Actively Recruiting
Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients
Led by Albany Medical College · Updated on 2025-01-15
84
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of vibrators to improve sexual and pelvic floor function in women with urogynecologic conditions who report sexual dysfunction. The study addresses a gap in current knowledge as no randomized controlled trials have yet investigated vibrators as a therapeutic tool in this patient group. It is sponsored by Albany Medical College and focuses on women aged 18 and older who have specific pelvic floor disorders or are recovering from urogynecologic surgery and are cleared for intercourse. Participants will be randomly assigned to one of two groups: one receiving an FDA-approved vibrator device and the other receiving an instructional handout on improving sexual function. The study involves monitoring sexual and pelvic floor function over a period of up to 12 weeks. The vibrator group will use the device as part of the intervention to assess its impact compared to standard educational materials. During the study, participants will undergo screening using the Female Sexual Function Index (FSFI) to confirm eligibility and will be evaluated using several questionnaires up to 12 weeks, including measures of sexual function, pelvic floor distress, sexual satisfaction, genitourinary pain, and mental health. Participants must be able to consent, read and write English, and not have used a vibrator in the past three months. The study includes follow-up assessments to monitor outcomes and safety, with total participation lasting up to 12 weeks.
CONDITIONS
Brief Title
Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 and over presenting to the urogynecology clinic
- Diagnosed with pelvic organ prolapse, urgency incontinence, overactive bladder, stress urinary incontinence, fecal incontinence, or recovering from urogynecologic surgery over 6 weeks post-op and cleared for intercourse
- Scoring less than 26.55 on the Female Sexual Function Index
- Willing to use a vibrator
- Able to provide informed consent
- Not currently using or used a vibrator in the past 3 months
- Able to read and write in English
You will not qualify if you...
- Patients with cognitive impairment
- Patients who refuse or are uncomfortable with vibrator use
- Currently using or used a vibrator in the past 3 months
- Unable to provide informed consent
- Not cleared for intercourse following surgery
- Surgery within 2 months of recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive either an instructional handout or an FDA approved vibrator device to improve sexual and pelvic floor function.
1 baseline visit and weekly follow-up visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Albany Medical Center
Albany, New York, United States, 12207
Actively Recruiting
Research Team
B
Brittany Roberts, MD
E
Erin Deverdis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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