Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06677541

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

65 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 experience sexual dysfunction. This study addresses the limited existing data and the lack of randomized controlled trials on vibrators as a therapeutic tool in this population. Participants include women diagnosed with conditions such as pelvic organ prolapse, urgency incontinence, overactive bladder, stress urinary incontinence, or fecal incontinence, including those recovering from urogynecologic surgery and cleared for intercourse. Participants will receive either an FDA-approved vibrator device or an instructional handout on improving sexual dysfunction. The intervention involves vibrator use intended to enhance sexual and pelvic floor function. Women must be willing to use the vibrator and must not have used one in the past three months. The study includes screening with the Female Sexual Function Index (FSFI) to identify eligible participants with scores below 26.55. During the study, participants will be monitored for changes in sexual function using the FSFI up to 12 weeks. Researchers will assess sexual and pelvic floor function to evaluate the vibrator's role as a therapeutic tool. Participants must provide informed consent and be able to read and write in English. Safety is monitored, especially for those recovering from surgery, with specific timing restrictions related to recent surgeries and clearance for intercourse.

CONDITIONS

Official Title

Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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 prior and cleared for intercourse
  • Scoring less than 26.55 on the Female Sexual Function Index (FSFI)
  • Willing to use a vibrator
  • Able to provide informed consent
  • Not currently using or have not used a vibrator in the past 3 months
  • Able to read and write in English
Not Eligible

You will not qualify if you...

  • Cognitive impairment
  • Refusal or discomfort 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

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Trial Site Locations

Total: 1 location

1

Albany Medical Center

Albany, New York, United States, 12207

Actively Recruiting

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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

Frequently Asked Questions

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Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients | DecenTrialz