Trials / Completed
CompletedNCT03536819
RF Rejuvenation for Pelvic Floor and Vagina
Radio-frequency Rejuvenation for Pelvic Floor and Vagina
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- InMode MD Ltd. · Industry
- Sex
- Female
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for vaginal treatments.
Detailed description
This study will evaluate the effects of radiofrequency on pelvic floor strength and the change in associated symptoms through direct measurement and patient reporting. The patients will undergo two separate evaluation appointments then receive two treatments. One group will receive a sham treatment and the other will receive the treatment. The sham group will be offered treatment at the end of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Votiva | The applicator uses radio-frequency energy to treat the vaginal canal |
Timeline
- Start date
- 2017-11-17
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
- First posted
- 2018-05-25
- Last updated
- 2020-11-18
- Results posted
- 2020-10-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03536819. Inclusion in this directory is not an endorsement.