We searched for observational studies reporting on the long term risks associated with long-term use of intermittent catheterisation, indwelling catheters (supra pubic and urethral) and penile sheath collection/pads. In addition, we searched for observational studies reporting on the quality of life associated with these methods of urine collection.
Long term risks outcomes
Renal impairment
Study: N=70233
Length of follow-up: years of bladder management ranged from 2 to 33 yrs, frequency of follow up not stated
Table 124Incidence of reflux and renal calculi
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Complication | Intermittent catheterisation (n=23) | Padding (n=25) | Urethral catheter (n=22) |
---|
Duration of follow-up | 2–10 yrs (n=17) | 2–10 yrs (n=7) | 11–23 (n=14) | 2–10 yrs (n=7) | 11–23 (n=9) | 24–33 (n=6) |
Reflux | 1 | - | - | 2 | 4 | 4 |
Renal calculi | - | - | 3 | - | 1 | 2 |
None of the 6 patients on intermittent catheterisation for 11 to 23 yrs or the 4 on padding for 24 to 33 yrs reported any complications.
Study: N=57237
Length of follow-up: 12 yrs, frequency of follow up yearly
Table 125Incidence of renal stones and pyelonephritis
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Complication | Total (n=57) | Catheterised group (n=32) | Non-catheterised group (n=25) | p-value (diff b/w catheterised and non catheterised group) |
---|
Renal stone | 14 | 8 | 6 | 0.93 |
Pyelonephritis | 13 | 8 | 5 | 0.66 |
Study: N=235239
Length of follow-up: Duration of bladder management 24.1 yrs (range 10 to 45 yrs), frequency of follow up 70% yearly or every other year
Study: N=140241
Length of follow-up: 17 yrs, frequency of follow up yearly
Table 127Incidence of renal stones
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| Spontaneous voiding (SV) | Clean intermittent catheterisation (CIC) | Suprapubic cystostomy (SC) | Urethral catheter (UC) |
---|
Accumulated incidence (%) | 6 (13) | 3 (9) | 4 (11) | 8 (33)* |
Episodes/100 person-years | 0.88 | 0.54 | 0.65 | 2.5 |
- *
<0.05 in the SV versus the UC group, the CIC versus UC group, and the SPC versus the UC group by Fisher’s exact test
Table 128Results of multivariate analysis for renal stones
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Bladder management | Renal stone OR adjusted (95%CI) | p |
---|
Spontaneous voiding (SV) | 1.0 | |
Clean intermittent catheterisation | 0.89 (0.17 to 4.6) | 0.89 |
Suprapubic cystostomy | 0.71 (0.16 to 3.2) | 0.66 |
Urethral catheter | 5.7 (1.3 to 25) | 0.021 |
Study: N=179240
Length of follow-up minimum 10 yrs, frequency of follow up yearly
Table 129Incidence of the complications of upper urinary tract
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| Urethral catheter | Intermittent catheterisation | Suprapubic cystostomy | Crede manoeuvre or reflex voiding | Condom catheter |
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Pyelonephritis | 12 (41.4%) | 20 (41.7%) | 13 (31.0%) | 10 (26.3%) | 6 (27.3%) |
Renal calculi | 6 (20.7%) | 6 (12.5%) | 15 (35.7%) | 13 (34.2%) | 4 (18.2%) |
Upper tract deterioration | 15 (51.7%) | 18 (37.5%) | 11 (26.2%) | 9 (23.7%) | 5 (22.7%) |
Table 130Multivariate risk factors for complications of the upper urinary tract - adjusted odds ratio (95%CI)
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| Pyelonephritis | Renal calculi | Upper tract deterioration |
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Urethral catheter | 1.0 | 1.0 | 1.0 |
Intermittent catheter | 0.930 (0.352–2.455) | 0.526 (0.147 to 1.888) | 0.330 (0.114 to 0.958) |
