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

NCT ID: NCT06677541

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Floor Dysfunction Sexual Dysfunction Female Vibrator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm

Group Type ACTIVE_COMPARATOR

Instructional handout

Intervention Type OTHER

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

Intervention arm

Group Type EXPERIMENTAL

Instructional handout

Intervention Type OTHER

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

Vibrator

Intervention Type DEVICE

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

Interventions

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Instructional handout

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

Intervention Type OTHER

Vibrator

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Albany Medical College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Albany Medical Center

Albany, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brittany Roberts, MD

Role: CONTACT

3057908544

Erin Deverdis, MD

Role: CONTACT

3152540263

Other Identifiers

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Protocol 7076

Identifier Type: -

Identifier Source: org_study_id

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