Review
Introduction
Methods
Search strategy and data extraction
Psychometric measures
Results
Author(s), Year | Country | Type of incontinence (e.g stress, urge) | Treatment (if any) | Study type (e.g. cross sectional, RCT, cohort) | Number of participants |
---|---|---|---|---|---|
Ternent et al, 2009 [20] | UK | Stress incontinence | No details | Cross sectional (self-selected sample) | 105 (of 188 approached) |
Ismail et al, 2009 [16] | UK | Urodynamic stress incontinence | Magnetic energy stimulation of pelvic floor muscles | Cohort | 48 |
Rinne et al, 2008 [22] | Finland | Stress UI with indications for surgical treatment | a) Tension-free vaginal tape (TVT) | RCT | 267 (of 273 randomised) |
b) TVT obturator (TVT-O) | |||||
Haywood et al, 2008 [7] | UK | Stress and/or urge incontinence in women referred for physiotherapy from primary or secondary care. | Physiotherapy | Cohort (RCT with data combined across arms) | 174 |
Monz et al, 2007 [12] | 15 European Countries (UK and Ireland subgroup) | UI of any type in women seeking treatment | At discretion of physician | Cross-sectional data from cohort study | 9487 |
Kobelt et al, 2006 [21] | France, Germany, Italy, Sweden, UK | Stress UI | NASHA/Dx gel | Cohort | 82 of 139 enrolled |
Dumville et al, 2006 [17] | UK | Proven stress UI requiring surgery | Laparoscopic vs open colposuspension | RCT | 291 |
Currie et al , 2006 [10] | UK | Stress and non-stress incontinence in patients identified from sample which had been treated by urology department. | None specified | Cross-sectional | 609 (from 2193 sent survey) |
Monz et al, 2005 [13] | 15 European countries | UI in women seeking treatment | None | Cross-sectional data from a cohort study | 9487 |
Manca et al, 2003 [18] (clinical outcomes from Ward 2002) | UK | Stress incontinence with indication for surgical management | Tension-free vaginal tape vs colposuspension | RCT | 344 |
Kobelt, 1997 [14] | Sweden | Mixed or urge incontinence in patients who had previously received therapy from a urotherapist. | None specified | Cross-sectional | 461 (541 sent questionnaire) |
Hawthorne, 2009 [2] | Australia | General population sample with data on presence and severity of UI | None | Cross-sectional | 3015 |
Tincello et al, 2010 [19] | Germany, UK, Sweden & Ireland | Stress UI, with or without urge symptoms, in women seeking treatment | 36.1% receiving conservative management at baseline. 18.0% receiving drug therapy at baseline. | Cross-sectional (baseline data from cohort study) | 3739 of 3762 enrolled |
Saarni, 2006 [9] | Finland | Self-reported UI in general population sample | None | Cross-sectional | 8028 of which 13.0% reported UI |
Noble et al, 2002 [11] | UK | Uncomplicated urinary tract symptoms in men with benign prostatic enlargement | Laser therapy vs Transurethral prostrate resection vs conservative management | RCT | 340 |
Mihaylova et al, 2010 [23] | Multicountry | Stress UI | Duloxetine vs conservative management vs duloxetine plus conservative management vs no treatment | Cohort (non randomised comparison of treatments) | 1510 |
(Germany, UK & Sweden) | 40% had pure stress incontinence with the rest reporting both stress and urge incontinence | ||||
Donovan et al, 1997 [8] | 12 countries | Outpatients attending urology department with symptoms (not specifically incontinence) and possible benign prostatic obstruction. GP sample (not selected for condition) | None | Cross-sectional | 1271 outpatient sample |
423 GP sample (UK) |
Generic measures | Other measures used | |||||
---|---|---|---|---|---|---|
Author(s), Year
|
Descriptive system
|
Tariff used
|
Direct valuation
|
Condition-specific HRQoL measures used
|
Clinical measures used
|
Qualitative questions
|
Ternent et al, 2009 [20] | EQ-5D | Not stated | None | KHQ | None | None |
PGI | ||||||
Ismail et al, 2009 [16] | EQ-5D | Not stated | None | KHQ | 1 hr pad test | None |
Leakage episodes | ||||||
Pad usage | ||||||
Rinne et al, 2008 [22] | EQ-5D | Not stated | None | UISS | Cough stress test | Satisfaction with operation. |
DIS | 24-hr pad | |||||
VAS | ||||||
IIQ-7 | ||||||
UDI-6 | ||||||
Haywood et al, 2008 [7] | EQ-5D | States general population utility weights. | None | I-QoL (index and individual domains) | SSI | Subjective treatment benefit assessed by patient. |
Incontinence episodes per week at baseline | ||||||
Monz et al, 2007 [12] | EQ-5D | Not stated | EQ-VAS | I-QOL | UI severity (Sandvik Index) | Bother (4 point scale) |
UI subtype (S/UIQ) | ||||||