Suprapubic catheter | 0.532 (0.186 to 1.519) | 1.827 (0.581 to 5.745) | 0.097 (0.026 to 0.359) |
Crede manoeuvre or reflex voiding | 0.464 (0.158 to 1.366) | 1.856 (0.579 to 5.955) | 0.123 (0.035 to 0.428) |
Penile sheath | 0.502 (0.148 to 1.704) | 0.746 (0.177 to 3.137) | 0.200 (0.051 to 0.780) |
Study: N=8314235
Length of follow up: Mean 3 yrs (range 7 mths to 13 yrs), frequency of follow up yearly
Table 131Incidence of stones in the kidney or ureter
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Bladder management at discharge | N | % | No. of stones 5-yr cumulative incidence | % | P |
---|
Catheter-free | 1710 | 20.6 | 20 | 1.6 | 0.002 |
Urethral catheter | 1027 | 12.4 | 49 | 6.9 | |
Penile sheath | 563 | 6.8 | 25 | 5.1 | |
Intermittent catheter | 4407 | 53.0 | 179 | 5.0 | |
Suprapubic catheter | 296 | 3.6 | 8 | 2.7 | |
Other | 248 | 3.0 | 5 | 3.4 | |
Unknown | 63 | 0.8 | 0 | | |
Table 132Risk factors for kidney stones occurring before and after the first year post injury – multivariate cox regression model
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| Year one RR (adjusted) (95%CI) | Year 2 and later RR (adjusted) (95%CI) |
---|
Catheter-free | 1.0 | 1.0 |
Urethral catheter | 1.3 (0.6 to 2.7) | 2.5 (1.1 to 5.7) |
Penile sheath | 1.3 (0.6 to 2.8) | 2.0 (0.9 to 4.6) |
Intermittent catheter | 1.2 (0.6 to 2.1) | 2.4 (1.2 to 5.2) |
Suprapubic catheter | 0.3 (0.1 to 1.3) | 2.6 (1.1 to 6.3) |
Other | 0.6 (0.1 to 2.6) | 4.2 (1.7 to 10.6) |
Study: N=149247
Length of follow-up: 68 months, range 3 to 179 months, frequency of follow up variable
Table 133Incidence of renal complications
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Complication | Suprapubic catheterisation |
---|
All renal complications | 20/149 |
Acute pyelonephritis | 8/149 |
Renal calculi | 12/149 |
Renal scarring | 9/149 |
All vesicoureteral reflux (VUR) VUR with renal stones VUR with renal scarring VUR with renal stones and scarring | 21/149 (bilateral in 5) 3/149 1/149 1/149 |
Renal scarring and calculi were more prevalent in quadriplegic than paraplegic patients. Renal scarring was generally mild, and the risk of scarring was zero if the bladder was normal or areflexic
Study: N=204 (142 followed up)242
Length of follow up: 12 years, frequency of follow up not stated
Table 134Incidence of renal complications
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Adverse event | Urethral catheter | Non catheterised | p |
---|
Renal stones | 18/56 | 6/86 | 0.0001 |
Recurrent pyelonephritis | 7/56 | 2/86 | 0.015 |
Parenchymal thinning | 13/56 | 4/86 | 0.0009 |
Study: N=316249
Follow up mean 18.3 (12.4) yrs since injury, frequency of follow-up unclear
Table 135Incidence of renal complications
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Complications | Urethral n=114 | CIC n=92 | Spontaneous n=74 | Suprapubic n=36 | p |
---|
pyelonephritis | 8% | 1% | 1.5% | 3% | <0.001 |
Renal stone | 55% | 22% | 20% | 36% | <0.001 |
VUR | 23% | 7% | 8% | 28% | 0.001 |
Abnormal upper tracts | 30% | 16% | 27% | 39% | 0.038 |
Hydronephrosis
Study: N=70233
Length of follow-up: range 2 to 33 yrs, frequency of follow-up not stated
Table 136Incidence of hydronephrosis
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Complication | Intermittent catheterisation (n=23) | Padding (n=25) | Urethral catheter (n=22) |
---|
Duration of follow-up | 2–10 yrs (n=17) | 2–10 yrs (n=7) | 11–23 (n=14) | 2–10 yrs (n=7) | 11–23 (n=9) | 24–33 (n=6) |
Hydronephrosis | - | 1 | - | 4 | 2 | - |
None of the 6 patients on intermittent catheterisation for 11 to 23 yrs or the 4 on padding for 24 to 33 yrs reported any complications.
