Current Research
Follow these links for information regarding each study:
The CARE Study: Colpopexy and Urinary Reduction Efforts
The CARE study involves women with pelvic organ prolapse who do not leak
urine. A common prolapse treatment is a surgery called “abdominal
sacral colpopexy.” The CARE study tested whether a procedure for
urinary incontinence (called a “Burch suspension”) should
be done during the prolapse surgery to keep women from leaking urine
in the future.
The women in the study were split into two groups. Half of the women
had only the prolapse surgery. The other half had both the prolapse
surgery and the Burch. All of the women had complete physical exams
that included special bladder testing. The women also answered questions
about their health; bladder, bowel, and prolapse problems; and sexual
function before surgery and several times after that for the next two
years.
Over 300 women agreed to be part of the CARE Study. The CARE Study has
finished enrolling women; in other words, no more women are needed to
join this study. The women who have agreed to be part of the CARE Study
are still being followed for 2 years after their prolapse surgery.
The results of the CARE study have helped answer a number of important
questions:
- Women who received the Burch had significantly less chance of
bothersome stress incontinence after abdominal prolapse surgery.
- There were not more major problems in the women who had the
extra (Burch) surgery.
- One year after the surgery, the women with the Burch continue
to do well.
- Sexual function improves after the prolapse surgery.
The researchers are still working with the information from the CARE
Study to help answer other important research questions. Some of the
results have been published, but more results will be published in medical
journals. A short summary of the current research results is posted
on this website under Research Results. The answers provided by this
study are helping doctors talk to their patients in need of surgery
for prolapse. Together, doctors and their patients will be able to make
the best choice about the type of surgery to have.
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The E-CARE Study: Extended Follow-up of Patients Enrolled into CARE
Women who enrolled in the CARE study agreed to be followed for two years after their surgery. Two years, though, is not enough time to allow doctors to see the benefits over the long-term. The PFDN asked women in the CARE study to join with them in this new effort. Women enrolled in E-CARE are followed for ten years after their surgery. They agree to have a physical exam and complete a telephone interview once a year for ten years.
The results of the E-CARE study will help answer a number of important questions:
- How successful is the prolapse surgery over ten years?
- How does the 'Burch Procedure' affect women's bladder function several
years after their surgery?
- Do some women have complications from the surgery that appear later?
- Which group of women is more likely to need more treatment or surgery
in the future?
- How do these treatments affect women's quality of life over many
years?
It is too soon to tell yet what any of the results of the E-CARE Study will be. The researchers will study this information over the next several years to help answer these questions.
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The CAPS Study: Childbirth
and Pelvic Symptoms
Pregnancy and childbirth can sometimes cause pelvic floor problems. The purpose of the CAPS study is to find out how many women have bladder and bowel leakage after giving birth to their first child.
The anal sphincter muscles normally keep women from passing stool or gas when they do not want to. During childbirth, some women will have a tear that extends from their vagina to the rectum, which tears the anal sphincter muscles. Some women with this kind of tear will start to have bowel problems after childbirth, like passing gas or stool when they do not want to.
Three groups of women were asked to be part of the CAPS Study:
- Women who delivered vaginally and had a tear through the wall of the vagina into the rectum, tearing the anal sphincter muscles.
- Women who delivered vaginally and did not have a tear into the rectum.
- Women who delivered by cesarean section before they were in labor.
Women completed two telephone interviews. The first call was six weeks
after the baby's birth, and the second was 6 months after the birth.
Women were asked about their general health, their bladder and bowel
control, and their quality of life including sexual function.
Over 900 women agreed to be part of the CAPS Study. The CAPS Study has finished enrolling women; in other words, no more women are needed to join this study.
The CAPS study will help answer such questions as:
- How many women in each of the three groups had bladder and bowel problems?
- Does one group have more bladder and bowel problems than the others?
- How do bladder and bowel problems affect women's lives?
- What are the risk factors for having bladder or bowel problems after childbirth?
- What effect does childbirth have on women's quality of life including
sexual functioning?
The researchers are working with the information from the CAPS Study to help answer these questions, and will be publishing the results in medical journals for doctors to learn the answers. Also, a short summary of the research results will be posted on this website. In that way, doctors will have better information to tell women before and after they give birth, in what to expect about bladder and bowel health, and when to get treatment.
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The CAPS Imaging Study: Anatomic Characterization of the External/Internal Anal Sphincter at Six Months Postpartum
Some women in CAPS were asked to join the CAPS Imaging Study after their 6-month telephone interview. The purpose of the CAPS Imaging Study is to learn more about how the pelvic muscles and anal sphincter muscles work after childbirth.
The anal sphincter muscles normally keep women from passing stool or gas when they do not want to. During childbirth, some women will have a tear that extends from their vagina to the rectum, which tears the anal sphincter muscles. Some women with this kind of tear will start to have bowel problems after childbirth, like passing gas or stool when they do not want to.
After agreeing to be in the CAPS Imaging Study, each woman had a pelvic
and rectal exam to check the pelvic muscles and anal sphincter muscles.
The women also had two tests that took pictures of the pelvic muscles
and anal sphincter muscles. The tests are called 'endoanal ultrasound'
and 'pelvic MRI'.
Over 200 women agreed to be part of the CAPS Imaging Study. The CAPS Imaging Study has finished enrolling women; in other words, no more women are needed to join this study.
The results from the CAPS Imaging Study will help answer a number of important questions:
- How many women have a separation in the anal sphincter muscle months after giving birth? Of these, how many tears were first seen and repaired at the time of delivery?
