Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Instructional handout, Vibrator.
- Who it may be relevant to
- Registry conditions: Pelvic Floor Dysfunction, Sexual Dysfunction Female, Vibrator. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Instructional handout
A handout on how to improve sexual dysfunction/function will be provided - Device Vibrator
An FDA approved vibrator device to improve sexual function will be provided
Primary outcome measures
- Female Sexual Function Index [Time frame: up to 12 weeks]
Secondary outcome measures (5)
- Pelvic Floor Distress Inventory -20 [Time frame: up to 12 weeks]
- Pelvic Organ Prolapse incontinence sexual questionnaire 12 [Time frame: up to 12 weeks]
- sexual satisfaction index [Time frame: up to 12 weeks]
- female genitourinary pain index [Time frame: up to 12 weeks]
- patient health questionnaire 9 [Time frame: up to 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Albany Medical Center — Albany
Identifiers
NCT: NCT06677541 · Protocol 7076