|
Before you can be enrolled in this study, the study coordinator
will talk with you to determine your eligibility and answer your
questions and concerns. You will also asked to review, discuss,
and sign a full informed consent document.
What is the purpose of this
research?
Who can participate in the study?
What are the benefits of participation?
How much time is involved?
What
tests are done?
What other things will I be asked
to do?
What are the risks involved with
this research?
What is the purpose
of this research?
The purpose of this research project is to develop
an effective behavioral therapy for urinary incontinence and specifically
to test a self-help treatment, called Knack
therapy. The Knack therapy involes learning the skill of performing
a pelvic muscle contraction simultaneously with an event known to
trigger leakage, such as coughing, exercising, in order to stop
that leakage. This study aims to understand who is and who is not
helped in overcoming long-term incontinence by using the Knack therapy.
back to top >
Who can participate in
the study?
Women who are mildly incontinent, experience leakage
with coughing, sneezing or exercising and are generally healthy,
over the age of eighteen and not pregnant nor expecting to become
pregnant within a year.
back to top >
What are the benefits
of participation?
Women may benefit by learning how to skillfully
use their pelvic muscles. This skill is taught within the context
of a full evaluation including urodynamic testing.
back to top >
How much time is involved?
The first visit is approximately 1 1/2 hours in
length with follow-up visits taking about 30 minutes. All visits
are conducted at the University of Michigan School of Nursing clinical
exam room.
back to top >
What tests are done?
All testing is conducted by a master’s level
or PhD prepared research nurses.
- Each woman is asked to cough while holding
a towelette against her bottom to see how much urine leakage results
from the coughing. A small sensor is placed into the vagina to
measure the strength of the cough. A tiny catheter (barely bigger
than a spaghetti noodle) is used to fill the bladder with 1 cup
of water right before this test.
- A modified pelvic exam determines health of
the muscles that support the pelvic organs. This part of the exam
includes a small speculum, like the kind a gynecologist uses,
inserted into the vagina. The speculum is connected to a computer
and allows measurement of the strength of the pelvic floor muscles
when a woman is asked to lift her muscles against the closed bills
of the speculum.
- Ultrasound measures are taken using a sensor
comfortably placed on the outside of the vagina. The ultrasound
picture allows each woman to see her own pelvic floor muscles
at work. Most women find it fascinating to finally be shown these
hidden muscles and can often improve ability to use the muscles
by seeing first hand how they work.
- Finally, each woman will be tested to determine
the strength of the urethra. This test uses a very thin catheter
with a special sensor on it. It is in place for less than 5 minutes.
The only test that is repeated after the first
visit is the cough test as listed in #1 above.
back
to top >
What other things will
I be asked to do?
You will be asked to record, by diary, your fluid
intake and output habits, for 3 days prior to each clinic visit.
In addition, you will be asked to complete brief questionnaires
prior to each visit.
back to top >
What are the risks
involved with this research?
There may be minor discomfort during the
pelvic exam and urethral testing (catheter placement). Based on
our experience with more than 500 women, we are confident that the
procedures do not involve significant discomfort. Any risk of infection
is addressed by sterilization of equipment before each participant’s
visit according to standard hospital practices. There is a known
2% risk of urinary tract infection following the simple catheterization
procedure that we perform. To reduce this risk, we use sterile procedures
for catheterization, and follow up immediately with antibiotics
should any symptoms occur. However, you may experience problems
or side effects even when precautions are taken to avoid them. If
complications occur, the researchers or University of Michigan will
help arrange for medical treatment, including, if necessary, emergency
treatment. However, this research study does not, pay for these
related medical or other follow-up costs. Therefore, the costs may
be billed to your insurer or you may have to pay for them if your
health insurance does not cover them. You do not waive any right
to seek additional compensation in the event of a personal injury
by participating in this study. Your participation in any aspect
of the study is entirely voluntary. You may decline to proceed with
any test or withdraw completely from the study at any time.
back to top >
|
