Ongoing Departmental Studies http://www.med.unc.edu/obgyn Interested in participating in one of our studies? Just review this listing of studies currently recruiting patients. daily 1 2013-02-03T08:02:21Z GYN | "LIFE" study for fecal incontinence http://www.med.unc.edu/obgyn/research/ongoing/gyn-life-study-for-fecal-incontinence STUDY BRIEF | The LIFE study is a trial for women experiencing symptoms for Fecal Incontinence (FI). This study is evaluating the use of the investigational LivSure vaginal insert for the control of FI. The insert is non-surgical and does not contain drugs or hormones. It resides in a similar position as a diaphragm or tampon and can be removed by the patient at any time. While in the vagina, the device supports the rectum in a way that may control bowel leakage. Name of Study
"LIFE" Study: LivSure for Fecal Incontinence

Principal Investigator
C. Matthews MD, Division Chief for Urogynecology & Reconstructive Pelvic Surgery

Recruitment Length
March 2013 -

Participation Details
Study participation lasts a minimum of 7 weeks with an optional extension of 12 more weeks for a total of up to 15 weeks. You may have study visits on 4-5 days of your time.

Compensation available?
Yes. Depending on the length of your participation and the number of study visits your payment could be a total of $50 up to $500.

Qualifiers for the study

  • Age 19-75 years old
  • History of FI for at least 6 months
  • At least 4 episodes of FI during a 2-week period

Contact study coordinator for a brief survey to determine your eligibility.
Study Coordinator Phone Number
919-843-2574

IRB Approval Number
13-0961

]]> No publisher Juli B Kidd study Urogyn 2013-03-26T18:08:49Z News Item GYN | A Necessary Multi-Parametric Evaluation of Vulvodynia http://www.med.unc.edu/obgyn/research/ongoing/a-necessary-multi-parametric-evaluation-of-vulvodynia STUDY BRIEF | To develop novel tools and classification algorithms to identify the relative contribution of multiple pain mechanisms in individual patients to enhance diagnosis of vulvodynia and choice of tailored, mechanistic-based treatments. Principal Investigator
D Zolnoun

Recruitment Length
7/2012- 6/2017

Participation Details
2 visits (1 visit at the UNC Dental School and 1 visit at the Women's Hospital)

Compensation available?
Yes

If yes, please list compensation
$200

Qualifiers for the study
Developed new symptoms or experienced exacerbation of existing symptoms of pelvic pain

Exclusion Criteria
Under 21 and over 64, pregnant, hyperthyroidism, epilepsy, rheumatoid arthritis, lupus erhematosis, ulcerative colitis, Crohn's disease, bowel resection

Study Contact Person Name and Number Jasmine Lewis, 1-866-857-9394
Website www.med.unc.edu/ppru

IRB Approval Number
12-1187

]]> No publisher Juli B Kidd study 2013-02-07T19:30:00Z News Item GYN | Metformin for the Treatment of Endometrial Hyperplasia http://www.med.unc.edu/obgyn/research/ongoing/metformin-for-the-treatment-of-endometrial-hyperplasia STUDY BRIEF | Trial to assess the impact of metformin for the treatment of simple or complex endometrial hyperplasia without atypia. Metformin may offer an alternative agent for treatment of endometrial hyperplasia without causing significant side effects common to progesterone-based treatment. Endometrial hyperplasia occurs when the endometrium, the lining of the uterus, becomes too thick. It is not cancer, but in some cases, it can lead to cancer of the uterus. ACOG Patient Information

Principal Investigator
V. Bae-Jump; E. Ko

Recruitment Length
10/1/2012; 12/31/2013

Participation Details
2 clinic visits in 3 months.

Compensation available?
No

Qualifiers for the study
Age 18-75; Diagnosis of endometrial hyperplasia without atypia; normal serum creatinine and liver function tests; no contraindication to metformin.

Exclusion Criteria
Currently taking metformin or metformin use in the past 6 months; current insulin use; liver or kidney dysfunction; history of alcoholism; history B12 deficiency; pregnant.

Study Contact Person Name, Number: Mark Bozymski Pager 919-216-2481, Office 919-966-4432

IRB Approval Number
12-0886

]]> No publisher Juli B Kidd study 2013-02-07T19:30:00Z News Item GYN | Peripheral and Central Mechanisms of Vulvar Vestibulitis Syndrome (VVS) http://www.med.unc.edu/obgyn/research/ongoing/peripheral-and-central-mechanisms-of-vulvar-vestibulitis-syndrome-vvs STUDY BRIEF | To explore the relative contribution of the mucosal and muscle pain sensitivity to clinical pain report among women with vestibulodynia. Principal Investigator
D Zolnoun

Recruitment Length
10/2011-10/2015

Participation Details
2 visits (1 visit at the UNC Dental School and 1 visit at the Women's Hospital)

Compensation available?
Yes

If yes, please list compensation
$40

Qualifiers for the study
Developed new symptoms or experienced exacerbation of existing symptoms of pelvic pain.

