Completed

Prevent Inability To Control Urination

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What is being tested

Bladder Health Class

Behavioral
Who is being recruted

Urinary Incontinence

From 55 to 80 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: September 2000

See protocol details

Summary

Principal SponsorUniversity of Michigan
Last updated: January 15, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2000Actual date on which the first participant was enrolled.

The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention. This is a study that will monitor and compare attitudes and strategies that women use to maintain behavior changes that prevent urination problems. Women will complete questionnaires, do muscle strength exercises, and bladder training at 3 months, one year, and 4 years post intervention.

Official TitlePromoting Self -Care to Prevent Urinary Incontinence 
Principal SponsorUniversity of Michigan
Last updated: January 15, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
417 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 55 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urinary Incontinence
Criteria

Inclusion and exclusion criteria 1. Female 55 through 80 years old 2. Post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy. 3. Continent of urine (using the MESA definition of continence) defined as: 1. No previous incontinence episode except during pregnancy and/or postpartum period. 2. Urine loss less than 6 days during the last 365 days 3. No previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy. 4. No history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma. 5. No reported difficulty with activities of daily living, i.e. walking about the house, dressing, getting in/out of bed, getting to/using the toilet, bathing/showering, or eating. Additional criteria are applied at a physical examination: 1. Mini Mental Status of at least 24 2. Negative for objective urine loss during coughing.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
A two-hour bladder health class presented by two experts in urinary incontinence and followed by an individual follow-up teaching session with an incontinence nurse specialist.
Group II
No Intervention
Participants randomized to this arm did not receive any interventions.
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of MichiganAnn Arbor, United StatesSee the location
CompletedOne Study Center