Study: N=65243
Length of follow-up: mean 3.7 yrs (range 1 to 7.5 yrs), frequency of follow up not stated
Findings:
0/28 of the patients had hydronephrosis
Urinary tract stones
Study: N=70233
Length of follow-up: range 2 to 33 yrs, frequency of follow up not stated
Table 137Incidence of bladder calculi
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Complication | Intermittent catheterisation (n=23) | Padding (n=25) | Urethral catheter (n=22) |
---|
Duration of follow- up | 2–10 yrs (n=17) | 2–10 yrs (n=7) | 11–23 (n=14) | 2–10 yrs (n=7) | 11–23 (n=9) | 24–33 (n=6) |
Bladder calculi | 1 | - | - | 1 | 3 | 12 |
None of the 6 patients on intermittent catheterisation for 11 to 23 yrs or the 4 on padding for 24 to 33 yrs reported any complications.
Study: N=140241
Length of follow-up: 17 yrs, frequency of follow up yearly
Table 138Incidence of bladder stones
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| Spontaneous voiding (SV) | Clean intermittent catheterisation (CIC) | Suprapubic cystostomy (SPC) | Urethral catheter (UC) |
---|
Accumulated incidence (%) | 14 (30) | 5 (15) | 15 (42)* | 5 (21) |
Episodes/100 person- years | 2.0 | 0.89 | 5.1 | 1.7 |
- *
<0.05 in the CIC vs SPC group by chi-square test
Table 139Risk of bladder stone – results of multivariate analysis
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Bladder management | Bladder stone OR adjusted (95%CI) | p |
---|
Spontaneous voiding (SV) | 1.0 | |
Clean intermittent catheterisation | 0.53 (0.16 to 1.8) | 0.30 |
Suprapubic cystostomy | 1.5 (0.56 to 3.9) | 0.43 |
Urethral catheter | 0.89 (0.24 to 3.3) | 0.86 |
Study: N=57237
Length of follow up: 12 yrs, frequency of follow-up yearly
Table 140Incidence of bladder stones
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Complication | Total (n=57) | Catheterised group (n=32) | Non- catheterised group (n=25) | p-value (diff b/w catheterised and non catheterised group) |
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Bladder stone | 18 | 13 | 5 | 0.10 |
Study: N=457246
Length of follow-up: median 60 months, frequency of follow up yearly
Table 141Risk of bladder stones
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Bladder management type | Mean follow- up(years) | No. of bladder stones/no. of pts | % forming bladder stones (no./total no.) | Total group follow-up (years) | % absolute annual risk stone formation |
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Penile sheath + sphincterotomy | 8.4 | 0 | 0 (0/55) | 463 | 0 |
Intermittent self catheterisation (ISC) | 6.75 | 1/1 | 1.5 (1/70) | 480 | 0.2 |
Expression voiding with or without penile sheath | 6.3 | 7/7 | 3 (7/240) | 1,515 | 0.5 |
Urethral catheter | 5.9 | 59/35 | 23 (35/152) | 789 | 4% (first stone), 16% (subsequent stones) |
Results of Cox- regression analysis: Although age, sex, and injury level were not significantly explanatory variables, degree of injury was considered (p=0.02) in the model. After correcting for degree of injury, both suprapubic and urethral forms of indwelling catheter were found to have a high risk of bladder stone formation compared with ISC or condom drainage with or without sphincterotomy.
The hazard ratio was 10.5 (p<0.0005, 95% CI 4.0–27.5) for patients with supra pubic catheters and 12.8 (p<0.005, 95% 5.1–31.9) for those with urethral catheters. Bladder stones were no more likely to form in patients with supra pubic catheters than in those with urethral urethral catheters (hazard ratio 1.2, p=0.6).
Study: N=149247
Length of follow-up: 68 months, range 3 to 179 months, frequency of follow up variable
Table 142Incidence of bladder stones
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Complication | Suprapubic catheterisation |
---|
Bladder stones | 33/149 |
Higher incidence in quadriplegics (26/96 quadriplegics versus 7/68 paraplegics). There were frequent recurrences, leading to a total of 56 episodes.
