See if pelvic floor endurance relates to stent symptoms after ureteroscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study evaluates whether the Pelvic Floor Fatigue Index (PFFI), an ultrasound-based measure of pelvic floor endurance, is associated with postoperative ureteral stent symptoms as reported on the Ureteral Stent Symptom Questionnaire (USSQ). Participants undergoing URS or RIRS with planned double-J stent placement will have preoperative PFFI measurements and later USSQ assessments. The study also examines test-retest reliability of the PFFI and its relation to stent-related symptom severity. The aim is to identify whether pelvic floor endurance contributes to interindividual variability in stent-related experiences beyond surgical factors. By understanding these associations, clinicians may better anticipate symptom burden and tailor perioperative care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Trabzon Kanuni Education and Research Hospital
  Trabzon, Trabzon, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Adem Deni̇z, Md
• Email: adeemdeniz@gmail.com
• Phone: +904623330030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.