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

Not Applicable

Recruiting

• Conditions: Pelvic Floor Dysfunction; Sexual Dysfunction Female; Vibrator

• Registration Number: NCT06677541
• Lead Sponsor: Albany Medical College

Brief Summary

Limited data exist describing the use and role of vibrators in a urogynecology population and no randomized controlled trials investigating the use of vibrators as a therapeutic tool to enhance sexual and pelvic floor function in urogynecology patients has been conducted. This study aims to evaluate the efficacy of vibrator use in improving sexual and pelvic floor function in urogynecology patients who report sexual dysfunction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-21
• Study Start: 2024-11-01
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-11-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• • Women aged 18 and over presenting to the urogynecology clinic.

  • Women diagnosed with one of the following urogynecologic conditions

    o Pelvic organ prolapse, urgency incontinence, overactive bladder, stress urinary incontinence, fecal incontinence, recovering from a urogynecologic surgery over 6 weeks following surgery and clear for intercourse. Patients post op who continue to have pelvic floor dysfunction can be candidates for the study if they continue to have one of the pelvic floor dysfunctions listed.

  • Patient will be screened with the FSFI and will be eligible if they score less than 26.55

  • Patient's must be willing to use a vibrator.

  • Able to provide informed consent.

  • Not currently using a vibrator or has not used a vibrator in the past 3 months.

  • Able to read and write in English

Exclusion Criteria

• • Patients with cognitive impairment.

  • Patients with refusal or discomfort with vibrator use.
  • Currently using a vibrator or has used a vibrator in the past 3 months.
  • Patients unable to provide informed consent.
  • Patients not clear for intercourse following their surgery
  • Patients with surgery within 2 months of recruitment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index	up to 12 weeks	A 19 question validated survey on sexual function with lower scores indicating worse outcome

Secondary Outcome Measures

Name	Time	Method
Pelvic Floor Distress Inventory -20	up to 12 weeks	20 question validated survey on pelvic floor dysfunction with lower scores indicating worse outcomes
Pelvic Organ Prolapse incontinence sexual questionnaire 12	up to 12 weeks	a 12 question validated survey on sexual function in patients with pelvic floor dysfunction with lower scores indicating worse outcomes
sexual satisfaction index	up to 12 weeks	a validated questionnaire on sexual satisfaction with lower scores indicating worse outcomes
female genitourinary pain index	up to 12 weeks	validated survey on genitourinary pain in females with lower scores indicating worse outcomes
patient health questionnaire 9	up to 12 weeks	validated questionnaire on depression with lower scores indicating worse outcomes

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States