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

Albany Medical College

Status: Enrolling

Conditions: Vibrator; Sexual Dysfunction Female; Pelvic Floor Dysfunction

Treatments: Device: Vibrator; Other: Instructional handout

Study type: Interventional

Funder types: Other

Identifiers

NCT06677541

Protocol 7076

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Control arm

Active Comparator group

Treatment:

Other: Instructional handout

Intervention arm

Experimental group

Treatment:

Other: Instructional handout

Device: Vibrator