Patients are invited to participate in any of our many ongoing research studies. These include the use of new therapies such as instillations for overactive bladder symptoms; new measurements with potential of clinical application such as pelvic floor pain sensitivity and endometrial gene expression; as well as testing the interaction between the practice of mindfulness and chronic pelvic pain.
If you are interested in learning more about any of the following, please contact Kristen Pozolo, Study Coordinator, at 847.570.1755 or at kpozolo@northshore.org.
Study Name:
Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Prospective Double-blinded Controlled Trial
Background:
Women with OAB have the unpleasant sensation of needing to urinate urgently and may occasionally lose urine as a result of that urgency. Up to 17% of women in the U.S may suffer from this condition with significant limitations in physical and social activity. Current drugs do not treat everyone and also may have irritating side effects. Our study looks at local anesthetic solution (lidocaine) placed directly into the bladder (with a catheter the size of a small sipping straw) as a new approach for treating this problem. This will be compared with a placebo instillation of harmless salt water for effectiveness and reduced side effects.
Inclusion Criteria:
- Female patient, 18 years of age and older
- Overactive bladder defined as
- Urinary frequency defined as eight or more voids in a 24 hour period > 50% of days of the week
- Symptoms of urgency
- Symptoms of frequency and urgency for at least three months’ duration
Exclusion Criteria:
- Positive urine culture in the past month or more than 3 episodes of bladder infection in the last 2 months
- Stress or overflow urinary incontinence (determined by clinician) if more than 14 episodes of urinary incontinence per week
- Insensate incontinence (urinating in your pants without being aware of it)
- Pregnancy
- Seizure disorder or clinically significant renal disease
- Allergy to Lidocaine
- Univestigated hematuria (blood in urine)
- History of urinary/reproductive tract malignancy
- Post-void residual more than 200 cc
Contact: Please contact Kristen, Study Coordinator, at 847.570.1755 or at kpozolo@northshore.org.
Study name: Novel pelvic floor pain measures to enhance female pelvic pain evaluation
Background: This is an innovative study to determine whether women suffering from painful bladder syndrome (PBS) have increased pelvic floor pain sensitivity, visceral pain sensitivity, and psychological factors as compared to healthy controls. If you participate, you will be asked to come in for a screening visit, an initial assessment and a follow-up assessment. The purpose of this study is to determine if women with chronic pelvic pain have lower tolerance of the pressure caused by a pelvic examination and bladder filling compared to pain-free women. This study uses a new device designed to measure pressure applied to four vaginal muscles and four external muscles.
Inclusion criteria: All participants must be female, between 18-55 years of age. There are 3 groups of subjects in this study. To participate, you must fit into one of the following groups:
1. Pelvic pain: for at least 3 months
2. Painful bladder syndrome (PBS): urgency to urinate occurring >50% of episodes during the daytime OR frequent urination (10 or more times/day) AND pelvic pain of at least 3 months duration.
3. Healthy controls: no regular pelvic pain over the last three months nor urinary urgency or frequency.
Exclusion criteria:
1. Active pelvic or abdominal malignancies (primary or metastatic)
2. Pregnant or have been pregnant in the last three months
3. Active genitourinary infection in the last 4 weeks
4. Unable to read or comprehend the informed consent or written questionnaires (Spanish translation services are available)
5. Unexplained hematuria or known diagnosis of inflammatory cystitis (e.g. radiation-induced, eosinophilic, chemical, tuberculosis).
6. Known active bladder or ureteral calculi
7. Vaginal wall prolapse more than 1 cm beyond the introitus (i.e. excluded if more than Stage II)
8. Menopause (defined as the removal of both ovaries, or the absence of menses for more than a year in the absence of exogenous hormones, a known reversible cause, pregnancy or lactation)
9. Unwillingness to abstain from taking short-acting opioids (ex. hydrocodone or oxycodone) immediately prior (< 3 hours) to any experimental pain assessments, or to stay on the same neurological pain medications during the experiment.
Contact: Please contact Kristen, Study Coordinator, at 847.570.1755 or at kpozolo@northshore.org
Study name: The role of hormonal and neurological factors on endometriosis-associated pelvic pain
Background: This study is focused on a women’s condition known as endometriosis. It is a confusing syndrome clearly associated with female pelvic pain. It is not yet known why tissue from the uterus, when it invades into the inside of the abdomen, causes pain in some women but not in others. We are interested in looking at how uterine gene levels are related to a woman’s symptoms of pelvic pain intensity. This study involves a biopsy of the inside of the uterus, a blood draw, a questionnaire and optional experimental measures of how sensitive you are to pain. If we can pinpoint the genes that cause the pain, we will have a much better understanding of which treatment options to use on endometriosis patients.
Inclusion criteria:
All participants must be female, between 18-45 years of age, who is having regular menstrual periods and is not pregnant. There are 4 groups of subjects in this study. To participate, you must fit into one of the following groups:
1. Endometriosis and Chronic Pelvic Pain: Confirmation of endometriosis from your doctor and the experience of regular pelvic pain over the last three months (this can include pain with urination, bowel movements, sex, or menstrual periods).
2. Endometriosis and NO Chronic Pelvic Pain
3. Chronic pelvic pain with NO Endometriosis
4. Healthy controls: no regular pelvic pain over the last three months
Exclusion criteria:
1. Irregular menstrual cycles or unevaluated abnormal uterine bleeding (i.e. cycles not conforming to 21-35 days in length, without intermenstrual bleeding)
2. Unevaluated clinically-suspected new pelvic masses at time of initial screening exam visit (will need ultrasound to rule out endometrioma, teratoma, leiomyoma, ovarian malignancy, etc.)
3. Use of depot hormonal medications (GnRH agonists, depot medroxyprogesterone acetate, levonorgestrel-containing intrauterine device) and oral contraceptive pills that have not washed out or been removed one month prior to the study assessment
4. Breast-feeding
5. Pregnant
Contact: Please contact Kristen, Study Coordinator, at 847.570.1755 or at kpozolo@northshore.org
Study name: Mindfulness Based Stress Reduction (MBSR) for Chronic Pelvic Pain
Background: This study is being conducted to test whether the practice of mindfulness can help decrease chronic pelvic pain in women. This practice has been tested on other health conditions but has not yet been studied in relation to chronic pelvic pain. This study involves an 8-week guided or unguided MBSR reading program on Jon Kabat-Zinn’s book Full Catastrophe Living as well as saliva sample collection to measure biological indicators of stress.
Inclusion criteria:
1. Diagnosed with a female pelvic pain disorder
2. Over 18 years of age
3. Proficient in English
Exclusion criteria:
1. Serious psychological or cognitive impairment
2. Visually or hearing impaired
Contact: Please contact Kristen, Study Coordinator, at 847.570.1755 or at kpozolo@northshore.org