Comparative Efficacy of Tamsulosin and Solifenacin in Managing Double J Stent-Related Symptoms: A Randomized Clinical Study Using the USSQ Tool.
Phase: PHASE4
Conditions: Ureteral Stent-Related Symptom, Alpha Blocker, Anticholinergics, Ureter Calculi
Sponsor: Liaquat National Hospital & Medical College

1 
 
Study Document Cover Page 
 
Official Title: 
Comparative Efficacy of Tamsulosin and Solifenacin in Managing 
Double J Stent-Related Symptoms: A Randomized Clinical Study 
Using the USSQ Tool 
NCT Number: Pending 
IRB Reference Number: 0996-2024-LNH-ERC 
Date of Document: June 12, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
SYNOPSIS 
 
ON 
 
 
COMPARISION BETWEEN TAMSULOSIN (ALPHA BLOCKER) AND 
SOLIFENACIN (ANTICHOLINERGIC IN PATIENTS WITH DOUBLE J 
STENT – RANDOMIZED COMPARATIVE STUDY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Presented By 
 
DR. FAREHA MANSOOR KHAN 
POSTGRADUATE STUDENT OF FCPS  
(UROLOGY) 
 
 
Under Supervision of 
 
DR. AZIZ ABDULLAH   
  
 
LIAQUAT NATIONAL HOSPITAL & MEDICAL COLLEGE 
KARACHI 
 
 

3 
 
TITLE: 
COMPARISION BETWEEN TAMSULOSIN (ALPHA BLOCKER) AND 
SOLIFENACIN (ANTICHOLINERGIC IN PATIENTS WITH DOUBLE J 
STENT – RANDOMIZED COMPARATIVE STUDY 
 
 
 
INTRODUCTION 
 
 
Ureteral stents, which were introduced by Zimskind et al in 1967, are widely used for urinary 
tract disease [1]. Ureteral stents preserve urine flow from the kidney to the bladder in cases of ureteral 
obstruction (intrinsic or extrinsic). In patients with obvious ureteral obstruction, the placement of a 
ureteral stent will restart urine transport and protect the kidney from possible risks. The stents also 
prevent urine extravasation after an operation or trauma[2].  
 
The double-J stent, which is the most common form of ureteral stent, is used in obstructive 
pyelonephritis, intolerable acute renal colic, ureteral edema, ureter perforation following endoscopic 
procedures, and with steinstrasse seen after Extracorporeal shockwave lithotripsy (ESWL)[3]. 
However, despite its usefulness, indwelling stents are often accompanied by significant morbidity, like 
infectious, stent encrustation, forgotten stent to mild-severe symptoms.  
 
Specifically, DJ stent-related symptoms are urinary frequency (50–60%), sexual dysfunction 
(male, 42–82% and female, 30–86%), reduced work capacity (58%), urgency (57–60%), dysuria (40%), 
flank pain (19–32%), incomplete emptying (76%), suprapubic pain (30%), hematuria (25%), and 
reduced quality of life (QOL) in approximately 80% of the patients[4]. It is reported that an important 
factor of stent-related symptoms is the pressure transmitted to the renal pelvis during voiding and 
trigonal irritation by the intravesicular part of the stent[5]. For this reason, several attempts to minimize 
stent-related symptoms have recently been reported. Pharmacologic management is one such trial[6]. 
Symptoms of stent discomfort, including bladder irritation symptoms and flank pain or discomfort, are 

4 
 
generally treated with oral analgesics, such as narcotics and anti-inflammatory medications; however 
these medications are only moderately effective. 
 
Alpha-blockers alleviate bladder irritation due to stents, resulting in reduced incidence of 
dysuria, frequency, and pain compared to placebo[7].  Additionally, solifenacin anticholinergic has also 
showed significant benefits in lower urinary tract symptoms, stent-related pain and hematuria[8]. 
 
RATIONALE: 
 
 
A comparison between taking either an alpha-blocker (tamsulosin) or an anti-cholinergic 
(solifenacin) to alleviate ureteral stent-related symptoms after patients have undergone Dj stenting prior 
to Extracorporeal shockwave lithotripsy (ESWL), Ureteroscopy (URS) with DJ stent placement or 
Percutaneous nephrolithotomy (PCNL) with DJ stent placement has not yet been done in Pakistan. 
 
