In this procedure, a small bag is placed in the rectum which is connected to a computer. This computer will insufflate air (in mL), measuring the pressure (in mmHg) inside the viscus (in this case the rectum) all time. With this system, a very precise feedback system is created allowing decrease or increase the pressure inside the rectum and thereby provoke the perception in the patient of different sensations. With the barostat we can simulate what happens when the stool reaches the rectum. Thus, the patient can report a first sensation, gas sensation, the need to defecate and even pain (mild, moderate or intense)
次要结局
- General Quality of Life questionnaire (SF-36, Short Form-36)(Baseline)
- Specific Quality of Life questionnaire (IBS-QOL, Irritable Bowel Syndrome-Quality of Life)(Baseline)
研究者
Santiago Camacho
Principal Investigator
Hospital General de Mexico
