1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drsanchit19@gmail.com].
   


6. For how long will this data be available start date provided 25-02-2026 and end date provided 25-02-2030?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

Background and Rationale

Urinary stents are commonly used in urological procedures. However, stent-related symptoms (SRS) can significantly impact patients’ quality of life. Anticholinergic medications, such as Solifenacin and Tolterodine, are frequently used to manage these symptoms, but their comparative efficacy is not well-established. Current standard of prescription is of tolterodine and solifenacin, Fesoteridine is relatively newer agent. Literature available suggests fesoterodine to be more specific hence lesser side effects, this fact is being explored and compared with the current standards of treatment

Objectives

• To compare the efficacy of Solifenacin, Tolterodine, and Fesoterodine in managing stent-related symptoms.
• To evaluate the side effect profiles of these medications.

Study Design

• Randomized, controlled, three-arm, parallel-group trial.
• Duration: 6 weeks.

Participants

Inclusion Criteria:

• Patients requiring stent insertion for short term indications such as pyeloplasty or surgery for urolithiasis.

Exclusion Criteria:

• Lower Urinary Tract Symptoms (LUTS) before stent insertion.
• Benign Prostatic Enlargement (BPE) with IPSS > 7.
• History of urinary tract surgery other than the current one.
• Use of alpha-1 blockers, anticholinergics, or analgesics prior to stent insertion.

 Interventions

• Group A: Solifenacin
• Group B: Tolterodine
• Group C: Fesoterodine

Outcome Measures

Primary Outcomes:

• Urinary symptoms (frequency, urgency, nocturia) at 2 days and 2 weeks post-stent insertion and 2 days post DJR
• Pain score (VAS) at 2 days and 2 weeks and 2 days post DJR

Variables Collected

• Patient Demographics:
• Name, Age, Sex, Address
• Medical History:
• Pre-existing LUTS, Preoperative urine CS, Date of surgery, Prior poor stent experience
• History of prior urinary tract surgery

• Surgical Details:
• Elective vs. emergency surgery, bilateral/unilateral stent, number of DJS, type, size, length of stent, stent crossing midline in fluoroscopy, diameter, stent duration (short term <6 weeks, long term >6 weeks), pre-index vs. index procedural stenting, drug administered (including analgesics).
• Post-DJ Insertion Symptoms:
• Urinary symptoms and pain scores at 2 days and 2 weeks, additional problems with stent in situ.
• General Health:
• Quality of work, days in bed, loss of activity, quality of work compared to pre-stent state, financial burden.

Study Procedures

• Randomization: Patients will be randomized into three groups using a computer-generated randomization schedule.
• Follow-Up: Patients will be followed up at 2 days, 2 weeks, and >2 days post-DJR.

Data Collection: Standardized forms will be used for data collection during admission and later at each visit

Statistical Analysis

• Primary Analysis: Comparison of urinary symptoms and pain scores between the three groups using ANOVA.
• Secondary Analysis: Analysis of side effects and quality of life using chi-square tests for categorical variables and t-tests for continuous variables.

Ethical Considerations

• Informed Consent: Written informed consent will be obtained from all participants.
• Confidentiality: Patient information will be kept confidential and stored securely.
• Adverse Events: All adverse events will be monitored and reported.