OBJECTIVE: 
 
 
In this study, we will assess the comparison between an alpha-blocker (tamsulosin) and an anti-
cholinergic (solifenacin) in the treatment of ureteral stent-related symptoms using the Ureteral Stent 
Symptom Questionnaire (USSQ).  
 
OPERATIONAL DEFINITIONS: 
 
Extra corporeal shockwave lithotripsy:  A procedure that utilizes shockwaves to fragment kidney 
stones that can then pass through the urinary tract and be removed. 
DJ Stent: A double-J stent is a ureteral stent with curving ends that prevent the stent slipping into the 
bladder or the kidney and allows continuous drainage of urine into the bladder. 
Lower Urinary Tract Sysmptoms:  Lower urinary tract symptoms (LUTS) include voiding or storage 
symptoms such as:- 
Hesitancy; Difficulty starting or maintaining a urine stream 

5 
 
Poor and intermittent stream; Intermittent urination is usually a sign of significant underlying bladder 
problem, most often incomplete bladder emptying can predispose to urinary tract infections, bladder stone 
formation, and renal insufficiency (damage to the kidneys). 
Incomplete bladder emptying; Incomplete bladder emptying occurs when the muscles of the bladder 
are not able to squeeze properly to empty the bladder. 
Frequency; Its normal and how many times is too frequent to urinate. 
Urgency; Urinary urgency occurs when the pressure in the bladder builds suddenly, and it becomes 
difficult to hold in the urine.  
Nocturia; the need for patients to get up at night on a regular basis to urinate 
Alpha Blockers: Alpha blockers are also known as α-blockers or α-adrenoreceptor antagonists, are a 
class of pharmacological agents that act as antagonists on α-adrenergic receptors. 
Anticholinergic: Anticholinergic drugs block the action of a neurotransmitter called acetylcholine. This 
inhibits nerve impulses responsible for involuntary muscle movements and various bodily functions. 
These drugs can treat a variety of conditions, from overactive bladder to chronic obstructive pulmonary 
disorder. 
USSQ: Ureteral Stent Symptoms Questionnaire; a psychometrically valid measure to evaluate symptoms 
and impact on quality of life of ureteral stents. 
HYPOTHESIS: 
Solifenacin group have better outcome in comparison to Tamsulosin. 
 
MATERIAL AND METHODS: 
 
Study Design: Comparative study 
 
Setting: Study will be conducted Department of Urology, Liaquat National Hospital Karachi. It will 
include the patients who had have complaints voiding symptoms like increased urinary frequency, 
urgency dysuria, incomplete bladder emptying and supra pubic pain.  

6 
 
Study Duration: 6 months after approval of synopsis. 
 
Sampling Technique: non-probability consecutive sampling. 
 
Sample size: The sample size is calculated by using the mean±SD of USSQ score i.e. 76±8 in tamsulosin 
group and 61±8.8 in solefinacin group.  Open Epi Software is used for sample size calculation by taking 
power of test = 90% and confidence interval 95%, the total calculated sample is 14 patients (7 in each 
group). To improve the power the study, we will have 30 patients in each group. 
 
Sample selection: 
 
Inclusion criteria: 
● Between the ages of 20 and 50 years,  
● Patients who consented for unilateral DJ stent placement to relieve upper urinary tract obstruction 
caused by ureteric calculi or after ureteroscopic lithotripsy for ureteral calculi 
Exclusion criteria: 
● Having a history of LUTS before DJ stent placement 
● Patients with bilateral DJ stent placement. 
● Produced Stent related complications (displacement of stent)  
 
DATA COLLECTION PROCEDURE: 
Patients fulfilling the inclusion criteria presenting via outpatient clinic or emergency department at 
Liaquat National hospital, will be included in the study after taking informed and written consent. The 
study will start after the approval of synopsis by CPSP and Ethical and Review board of Liaquat National 
Hospital.  
Patients will be randomly allocated into two groups according to lottery method. The randomization 
process will be performed using random allocation and patients divided in ratio 1:1. Patients will be 
randomly assigned to one of the two study groups; group one (tamsulosin), and group two (solifenacin) 

7 
 
on the day of the surgery after placement of the stent. Patients in group 1 will receive tamsulosin capsule 
(Brand: Cap Tamsolin) 0.4 mg/day, while patients in group 2 will receive solifenacin tablet (Brand: Tab 
Solifen) 5 mg/day. The cost will be beard by the patient as these medications are routinely given to the 
patient post DJ stenting, irrespective of their participation in the study. The medication will be taken until 
removal of the stent. Patients will be reviewed 2 weeks after stenting in opd. The USSQ is the only 
validated scoring system for evaluation of ureteral stent-related symptoms [9] and therefore has to be 
used for comparing different treatments for alleviation of these symptoms. USSQ translated into Urdu 
will be used for patients who are unable to answer questionnaire in English [10]. 
 
