Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT02078895
Eligibility Criteria:
Inclusion Criteria:
* Patients requiring unilateral ureteral stent insertion
* Age \> 18
* Renal/ureteral stones (single or multiple)
* Ureteral strictures
* Surveillance ureterscopy
* Willing and able to consent
* Willing and able to complete study questionnaires/diaries
* Willing to use CIC to empty the bladder at any time after study treatment if it is determined to be necessary by the investigator
Exclusion Criteria:
* History of malignancy
* Patients on medical therapy for benign prostatic hyperplasia (alpha blocker and/or 5alpha reductase inhibitor)
* Patients taking muscarinic-receptor antagonists (Ex. detrol, ditropan etc.)
* Patients who have an interstim sacral neuromodulator
* History of urinary retention
* Neurogenic or non-neurogenic detrusor overactivity
* Pregnancy
* Solitary kidney
* Insulin dependent Diabetes Mellitus (Uncontrolled Diabetes (HbA1c \> 8))
* Neuropathy
* History of transplant kidney
* History of narcotic abuse or chronic pain
* Anatomic bladder/ureteral abnormality
* Previous cystectomy/urinary diversion
* Conditions necessitating bilateral ureteral stents
* History of Interstitial cystitis
* Patients with a post-void residual volume of \> 100ml
* Patients with history of urinary retention
* Patients with active urinary tract infection
* Patients with history of chronic urinary tract infections
* Patients with concomitant use of any botulinum toxin within 3 months or any urological use of botulinum toxin in the past
* Patients with active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening
* Patients with concurrent or previously uninvestigated hematuria within 6 months prior to screening. -Patients with investigated hematuria may have entered the study if urological/renal pathology had been ruled out to the satisfaction of the investigator
* Patients with hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis Patients with a known allergy or sensitivity to any botulinum toxin preparation (including study medication preparation), anesthetics, or antibiotics used during the study
* Patients with any medical condition that may have put them at increased risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02078895
Study Brief:
Protocol Section:
NCT02078895