Visceral Sensitivity in Women With BS and Sexual Dysfunction

NCT04716738 | Unknown

• 1 other identifier: DI/19/107/03/080
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Irritable Bowel Syndrome; Sexual Dysfunction

Keywords

Visceral sensitivity; Barostat; Quality of life; Irritable Bowel Syndrome; Sexual dysfunction; Biological marker

Outcome Measures

Primary Outcomes (1)

• Change on barostat study during 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)

  Second and third visit: Day 7 and day 21 of the menstrual cycle

Secondary Outcomes (2)

• 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

Study Arms (2)

Irritable Bowel Syndrome with Sexual Dysfunction

We use Rome IV criteria, scale bristol and the female sexual fuction to establish IBS and sexual dysfunction diagnosis, and SF-36 to determinated quality of life.

Diagnostic Test: Blood analyses and coprological

Irritable Bowel Syndrome without Sexual Dysfunction

We use Rome IV criteria, scale bristol and the female sexual fuction to establish IBS and sexual dysfunction diagnosis, and SF-36 to determinated quality of life.

Diagnostic Test: Blood analyses and coprological

Interventions

Blood analyses and coprological DIAGNOSTIC_TEST

We will take a blood and stool sample

Irritable Bowel Syndrome with Sexual Dysfunction; Irritable Bowel Syndrome without Sexual Dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with irritable bowel syndrome with and without sexual dysfunction who are cared for in the gastroenterology service of the general hospital of Mexico.

You may qualify if:

• Years And Older,
• Meet The Diagnostic Criteria Of Roma Iv For Ibs ,
• \- Agreeing To Participate In The Study And Sign Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de Mexico: lead
• Miguel Motola Kuba: collaborator
• María de Fátima Higuera de la Tijera: collaborator
• Yoshua Flores Bravo: collaborator

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MeSH Terms

Conditions

Irritable Bowel Syndrome; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Santiago Camacho, MD, MSc

  6761

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santiago Camacho, MD, MSc

CONTACT

+525527462640; santiach@yahoo.com.mx

Miguel Motola, Researcher

CONTACT

+525519484826; drmotola@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: February 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 1, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09