Study: N=204 (142 followed up)242
Length of follow up: 12 years, frequency of follow up not stated
Table 143Incidence of bladder stones
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Adverse event | Urethral catheter | Non catheterised | p |
---|
Bladder stones | 34/56 | 10/86 | 0.0001 |
Study: N=35249
Length of follow up: 6 years (range 2–12 years), frequency of follow up 6 monthly for two years then yearly
Table 144Incidence of recurrent bladder stones
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Adverse event | Urethral catheter | Intermittent catheterisation | p |
---|
Recurrent bladder stones | 13/13 | 0/13 | Not stated |
Study: N=316249
Follow up mean 18.3 (12.4) yrs since injury, frequency of follow up unclear
Urinary tract infection
Study: N=129236
Length of follow-up: One yr
Table 146Incidence of upper tract infection (data extracted from graph)
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Bladder management | Urinary tract infection % (95%CI) |
---|
Normal voiding | 6 (2 to 36%) |
Controlled voiding | 20 (5 to 50%) |
Clean intermittent catheterisation | 70 (43 to 90) |
Mixed (using clean intermittent catheterisation plus other method) | 72 (58 to 90) |
Suprapubic tapping | 48 (30 to 68) |
Compression or straining | 31 (11 to 59) |
Study: N=65243
Length of follow-up: mean 3.7 yrs (range 1 to 7.5 yrs), frequency of follow up not stated
Findings:
12/28 patients had received treatment for one or more urinary tract infection
Study: N=125245
Length of follow-up: One yr
Findings:
Table 147Episodes and timing of urinary infections post admission
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Timing (weeks) | Urethral catheterisation (n=85) | Supra-pubic cystostomy (n=40) | Total (n=125) |
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1,2 | 12 (20%) | 6 (14%) | 16 (13%) |
2,4 | 10(16%) | 3 (21%) | 13 (10%) |
4,6 | 33(52%) | 1 (7%) | 34 (27%) |
6,8 | 4 (6%) | 2 (14%) | 6 (4%) |
8,10 | 2 (3%) | 1 (7%) | 3 (2%) |
10,12 | 2(3%) | 1 (7%) | 3 (2%) |
Study: N=149247
Length of follow-up: 68 months, range 3 to 179 months, frequency of follow up variable
Some had more than one episode.
Study: N=204 (142 followed up)242
Length of follow up: 12 years, frequency of follow up not stated
Table 149Incidence of urinary tract infections
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Adverse event | Urethral catheter | Non catheterised | p |
---|
Symptomatic UTIs (1 episode) | 6/56 | 35/86 | 0.0001 |
Symptomatic UTIs (> 1 episode) | 42/56 | 11/86 | 0.0001 |
Urosepsis Leading to death | 12/56 2/56 | 7/86 0/86 | 0.023 |
Study: N=64248
Length of follow up: 1 year, frequency of follow up monthly
Table 150Incidence of urinary tract infections
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Adverse event | Intermittent catheterisation | Condom and collection bag | p |
---|
Urinary tract infection | 17.2 infections/person- year | 18.9 infections/person-year | NS |
Study: N=35244
Length of follow up: 6 years (range 2–12 years), frequency of follow up 6 monthly for two years then yearly
Table 151Incidence of urinary tract infections
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Adverse event | Urethral catheter | Intermittent catheterisation | p |
---|
Symptomatic (febrile) UTIs | 12/13 | 7/22 | Not stated |
Study: N= 705234
Length of follow up: 1 year
Findings:
At discharge there was no significant difference in rate of bacteriuria with fever (BWF) between those with self intermittent catheterisation, those with intermittent catheterisation by someone else and those with a urethral catheter.
Table 152Rates of BWF at hospital discharge and at 1 year follow up N (%)
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| At discharge | At 1 year follow up |
---|
Self intermittent catheterisation | 77/155 (50) | 33/62 (53) |
Intermittent catheterisation by other | 60/103 (58) | 20/24 (83) |
Urethral catheter | 48/114 (42) | 25/57 (44) |
Examining only those who were on the same system of drainage at discharge from the initial rehabilitation and at year 1 follow-up, the patients on intermittent catheterisation by someone else (ICO) were more likely to have experienced at lease one episode of BWF than the group on self intermittent catheterisation and patients with urethral catheter (p<0.025).
