Pelvic Floor DisordersACE-UPNCT03480477
Adverse Childhood Experiences in Urogynecologic Patients
An observational study of Pelvic Floor Disorders and Interstitial Cystitis, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Interstitial Cystitis, Urinary Incontinence
- What is being tested?
- ACE questionnaire
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- English or Spanish speaking
- Evaluated in Urogynecology Clinic or Gynecology Clinic
Who cannot join
- Currently pregnant
- Incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Clinics
Albuquerque, New Mexico, 87110
About this study
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.
Read the detailed description
Adverse Childhood Experiences (ACEs) are categorized into groups of abuse, neglect, and family/household challenges. This includes psychological, physical or sexual abuse; violence against mother, living with household members who were substance abusers, mentally ill or suicidal, or imprisoned have been shown to impact long term health in adulthood. Patients with a history of ACEs are known to be at increased risk of psychological and medical complications including depression, anxiety, low self-esteem and shame, suicidal thoughts. Medical health-related risks include obesity, chronic pain, fibromyalgia,and diabetes. The Prevalence of ACEs has been evaluated in the general population, however the prevalence in the Urogynecologic and Chronic Pelvic Pain Population have never been explored.
The Urogynecologic and Chronic Pelvic Pain population is a unique population of patients that warrants exploration. It is well known that stress levels, anxiety, and depression are further increased in patient's with Urgency Urinary Incontinence (UUI )(urinary incontinence often times associated with urinary urgency, frequency or nocturia) and overactive bladder (OAB) (urinary urgency, frequency with or without incontinence) patients with a childhood history of trauma. The investigators long-term goal is to improve treatment in the Urogynecologic and Chronic Pelvic Pain population by understanding the contributions to the development of their symptomatology. Understanding childhood experiences can help determine the challenges and development of symptoms such as OAB or Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) (pain attributed to the bladder in the absence of organic causes such as infection, present for 6 weeks) as well as the other Urogynecologic conditions, including urinary incontinence or pelvic organ prolapse.
A key gap in the literature is how childhood experiences such as abuse may be related to Urogynecologic symptoms such as OAB or Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) as well as Chronic Pelvic Pain.
The objective of this research is to describe the prevalence of Adverse Childhood Experience (ACES) in patients in the Urogynecologic and Chronic Pelvic Pain population as well as relative to the control group. The central hypothesis is that women with Interstitial Cystitis and/or OAB as well as Chronic Pelvic Pain will report higher amount of childhood exposures than the control group.
The investigators will test the central hypothesis with the following specific Urogynecologic aims:
Aim #1: To describe the prevalence of ACEs, frequency and type of childhood exposures overall in a population of women with pelvic floor disorders, as well as differences in prevalence in a control group. Hypothesis: 1a. ACE history, based on the BRFSS-ACE Module, will be prevalent in women with pelvic floor disorders and 1b. Specific pelvic floor diagnoses (OAB/UUI +/or IC/Bladder Pain) will more commonly be associated with increased ACEs than the control group.
Aim #2: To describe frequency and ACE types/domains relative to pelvic floor diagnoses (pelvic organ prolapse, stress urinary incontinence, overactive bladder and Interstitial Cystitis/Bladder Pain Syndrome) and in the control group. And to describe their relationship with depression/anxiety and symptom severity based on validated questionnaires. Hypothesis 2a: Women with OAB and/or IC/BPS will more commonly report childhood abuse and will have increased numbers of specific ACE events, compared to the control group. Hypothesis 2b: Increased numbers of ACEs will be associated with increased anxiety, depression and symptom severity in these specific pelvic floor conditions.
The investigators will test the central hypothesis with the following specific Chronic Pelvic Pain aims:
Aim#1: 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. Hypothesis 1: Chronic Pelvic Pain patients have a higher rate of ACEs than controls. Aim #2: 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. Hypothesis #2: Chronic Pelvic Pain patients have an increase in ACEs and ACE domains controls, as well as more symptom severity in depression and anxiety.
- Being tested
- ACE questionnaire
- Keywords
- Adverse Childhood Experiences
- Medical subject headings
- Pelvic Floor Disorders, Cystitis, Interstitial, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE questionnaireOther
No intervention is performed, patients will complete BRFSS Adverse Childhood experiences questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Disorders Group | Will collect patient information from new patients who present to the Urogynecology Clinic Receives: Other: ACE questionnaire | |
| Control Group | Will collect patient information from patients who present to Gynecologic Clinic for their annual examination Receives: Other: ACE questionnaire | |
| Chronic Pelvic Pain Group | Will collect patient information from patients who present to their Chronic Pelvic Pain Clinic appointment Receives: Other: ACE questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: we will enroll patients in the study over the course of one year
Secondary outcomes (1)
Describe the frequency and ACE types/domains
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.
Measured: we will enroll patients in the study over the course of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start9 Apr 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Why it stopped: PI confirmed that this not a Clinical trial and was inadvertently entered in the system
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuko Komesu, University of New Mexico
- Investigators
- Yuko Komesu, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480477
- Sponsor's protocol ID
- 18-010
- Acronym
- ACE-UP
- Status last verified
- Feb 2024
- First submitted
- 21 Mar 2018
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9635069Dube 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.
PubMed 11754674Anda 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.
PubMed 16311898Swift 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.
PubMed 10942459Hendrix 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.
PubMed 12066091Jelovsek 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.
PubMed 16647928Lai 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.
PubMed 27450939Lai 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.
PubMed 27716241Kanter 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.
PubMed 27581769Nickel 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.
PubMed 22154637Jundt 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.
