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Urogynecology Clinical Trials

With groundbreaking studies in urogynecology and other gynecologic issues, Cedars-Sinai is committed to research that leads to better treatments and healthier lives for women.

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Interstitial Cystitis/Painful Bladder Syndrome and Overactive Bladder

Condition/Intervention:

Interstitial cystitis/painful bladder syndrome and overactive bladder

Key Inclusion Criteria:
  • Women who are at least 21 years old
  • Has symptoms of IC/PBS or OAB that are clinically diagnosed
  • "Normal" control subjects (without lower urinary tract symptoms)
Summary:

The purpose of this study is to examine interstitial cystitis/painful bladder syndrome (IC/PBS) and overactive bladder (OAB) in women. The study focuses on women who have expressed pain or discomfort with their bladder (IC/PBS) or feel a sudden urge to urinate that is difficult to control, experience urge incontinence, frequent urination or nocturia (excessive urination at night). Participants may also be part of the "normal control" group with neither OAB or IC/PBS, or a control group with only OAB. (A "normal control" means that the participant does not have the condition that is being studied.) Participants will be asked to give a urine sample, among other samples, and complete questionnaires.

Interstitial cystitis is very similar to overactive bladder, with urge to go to the bathroom, frequent urination, or nighttime urination, but overactive bladder does not have bladder pain. Researchers hope that the information on fungal and bacterial species examined in this study may support the development of diagnostic procedures and a better understanding of these diseases in the future.

Female Pelvic Floor Disorders

Condition/Intervention:

Female pelvic floor disorders

Key Inclusion Criteria:
  • Female
  • At least 18 years old, at least 19 years old in Alabama or Nebraska, or at least 20 years old in Puerto Rico
  • Newly selecting surgical or non-surgical (pessary) management of pelvic organ prolapse (POP) in one or more compartments
Summary:

The Pelvic Floor Disorders Registry is a national database for doctors and surgeons who care for patients with pelvic floor disorders. It provides information about the comparative effectiveness of various surgical and nonsurgical treatments and will measure quality of life and safety issues associated with the treatment of these conditions. It will also help to improve the quality of care for women with these conditions.

The study will enroll patients at Cedars-Sinai who have undergone procedures using mesh (either vaginal or abdominal) as well as non-mesh repairs (vaginal and abdominal) and nonsurgical management with pessaries (removable devices), in order to evaluate both mesh and non-mesh repairs and treatments.

Fungal Species in the Genitourinary Tract

Condition/Intervention:

Fungal Species in the Genitourinary Tract

Key Inclusion Criteria:
  • Healthy patients attending routine visits at the Cedars-Sinai Urology Clinic
Summary:

The purpose of this study is to determine what fungi and bacteria are present in the vagina, bladder, external anal canal, and on the skin of healthy women, as well as on the skin and in the bladder and external anal canal of men at different times. This information may help physicians better understand and treat a variety of lower urinary tract conditions and learn the relationships between mycobiome (fungi) and hormonal, medical and lifestyle factors. The study focuses on healthy women and men. Researchers aim to better understand the role of fungi in urinary tract disease by examining healthy volunteers and the relationship of fungal communities in different parts of the body.

Improving Care for Urinary Incontinence

Condition/Intervention:

Urinary incontinence

Key Inclusion Criteria:
  • Female, adult patients who report urinary incontinence and are seeing a primary care physician about the condition
Summary:

This study focuses on patients who have sought care for urinary incontinence from their primary care physician. The purpose of the study is to examine and improve the quality of care for urinary incontinence in women. Researchers aim to determine whether they can improve care by providing additional training and support to primary care physicians and by offering more patient education about the condition.

Participants will be randomly assigned to one of two groups. In the first group, the patient's primary care physician received additional training in the treatment of urinary incontinence and was provided with checklists and indicators of best practices, as well as additional educational materials for the patient. In the second group, the primary care physician did not receive additional education or the educational materials to give to patients; patients will be followed as they receive the care generally followed for individuals with their condition.

Botox in Women with Overactive Bladder

Condition/Intervention:

Overactive bladder

Key Inclusion Criteria:
  • Women who are at least 21 years old
  • Women with overactive bladder symptoms
Summary:

The purpose of this study is to learn how Botox works on patients with overactive bladder. Researchers aim to understand how Botox acts on an overactive bladder by adding magnetic resonance imaging (MRI) technology to routine urodynamics (a test commonly performed in the urologists' office for patients with overactive bladder). In so doing, researchers may better see and document Botox's action on the bladder. The study focuses on patients with overactive bladder who have chosen Botox as a treatment option and who have planned to undergo urodynamics as part of their evaluation.

Stress Urinary Incontinence

Condition/Intervention:

Stress urinary incontinence

Key Inclusion Criteria:
  • Diagnosis of stress urinary incontinence
  • Leakage demonstrated on physical exam and/or a study, and a planned mid-urethral sling surgery
Summary:

The purpose of this study is to determine whether activity needs to be restricted after surgery for patients who have sling surgery. Currently, patients who undergo sling surgery are restricted to six weeks of no activity. Participants will be randomly assigned to one of two groups. One group will be restricted to six weeks of no activity after surgery (standard of care), while the other group will not be restricted at all. Researchers will compare the two groups to learn whether activity restriction contributes to patients' quality of life.

Condition/Intervention:

Stress urinary incontinence

Key Inclusion Criteria:
  • Female
  • At least 18 years old
  • History of stress urinary incontinence
  • Scheduled for outpatient mid-urethral sling procedure at Cedars-Sinai
Summary:

The purpose of this study is to determine whether filling the bladder at the time of sling surgery for stress urinary incontinence results in a shorter hospital stay. Currently, patients who undergo sling surgery are treated in one of two ways. In the first method, the catheter is removed in the operating room, and the bladder is left empty. Alternatively, the catheter is removed in the operating room, and the bladder is left half-full. The study will compare both options, and participants will be randomly assigned to undergo either one of these methods. Researchers aim to determine whether the time to return home and time spent in the recovery room is reduced when the bladder is left half-full.