Status:
COMPLETED
Intravaginal Devices for Pelvic Floor Motion
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Renovia, Inc.
Conditions:
Pelvic Floor Disorders
Eligibility:
FEMALE
18-100 years
Phase:
NA
Brief Summary
The leva and PFDx devices accurately reflect pelvic floor motion consistent with TPUS evaluation. During a voluntary PFM contraction, the change in angle from a position of rest to maximal effort that...
Detailed Description
Thirty women 18 years or older will be recruited from OB/GYN, FPMRS or other clinics. Following informed consent and successful screening, subjects will undergo testing as outlined below. Five subject...
Eligibility Criteria
Inclusion
- Female
- 18 years of age or older
- Presence of a vagina
- Ability to read and write English
- BMI \<30
- Reports they are able to perform a kegel exercise
Exclusion
- Inability to perform a kegel exercise
- Pelvic organ prolapse greater than ICS POP-Q Stage II
- Known, untreated pelvic, vaginal or urinary tract infection
- Currently pregnant
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04826939
Start Date
March 25 2021
End Date
September 26 2022
Last Update
June 13 2023
Active Locations (2)
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1
OU Physicians
Oklahoma City, Oklahoma, United States, 73104
2
University ofOklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104