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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAlbany Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vibrator

    Device

    Scheduled vibrator use

  • Behavioral modification

    Behavioral

    Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Lifestyle and behavioral modificationsActive comparator 1 intervention
Group B: Scheduled vibrator useExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Submitted

Time frame
12 weeks

Secondary outcomes

1

Female Sexual Function Index (FSFI)

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.

Time frame
12 weeks
2

Brief Pittsburgh Sleep Quality Index (B-PSQI)

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.

Time frame
12 weeks
3

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

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.

Time frame
12 weeks
4

Patient Global Impression of Improvement (PGI-I)

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.

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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