Recruiting

Vibrator Use

Sponsor:

Albany Medical College

Code:

NCT06677541

Conditions

Pelvic Floor Dysfunction

Sexual Dysfunction Female

Vibrator

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Instructional handout

Vibrator

Study Details

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

Study ID

NCT06677541

Start date

Nov 1, 2024

Status verified date

Jan, 2025

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control arm

experimental: Intervention arm

Interventions

Instructional handout

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

Vibrator

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

Primary outcome measure

  • Female Sexual Function Index [ Time Frame: up to 12 weeks ]

Central Contacts and Locations

Central contacts

Brittany Roberts, MD

3057908544robertsbrittanylee@gmail.com

Erin Deverdis, MD

3152540263deverde@amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12207

More Information

Sponsor

Albany Medical College

Last update posted

Jan 15, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2025-01-15.