An observational study in Pelvic Floor Disorders, Interstitial Cystitis and Urinary Incontinence, sponsored by University of New Mexico. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by University of New Mexico · Observational
Among 61 studies in Pelvic Floor Disorders with a site in United States — 12 open to participants now, 16 under way, none of them phase 3. Pelvic Floor Disorders · United States.
Among the 61 studies in Pelvic Floor Disorders with a site in United States, this one is the 5th largest by enrollment of the 11 observational ones that give a count, is one of 5 that started in 2018, is one of 11 observational ones, and was the 24th registered.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
Browse Pelvic Floor Disorders studies →12 of the 61 studies in Pelvic Floor Disorders with a site in United States are open now. Recruiting first, the newest first:
Cassandra Kisby · Sites in United States
Ages 21+ · Women only
University of Cincinnati · Sites in United States
Ages 18+ · Women only
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18+ · Women only
Yale University · Sites in United States
Ages 18+ · Women only
University of Miami · Sites in United States
Ages 18–75 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 27 Pelvic Floor Disorders studies recruiting now, 17 (63%) set no upper age limit and 10 (37%) stop at 75 or younger; none take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
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61 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 356 is above the median of 161 across 60 observational studies indexed under Pelvic Floor Disorders.
Median enrollment 57 across the 50 interventional studies, 133 across the 11 observational. Of the 38 that completed or were terminated, 15 (39%) have results posted.
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11 of 61 have an industry lead sponsor. The 10 most frequent:
University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
University of New Mexico has 3 studies filed under Pelvic Floor Disorders — fewer than ten, so there is no comparison to draw.
8 of the studies in Pelvic Floor Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07387315TriHealth Inc.A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections | 2026-11 |
| NCT06689891Yale UniversityVideo-Based Pelvic Floor Muscle Therapy | 2026-12 |
| NCT06111209Brigham and Women's HospitalThe Anabolic Effect of Testosterone on Pelvic Floor Muscles | 2026-12-31 |
| NCT06796985University of MiamiBotox for Chronic Pelvic Pain | 2027-03-22 |
| NCT06798311University of ChicagoReducing Disparities in Urinary Control Symptoms for Minority Women | 2027-05 |
Add all 8 to your calendar (.ics) → With an account.
Among the 61 studies in Pelvic Floor Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Will collect patient information from new patients who present to the Urogynecology Clinic
Other: ACE questionnaire
Will collect patient information from patients who present to Gynecologic Clinic for their annual examination
Other: ACE questionnaire
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
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
Time frame: we will enroll patients in the study over the course of one year
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.
Time frame: we will enroll patients in the study over the course of one year
Plan to share: Undecided
Ran from Apr 2018 to primary completion in Feb 2019, 9 months.
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This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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