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Research & Innovations

Gynecological Cancers

View the complete list of Gynecological Cancer Clinical Trials

Pelvic Organ Prolapse

Title: A prospective randomized trial comparing restorelle Y mesh vs. restorelle dual flat mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy
IRB: 14-354
Treatment: Pelvic Organ Prolapse
Status: Open
Principal Investigator: Cecile Unger, MD
Research Line: 216.445.8090

Title: A randomized control trial on the effect of local analgesia on postoperative gluteal pain in patients undergoing sacrospinous ligament colpopexy
IRB: 13-1413
Treatment: Pelvic Organ Prolapse
Status: Open
Principal Investigator: Cecile Unger, MD
Research Line: 216.445.8090

Title: Evaluation of the use of transvaginal Resorbable biologic mesh as compared to traditional non-mesh surgical repair for treating pelvic floor disorders
IRB: 14-260
Treatment: Pelvic Organ Prolapse
Status: Open
Principal Investigator: Marie Paraiso, MD
Research Line: 216.445.8090

Incontinence

Title: Controlling Anal Incontinence by Performing Anal Exercises with Biofeedback or Loperamide: a Randomized Placebo-Controlled Trial (CAPABLE)
IRB: 13-1503
Treatment: Fecal incontinence
Status: Open
Principal Investigator: Eric Jelovsek, MD
Research Line: 216.445.8090

Title: Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM)
IRB: 13-1061
Treatment: Combined treatment for mixed incontinence (stress and urge)
Status: Open
Principal Investigator: Beri Ridgeway, MD
Research Line: 216.445.8090

Women's Pelvic Pain

Title: Treatment of pain using a non-implanted intra-vaginal electrical stimulation device compared to a vaginal dilator in chronic pelvic pain patients
IRB: 15-150
Treatment: Pelvic pain
Status: Open
Principal Investigator: Elim Shih, MD
Research Line: 216.445.8090

Why is the research study being done?

This research study involves an experimental treatment for chronic pelvic pain. The purpose of this study is to investigate whether a vaginal electrical stimulation device is successful in treating the pain associated with chronic pelvic pain. The device is not FDA approved for chronic pelvic pain. The device is called ApexM and is placed inside the vagina providing non-painful electrical stimulation. We will compare the active device with a sham device that is identical to the ApexM but will not deliver any electrical stimulation.

What is involved if you decide to take part in this research study?

If you decide to be in this study, you will be “randomized” into one of two study groups. Randomization means that you are put into a group by chance, much like a flip of a coin. One study group will use the ApexM and the other will use the sham device. If you enroll, there is no way to guarantee whether you will be assigned to the ApexM group or the sham group.

There is a time commitment associated with entering the study. Each visit in the office will likely last approximately 1 hour with the initial visit slightly longer. The study involves a total of 4 study visits; initial, 4 weeks, 8 weeks, and 12 weeks. At the end of 12 weeks, we will encourage you to resume standard care for your chronic pelvic pain.

If you wish to participate in the research, you will not be permitted to initiate any other new treatments for your chronic pelvic pain. We ask that you do not use any ​new medications for the treatment of your condition while taking part in the study. You may, however, use common over the counter pain medications such as ibuprofen (Advil or Motrin) or acetaminophen (Tylenol).

What are possible benefits of participating in the research?

There are no guaranteed benefits from taking part in this study.​

Are there any costs to you if you participate in this study?

The following research study services are being done only because you are participating in this research study. You will not be billed for the device or any of your research visits.

​Is there any compensation for your time and effort?

You will be compensated $25 at each visit for a total of $100 after four visits. Additionally, you will be provided with parking validation for each research visit.

Not everyone will meet the criteria for participation in this research project. If you are interested, please inquire about this research with your doctor at your upcoming chronic pelvic pain visit.

