NCT03057158

Brief Summary

Millions of women suffer from overactive bladder, and the changes in bladder function affect their quality of life. The study team believes that it needs to be better understand why women get overactive bladder in the first place so that better treatments can eventually be offered. The purpose of this study is to determine why women with insulin resistance are more likely to get overactive bladder. Overactive bladder is a type of bladder control problem that can cause some women to have bladder leakage. This problem is more common in women with diabetes and pre-diabetes, but it isn't known why.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

September 29, 2020

Status Verified

November 1, 2019

Enrollment Period

2.9 years

First QC Date

February 13, 2017

Last Update Submit

September 28, 2020

Conditions

Overactive BladderInsulin Resistance

Keywords

OABInsulin resistancediabetespre-diabetes

Outcome Measures

Primary Outcomes (1)

  • Proportions of differentially methylated CpG sites between cohorts, from Illumina EPIC chip

    Extract DNA from voided urine cells and compare human DNA using Illumina EPIC Methylation Chip to assess methylation of different sites across the genome

    2 years

Secondary Outcomes (3)

  • Compare methylation between DNA extracted from voided urine cells and bladder urothelial biopsies

    2 years

  • Gene expression (from RNA-sequencing)

    2 Years

  • Gene expression (from PCR)

    2 Years

Study Arms (4)

1

Women with Urgency Incontinence (At least three times per week) greater than three months, and without insulin resistance.

2

Women with insulin resistance (pre-diabetes or diabetes based on Hemoglobin A1C).

3

Women with both UUI (at least three times per week for over three months) and Insulin Resistance (pre-diabetes or diabetes based on Hemoglobin A1C).

4

Healthy Volunteers

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will recruit of a total of 450 women from three groups (at least 130 women in each cohort: 1) OAB and IR; 2) IR only; and 3) OAB only) to provide limited clinical information, blood, and urine samples. A subset of these participants (20 from each group, or 60 total) will be further recruited to provide non-muscle invasive (urothelium only) bladder biopsies. Women will be recruited through advertising and from clinical sites at Duke University Health System.

You may qualify if:

  • Women over the age of 18.
  • Urgency incontinence (at least 3 times per week) for \> 3months
  • History of elevated A1C or Type II diabetes (UUI+IR and IR only groups)
  • Non-pregnant
  • At least 6 months since most recent childbirth

You may not qualify if:

  • Active pregnancy, or within 6 months of childbirth
  • Breastfeeding
  • Proteinuria (defined as \>1+ protein on urine dipstick in the absence of infection)
  • Gross hematuria (in the absence of UTI)
  • Type I diabetes mellitus
  • Type II diabetes with chronic renal impairment (Cr \>1.5)
  • Chronic renal disease (includes vasculitis, focal segmental glomerulosclerosis, lupus nephritis, polycystic kidney disease, nephropathy)
  • Receiving chemotherapy or radiation for malignancy
  • Taking one of the following drugs that influence DNA methylation: hydralazine, procainamide, methotrexate, valproic acid, tamoxifen, raloxifene, letrozole, anastrozole (Arimidex), or exemestane (Aromasin)
  • Any history of urinary tract malignancy (bladder, urethra, ureter, kidney)
  • Intradetrusor Botox injection within the prior 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27707, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine and blood samples.

MeSH Terms

Conditions

Urinary Bladder, OveractiveInsulin ResistanceDiabetes MellitusGlucose Intolerance

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Nazema Y Siddiqui, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 17, 2017

Study Start

May 1, 2017

Primary Completion

March 9, 2020

Study Completion

March 11, 2020

Last Updated

September 29, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)