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Visceral Sensitivity in Women With BS and Sexual Dysfunction

Hospital General de Mexico · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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irritable-bowel-syndromequality-of-life
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 c
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