A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes

Completed

Conditions studied: Sexual Dysfunction, Stress Incontinence

In brief

A pilot study to determine the degree and effectiveness of the various modes of vSculpt, an over-the-counter "OTC" medical device, on enhanced genital blood flow and improvement in quality of life in menopausal women who suffer sexual dysfunction and stress incontinence

Key facts

Study ID

NCT02856490

Run by

Joylux, Inc.

People needed

6

Starts

2016-07-01

Expected to finish

2016-12-01

Last updated by the study team

2021-11-24

Who can join

Age: 48 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Study participants will be female
• Female participants who are capable of giving informed consent
• Female participants who are menopausal who have not had a menses within one year, and are within the ages of 48 and 60
• Female participants who have had one or more vaginal births
• Female participants who are currently engaged in vaginal sexual intercourse with a partner
• Female participants who are presently experiencing bladder control issues either leakage, frequency or urgency
• Female participants who are presently experiencing pain during sexual intercourse

You may not qualify if…

• Female participants shall not have an active sexually transmitted disease and/or infection
• Female participants who are actively undergoing chemotherapy
• Female participants who are currently taking any cancer-related drugs
• Female participants who are breastfeeding or lactating
• Female participants who have a medical history of neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
• Female participants with an active urinary tract infection (UTI)
• Female participants with active bladder stones
• Female participants with active bladder tumor(s)
• Females with prior laser or vaginal rejuvenation surgeries or treatments
• Females with a medical history of vaginal cancer or radiation or surgery with exception of related to childbirth
• Females with prior non-invasive treatments (estrogen cream) or pelvic floor physical therapy for the vaginal area/ pelvic floor in the past six month
• Females with a physical disability precluding her from holding a lithotomy for an hour
• Females who are homeless

Where it is running

• San Diego Sexual Medicine — San Diego, California, United States

Full record on ClinicalTrials.gov

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