Disorder of Urinary Stent
Conditions
Brief summary
The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.
Detailed description
Ureteral stent (US) has been as essential tool in the urologist's surgeries and is useful instruments that its indications increase due to new stent technologies and improvement of patient's comfort. US associated with discomfort complications that include lower urinary tract symptoms (LUTS) as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic's pain, incontinence, hematuria, movement of stent, infection and encrustation of stent. US related symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate the effect of terazosin and tolterodine lonely and together in comparison of placebo on US related symptoms. The investigators study will be done prospectively. The patients who underwent indwelling Double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice 3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All of the patients receive prophylactic antibiotic and on demand analgesic. After entrance to study, they fulfill the International Prostatic Symptoms Score (IPSS) and Visual Analog Scale (VAS) on the before indwelling US, two weeks after indwelling US and US removal time, then the investigators will evaluate the drug's effect on US related symptoms.
Interventions
DRUGPlacebo
same as tolterodine and terazosin dose
DRUGTerazosine
2 mg BID
DRUGTolterodine
2 mg daily
DRUGTolterodine + Terazosin
2mg daily and 2mg BID
Sponsors
Urmia University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
If a patient does not meet any
Exclusion criteria
and to be undergone double-J stent indwelling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Urinary Tract Symptoms (LUTS) | Expected average of 2 weeks | LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Expected 2 weeks later | The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain | Expected 2 weeks later | The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain. |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: same as tolterodine and terazosin dose | 24 |
| Terazosin Terazosine: 2 mg BID | 23 |
| Tolterodine Tolterodine: 2 mg daily | 23 |
| Tolterodine + Terazosin Tolterodine + Terazosin: 2mg daily and 2mg BID | 24 |
| Total | 94 |
Baseline characteristics
| Characteristic | Placebo | Terazosin | Tolterodine | Tolterodine + Terazosin | Total |
|---|---|---|---|---|---|
| Age, Continuous | 33.37 years STANDARD_DEVIATION 9.58 | 38.35 years STANDARD_DEVIATION 9.23 | 37.04 years STANDARD_DEVIATION 9.04 | 35.75 years STANDARD_DEVIATION 9.38 | 36.53 years STANDARD_DEVIATION 9.53 |
| Region of Enrollment Iran, Islamic Republic of | 24 participants | 23 participants | 23 participants | 24 participants | 94 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Male | 21 Participants | 16 Participants | 19 Participants | 19 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 23 | 0 / 23 | 0 / 24 |
| serious Total, serious adverse events | 2 / 24 | 4 / 23 | 1 / 23 | 6 / 24 |
Outcome results
Primary
Lower Urinary Tract Symptoms (LUTS)
LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.
Time frame: Expected average of 2 weeks
Population: The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Lower Urinary Tract Symptoms (LUTS) | 11.12 units on a scale | Standard Deviation 7.84 |
| Terazosin | Lower Urinary Tract Symptoms (LUTS) | 4.39 units on a scale | Standard Deviation 6.03 |
| Tolterodine | Lower Urinary Tract Symptoms (LUTS) | 7.21 units on a scale | Standard Deviation 6.57 |
| Tolterodine + Terazosin | Lower Urinary Tract Symptoms (LUTS) | 5.58 units on a scale | Standard Deviation 4.82 |
Secondary
Quality of Life
The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life.
Time frame: Expected 2 weeks later
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Quality of Life | 3.37 units on a scale | Standard Deviation 2.16 |
| Terazosin | Quality of Life | 2 units on a scale | Standard Deviation 2.25 |
| Tolterodine | Quality of Life | 2.30 units on a scale | Standard Deviation 1.89 |
| Tolterodine + Terazosin | Quality of Life | 0.95 units on a scale | Standard Deviation 1.12 |
Other Pre-specified
Pain
The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain.
Time frame: Expected 2 weeks later
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pain | 4.16 units on a scale | Standard Deviation 3.59 |
| Terazosin | Pain | 3.21 units on a scale | Standard Deviation 4.14 |
| Tolterodine | Pain | 1.34 units on a scale | Standard Deviation 2.6 |
| Tolterodine + Terazosin | Pain | 1.37 units on a scale | Standard Deviation 2.56 |