- Do women who have an anal sphincter muscle tear have more bowel problems than women who do not have such a tear?
- Which test (endoanal ultrasound or MRI) is better for showing anal sphincter muscle separation?
- What are the risk factors that cause women to have an anal sphincter tear during childbirth?
The researchers are working with the information from the CAPS Imaging Study to help answer these questions, and will be publishing the results in medical journals for doctors to learn the answers. Also, a short summary of the research results will be posted on this website. With the study results, doctors will have better information to tell women after they give birth if they have had a tear in the anal sphincter muscles, in what to expect about bowel health, and when to get treatment.
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The ATLAS Study: Ambulatory Treatments
for Leakage Associated with Stress. Pessary versus Pelvic Floor Muscle
Therapy versus Combined Therapy: A randomized Controlled Trial of Non-Surgical
Treatment for Stress Urinary Incontinence
Women commonly have symptoms of stress urinary incontinence which is
the uncontrollable leakage of urine with physical effort or stress,
such as coughing, sneezing, or exercise. Treatment for stress incontinence
can be
surgical or non-surgical. Different non-surgical treatments include
pelvic muscle exercises and pessary use. Pelvic muscle exercises (often
known as "Kegel" exercises) train and strengthen the pelvic
muscles and may reduce incontinence by strengthening the muscles that
are used to hold the urethra closed. A pessary is a medical device that
fits inside the vagina to give the urethra and bladder extra support
and prevent or reduce urinary incontinence. Both exercise and pessary
use can help women with stress
incontinence but it is not known which treatment is better, or if a
combination of the two treatments at the same time is best. This study
will determine whether
(1) pelvic muscle training and exercises,
(2) use of a pessary, or
(3) a combination of both exercise and pessary
is most effective at reducing incontinence in women.
Women with stress or mixed urinary incontinence will be randomly assigned
to 1 of 3 groups:
(1) pelvic muscle training and exercise;
(2) pessary use; and
(3) both exercise and pessary.
Women in the exercise groups will have 4 visits over 8 weeks with a
specially trained therapist for pelvic muscle training and exercise.
Women in the pessary group will be fitted with a pessary to be worn
continuously. Assessments will include questionnaires, bladder diary,
and physical examination. Follow-up evaluations occur at 3 months, 6
months (by telephone only), and 1 year after initial treatment.
The level of improvement in symptoms of stress incontinence after treatment
will be compared between the 3 groups. In addition, women in the 3 groups
will record the number of accidental leakage episodes by bladder diary;
and the frequency of those episodes will be compared between the 3 groups.
Other aspects of health, including health-related quality of life, will
also be
compared between the 3 groups.
It is too soon to tell yet what any of the results of the ATLAS Study
will be. The study began in June 2005 and data collection will continue
until August or September of 2008.
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The Colpocleisis Study: Pelvic Symptoms and Patient
Satisfaction After Colpocleisis
Colpocleisis is a type of surgery used to treat severe prolapse. Many women choosing this treatment also have bladder symptoms, sometimes because of their prolapse. Doctors are not sure how these bladder symptoms will change after surgery. The purpose of the Colpocleisis Study is to learn more about how women do after this type of surgery, especially with their bladder health.
Women enrolled in the Colpocleisis Study answer questions about their health and any bladder or bowel problems, before and 1 year after the colpocleisis surgery.
The results of the Colpocleisis Study will help answer a number of important questions:
- How does the colpocleisis surgery affect pelvic support and bladder problems?
- How often do new bladder problems arise after colpocleisis surgery?
- What is the rate of common problems linked to colpocleisis surgery?
- How does colpocleisis surgery affect the quality of women's lives?
- How satisfied are women after the colpocleisis surgery?
- What risk factors are linked to problems after colpocleisis surgery?
The results of the Colpocleisis Study will help doctors explain this
surgery to their patients, so women have better information about what
to expect after colpocleisis surgery. The results may help doctors decide
how best to treat women with prolapse and bladder control problems.
It is too soon to tell yet what any of the results of the Colpocleisis
Study will be. The researchers will study this information over the
next few years to help answer these questions.
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The Voiding Study: Voiding Function in Women
with Pelvic Organ Prolapse and Urinary Incontinence
Women who have pelvic organ prolapse may also have bladder problems.
These bladder symptoms include:
- Urine leakage when coughing, sneezing, or laughing
- Urine leakage with a strong urge to urinate (not having enough time
to get to the bathroom before leaking, or worrying that urine leakage
might happen on the way to the bathroom)
- Too frequent urination during the day and at night
- Trouble emptying the bladder or feeling that the bladder doesn’t
empty completely
Some women with prolapse have one or more of these symptoms, but some
women with prolapse have none of these symptoms.
The purpose of the Voiding Study is to look closely at bladder function
in women with prolapse. These women will have special bladder testing
called 'urodynamic testing' to see if there are any bladder problems
along with the prolapse.
Over 150 women agreed to be part of the Voiding Study. The Voiding
Study has finished enrolling women; in other words, no more women are
needed to join this study.
The Voiding Study will help answer these questions:
- Do women with more severe prolapse have more bladder symptoms?
- Can testing point out women who have bladder symptoms before surgery
and those who do not have symptoms?
- How do bladder symptoms affect women's quality of life?
The researchers are working with the information from the Voiding Study
to help answer these questions, and will be publishing the results in
medical journals for doctors to learn the answers. Also, a short summary
of the research results will be posted on this website. The results
from the Voiding Study will help doctors better understand how the bladder
works in women with prolapse.
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