Gynecologic Oncology

Research in the section of gynecologic oncology has covered the gamut of gynecologic malignancies. We presently have phase 3 trials in ovarian, cervical and endometrial cancers, involving both national cooperative groups from the Gynecologic Oncology Group (GOG) as well as industry trials to assess the standard of care for these diseases. We are participating in phase 1 clinical trials nationally to evaluate cutting edge therapies for cervical and ovarian cancers, including antiangiogenic agents. Our clinical trials cover both primary therapy as well as recurrent disease, with the hope of expanding our knowledge as well as offering our patients unique treatments not offered elsewhere. Finally, our department is also investigating novel MUC1 vaccine agents in the attempt to prevent recurrence of ovarian cancer with some promising results.

Maternal-Fetal Medicine

Research activity in the section of maternal-fetal medicine primarily deals with the pathogenesis of preeclampsia. This includes the putative effects of progesterone on activation of vascular endothelial cells by TNFα, sFlt-1 and sEng, and the role of heme oxygenases and carbon monoxide system. Also, we are studying the potential impact of new insights into the natriuretic peptide system on hypertensive disease in pregnancy. On the clinical side, we continue to participate in the PCOR study (Pregnancy and Cardiovascular Outcomes Registry), which looks at the relationship between certain complications during pregnancy and the development of cardiovascular disease later in life. Finally, we continue to assess the impact of new protocols for aneuploidy screening and patient preferences.

Reproductive Endocrinology & Infertility

The Section of Reproductive Endocrinology and Infertility has an active and varied basic science and clinical research program. Residents at all levels of training are encouraged to participate in ongoing projects. We will also support studies on other topics that they may want to investigate. The following is a list of the areas of research our labs are currently pursuing.

  • Development of 3-D culture models for prolonged in vitro cultivation and maturation of human preantral ovarian follicles.
  • Study of extracellular matrix components and their role in folliculogenesis.
  • Derivation of embryonic stem cell lines using a novel feeder layer.
  • Co-culture models and identification of embryotrophic secretions.
  • Growth factor modulation of embryonic growth, blastocyst differentiation and apoptosis.
  • Non-invasive techniques including time-lapse photography and characterization of embryonic secretions for assessing embryo vitality and predicting clinical outcome.
  • Characterization of endometrial secretions during the window of implantation.
  • Optimizing ovarian tissue cryopreservation and transplantation.
  • Development of methodology for single sperm cryopreservation.
  • DNA fragmentation and hyaluron binding for sperm selection for ICSI.
  • Role of oxidative stress in endometriosis.
  • Role of angiogenic stem cells on endometrial development and IVF success.

For more information on andrology services at Cleveland Clinic Beachwood please visit the Andrology Laboratory Services at Cleveland Clinic Beachwood Fertility Center.

Center for Urogynecology and Reconstructive Pelvic Surgery

The Center for Urogynecology and Reconstructive Pelvic Surgery at Cleveland Clinic includes nationally and internationally recognized scientists and clinician-investigators performing basic, translational and clinical research dedicated to improving the understanding and treatment of pelvic floor disorders such as urinary incontinence, pelvic organ prolapse and fecal incontinence. Highlights of current research activities include:

Women's Health

The Center for Specialized Women’s Health encompasses holistic care of women, often with complex medical conditions, and provides cutting edge evidence based therapies. The research program emphasizes an interdisciplinary approach to the study of women’s health concerns. Collaboration between the multidisciplinary staff at the Center with a diverse group of clinicians from across Cleveland Clinic and Case Western university allows for novel approaches and the dissemination of the latest breakthroughs in women’s health research. Our staff have worked along with the Case Western School of Dentistry to examine periodontal issues in women taking bisphosphonate therapy and with Cleveland Clinic's Department of Radiology to assess compliance with osteoporosis screening. Ongoing areas of study include treatment of osteoporosis, gynecologic concerns after bone marrow transplant, resident education, cervical cancer screening, sexual dysfunction, pelvic organ prolapse and stress incontinence. Additionally, Dr. Holly L. Thacker, MD, is the recipient of a $10,000 research grant from the Healthnetwork Foundation Service Excellence Awards, given annually to 10 top physicians who have consistently gone above and beyond for members. Dr. Thacker also is being recognized for demonstrating a long-term commitment to premium-level patient care and medical research.