Current Research

Follow these links for information regarding each study:

• The OPTIMAL Study: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: A Randomized trial of Sacrospinous Ligament Fixation (SSFL) versus Uterosacral Ligament Suspension (ULS) with and without Perioperative Behavioral Therapy/Pelvic Muscle Training
  
  
• The E-OPTIMAL Study: Extended Follow-up of Patients Enrolled in OPTIMAL
  
  
• The ABC Study: Anticholinergics versus Botox Comparison in Women with Urge Incontinence
  
  
• The BOOST Study: A Randomized Trial of Behvioral Therapy versus Usual Care in Primiparous Women with Anal Sphincter Tears and Fecal Incontinence

• The OPUS Study: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling

• The E-CARE Study: Extended Follow-up of Patients Enrolled into CARE
  

• Adaptation: Patient Initiated Adaptive Behaviors among Women with Pelvic Floor Disorders
  

The OPTIMAL Study: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: A Randomized trial of Sacrospinous Ligament Suspension (ULS) with and without Perioperative Behavioral Therapy/ Pelvic Muscle Training

Pelvic organ prolapse is a condition where the pelvic organs (the uterus, bladder, rectum or small bowel) sag into or through the vagina, creating a bulge. Pelvic organ prolapse is common and happens to some degree in one-third of women. When pelvic organ prolapse causes symptoms or discomfort, it can be treated with surgery. Stress urinary incontinence is a condition where urine leakage occurs with coughing, laughing and other physical activities and can also be treated with surgery. Pelvic organ prolapse and stress urinary incontinence often occur together and can be treated simultaneously.

The Operations and Pelvic Muscle Training In the Management of Apical support loss (OPTIMAL) trial has two main objectives. The first is to compare two different methods of suspending the prolapsed vagina using a vaginal approach in women with both pelvic organ prolapse and stress urinary incontinence, sacrospinous ligament suspension and uterosacral ligament suspension. Both types of surgery are commonly used but have never been directly compared. The second objective of the trial is to evaluate the value of pelvic muscle training before and after surgery to see if it improves short and long-term results after surgery. Pelvic muscle training is not currently standard of care for women having prolapse surgery, so this study investigates the value of this additional therapy.

The results from the OPTIMAL study will help answer a number of important questions for women with pelvic organ prolapse and stress urinary incontinence who are planning vaginal surgery:

• Which surgical approach is more effective for treating pelvic organ prolapse in women undergoing vaginal surgery: sacrospinous ligament suspension or uterosacral ligament suspension?
• Does the addition of pelvic muscle training before and after surgery improve urinary outcomes in women undergoing vaginal surgery for pelvic organ prolapse and stress urinary incontinence?
• Does the addition of pelvic muscle training before and after surgery improve the long-term success of vaginal prolapse surgery?
• Are the costs to society and patients of routinely performing pelvic muscle training before and after prolapse surgery worth the benefit?

>back to top of page

The E-OPTIMAL Study: Extended Follow-up of Patients Enrolled in OPTIMAL

Women who enrolled in the OPTIMAL 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 purpose of the E-OPTIMAL study is to extend the follow up of women in the OPTIMAL trial for 3 additional years (to continue follow up for 5 years from the time of their prolapsed surgery). In this way, we will learn more about how the prolapse repair surgery affects women over a longer period of time. The women in E-OPTIMAL agree to have a physical exam and complete a telephone interview once a year for 3 additional years.
The results of the E-OPTIMAL study will help answer a number of important questions:

• How successful is the prolapse surgery over 5 years?
• Does pelvic muscle training improve stress urinary incontinence?
• 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-OPTIMAL Study will be. The researchers will study this information over the next several years to help answer these questions.

>back to top of page

The ABC Study: Anticholinergics versus Botox Comparison in Women with Urge Incontinence

ABC stands for Anticholinergic vs. Botox Comparison study. This study will compare the effect of Botox injected into the bladder to pills taken by mouth on improvement in urinary symptoms in women with urge incontinence or overactive bladder. Participation will last six to 12 months.

Many women experience accidental loss of urine called urge incontinence or overactive bladder (OAB). Women describe this as a sudden, strong desire to pass urine that results in leakage before reaching the toilet. Doctors refer to this as detrusor overactivity incontinence. The detrusor muscle is the bladder muscle that contracts to empty the bladder.

In this research study, we will compare how useful Botox injections and bladder medications are in treating overactive bladder symptoms. The bladder medications used in this study have been approved by the FDA (Food and Drug Administration) to treat urge incontinence. While Botox has been approved by the FDA to treat conditions like spastic muscles and wrinkles, it is still considered experimental for treating urge incontinence. Preliminary evidence suggests that it can be helpful.

