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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Dysfunction; Sexual Dysfunction Female; Vibrator
• Intervention / Treatment: Other: Instructional handout; Device: Vibrator

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brittany Roberts, MD; Phone Number: 3057908544; Email: robertsbrittanylee@gmail.com
• Study Contact Backup: Name: Erin Deverdis, MD; Phone Number: 3152540263; Email: deverde@amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12207
      • Recruiting
      • Albany Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm	Other: Instructional handout; A handout on how to improve sexual dysfunction/function will be provided; Device: Vibrator; An FDA approved vibrator device to improve sexual function will be provided
Active Comparator: Control arm	Other: Instructional handout; A handout on how to improve sexual dysfunction/function will be provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Function Index	A 19 question validated survey on sexual function with lower scores indicating worse outcome	up to 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Protocol 7076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Uncertain, might be with publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No