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

April 29, 2026 updated by: Albany Medical College
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized superiority trial designed to evaluate the efficacy of scheduled vibrator use as an adjunct to standard lifestyle and behavioral modifications for urgency urinary incontinence (UUI) or urgency-predominant mixed urinary incontinence (MUI). UUI is defined as involuntary urine leakage preceded by a sudden, compelling urge to void. This will be identified and confirmed by patient report and screening with urgency-related items on the Urogenital Distress Inventory-6 (UDI-6), with participants required to report urgency-related leakage at least once per week.

Eligible participants will be recruited from the Albany Medical Center Urogynecology clinic during routine outpatient visits. After informed consent and baseline assessment, participants will be randomized 1:1 to either (1) lifestyle and bladder training counseling alone (control arm) or (2) lifestyle and bladder training counseling plus scheduled vibrator use (intervention arm). Participants in the intervention group will be instructed to use a provided FDA-registered Class II wellness vibrator for 5-10 minutes at least three times per week over an eight-week period, while all participants will receive standardized bladder retraining education materials. The primary outcome measure will be change in UDI-6 score, Female Sexual Function Index (FSFI), and Brief Pittsburgh Sleep Quality Index (B-PSQI) from baseline to eight weeks. Secondary outcomes will include validated assessments of quality of life and distress, including the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Patient Global Impression of Improvement (PGI-I), Patient Health Questionnaire-4 (PHQ-4).

The study will be conducted at Albany Medical Center, Department of Obstetrics and Gynecology, Division of Urogynecology and Pelvic Reconstructive Surgery, following approval by the Institutional Review Board (IRB).

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vinita Gottipati, MD
  • Phone Number: 518-262-5013
  • Email: gottipv@amc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lifestyle and behavioral modifications
Behavioral: Behavioral modification
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
Experimental: Scheduled vibrator use
Standard behavioral modifications and vibrator use
Behavioral: Behavioral modification
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
Device: Vibrator
Scheduled vibrator use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score on UDI-6 from baseline to follow-up in 8 weeks.
Time Frame: 12 weeks
Submitted
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Female Sexual Function Index (FSFI)
Time Frame: 12 weeks
The Female Sexual Function Index is a 19-item questionnaire assessing domains of sexual function including desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2 to 36, with higher scores indicating better sexual function and lower likelihood of dysfunction.
12 weeks
Brief Pittsburgh Sleep Quality Index (B-PSQI)
Time Frame: 12 weeks
The Brief Pittsburgh Sleep Quality Index is a shortened version of the Pittsburgh Sleep Quality Index that evaluates sleep quality and disturbances over a recent time period. Scores typically range from 0 to 15 (depending on version), with higher scores indicating worse sleep quality.
12 weeks
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Time Frame: 12 weeks
The PISQ-IR assesses sexual function in women with pelvic floor disorders and includes separate scoring for sexually active and non-sexually active individuals. Scores vary by domain, but are generally transformed to a 0-100 scale, with higher scores indicating better sexual function and condition-specific quality of life.
12 weeks
Patient Global Impression of Improvement (PGI-I)
Time Frame: 12 weeks
The Patient Global Impression of Improvement is a single-item scale that asks patients to rate their condition after treatment compared to baseline. It ranges from 1 (very much better) to 7 (very much worse), with lower scores indicating better outcomes/improvement.
12 weeks
Patient Health Questionnaire-4 (PHQ-4)
Time Frame: 12 weeks
The Patient Health Questionnaire-4 is an ultra-brief screening tool combining 2 items for anxiety and 2 for depression. Scores range from 0 to 12, with higher scores indicating greater psychological distress.
12 weeks
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time Frame: 12 weeks
The International Consultation on Incontinence Questionnaire-Short Form evaluates the frequency, severity, and impact of urinary incontinence on quality of life. Scores range from 0 to 21, with higher scores indicating more severe symptoms and worse quality of life impact.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urgency Urinary Symptoms

Clinical Trials on Behavioral modification

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe