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A simple ultrasound test might predict who suffers most from stent pain

NCT ID NCT07763613

Knowledge-focused Sponsor: Trabzon Kanuni Education and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This observational study tests a new ultrasound-based measure called the Pelvic Floor Fatigue Index (PFFI), which gauges how quickly pelvic floor muscles tire. Researchers will measure PFFI in 75 adults before they undergo ureteroscopy or retrograde intrarenal surgery for kidney stones, followed by placement of a ureteral stent. They will then see if a higher PFFI (more fatigable muscles) correlates with worse stent-related symptoms, as reported on a questionnaire 10 days after surgery. The study also checks whether the PFFI measurement is consistent when repeated, aiming to validate it as a useful clinical tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pelvic Floor Fatigue Index (PFFI) measurement via ultrasound
What this could lead to
If the PFFI proves reliable, it could become a standard tool to predict which patients may suffer more from stent discomfort, enabling personalized care.
What could go wrong
This is a small observational study, so the index may not strongly predict symptoms or may not be reproducible in broader populations. It does not test any treatment.

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.

Participants

About 75 people

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

Started

Aug 2026

Expected to finish

Dec 2026

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.

Who is studied

Adult patients with urolithiasis scheduled to undergo ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with postoperative double-J ureteral stent placement at the study center. Eligible participants will undergo standardized transabdominal ultrasonographic assessment of pelvic floor fatigability before surgery and will complete postoperative ureteral stent symptom assessment according to the study protocol.

Ages

18 to 65 years

Sex

Anyone

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: Adults aged 18-65 years. Diagnosis of urolithiasis requiring ureteroscopy (URS) or retrograde intrarenal surgery (RIRS). Planned postoperative double-J ureteral stent placement. Patients belonging to either the Non-pre-stented Group or the Pre-stented Group according to the study protocol. Ability to read and understand the validated Turkish version of the Ureteral Stent Symptom Questionnaire (USSQ). Ability to independently complete the USSQ. Ability to perform an adequate voluntary pelvic floor muscle contraction. Provision of written informed consent. Exclusion Criteria: Clinically significant diabetic neuropathy. Neurological disorders affecting lower urinary tract function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury). Active lower urinary tract dysfunction (e.g., overactive bladder, neurogenic bladder, interstitial cystitis). Previous pelvic floor surgery. Known urinary incontinence. Urethral stricture. Chronic prostatitis. Recurrent urinary tract infection. Urinary tract malignancy. Advanced chronic kidney disease. Previous upper urinary tract reconstructive surgery. Pregnancy. Active urinary tract infection. Inability to perform an adequate voluntary pelvic floor muscle contraction. Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

urolithiasis

As listed by the trial registrant

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

Urolithiasis

How to take part

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  1. The places running it

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  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

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Contacts and locations

Locations

  • Trabzon Kanuni Education and Research Hospital

    RECRUITING

    Trabzon, Trabzon, 61080, Turkey (Türkiye)

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