Exclusion Criteria
under 21 and over 64, pregnant, hyperthyroidism, epilepsy, rheumatoid arthritis, lupus erhematosis, ulcerative colitis, Crohn's disease, bowel resection.

Study Contact Person Name and Number Jasmine Lewis, 1-866-857-9394
Website www.med.unc.edu/ppru

IRB Approval Number
11-0867

]]> No publisher Juli B Kidd study 2013-02-07T19:30:00Z News Item GYN | VAULT study for pelvic organ prolapse http://www.med.unc.edu/obgyn/research/ongoing/gyn-vault-study-for-pelvic-organ-prolapse STUDY BRIEF | The purpose of this research study is to learn about the effectiveness of 2 surgical techniques for treatment of uterovaginal prolapse: Laparoscopic/ robotic-assisted sacral hysteropexy and Vaginal Uphold Hysteropexy will be compared. Both procedures leave the uterus in place and use mesh to support the uterus and vagina. The cure rates, complications, and improvement of symptoms after these two procedures will be compared. Name of Study
VAULT - Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Uterovaginal Pelvic Organ Prolapse

Principal Investigator
C. Matthews MD - Division Chief for Urogynecology & Reconstructive Pelvic Surgery

Recruitment Length
November 2011 -

Participation Details
Total participation in the study will be completed 1 year after surgery. Assessment with exam and questionnaires will be made at baseline, 3 months, and 12 months after surgery. You will have a routine postoperative examination at 6 weeks after surgery.

Compensation available?
Yes.  Up to $150

Qualifiers for the study
Desires surgical treatment for uterovaginal prolapse; Symptmatic stage II-IV Pelvic Organ Prolapse; Eligible for and undergoing one of the following procedures: laparoscopic sacral hysteropexy (LSHP) or Vaginal Uphold hysteropexy (VUHP); Female age 35-80;

Exclusion Criteria
Contact study coordinator for a brief survey to determine your eligibility

Study Contact Number
919-843-2574

IRB Approval Number
11-2274

]]> No publisher Juli B Kidd study Urogyn 2013-03-26T18:08:44Z News Item Mood, Mother and Infant Study http://www.med.unc.edu/obgyn/research/ongoing/mood-mother-and-infant-study You are invited to help UNC researchers understand how breastfeeding builds bonds between mothers and babies. Click here for details.

]]> No publisher Juli B Kidd study 2013-05-10T17:35:00Z News Item OB | Time to Conceive http://www.med.unc.edu/obgyn/research/ongoing/time-to-conceive STUDY BRIEF | Time to Conceive is a research study that hopes to find a way to accurately measure a woman’s fertility. Women between 30 and 44 years of age who are trying to become pregnant or about to start trying are eligible to participate in the study. Women are not eligible to participate if they or their partner have a history of infertility or fertility treatment. Principal Investigator
A. Steiner

Recruitment Length
April 2008 - January 2015

Participation Details
(1) Study visit (sign Consent forms, provide blood sample and urine sample), (2) Tracking fertility online, (3) Pregnancy testing, (4) Free 7-week ultrasound

Compensation available?
Yes

If yes, please list compensation
Up to $175, depending on study components completed

Qualifiers for the study
Women between 30-44 years of age who are about to start trying, or have been trying for less than 3 months

Exclusion Criteria
(1) If she OR her partner has a history of infertility or fertility treatments, (2) cannot speak or read English, (3) Have used hormone shots in the past year, (4) Have Polycystic Ovarian Disease (PCOS) or a history of Pelvic Inflammatory Disease (PID)

Study Contact Person Name, Number and Email Ashley Calingo, MPH; 919-843-8246; fertility@unc.edu
Website www.timetoconceive.org

IRB Approval Number
08-0423

]]> No publisher Juli B Kidd study 2013-02-07T19:30:00Z News Item WOMENS HEALTH | Physical activity and health lifestyle for cancer survivors and daughters http://www.med.unc.edu/obgyn/research/ongoing/translating-healthy-lifestyle-interventions-for-obesity-related-breast-colorectal-endometrial-cancer-survivors-and-their-daughters STUDY BRIEF | Are you a survivor of Breast, Endometrial or Colorectal Cancer? If yes, we're looking for you! UNC Researchers in the Obstetrics and Gynecology Department are currently recruiting participants to attend a 90 minute focus group to determine the delivery, preferences and preferred components of a physical activity and healthy lifestyle intervention for cancer survivors and special populations. Formal Study Title:
Translating Healthy Lifestyle Interventions for Obesity-related (Breast, Colorectal, Endometrial) Cancer Survivors and their Daughters

Principal Investigator
Dr. W. Nicholson

Recruitment Length
January 2013 to June 2013

Participation Details
Participants will be asked to attend a 90 minute focus group.

Compensation available?
Yes

If yes, please list compensation
Focus group participants will receive a $25 gift card and refreshments.

Qualifiers for the study
Interested participants should be: * Female * African American * 4 months or more post treatment for Breast, Endometrial or Colorectal Cancer

Exclusion Criteria
None.
Study Contact Person Name, Number and Email Project Manager at 919-843-1479 or email lturnbul@email.unc.edu

IRB Approval Number
#12-2313

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