Adverse Childhood Experiences in Urogynecologic Patients

NCT03480477 | Terminated

• 1 other identifier: 18-010
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders; Interstitial Cystitis; Urinary Incontinence

Keywords

Adverse Childhood Experiences

Outcome Measures

Primary Outcomes (1)

• Prevalence

  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

  we will enroll patients in the study over the course of one year

Secondary Outcomes (1)

• Describe the frequency and ACE types/domains

  we will enroll patients in the study over the course of one year

Study Arms (3)

Pelvic Floor Disorders Group

Will collect patient information from new patients who present to the Urogynecology Clinic

Other: ACE questionnaire

Control Group

Will collect patient information from patients who present to Gynecologic Clinic for their annual examination

Other: ACE questionnaire

Chronic Pelvic Pain Group

Will collect patient information from patients who present to their Chronic Pelvic Pain Clinic appointment

Other: ACE questionnaire

Interventions

ACE questionnaire OTHER

No intervention is performed, patients will complete BRFSS Adverse Childhood experiences questionnaire

Chronic Pelvic Pain Group; Control Group; Pelvic Floor Disorders Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Currently pregnant
• Incarcerated

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Clinics

Albuquerque, New Mexico, 87110, United States

Location

Related Publications (13)

• Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

  PMID: 9635069 BACKGROUND

• Dube SR, Anda RF, Felitti VJ, Chapman DP, Williamson DF, Giles WH. Childhood abuse, household dysfunction, and the risk of attempted suicide throughout the life span: findings from the Adverse Childhood Experiences Study. JAMA. 2001 Dec 26;286(24):3089-96. doi: 10.1001/jama.286.24.3089.

  PMID: 11754674 BACKGROUND

• Anda RF, Felitti VJ, Bremner JD, Walker JD, Whitfield C, Perry BD, Dube SR, Giles WH. The enduring effects of abuse and related adverse experiences in childhood. A convergence of evidence from neurobiology and epidemiology. Eur Arch Psychiatry Clin Neurosci. 2006 Apr;256(3):174-86. doi: 10.1007/s00406-005-0624-4. Epub 2005 Nov 29.

  PMID: 16311898 BACKGROUND

• Swift SE. The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care. Am J Obstet Gynecol. 2000 Aug;183(2):277-85. doi: 10.1067/mob.2000.107583.

  PMID: 10942459 BACKGROUND

• Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. doi: 10.1067/mob.2002.123819.

  PMID: 12066091 BACKGROUND

• Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol. 2006 May;194(5):1455-61. doi: 10.1016/j.ajog.2006.01.060.

  PMID: 16647928 BACKGROUND

• Lai HH, Rawal A, Shen B, Vetter J. The Relationship Between Anxiety and Overactive Bladder or Urinary Incontinence Symptoms in the Clinical Population. Urology. 2016 Dec;98:50-57. doi: 10.1016/j.urology.2016.07.013. Epub 2016 Jul 19.

  PMID: 27450939 BACKGROUND

• Lai HH, Shen B, Rawal A, Vetter J. The relationship between depression and overactive bladder/urinary incontinence symptoms in the clinical OAB population. BMC Urol. 2016 Oct 6;16(1):60. doi: 10.1186/s12894-016-0179-x.

  PMID: 27716241 BACKGROUND

• Kanter G, Volpe KA, Dunivan GC, Cichowski SB, Jeppson PC, Rogers RG, Komesu YM. Important role of physicians in addressing psychological aspects of interstitial cystitis/bladder pain syndrome (IC/BPS): a qualitative analysis. Int Urogynecol J. 2017 Feb;28(2):249-256. doi: 10.1007/s00192-016-3109-2. Epub 2016 Aug 31.

  PMID: 27581769 BACKGROUND

• Nickel JC, Tripp DA, Pontari M, Moldwin R, Mayer R, Carr LK, Doggweiler R, Yang CC, Mishra N, Nordling J. Childhood sexual trauma in women with interstitial cystitis/bladder pain syndrome: a case control study. Can Urol Assoc J. 2011 Dec;5(6):410-5. doi: 10.5489/cuaj.11110.

  PMID: 22154637 BACKGROUND

• Jundt K, Scheer I, Schiessl B, Pohl K, Haertl K, Peschers UM. Physical and sexual abuse in patients with overactive bladder: is there an association? Int Urogynecol J Pelvic Floor Dysfunct. 2007 Apr;18(4):449-53. doi: 10.1007/s00192-006-0173-z. Epub 2006 Aug 18.

  PMID: 16917674 BACKGROUND

• Lai HH, Morgan CD, Vetter J, Andriole GL. Impact of childhood and recent traumatic events on the clinical presentation of overactive bladder. Neurourol Urodyn. 2016 Nov;35(8):1017-1023. doi: 10.1002/nau.22872. Epub 2015 Sep 1.

  PMID: 26332868 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Adverse childhood experiences reported by adults --- five states, 2009. MMWR Morb Mortal Wkly Rep. 2010 Dec 17;59(49):1609-13.

  PMID: 21160456 BACKGROUND

Related Links

• Behavioral Risk Factor Surveillance System

MeSH Terms

Conditions

Pelvic Floor Disorders; Cystitis, Interstitial; Urinary Incontinence

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Cystitis; Urinary Bladder Diseases; Urologic Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuko Komesu, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Obstetrics & Gynecology

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: April 9, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

US (1)