Effect of Vibrator Use on Symptoms of Urgency Urinary Incontinence, Sexual Function, and Sleep

NCT07569822 | Not Yet Recruiting FDA Device

• 1 other identifier: 7438
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to understand if using a vibrator affects urgency related urinary incontinence. Insights from this study may open new recommendations for treating urinary urgency and incontinence.

Conditions

Urgency Urinary Symptoms

Keywords

incontinence

Outcome Measures

Primary Outcomes (1)

• Change in score on UDI-6 from baseline to follow-up in 8 weeks.

  Submitted

  12 weeks

Secondary Outcomes (6)

• Female Sexual Function Index (FSFI)

  12 weeks

• Brief Pittsburgh Sleep Quality Index (B-PSQI)

  12 weeks

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)

  12 weeks

• Patient Global Impression of Improvement (PGI-I)

  12 weeks

• Patient Health Questionnaire-4 (PHQ-4)

  12 weeks

Study Arms (2)

Lifestyle and behavioral modifications

ACTIVE COMPARATOR

Lifestyle and behavioral modifications

Behavioral: Behavioral modification

Scheduled vibrator use

EXPERIMENTAL

Standard behavioral modifications and vibrator use

Device: Vibrator; Behavioral: Behavioral modification

Interventions

Vibrator DEVICE

Scheduled vibrator use

Scheduled vibrator use

Behavioral modification BEHAVIORAL

Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence

Lifestyle and behavioral modifications; Scheduled vibrator use

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Assigned female at birth.
• Age ≥18 years.
• Able to read and speak English.
• Diagnosis of urgency urinary incontinence or mixed urinary incontinence (based on clinical assessment and UDI-6 urgency questions).
• Leaks urine at least once per week due to urgency.
• Postvoid residual volume \<100 mL or a third of the voided volume

You may not qualify if:

• Pelvic organ prolapse beyond the hymen
• Neurogenic bladder, multiple sclerosis, or other neurologic causes of incontinence.
• Recurrent urinary tract infection (\>3 UTIs in the past year or \>2 in the past 6 months).
• Active urinary tract infection at the time of enrollment.
• Interstitial cystitis/bladder pain syndrome.
• Current use of sacral neuromodulation or percutaneous tibial nerve stimulation (PTNS).
• Bladder Botox injection within the past 6 months.
• Vibrator use within the past 3 months.
• Patients uncomfortable with vibrator use
• Pregnancy or plans for pregnancy during the study period.

Sponsors & Collaborators

• Albany Medical College: lead

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Vinita Gottipati, MD

CONTACT

518-262-5013; gottipv@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share