A Long-term Evaluation of a Novel Intravaginal Device



Status:Completed
Conditions:Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:30 - 59
Updated:12/5/2018
Start Date:March 6, 2017
End Date:November 29, 2018

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An Open-label Long-term Evaluation of a Novel Intravaginal Device in Female Patients Experiencing Sexual and Bladder Function Issues

An open-label long-term evaluation of a novel intravaginal device in female patients
experiencing sexual and bladder function issues.

To determine the long-term clinical efficacy of the vSculpt therapy on treating the pelvic
floor area and vaginal tissue for females who experience bladder and sexual dysfunction.

Inclusion Criteria:

- All study participants are required to be biological females (genotype XX) to
participate

- Female participants will be of adult age, over 18

- Female participants with self-reported concerns with bladder and sexual function

- Female participants who have reliable and consistent computer and internet access on a
daily basis

Exclusion Criteria:

- Female participants shall not have an active sexually transmitted disease and/or
infection

- Female participants who are actively undergoing chemotherapy or radiation

- Female participants who are currently taking any cancer-related or photosensitivity
drugs

- Female participants who are pregnant, who may think they are pregnant, and/or actively
trying to get pregnant during the clinical study
We found this trial at
2
sites
1101 Madison Street
Seattle, Washington 98104
Phone: 206-799-7123
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Seattle, WA
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2950 Northup Way
Bellevue, Washington 98004
Phone: 425-827-8285
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Bellevue, WA
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