Status:
UNKNOWN
Radiofrequency and Pelvic Organ Prolapse
Lead Sponsor:
Fundació d'investigació Sanitària de les Illes Balears
Collaborating Sponsors:
University of the Balearic Islands
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
Aim To compare the effectiveness of the application of non-ablative radiofrequency (RF) applied in combination with the usual treatment for the treatment of pelvic organ prolapse (POP) versus the usua...
Detailed Description
Effectiveness and safety of non-ablative radiofrequency in the treatment of pelvic organ prolapse and its associated symptoms OBJECTIVES Primary To compare the effectiveness of application of non-abla...
Eligibility Criteria
Inclusion
- Women between 18 and 75 years old.
- Women who state symptoms of vaginal prolapse, defined as "sensation of mass or lump" and / or "sensation of dragging in the vagina" and who also have the presence of POP; i.e. descent of one of the anterior, posterior or uterus vaginal walls (cervix) diagnosed under clinical criteria and quantified using the simplified POP-Q assessment system.
Exclusion
- Prolapse vaginal GIV (according to clinical stage evaluated by POP-Q -Pelvic Organ Prolapse Quantification-).
- Presence of more than one POP
- Asymptomatic vaginal prolapse grade IV or less than GI of the cervix or less than or equal to GI of the anterior and / or posterior vaginal Wall
- Women with chronic connective tissue diseases
- Women who present contraindication to the application of RF therapy such as: pregnancy, metallic prostheses within the electric field, decompensated arteriopathies, malignant neoplasms, active infectious processes, pacemakers, loss of thermal sensitivity,….
- Revocation of informed consent
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 23 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04855071
Start Date
April 23 2021
End Date
October 23 2022
Last Update
April 23 2021
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