Health TrialsbyHealthPanel

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

ConditionsPelvic Floor DysfunctionSexual Dysfunction FemaleVibrator
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAlbany Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Women aged 18 and over presenting to the urogynecology clinic.

Women diagnosed with one of the following urogynecologic conditions

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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Instructional handout

    Other intervention

    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

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Control armActive comparator 1 intervention
Group B: Intervention armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Female Sexual Function Index

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

Time frame
up to 12 weeks

Secondary outcomes

1

Pelvic Floor Distress Inventory -20

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

Time frame
up to 12 weeks
2

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

Time frame
up to 12 weeks
3

sexual satisfaction index

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

Time frame
up to 12 weeks
4

female genitourinary pain index

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

Time frame
up to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Albany Medical College

Lead sponsor

Source ClinicalTrials.gov
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