Bladder cancer
Study: N=3670238
Length of follow-up: mean 2 yrs
Findings:
Analyses of potential risk factors for bladder cancer revealed a significantly greater proportion of participants who used an indwelling urethral catheter (IDC) (46% of IDC group, 39% of multi group (using both dwelling and non dwelling)) developed bladder calculi compared with 10% in the non-urethral catheter (NIDC) group (×2 =537.64, p<0.001).
Age- adjusted analyses revealed that increasing exposure to IDC use was associated with bladder cancer in spinal cord injury. The IDC group had an age – adjusted rate of 77 per 100,000 person-years, compared with rates of 56.1 and 18.6 per 100,000 person-years in the multi and NIDC groups, respectively.
After age and gender adjustment, participants with spinal cord injury were 15.2 (95% CI, 9.2 –23.3) times likely to develop bladder cancer than the general population. Of those using IDC only as their method of bladder management, the observed 15 cases of bladder cancer were compared with an expected 0.6 cases, yielding a ratio of 25.4 (95%, 14.0 –41.9).
Calculations of attributable risk (AR), revealed that IDC was responsible for 34.1 cases of bladder cancer per 100,000 person-years of SCI. This yielded an AR percentage of 55.8% for IDC use, whereas male gender and bladder calculi were responsible for fewer cases of bladder cancer, at 32.9% and 10.7% respectively. In those using IDC only, IDC was responsible for 58.4 cases per 100,000 person-years, or 64.8% of all bladder cancer occurring in the IDC population.
At the completion of the study, 13 persons with bladder cancer had died, with the cause of death identified as bladder cancer in 12. Of the 12, 10 had solely used IDC, where as 2 used multiple techniques. There were no bladder cancer deaths in the NIDC group.
Study: N=149247
Length of follow-up: 68 months, range 3 to 179 months, frequency of follow up variable
Table 153Incidence of cancer
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Complication | Suprapubic catheterisation |
---|
Low grade superficial transitional cell carcinoma | 1/149 |
Quality of life outcome
Study: N=22250
Young patients with spina bifida (Myelomeningocele MMC) aged 13–26 who had been using clean intermittent catheterisation (CIC) independently for at least 5 years. This was a qualitative study, using semi-structured interviews, to elicit attitudes to their condition and CIC. The study was conducted in Sweden.
Telling peers of their use of CIC was deemed as difficult but important and satisfying. Peer reactions ranged from disgust (catheter insertion) to childish (use of diapers) to admiration. Those not in wheelchairs experienced less belief from others about their CIC use, and some of these wished they were in a wheelchair to increase acceptance of their CIC use. Lack of medical staff understanding of CIC was perceived as a major problem.
All disliked being catheterised by someone else, but in medical appointments most were reticent at stating this, and the clinician would do the catheterisation.
Most of the participants rated their incontinence as a mild disability, and rated non-MMC disabilities they didn’t have, such as blindness, as more severe.
Eight participants had no friends at all. Two others spoke of friends, but on later investigation these were really casual acquaintances. 12 had a best friend. 15 found it easy to make friends but harder to keep them. Barriers to friendship were perceived as an inability to run, the use of crutches or the need for diapers. 12 were currently involved with a partner. Finding a partner was strongly desired by 17, but they found it difficult to realise this wish. None knew of the effects of their condition on sexual function, and felt that a medical professional should give them more information on this. Some could not imagine a future without children of their own. 19 were preoccupied with thoughts of parenthood in the future, but 9 were unsure if they would be able to do this. Of the 3 female adults in a relationship, one had had a healthy baby. At the end of the interview the participants were invited to ask anything. Two males and two females asked: “How am I going to find someone to marry?”
Overall all participants were satisfied with CIC and would not want to return to their previous voiding technique. Most, after five years experience, did not find it a problem in daily life. Overall, CIC was regarded as positive and most of the children’s negative experiences were related to their overall disability, independent of CIC.