DATA ANALYSIS PROCEDURE: 
Patient’s data will be compiled and analyzed through statistical package for Social Sciences (SPSS) 
Version 25. Normality of the data will be checked by Shapiro wilk’s test. Mean±SD will be calculated 
for quantitative variable for groups i.e. age, height, weight, body mass index, length of stent placed and 
total USSQ score. If the data is non normal, median (iqr) will be reported instead of mean± SD. Frequency 
and percentage will be computed for qualitative variables for groups like gender, any addiction, diabetes, 
hypertension, smoker, occupation, surgical procedure and indications of stent placement. ANOVA will 
be applied to see the mean differences between groups. Chi square test or Fischer exact test will be used 
for finding association between categorical variables. Post stratification will be done on age, gender, 
height, weight, body mass index, any addiction, diabetes, hypertension, smoker, occupation, surgical 
procedure and indications of stent placement to see the effect of these modifiers on outcome. P-value 
≤0.05 will be considered as significant. 
 
 
 

8 
 
ETHICAL CONSIDERATION: 
Conducting a randomized control trial (RCT) comparing alpha-blocker and anti-cholinergic drugs 
involves several ethical considerations. It's crucial to prioritize the well-being and rights of participants 
while ensuring scientific rigor. Here are some ethical concerns associated with this a trial: 
1. Informed Consent: 
Ensuring that participants fully understand the nature of the study, potential risks, benefits, and 
alternatives before providing informed consent. It will be clearly communicated that 
participation is voluntary, and individuals have the right to withdraw at any time without facing 
negative consequences. 
2. Participant Selection and Equity: 
Ensuring that the selection criteria for participants are fair and do not disproportionately exclude 
certain demographic groups, potentially leading to biased results.  
3. Confidentiality and Privacy: 
Safeguarding participant confidentiality and privacy by implementing robust data protection 
measures. Clearly communicating how participant data will be handled, stored, and shared to 
maintain trust and comply with relevant privacy regulations. 
4. Publication and Reporting: 
Committing to transparent and timely reporting of study results, whether positive or negative, to 
contribute to scientific knowledge and prevent publication bias. 
In case of any adverse event, the patient will contact us in LNH emergency. However, we have not 
come across any adverse/ critical adverse effect till date.  
 
The researcher bears no financial responsibility. 
 
 
 

9 
 
REFERENCES: 
 
1. Lim KT, Kim YT, Lee TY, Park SY. Effects of tamsulosin, solifenacin, and combination therapy 
for the treatment of ureteral stent related discomforts. Korean journal of urology. 2011 Jul 
1;52(7):485-8. 
2. Kuyumcuoglu, U., Eryildirim, B., Tuncer, M., Faydaci, G., Tarhan, F., & Ozgül, A. (2012). 
Effectiveness of medical treatment in overcoming the ureteral double-J stent related symptoms. 
Canadian Urological Association Journal, 6(6), E234. https://doi.org/10.5489/cuaj.10143. 
3. Lim KT, Kim YT, Lee TY, Park SY. Effects of tamsulosin, solifenacin, and combination therapy 
for the treatment of ureteral stent related discomforts. Korean journal of urology. 2011 Jul 
1;52(7):485-8. 
4. Angela Pecoraro, Dario Peretti, Zhe Tian, Roberta Aimar, Gabriel Niculescu, Giorgio Alleva, 
Alberto Piana, Stefano Granato, Michele Sica, Daniele Amparore, Enrico Checcucci, Matteo 
Manfredi, Pierre Karakiewicz, Cristian Fiori, Francesco Porpiglia; Treatment of Ureteral Stent-
Related Symptoms. Urol Int 17 March 2023; 107 (3): 288–303. 
5. D KKamalesh "A S on the effect of tamsulosin in ureteric stent related morbidity. PhD diss. 
Stanley Medical College Chennai; 2014. 
6. Lim KT, Kim YT, Lee TY, Park SY. Effects of tamsulosin, solifenacin, and combination therapy 
for the treatment of ureteral stent related discomforts. Korean journal of urology. 2011 Jul 
1;52(7):485-8.Lee YJ, Huang KH, Yang HJ, Chang HC, Chen J, Yang TK (2013) Solifenacin 
improves double-J stent-related symptoms in both genders following uncomplicated 
ureteroscopic lithotripsy. Urolithiasis 41:247–252 
7. Kwon JK, Cho KS, Oh CK, Kang DH, Lee H, Ham WS, Choi YD, Lee JY. The beneficial effect 
of alpha-blockers for ureteral stent-related discomfort: systematic review and network meta-
analysis for alfuzosin versus tamsulosin versus placebo. BMC urology. 2015 Dec;15:1-0. 

