Brain Areas Involved in Bladder Filling and Contraction

NCT02477241 | Unknown DMC

• 1 other identifier: NL52605.068.15
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive Bladder syndrome (OAB) is a medical condition with symptoms of urgency, with or without incontinence, usually with frequency and nocturia, with no proven infection or obvious pathology 1. This study will explore the relationship between OAB, obstruction and the micro contractions as well as the brain areas involved in both normal desire to void and urgency, gaining a better understanding of the bladder pathophysiology and in the future allowing better strategy of treatment options for patients suffering from OAB.

Conditions

Urinary Bladder, Overactive

Keywords

overactive bladder syndrome; urgency urinary incontinence; fMRI; urodynamics

Outcome Measures

Primary Outcomes (1)

• Bladder pressure changes during the filling phase with water pressure

  urodynamics during the fMRI study.

  up to two hours

Secondary Outcomes (1)

• HADS questionnaire (self-administered) screening for anxiety and depression

  cross-sectional; filling out the HADS questionnaire (15 minutes)

Study Arms (1)

Healthy female subjects

OTHER

Healthy female subjects with or without overactive bladder undergoing functional MRI brain and urodynamic study.

Procedure: Uroflowmetry; Device: fMRI

Interventions

Uroflowmetry PROCEDURE

A cystometric test measures how much urine the bladder can hold, how much pressure builds up inside the bladder as it stores urine, and how full it is when the urge to urinate begins. Uroflowmetry is the measurement of urine speed and volume.

Also known as: urodynamic investigation

Healthy female subjects

fMRI DEVICE

Functional magnetic resonance imaging or functional MRI (fMRI) is a functional neuroimaging procedure using MRI technology that measures brain activity by detecting associated changes in blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases.

Healthy female subjects

Eligibility Criteria

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

You may qualify if:

• Healthy female subjects above 18 years of age.
• Has provided written informed consent prior to any study related procedures.
• Overactive bladder patients
• Female subjects above 18 years of age.
• Has provided written informed consent prior to any study related procedures.
• History of signs and symptoms of OAB including urinary frequency, urgency or urge incontinence for greater than or equal to 3 months.
• At the screening visit, the subject should be either naïve to OAB treatment (e.g. no prior history of medications to treat lower urinary tract symptoms (LUTS), including OAB) or currently on treatment for LUTS (including OAB) and is willing to undergo a washout period for 3 weeks.
• Healthy subjects:

You may not qualify if:

• History of lower urinary tract symptoms (LUTS), including OAB.
• History of stress urinary incontinence, urethral sphincter incompetence and neurogenic detrusor overactivity.
• History of signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).
• History of bladder outlet obstruction (not including detrusor-overactivity) for example bladder/vesico-uterine prolapse (\> grade II) or chronic obstruction.
• History of urinary tract surgery less than or equal to 6 months prior to screening.
• Has an indwelling catheter or permanent catheter fitted.
• History of pelvic area radiotherapy treatment.
• Uncontrolled diabetes mellitus.
• History of fibromyalgia.
• Pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants, injectable contraceptives, sexual abstinence and vasectomized partner).
• Pregnancy within 6 months before screening or breast feeding within 3 months before screening.
• History of positive hepatitis A, B surface antigen, hepatitis C antibody or HIV test results.
• Any use of drugs of abuse within 3 months prior to screening visit.
• History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening visit.
• History of drinking more than 14 units of alcohol per week within 3 months prior to screening visit.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6202AZ, Netherlands

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gommert A. van Koeveringe, M.D. PhD

  Maastricht University Medical Centre, Head of Department of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sajjad Rahnama'i, M.D. PhD

CONTACT

0031433877262; s.rahnamai@mumc.nl

Jamie M. Drossaerts, M.D.

CONTACT

0031433877262; j.drossaerts@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 22, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 22, 2015

Record last verified: 2015-06

Locations

NL (1)