PubMed 16917674Lai 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.
PubMed 26332868Centers 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.
PubMed 21160456
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Childhood Experiences in Urogynecologic Patients
- ClinicalTrials.gov ID
- NCT03480477
- Acronym / sponsor ID
- ACE-UP / 18-010
- Keywords
- Adverse Childhood Experiences
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI confirmed that this not a Clinical trial and was inadvertently entered in the system
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adverse Childhood Experiences (ACEs) are categorized into groups of abuse, neglect, and family/household challenges. This includes psychological, physical or sexual abuse; violence against mother, living with household members who were substance abusers, mentally ill or suicidal, or imprisoned have been shown to impact long term health in adulthood. Patients with a history of ACEs are known to be at increased risk of psychological and medical complications including depression, anxiety, low self-esteem and shame, suicidal thoughts. Medical health-related risks include obesity, chronic pain, fibromyalgia,and diabetes. The Prevalence of ACEs has been evaluated in the general population, however the prevalence in the Urogynecologic and Chronic Pelvic Pain Population have never been explored.
The Urogynecologic and Chronic Pelvic Pain population is a unique population of patients that warrants exploration. It is well known that stress levels, anxiety, and depression are further increased in patient's with Urgency Urinary Incontinence (UUI )(urinary incontinence often times associated with urinary urgency, frequency or nocturia) and overactive bladder (OAB) (urinary urgency, frequency with or without incontinence) patients with a childhood history of trauma. The investigators long-term goal is to improve treatment in the Urogynecologic and Chronic Pelvic Pain population by understanding the contributions to the development of their symptomatology. Understanding childhood experiences can help determine the challenges and development of symptoms such as OAB or Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) (pain attributed to the bladder in the absence of organic causes such as infection, present for 6 weeks) as well as the other Urogynecologic conditions, including urinary incontinence or pelvic organ prolapse.
A key gap in the literature is how childhood experiences such as abuse may be related to Urogynecologic symptoms such as OAB or Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) as well as Chronic Pelvic Pain.
The objective of this research is to describe the prevalence of Adverse Childhood Experience (ACES) in patients in the Urogynecologic and Chronic Pelvic Pain population as well as relative to the control group. The central hypothesis is that women with Interstitial Cystitis and/or OAB as well as Chronic Pelvic Pain will report higher amount of childhood exposures than the control group.
The investigators will test the central hypothesis with the following specific Urogynecologic aims:
Aim #1: To describe the prevalence of ACEs, frequency and type of childhood exposures overall in a population of women with pelvic floor disorders, as well as differences in prevalence in a control group. Hypothesis: 1a. ACE history, based on the BRFSS-ACE Module, will be prevalent in women with pelvic floor disorders and 1b. Specific pelvic floor diagnoses (OAB/UUI +/or IC/Bladder Pain) will more commonly be associated with increased ACEs than the control group.
Aim #2: To describe frequency and ACE types/domains relative to pelvic floor diagnoses (pelvic organ prolapse, stress urinary incontinence, overactive bladder and Interstitial Cystitis/Bladder Pain Syndrome) and in the control group. And to describe their relationship with depression/anxiety and symptom severity based on validated questionnaires. Hypothesis 2a: Women with OAB and/or IC/BPS will more commonly report childhood abuse and will have increased numbers of specific ACE events, compared to the control group. Hypothesis 2b: Increased numbers of ACEs will be associated with increased anxiety, depression and symptom severity in these specific pelvic floor conditions.
The investigators will test the central hypothesis with the following specific Chronic Pelvic Pain aims:
Aim#1: 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. Hypothesis 1: Chronic Pelvic Pain patients have a higher rate of ACEs than controls. Aim #2: 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. Hypothesis #2: Chronic Pelvic Pain patients have an increase in ACEs and ACE domains controls, as well as more symptom severity in depression and anxiety.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Disorders Group | – | Other: ACE questionnaireWill collect patient information from new patients who present to the Urogynecology Clinic |
| Control Group | – | Other: ACE questionnaireWill collect patient information from patients who present to Gynecologic Clinic for their annual examination |
| Chronic Pelvic Pain Group | – | Other: ACE questionnaireWill collect patient information from patients who present to their Chronic Pelvic Pain Clinic appointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- English or Spanish speaking
- Evaluated in Urogynecology Clinic or Gynecology Clinic
Key exclusion criteria (2 listed)
- Currently pregnant
- Incarcerated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE questionnaireNo intervention is performed, patients will complete BRFSS Adverse Childhood experiences questionnaire | Other | Chronic Pelvic Pain Group, Control Group, Pelvic Floor Disorders Group |
Primary outcome
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
1 secondary outcome
Describe the frequency and ACE types/domains
Time frame: we will enroll patients in the study over the course of one year
Results and safety
The study was stopped early (reason given: PI confirmed that this not a Clinical trial and was inadvertently entered in the system). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 9635069Felitti 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.
- Background: PubMed 11754674Dube 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.
- Background: PubMed 16311898Anda 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.
- Background: PubMed 10942459Swift 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.
- Background: PubMed 12066091Hendrix 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.
- Background: PubMed 16647928Jelovsek 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.
- Background: PubMed 27450939Lai 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.
- Background: PubMed 27716241Lai 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.
- Background: PubMed 27581769Kanter 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.
- Background: PubMed 22154637Nickel 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.
- Background: PubMed 16917674Jundt 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.
- Background: PubMed 26332868Lai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuko Komesu, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders and Interstitial Cystitis, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI confirmed that this not a Clinical trial and was inadvertently entered in the system). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: we will enroll patients in the study over the course of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480477, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.