Pelvic Floor DysfunctionNCT06677541
Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients
A study testing Instructional handout and Vibrator in people with Pelvic Floor Dysfunction and Sexual Dysfunction Female, run by Albany Medical College at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Dysfunction, Sexual Dysfunction Female, Vibrator
- What is being tested?
- Instructional handout and Vibrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12207
About this study
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.
- Being tested
- Instructional handout, Vibrator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructional handoutOther
A handout on how to improve sexual dysfunction/function will be provided
VibratorDevice
An FDA approved vibrator device to improve sexual function will be provided
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Not described Receives: Other: Instructional handout |
| Intervention arm | Experimental | Not described Receives: Other: Instructional handout; Device: Vibrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index
A 19 question validated survey on sexual function with lower scores indicating worse outcome
Measured: up to 12 weeks
Secondary outcomes (5)
Pelvic Floor Distress Inventory -20
20 question validated survey on pelvic floor dysfunction with lower scores indicating worse outcomes
Measured: up to 12 weeks
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
Measured: up to 12 weeks
sexual satisfaction index
a validated questionnaire on sexual satisfaction with lower scores indicating worse outcomes
Measured: up to 12 weeks
female genitourinary pain index
validated survey on genitourinary pain in females with lower scores indicating worse outcomes
Measured: up to 12 weeks
patient health questionnaire 9
validated questionnaire on depression with lower scores indicating worse outcomes
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677541
- Sponsor's protocol ID
- Protocol 7076
- Status last verified
- Jan 2025
- First submitted
- 21 Oct 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Uncertain, might be with publication
Publications
Roberts BL, Rogers RG, Leong KA, Carlton CE, Grimes CL, Jacobs BE, Dahl JA, Deverdis EC. Vibrational Interventions for Sexual and Pelvic Health: A Randomized Controlled Trial. Obstet Gynecol. 2026 Aug 27. doi: 10.1097/AOG.0000000000006411. Online ahead of print.
PubMed 42671435
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients
- ClinicalTrials.gov ID
- NCT06677541
- Acronym / sponsor ID
- Protocol 7076
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Other: Instructional handout |
| Intervention arm | Experimental | Other: Instructional handout, Device: Vibrator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Women aged 18 and over presenting to the urogynecology clinic.
- 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.
Key exclusion criteria (6 listed)
- • Patients with cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructional handoutA handout on how to improve sexual dysfunction/function will be provided | Other | Control arm, Intervention arm |
| VibratorAn FDA approved vibrator device to improve sexual function will be provided | Device | Intervention arm |
Primary outcome
Female Sexual Function Index
Time frame: up to 12 weeks
A 19 question validated survey on sexual function with lower scores indicating worse outcome
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 42671435Roberts BL, Rogers RG, Leong KA, Carlton CE, Grimes CL, Jacobs BE, Dahl JA, Deverdis EC. Vibrational Interventions for Sexual and Pelvic Health: A Randomized Controlled Trial. Obstet Gynecol. 2026 Aug 27. doi: 10.1097/AOG.0000000000006411. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Uncertain, might be with publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructional handout and Vibrator in people with Pelvic Floor Dysfunction and Sexual Dysfunction Female, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany Roberts, MD (3057908544, robertsbrittanylee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06677541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.