Status:
COMPLETED
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Prolapse
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE). Women with symptomatic prolapse (grade I...
Eligibility Criteria
Inclusion
- The presence of POP symptoms
- Diagnosis of cystocele or rectocele of grade II to IV according to the POP-Q system, leading the prolapse (i.e. C ≤ Ba/Bp)
- Voluntary informed consent
Exclusion
- Symptoms or anatomical evidence for intussusception / rectal prolapse
- Leading descent of the middle compartment (C \> Ba/Bp)
- Grade IV prolapse
- Previous POP surgery
- Pregnancy or \<12 months postpartum
- Vaginal bleeding, injuries or infection in the treated area
Key Trial Info
Start Date :
November 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04523298
Start Date
November 8 2020
End Date
December 30 2023
Last Update
May 14 2024
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000