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New wearable gadget aims to curb nighttime bathroom runs

NCT ID NCT07635251

Symptom relief Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test whether a wearable device that stimulates a nerve in the leg can help women with overactive bladder and frequent nighttime urination. Participants will either use the device plus behavioral therapy or behavioral therapy alone. The goal is to see if the device reduces how often they need to urinate and improves sleep quality.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. age ≥20 years old, ≤80 years old, female; 2. patients with overactive bladder (OAB) symptoms for more than 8 weeks; The inclusion criteria were as follows: voiding frequency ≥8 times in 24 hours, urgency attack ≥1 time in 24 hours, nocturnal voiding ≥2 times (OABSS score ≥6 points), and nocturnal polyuria index (NPi) ≤0.33. 3. the patient's physical condition is stable and can be treated at home; 4. All participants volunteered to participate in the study and provided written informed consent before the study began. Exclusion Criteria: 1. Residual urine volume ≥100 mL; 2. difficulty walking; 3. urethral stricture; 4. bladder stones; 5. bladder cancer; 6. urinary tract infection; 7. pregnant, lactating women, women of childbearing age who plan to become pregnant during the study or who do not use safe contraception; 8. pelvic organ prolapse; 9. neuropsychiatric disorders (including cerebrovascular diseases) associated with neurogenic bladder; 10. taking medications for urinary system diseases within 2 weeks before enrollment; 11. patients with mental and cognitive impairment who are unable to cooperate with treatment; 12. other conditions considered by the investigator to be inappropriate for study participation.

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Conditions

The condition(s) this trial relates to.

Nocturia overactive bladder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nocturia Overactive bladder (OAB)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    Jinan, Shandong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.