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NCT Number: NCT06677541

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.

Recruiting

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Key information

Conditions

Pelvic Floor Dysfunction Sexual Dysfunction Female Vibrator

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center

Albany, New York, 12207, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Instructional handout

Other

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

Vibrator

Device

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

Primary outcomes

  1. Female Sexual Function Index

    Time frame: up to 12 weeks

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

Secondary outcomes

  1. Pelvic Floor Distress Inventory -20

    Time frame: up to 12 weeks

    20 question validated survey on pelvic floor dysfunction with lower scores indicating worse outcomes

  2. Pelvic Organ Prolapse incontinence sexual questionnaire 12

    Time frame: up to 12 weeks

    a 12 question validated survey on sexual function in patients with pelvic floor dysfunction with lower scores indicating worse outcomes

  3. sexual satisfaction index

    Time frame: up to 12 weeks

    a validated questionnaire on sexual satisfaction with lower scores indicating worse outcomes

  4. female genitourinary pain index

    Time frame: up to 12 weeks

    validated survey on genitourinary pain in females with lower scores indicating worse outcomes

  5. patient health questionnaire 9

    Time frame: up to 12 weeks

    validated questionnaire on depression with lower scores indicating worse outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Brittany Roberts, MD

CONTACT

[email protected]

3057908544

Erin Deverdis, MD

CONTACT

[email protected]

3152540263

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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