Glossary of terms

Active treatment

The drug being investigated (not placebo)

Anticholinergic

A class of drugs that inhibit the transmission of nerve impulses and thereby reduce muscle spasms in the bladder

Bladder

The muscular balloon-shaped organ that stores urine from the kidney until it is expelled from the body

Catheter

An artificial flexible tube that can be inserted through the urinary opening into the bladder to drain urine that cannot be expelled normally; the catheter can be permanently implanted or inserted intermittently when needed

Clinically stable

The control and maintenance of a disease state, usually through treatment with drugs at a consistent dosage

Clinical trial

Rigorously controlled study of a treatment, which is designed to provide extensive data on the safety and efficacy of the treatment

Detrusor muscle

A muscle in the bladder wall that contracts to expel urine out of the bladder

Dignity study

A controlled clinical trial designed to assess the efficacy and safety of an investigational medication for overactive bladder

Efficacy

The ability of a treatment to produce a desired effect, e.g. the reduction in symptoms of a disorder

Exclusion criteria

Characteristics, such as medical history and existing treatments, that prevent someone from taking part in a clinical trial, usually because they would make it difficult to assess the efficacy of a treatment or because they would put the person at undue risk of worsening illness

Food and Drug Administration, FDA

The U.S. federal agency that is responsible for approving the use of new drugs, based on evidence of efficacy and safety from clinical trials

Frequency

Feeling the urge to urinate even when urination has occurred very recently

Inadequate response

A response to a stimulus (such as a drug) that is not sufficient to be measured or have a meaningful effect

Inclusion criteria

Characteristics, such as specific health problems, that a person must have in order to be able to take part in a clinical trial; they ensure that the participants in the trial are sufficiently similar for comparisons to be made

Incontinence, urinary

The inability to control passage of urine out of the bladder. For the purposes of the Dignity study, a urinary incontinence episode includes each time the patient experiences the involuntary release of urine – even a single drop

Independent Ethics Committee

A group of people who are responsible for helping to protect the rights and welfare of clinical trial participants. Known in the U.S. as an Institutional Review Board, the committee is usually made up of doctors, scientists, religious representatives, and other medical and non-medical people

Informed consent form

A form that provides a detailed description of the study, any possible known risks and benefits of participating, and what is expected of participants; this form needs to be signed by the participant before he or she can take part in the trial

Institutional Review Board

A group of people who are responsible for helping to protect the rights and welfare of clinical trial participants. Known outside the U.S. as an Independent Ethics Committee, the board is usually made up of doctors, scientists, religious representatives, and other medical and non-medical people

Intolerable

Symptoms which are so bad, difficult, or painful that they cannot be endured

Investigational medication

A new medication that is being studied in clinical trials but has not yet been approved by the FDA or other regulatory bodies

Medical history

Information about a person's present and past illnesses and symptoms, the treatments that he or she has taken from them, and the risk factors that he or she has for developing other disorders

MS (multiple sclerosis)

MS is the most common disabling neurological condition affecting young adults. It is the result of damage to myelin - a protective sheath that surrounds nerve fibres of the central nervous system. When myelin is damaged, this interferes with messages between the brain and other parts of the body. For some people, MS is characterized by periods of relapse and remission while for others it has a progressive pattern

Multi-center

Studies that are undertaken at many different surgeries, hospitals or other medical institutions are described as multicenter studies

Nerve

A bundle of fibers that transmit information and instructions to and from the brain. The fibers are either afferent (leading toward the brain) or efferent (leading away from the brain)

Optimized dose

The dose that provides the greatest clinical benefit without producing intolerable side effects

Overactive bladder

A condition where the muscles in the bladder wall contract inappropriately to expel urine, even when the bladder is not full, resulting in a sensation of urgent and frequent need to urinate, which may or may not result in incontinence

Phase III

A stage of research into an investigational treatment in which the treatment is given to larger numbers of patients, after it has been tested in animals ("preclinical"), healthy humans ("phase I") and a limited number of patients with the disorder that it is intended to treat ("phase II"). The Dignity study is phase III

Placebo

An inactive compound that is designed to look just like the investigational medication. It is administered to some participants in clinical trials so that the effects of the investigational medication can be assessed in comparison

Safety

The absence of harmful effects of a treatment

SCI (spinal cord injury)

An SCI is damage or trauma to the spinal cord that results in a loss or impaired function causing reduced mobility or feeling. Common causes of damage are trauma or disease. In most people with SCI, the spinal cord is intact, but the cellular damage to it results in loss of functioning

Side effect

An unwanted medical problem that happens during treatment; also known as adverse event

Sphincter

A circular band of muscle fibers that tightens or closes a natural opening of the body, such as the internal and external urinary sphincters, which control the flow of urine into and out of the bladder

Therapy

The treatment of physical, mental, or behavioral disorders that aims to cure or rehabilitate

Urethra

Tube that drains urine from the bladder out of the body

Urgency

The inability to postpone urination once the need to void has been felt

Urinary incontinence (episode)

Urinary tract

The organs of the body that are involved in the creation and elimination of urine, including the kidneys and bladder