Trials / Unknown
UnknownNCT03714607
Laser Therapy in Managing Vaginal Prolapse
Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- National and Kapodistrian University of Athens · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
Summary
Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage \>1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.
Detailed description
Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Erbium Yttrium Aluminum Garnet (Er:YAG) laser | 5 Er:YAG laser therapies vaginally administered at monthly intervals |
Timeline
- Start date
- 2018-11-30
- Primary completion
- 2019-12-01
- Completion
- 2020-01-01
- First posted
- 2018-10-22
- Last updated
- 2019-09-17
Locations
1 site across 1 country: Greece
Source: ClinicalTrials.gov record NCT03714607. Inclusion in this directory is not an endorsement.