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Adverse Childhood Experiences in Urogynecologic Patients (ACE-UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480477
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Yuko Komesu, University of New Mexico

Brief Summary:
Adverse Childhood Experiences (ACEs) have been associated with negative health outcomes, yet scant information exists regarding the relationship between ACEs, Pelvic floor disorders, and Chronic Pelvic Pain. Pelvic floor disorders (dysfunction of pelvic floor structures) are increasingly common in women, negatively affect their quality of life, and certain of these are refractory to treatment. Despite scattered reports suggesting an association between childhood abuse and specific pelvic floor disorders, the overall association between ACEs & the spectrum of pelvic floor disorders is unknown. The investigators' previous work suggests that ACEs may be associated with urgency incontinence and work by others suggest ACEs may be associated with Interstitial Cystitis/Bladder Pain Syndrome. These reports are few in number and comprehensive evaluations of ACEs relative to pelvic floor disorders are lacking. The investigators long-term objective is to investigate the relationship between ACEs in patients in the Urogynecologic and Chronic Pelvic Pain population by understanding the contributions to the development of their symptomatology. The current Urogynecology study's Primary Aims are to--1a) Describe the overall prevalence of ACEs, frequency and type of ACEs in a population of women with pelvic floor disorders 1b) Describe differences in ACE prevalence compared to the general population. Secondary Aims are to-2a) Describe ACE types/domains of controls relative to specific pelvic floor diagnoses 2b) Describe their relationship with pelvic floor disorder symptom severity. The investigators central hypothesis is that ACEs are common in women with pelvic floor disorders, that ACE frequency varies by pelvic floor diagnoses, and that ACEs may have profound effects on adult women's quality of life and responsiveness to treatment. The Chronic Pelvic Pain aims, are to 1a) describe the prevalence of ACEs in women with chronic pelvic pain. 1b) To compare the prevalence of ACEs in chronic pain patients to controls. Secondary aims are to 2a) compare the frequency and ACE type/domain of controls relative to chronic pelvic pain patients. 2b) Describe their relationship to depression/anxiety and symptom severity.The positive outcome of this prospective, cross-sectional cohort study will be its description of ACE prevalence in women with pelvic floor disorders and Chronic Pelvic Pain.

Condition or disease Intervention/treatment
Pelvic Floor Disorders Interstitial Cystitis Urinary Incontinence Other: ACE questionnaire

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Study Type : Observational
Actual Enrollment : 356 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Adverse Childhood Experiences in Urogynecologic Patients
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pelvic Floor Disorders Group
Will collect patient information from new patients who present to the Urogynecology Clinic
Other: ACE questionnaire
No intervention is performed, patients will complete BRFSS Adverse Childhood experiences questionnaire

Control Group
Will collect patient information from patients who present to Gynecologic Clinic for their annual examination
Other: ACE questionnaire
No intervention is performed, patients will complete BRFSS Adverse Childhood experiences questionnaire

Chronic Pelvic Pain Group
Will collect patient information from patients who present to their Chronic Pelvic Pain Clinic appointment
Other: ACE questionnaire
No intervention is performed, patients will complete BRFSS Adverse Childhood experiences questionnaire




Primary Outcome Measures :
  1. Prevalence [ Time Frame: we will enroll patients in the study over the course of one year ]
    Report the overall prevalence of ACEs in women with pelvic floor disorders and chronic pelvic pain patients and compare the prevalence of ACEs to a control group


Secondary Outcome Measures :
  1. Describe the frequency and ACE types/domains [ Time Frame: we will enroll patients in the study over the course of one year ]
    To describe frequency & ACE types/domains relative to pelvic floor diagnoses (pelvic organ prolapse, stress urinary incontinence, overactive bladder and Interstitial Cystitis/Bladder Pain) and Chronic Pelvic Pain as well as the control group and to describe their relationship with depression/anxiety & symptom severity based on validated questionnaires.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
For the Urogynecology group, the investigators will recruit patients who present to the University of New Mexico Urogynecology clinics. For the control group, investigators will recruit patients who present to the University of New Mexico gynecology clinic for their annual examination. For the Chronic Pelvic Pain group, patients will be recruited from the University of New Mexico Chronic Pelvic Pain clinic. Participants will be offered study enrollment if they satisfy the inclusion/exclusion criteria. In general, the investigators will recruit study participants at their initial Urogynecology appointment, Chronic Pelvic Pain clinic and participants who present for their annual Gynecologic examination.
Criteria

Inclusion Criteria:

  • English or Spanish speaking
  • Evaluated in Urogynecology Clinic or Gynecology Clinic

Exclusion Criteria:

  • Currently pregnant
  • Incarcerated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480477


Locations
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United States, New Mexico
University of New Mexico Clinics
Albuquerque, New Mexico, United States, 87110
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Yuko Komesu, MD University of New Mexico
Additional Information:
Publications:

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Responsible Party: Yuko Komesu, Associate Professor Obstetrics & Gynecology, University of New Mexico
ClinicalTrials.gov Identifier: NCT03480477    
Other Study ID Numbers: 18-010
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuko Komesu, University of New Mexico:
Adverse Childhood Experiences
Additional relevant MeSH terms:
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Urinary Incontinence
Cystitis
Cystitis, Interstitial
Pelvic Floor Disorders
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Bladder Diseases
Pregnancy Complications