10 
 
8. Lee YJ, Huang KH, Yang HJ, Chang HC, Chen J, Yang TK. Solifenacin improves double-J stent-
related symptoms in both genders following uncomplicated ureteroscopic lithotripsy. Urolithiasis. 
2013 Jun;41:247-52.  
9. Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG (2003) Ureteral 
stent symptom questionnaire: development and validation of a multidimensional quality of life 
measure. J Urol 169:1060–1064 
10. Mirani K K, Ather M H (August 08, 2022) Translation and Validation of the Ureteral Stent 
Symptoms Questionnaire in Urdu. Cureus 14(8): e27764. DOI 10.7759/cureus.27764  
 
 
 
 
 
 
 
 
 

11 
 
ANNEXURE-I PROFORMA 
GROUP:________________________ 
Serial No: ________________  
 
 
 
Case No: ________________ 
Patient’s Name: ___________________________________________________ 
Patient’s contact #: ________________________________________________ 
S/O, D/O, W/O:___________________________________________________  
Patient’s Age: ___________________ years        
Gender:                 
___Male  
 
___Female 
Height: _____ 
Weight: _____  
BMI: _______              
Any Addiction: 
   Yes                    
___No           _________________________________          
Diabetes:                  ___Yes                           ___No 
Hypertension:         
 ___Yes                           ___No 
Smoker:                 
  ___Yes                          ___No 
Occupation: 
 
_________________________________ 
Surgical Procedure: ___________________________________ 
Indication of stent placement: ___________________________ 
Date of stent placement: _______________________________ 
Length of stent placed: ________________________________ (cm) 
Total USSQ score: _____________________________________ 
 
 
 
 

12 
 
ANNEXURE-II USSQ( Stent in situ ) 
 
We are interested to know about various aspects of your health, following 
insertion of the stent and the effect the stent has had on your health. 
 
Please complete the following questionnaire, which has different sections. 
 
Please answer all questions in each section. 
 
(We would be grateful if you could complete and post the questionnaire within seven days) 
 
 
 
Please complete: 
Today’s Date: 
/ 
/
Date of Birth: 
/ 
/
  

13 
 
You will see that some questions ask if you have a symptom occasionally, sometimes or most of the time. 
 
Occasionally 
= 
less than one third of the time 
Sometimes 
= 
between one and two thirds of the time 
Most of the time 
= 
more than two thirds of the time 
 
URINARY SYMPTOMS 
 
Please answer the questions thinking about the urinary symptoms you have experienced following insertion 
of the stent. 
 
Please put a tick in one box for each question 
  
Please think about your experience since insertion of the stent. 
 
U1. During the day, how often do you pass urine, on average? 
  
Less than hourly 
5 
Every 3 hourly 
Hourly 
4 
Every 4 hours or more 
Every 2 hourly 
3 
 
 
 
 
 
2  
 
1 
 
 
U2. During the night, how many times do you have to get up to pass urine, on average? 
  
None 
1 
3 
4 
  
                                           1 
 
  
                                           2 
 
 
  
 
2 
                                                   4 or more 
5 
3 
 
 
 
U3. Do you have to rush to the toilet to urinate? 
  
Never 
1 
Most of the time 
4 
(more than two thirds for the time) 
Occasionally 
2 
All of the time 
5 
(less than one third of the time) 
Sometimes 
3 
 
                                (between one and two thirds of the time) 
 
U4. Does urine leak before you can get to the toilet? 
  
Never 
1 
Most of the time 
4 
Occasionally 
2 
All of the time 
5 
Sometimes 
3 
 
 
 
U5. Do you leak urine without feeling the need to go to the toilet? 
  
