Comparing Solifenacin, Tolterodine, and Fesoterodine in Patients with Ureteral Stent Related Symptoms: Evidencefrom a Randomized Controlled Trial

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.