In this study, all women will undergo injection of study medication (either Botox or placebo) into the bladder muscle through a cystoscope (a thin telescope) into the bladder AND all women will take either active anticholinergic bladder medications or placebo. A placebo is a pill or liquid that looks just like the real medicine, but has no actual medication in it. ALL women in this study will receive active treatment (that is, either Botox or real bladder medication) as well as a placebo. All treatments provided during the course of this study are at no charge to the participants.

For more information on ABC click here.

>back to top of page

BOOST: Behavioral Therapy Of Obstetric Sphincter Tears
A Randomized Trial of Behavioral Therapy versus Usual Care in Primiparous Women with Anal Sphincter Tears and Fecal Incontinence

Sometimes during the course of a vaginal delivery, the baby’s head can tear through part or all of the anal sphincter muscle (called an “obstetric anal sphincter injury). When this happens, the obstetrician repairs the muscle. Most women afterwards do fine, but some women develop leakage of stool (called “fecal incontinence”), which may or may not get better over time. We don’t know whether there is any way to maximize chances for improvement in these women.

The purpose of the study “Behavioral Therapy versus Usual Care in Primiparous Women with Anal Sphincter Tears and Fecal Incontinence: A Randomized Trial" is to study whether behavioral therapy, including pelvic floor muscle training and education on bowel habits, decreases fecal incontinence symptoms in women who have sustained an obstetric anal sphincter injury at the time of their first vaginal delivery.

This trial will help us to determine if a “proactive” approach to managing symptoms starting 6 weeks after delivery reduces fecal incontinence symptoms 6 and 12 months after starting behavioral therapy. Participants will be randomly put into one of two groups: 1) usual care, and 2) behavioral therapy. We will also study the effect of this therapy on other outcomes, including other pelvic floor symptoms, and will find out whether the appearance of the anal sphincter (examined by ultrasound) predicts how women do.

Recruitment for the BOOST trial is scheduled to start June 28, 2010 at all sites in the Pelvic Floor Disorders Network.
For more information please contact the Study Coordinator in your area:

>back to top of page

The OPUS Study: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling

Pelvic organ prolapse is a condition where the pelvic organs (the uterus, bladder, rectum or small bowel) sag into or through the vagina, creating a bulge. Pelvic organ prolapse is common and happens to some degree in one-third of women. When pelvic organ prolapse causes symptoms or discomfort, it can be treated with surgery. Surgery can be done using either a vaginal or abdominal incision. While surgery is quite effective at fixing the symptoms from the bulge, some women develop new stress urinary incontinence (leakage with coughing, sneezing and activities) after surgery.

A prior PFDN randomized trial showed that adding an abdominal anti-leakage surgery (called a Burch colposuspension) at the time of abdominal surgery for pelvic organ prolapse (called abdominal sacrocolpopexy) helped to prevent leakage in some women after surgery, without increasing risk. However, we don’t know if this holds true for women getting vaginal surgery for prolapse, because each type of surgery changes the anatomy of the pelvis differently, and each type of anti-leakage surgery has different risks.

The objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether doing a vaginal anti-incontinence surgery (called the Tension-free Vaginal Tape, or TVT) at the time of vaginal prolapse surgery helps to cut down on urinary incontinence in women without stress urinary incontinence before surgery.

The results from the OPUS study will help answer a number of important questions for women without stress urinary incontinence who are planning vaginal surgery for pelvic organ prolapse:

Is the rate of significant urinary incontinence different between women that get vaginal prolapse repair versus vaginal prolapse repair plus TVT during the first 3 months after the surgery?

A year after surgery, are women equally dry and satisfied whether they get the TVT at the time of prolapse surgery or whether they get treatment for urinary leakage, if needed, during the year after surgery?

Which costs society and patients more: doing a TVT in all women at the time of vaginal prolapse surgery or waiting to treat those that end up with leakage problems after surgery?

>back to top of page

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:

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.

>back to top of page

Adaptation: Patient Initiated Adaptive Behaviors among Women with Pelvic Floor Disorders

It is common knowledge that women with pelvic floor dysfunction will develop, initiate and adopt behaviors which mitigate their symptoms or impairment. For some women, this involves wearing a pad and for others, knowledge of restroom locations. Little is known about the role of such behaviors in helping women adapt to urinary (UI) and fecal incontinence (FI) or pelvic organ prolapse (POP). Additionally, there are no studies that address the persistence of these behaviors following “cure” as measured by traditional outcomes.

Results of a pilot study that assessed quality of life (QOL) in women with pelvic floor disorders (PFD) indicated that women relied heavily on behavioral adaptation in order to cope with PFD symptoms. Subsequently, a draft Adaptation Index was developed with input from investigators of the Pelvic Floor Disorders Network (PFDN). This measure was further refined by focus groups.

We are now validating this tool as a measurement of adaptive behaviors used to reduce symptoms of PFD and to describe the use of adaptive behaviors among women with POP, FI and urinary incontinence (UI). For validation purposes, the Adaptation Index is in use in the OPUS, OPTIMAL, ABBI, BOOST and ABC clinical
trials.

>back to top of page