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

NCT06677541 | Recruiting DMC FDA Device

• 1 other identifier: Protocol 7076
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Dysfunction; Sexual Dysfunction Female; Vibrator

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index

  A 19 question validated survey on sexual function with lower scores indicating worse outcome

  up to 12 weeks

Secondary Outcomes (5)

• Pelvic Floor Distress Inventory -20

  up to 12 weeks

• Pelvic Organ Prolapse incontinence sexual questionnaire 12

  up to 12 weeks

• sexual satisfaction index

  up to 12 weeks

• female genitourinary pain index

  up to 12 weeks

• patient health questionnaire 9

  up to 12 weeks

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Other: Instructional handout

Intervention arm

EXPERIMENTAL

Other: Instructional handout; Device: Vibrator

Interventions

Instructional handout OTHER

A handout on how to improve sexual dysfunction/function will be provided

Control arm; Intervention arm

Vibrator DEVICE

An FDA approved vibrator device to improve sexual function will be provided

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12207, United States

RECRUITING

Central Study Contacts

Brittany Roberts, MD

CONTACT

3057908544; robertsbrittanylee@gmail.com

Erin Deverdis, MD

CONTACT

3152540263; deverde@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 6, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: January 31, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

US (1)