Never 
1 
Most of the time 
Occasionally 
2 
All of the time 
Sometimes 
3 
 
 
 
 
 
 
4  
 
5 
 
 

14 
 
U6. how often do you feel that your bladder has not emptied properly after you have passed urine? 
  
Never 
1 
Most of the time 
4 
(more than two thirds for the time) 
Occasionally 
2 
All of the time 
5 
(less than one third of the time) 
Sometimes 
3 
 
                                (between one and two thirds of the time) 
 
U7. Do you have a burning feeling when you pass urine? 
  
Never 
1 
Most of the time 
4 
Occasionally 
2 
All of the time 
5 
Sometimes 
3 
 
 
U8. How often do you see blood in your urine? 
  
Never 
1 
Most of the time 
Occasionally 
2 
All of the time 
Sometimes 
3 
 
 
 
 
 
 
4  
 
5 
 
 
U9. How much blood do you see in your urine? 
  
                          Do not see any blood 
 1  
            Urine is slightly blood stained 
 2 
 
 
 
 
                                Urine is heavily blood stained 
  
        Urine is heavily blood stained and has clot(s) 
 
 
 
 
 
 
3  
 
4 
 
 
U10. Overall, how much of a problem are your urinary symptoms to you? 
  
Not at all 
1 
Quite a bit 
A little bit 
2 
Extreme 
Moderate 
3 
 
 
 
 
 
4  
 
5 
 
 
U11. If you were to spend the rest of your life with the urinary symptoms, if any, associated with the stent 
just the way they are, how would you feel about it? 
 
Delighted 
1 
Mostly dissatisfied 
Pleased 
2 
Unhappy 
Mostly satisfied 
3 
Terrible 
Mixed feelings (about equally satisfied and dissatisfied 
4 
 
 
 
 
 
 
5  
 
6 
 
7 
 
 
Please go to next section -- 
 
 
 
 
3 

15 
 
BODY PAIN (for women): 
 
This section asks about the body pain or discomfort, which you associate with the stent. 
 
Please think about your experience following insertion of the stent. 
 
P1. Do you experience body pain or discomfort in association with the stent? 
 
YES  1, please go to question P2 
NO  2, please go to next section on General Health 
(Ignore questions P2 to P9) 
 
P2. Think of the drawings below as the drawings of your body. Please mark (X) or shade the site(s) 
where you experience pain or discomfort in association with the stent typically (e.g. during the 
day to day activities, whenever you pass urine) 
 
If you get pain at more than one site, please use a separate mark for each site. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The numbers I - IV represent following areas for the right and left sides 
 
I – Kidney front/side area III – Bladder area II - Groin area IV– Kidney back (loin) area 
Please use O for any other marked area and write the name of the site 
 
P3. Please place a mark (X) to a point on the line below that indicates your pain or discomfort in 
association with the stent. Please put a separate mark for each site if the pain or discomfort is different 
in severity and write the corresponding number of each site used in the drawing above. 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
No Pain or discomfort 
Worst Possible Pain 
4 
 

16 
 
BODY PAIN (for men): 
 
This section asks about the body pain or discomfort, which you associate with the stent. 
 
Please think about your experience following insertion of the stent. 
 
P1. Do you experience body pain or discomfort in association with the stent? 
YES 1, please go to question P2 
NO 2, please go to next section on General Health 
(Ignore questions P2 to P9) 
 
P2. Thinking the drawings below as the drawings of your body, mark (X) or shade the site(s) where 
you experience pain or discomfort in association with the stent typically (e.g. during the day to day 
activities, whenever you pass urine) 
 
If you get pain at more than one site, please use a separate mark for each site. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The numbers I - V represent following areas for the right and left side. 
 
I – Kidney front/side area 
IV– Kidney back (loin) area 
II - Groin area 
V – Penis 
III – Bladder area 
Please use O 
for any other marked site and name that site. 
 
P3. Please place a mark (X) to a point on the line below that indicates your pain or discomfort in 
association with the stent. Please put a separate mark for each site if the pain or discomfort is different 
in severity and write the corresponding number of each site used in the drawing above. 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9
10 
No Pain or discomfort 
Worst Possible Pain 
 
 
 
 
 
 
5 

17 
 
P4. Which of the following statements best describe your experience regarding physical 
activities and the pain or discomfort in association with the stent? 
 