Study: N=41252
SCI patients, mean age 39.5 yrs. Mean time post SCI 4 years. The study was conducted in Germany. Patients divided into “treatment successes” and “treatment failures”. Success determined by a bladder capacity of >360 mL, absence of autonomic dysregulation and continence
Table 154Qualiveen scale scores in relation to bladder function after correction for depression
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| Bladder management mean (SD) | |
---|
Scale | Success (n=14) | Failure (n=27) | P value |
---|
Limitations | 37.2 (22.10) | 48.6 (18.29) | .0544 |
Constraints | 39.2 (21.44) | 52.9 (25.68) | .0377 |
Fears | 20.0 (16.40) | 44.7 (19.65) | .0014 |
Feelings | 12.7 (15.22) | 39.8 (27.69) | .0182 |
Study: N=132251
Follow up: 24 months. SCI patients using clean intermittent catheterisation, compared to healthy controls.
Effect
Comparison of SF-36 scores of patients and controls (general population) with respect to gender.
Table 155Comparison of SF-36 scores of patient and controls (general population) with respect to sex
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| Male mean (SE) | Female mean (SE) |
---|
Domain | Patients (n=81) | Controls (n=90) | P value | Patients (n=51) | Controls (n=60) | P value |
---|
Physical functioning | 18.4 (3.2) | 85.3 (1.7) | <0.001 | 28.3 (4.4) | 72.0 (2.3) | <0.001 |
Role-physical functioning | 26.2 (4.5) | 81.8 (2.9) | <0.001 | 30.9 (5.7) | 71.2 (3.6) | <0.001 |
Role- emotional functioning | 29.2 (4.8) | 70.2 (3.4) | <0.001 | 38.6 (6.4) | 60.8 (3.9) | 0.002 |
Vitality | 43.6 (2.4) | 52.7 (2.0) | 0.005 | 42.3 (3.0) | 48.8 (1.9) | 0.064 |
Mental health | 55.6 (2.4) | 67.2 (1.7) | <0.001 | 51.9 (3.1) | 64.6 (1.7) | <0.001 |
Social functioning | 49.5 (2.9) | 85.2 (1.8) | <0.001 | 54.4 (4.0) | 81.7 (2.1) | <0.001 |
Bodily pain | 62.4 (3.3) | 81.4 (1.8) | <0.001 | 60.5 (4.0) | 70.9 (2.1) | 0.025 |
General health | 46.9 (2.1) | 54.7 (1.5) | 0.002 | 44.0 (2.3) | 51.7 (1.8) | 0.013 |
Table 156Comparison of SF-36 scores of patients and controls (general population) with respect to age
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| < 50 yr | ≥ 50 yr |
---|
Domain | Patients (n=90) | Controls (n=100) | P value | Patients (n=41) | Controls (n=50) | P value |
---|
Physical functioning | 20.1 (3.0) | 83.5 (1.7) | <0.001 | 27.1 (5.1) | 74.9 (2.3) | <0.001 |
Role-physical functioning | 28.3 (4.2) | 81.0 (2.9) | <0.001 | 27.4 (6.6) | 73.0 (3.6) | <0.001 |
Role- emotional functioning | 32.6 (4.7) | 66.9 (3.4) | <0.001 | 33.3 (7.0) | 64.4 (4.0) | <0.001 |
Vitality | 46.8 (2.1) | 51.0 (1.9) | 0.146 | 34.9 (3.5) | 50.9 (2.1) | <0.001 |
Mental health | 56.2 (2.2) | 63.7 (1.7) | 0.005 | 49.7 (3.7) | 68.4 (1.8) | <0.001 |
Social functioning | 54.0 (2.8) | 84.2 (1.7) | <0.001 | 45.7 (4.3) | 83.3 (2.2) | <0.001 |
Bodily pain | 64.4 (2.9) | 80.0 (1.7) | <0.001 | 55.7 (5.2) | 72.7 (2.3) | 0.004 |
General health | 47.1 (1.8) | 54.4 (1.6) | 0.003 | 42.9 (3.2) | 52.1 (1.6) | 0.006 |
The results of this study demonstrate that a treatment regimen leading to favourable urodynamic data and continence correlates with better quality of life.