I do not experience any pain or discomfort during physical activities 
1 
I experience pain or discomfort only when I perform vigorous activities 
2 
(e.g. strenuous sports, lifting heavy objects) 
I experience pain when I perform activities of moderate severity but not with basic activities 
3 
(e.g. walking few hundred yards, driving a car) 
I experience pain even when I perform basic activities of daily living 
4 
(e.g. walking indoors, dressing) 
I experience pain while also being at rest 
5 
  
P5. Does the pain or discomfort, in association with the stent, interrupt your sleep? 
  
Never 
1 
Most of the time 
Occasionally 
2 
All of the time 
Sometimes 
3 
 
 
 
 
4  
 
5 
 
P6. Do you experience pain or discomfort, in association with the stent, while passing urine? 
  
Never 
1 
Most of the time 
Occasionally 
2 
All of the time 
Sometimes 
3 
 
 
 
 
4  
 
5 
 
 
P7. Do you experience pain or discomfort in the kidney area, while passing urine? 
 
 
                                   No        1 
                                      
 
                                   Yes  
2 
 
 
P8. How frequently have you required painkillers to control the pain or discomfort associated with 
the stent? 
 
Never 
1 
Most of the time 
Occasionally 
2 
All of the time 
Sometimes 
3 
 
 
 
 
 
 
4  
 
5 
 
 
P9. Overall, how much does the pain or discomfort, in association with the stent, (as distinct from 
other symptoms) interfere with your life? 
 
Never 
1 
Most of the time 
Occasionally 
2 
All of the time 
Sometimes 
3 
 
 
 
 
 
4  
 
5 
 
 
Please go to next section -- 
 
6 

18 
 
GENERAL HEALTH: 
 
Following insertion of the stent: 
 
G1. Have you had difficulty in performing light physical activities (e.g. walking short 
distances, driving a car)? 
 
Usually with no difficulty 
1 
Usually did not do because of the stent
Usually with some difficulty 
2 
All of the time
Usually with much difficulty 
3 
 
 
 
 
 
 
4  
 
0 
 
 
G2. Have you had difficulty in performing heavy physical activities (e.g. strenuous sports, lifting 
heavy objects)? 
 
                              Usually with no difficulty  
 
  
                          Usually with some difficulty 
 
  
                         Usually with much difficulty 
 
 
  
1 
 
2 
 
3 
 
   Usually did not do because of the stent 
All of the time 
 
 
  
4 
 
0 
 
 
G3. Have you felt tired and worn out? 
  
Never 
 
  
Occasionally (less than one third of the time) 
 
  
           Sometimes (between one and two thirds of the time) 
 
 
 
 
 
1 
 
2 
 
3 
 
 
Most of the time (more than two thirds of the time) 
 
  
All of the time 
 
 
 
 
 
4  
 
5 
 
 
G4. Have you felt calm and peaceful? 
  
                                                          All of the time 
 
  
              Most of the time (less than one third of the time) 
 
  
           Sometimes (between one and two thirds of the time) 
 
 
  
1 
 
2 
 
3 
  
Occasionally (more than two thirds of the time) 
 
  
Never 
 
 
  
4 
 
5 
 
 
G5. Have you enjoyed your social life ( going out, meeting friends and so on )? 
  
All of the time 
1 
Occasionally
Most of the time 
2 
Never
Sometimes 
3 
 
 
 
 
4  
 
5 
 
 
G6. Have you needed extra help from your family members or friends? 
  
Never 
1 
Most of the time
Occasionally 
2 
All of the time
Sometimes 
3 
 
 
 
 
4  
 
5 
 
 
Please go to next section – 
 
 
 
 
7 

19 
 
WORK PERFORMANCE: 
 
W1. Regarding your employment status, are you 
In full time employment 
1 
Student 
4
In part time employment 
Unemployed, looking for work 
2 
5
Retired on health ground 
Retired for other reason (including age) 
3 
6
Not working for other reason (please specify) 
7 
 
 
W2. Following insertion of the stent, how many days did the symptoms associated with the stent keep you 
in bed all or most of the day? 
 
                                                                                                                                                                    Day(s) 
 
W3. Following insertion of the stent, for how many half days or more did you cut down your routine 
activities because of the symptoms associated with the stent? 
 
                                                                                                                                                           Half Day(s) 
 
Please answer the questions below (W4 –W7 ) only if you are in active paid work. 
 
(Otherwise ignore questions W4 – W7). 
 
W4. a) Job title or description of your role: _________________________________ 
b) Are you an: 
       Employee 
1                   Employer 
2 
       Self employed 
3 
 
 
Please answer following questions if you have worked after insertion of the stent, 
 
W5. Have you worked for short periods of time or taken frequent rests because of the symptoms 
associated with the stent? 
 
Never 
 
  
Occasionally 
 
  
Sometimes 
 
 
  
1 
 
2 
 
3 
 
Most of the time 
 
  
All of the time 
 
 
  
4 
 
5 
 
W6. Have you worked at your usual job, but with some changes because of the symptoms 
associated with the stent? 
 
Never 
 
  
Occasionally 
 
  
Sometimes 
 
 
  
1 
 
2 
 
3 
 
Most of the time 
 
  
All of the time 
 
 
  
4 
 
5 
 
W7. Have you worked your regular number of hours? 
  
Never 
1 
Most of the time
Occasionally 
2 
All of the time
Sometimes 
3 
 
 
 
 
4  
 
5 
 
Please go to next section –8 

20 
 
 
SEXUAL MATTERS: 
 
Please tick one box for each question by thinking about your experience following insertion of the stent. 
 
S1. Currently, do you have an active sex life? 
 
No 
1, Please answer question S2 and go to next section (Ignore questions S3 and S4). 
Yes 
2, Please go to question S3 (Ignore question S2). 
 
 
S2. (i) If NO sex life, how long ago did this stop? 
  
After insertion of the stent 
 
 
Before insertion of the stent 
  
(ii)AND, why did this stop? 
 
Because of the problems associated with the stent 
 
Did not attempt any sexual activity 
 
 
Some other reason – not to do with the symptoms of the stent 
 
 
 
 
 
1  
 
0 
 
 
10 
 
0 
 
0  
( Ignore questions S3 – S4 ) 
 
 
Please answer questions S3 and S4, only if you have answered ‘yes’ to question S1. 
 
Please think about your experience following insertion of the stent. 
 
S3. Do you have pain when you have sexual intercourse? 
  
Not at all 
1 
Severe
Mild 
2 
Extreme
Moderate 
3 
 
 
 
 
 
4  
 
5 
 
 
S4. How satisfied are you with your sex life? 
  
Very satisfied 
1 
Dissatisfied
Satisfied 
2 
Very dissatisfied
Not sure 
3 
 
 
 
 
4  
 
5 
 
 
Please go to next section --- 
 
 
 
 
 
 
 
 
9 

21 
 
ADDITIONAL PROBLEMS: 
 
The following questions ask about your experience following insertion of the stent. Please 
indicate your experience by ticking the appropriate box. 
 
A1. How many times have you felt you may be suffering from a urinary tract infection (e.g. 
running temperature, feeling unwell and pain while passing urine)? 
 
Never 
 
  
Occasionally 
 
  
Sometimes 
 
 
  
1 
 
2 
 
3 
 
Most of the time 
 
  
All of the time 
 
 
  
4 
 
5 
 
 
A2. Have you needed to take antibiotics as a result of insertion of the stent? ( Please ignore the course 
of antibiotics, which may have been given at the time of insertion of the stent. ) 
 
                                       Not at all 
 
  
                                   One Course 
 
 
  
1 
 
2 
 
Two Courses 
 
  
Three or more Courses 
 
 
  
3 
 
4 
 
 
A3. Have you needed to seek help of a health professional (such as GP, nurse) due to any problem 
associated with the stent? 
 
Never 
 
  
Once 
 
 
  
1 
 
2 
 
Twice 
 
  
Three or more times 
 
 
  
3 
 
4 
 
 
A4. Have you needed to visit the hospital due to any problem associated with the stent? 
  
Never 
1 
Twice
Once 
2 
Three or more times
 
 
 
 
 
3  
 
4 
 
 
GQ In the future, if you were advised to have another stent inserted, how would you feel about 
it? 
 
Delighted 
1 
Mostly dissatisfied
Pleased 
2 
Unhappy
Mostly satisfied 
3 
Terrible
Mixed feelings (about equally satisfied and dissatisfied) 
4 
 
  
5  
 
6  
 
7 
 

22 
 
 
AQ. If there are any comments you would like to make about the questionnaire or 
any of your symptoms, please use the space below. 
 
 
 
 
 
 
THANK YOU VERY MUCH FOR YOUR HELP 
 
All information will remain confidential 
 
 
10