Kobelt et al, 2006 [21] | EQ-5D | Reference suggests UK tariff used. | None | None | Incontinence grade | |
Median number of episodes per day | ||||||
Dumville et al, 2006 [17] | EQ-5D | UK tariff | None | None | Objective cure* (negative 1 hr pad test) | Subjective cure* (perfectly happy / pleased) to spend rest of life with current urinary symptoms |
SF-36 | ||||||
*(reported in related clinical paper) | ||||||
Currie et al, 2006 [10] | EQ-5D | Not stated | None | None | None | None |
SF-36 | ||||||
Monz et al, 2005 [13] | EQ-5D | Not stated | None | I-QOL | Sandvik index (severity based on frequency and leakage amount) | Bothersomeness and limitations of daily activities |
Manca et al, 2003 [18] | EQ-5D | UK tariff | Objective cure (based on negative pad test and negative cystometry) | |||
SF-36 | ||||||
Subjective cure (based on BFLUTS) | ||||||
Kobelt, 1997 [14] | EQ-5D | UK tariff. | EQ-VAS [15] | Frequency of micturitions and involuntary urine loss (combined measure) | ||
SF-36 | ||||||
Hawthorn, 2009 [2] | EQ-5D | EQ-5D: UK tariff | ||||
SF-6D | ||||||
AQoL | SF-6D: Not stated | |||||
AQoL-8 (derived from | ||||||
AQoL & | ||||||
AQoL) | AQoL-8: community TTO | |||||
HUI-3 (deciles) | ||||||
Tincello et al, 2010 [19] | EQ-5D | UK tariff | None | None | Episodes per week | None |
Saarni, 2006 [9] | EQ-5D | EQ-5D: UK tariff | None | None | None | |
15-D | ||||||
15-D Finnish valuation set | ||||||
Noble et al, 2002 [11] | EQ-5D | Not stated | None | I-PSS which includes a quality of life score. | Maximum flow rate | |
Post void residual urine | ||||||
Number of successful procedures (based on I-PSS and maximum urinary flow) | ||||||
Mihaylova et al, 2010 [23] | EQ-5D | UK tariff | Number of leaks during 7 days | |||
Donovan et al, 1997 [8] | EQ-5D (UK, Denmark and Netherland only, N=359) | Not reported | ICSQol (ICSmale) | |||
SF-36 (UK only, N=205) |
‘Known group’ validity
Author(s), Year |
Groups defined as
|
Instrument
|
Direction of change consistent across groups and consistent with clinical expectation?
|
Difference between groups statistically significant?
|
---|---|---|---|---|
Haywood et al, 2008 [7] | Number of episodes at baseline: | |||
EQ-5D | Yes‡ | No at p=0.01 | ||
Not at all | SSI | Yes | Yes, p<0.01 | |
A few days | I-QoL index | Yes | Yes, p<0.01 | |
Half the week | I-QoL domains | Mixed† | Yes, p<0.01 | |
Most days | ||||
Every day | ||||
Tincello et al, 2010 [19] | Episode frequency: | |||
<=7 per week | EQ-5D | Yes | Yes, p<0.0001 | |
7 to 13 per week | ||||
>=14 per week | ||||
Monz et al, 2005 [13] | Severity (reported for each subtype) | |||
Slight | EQ-5D | Yes | Not reported | |
Moderate | EQ-VAS | Yes | Not reported | |
Severe | Mean I-QoL | Yes | Not reported | |
Very severe | I-QoL domains | Yes | Not reported | |
Hawthorne, 2009 [2] | Continence status: | |||
a) None | EQ-5D | Yes | Yes, p<0.0001 | |
b) Slight/mild | SF-6D | Yes | Yes, p<0.0001 | |
c) Moderate | AQoL | Yes | Yes, p<0.0001 | |
d) Severe | AQoL-8 | Yes | Yes, p<0.0001 | |
Currie et al, 2006 [10] | Type of incontinence: | |||
General | EQ-5D | Stress<general<none* | Not reported | |
Stress | SF-36 | As for EQ-5D | As for EQ-5D | |
None | ||||
Monz et al, 2005 [13] | Subtype (reported for each severity category): | |||
EQ-5D | Stress>urge>mixed* | Not reported | ||
EQ-VAS | As for EQ-5D (except when severity slight) | Not reported | ||
Stress | ||||
Mean I-QoL | As for EQ-5D | Not reported | ||
Urge | I-QoL domains | No consistent pattern across all domains | Not reported | |
Mixed | ||||
Tincello et al, 2010 [19] | UI subtype: | |||
Mixed | EQ-5D | Stress>urge>mixed* | Yes, p<0.0001 | |
Pure stress | ||||
Pure urge |
Convergent validity
Responsiveness
Author(s), Year |
Comparison
|
Change in clinical measure(s) or other preference based utility
|
Change in EQ-5D
|
Agreement with direction?
|
Agreement with statistical significance?
|
---|---|---|---|---|---|
Ismail et al, 2009 [16] | Change over time | No significant change on any measure (KHQ,1 hr pad test, pad use, leakage episodes) | No significant change | NA | Yes |
Rinnie et al, 2008 [22] | Change over time | 24 hr pad test significantly improved in both arms | Significant improvement in both arms | Yes | Yes |
All condition specific measures (UISS, DIS, VAS, IIQ-7, UDI-6) significantly improved in both treatment groups | |||||
EQ-VAS significantly improved in both treatment groups | |||||
Difference between treatment arms | No significant difference in objective cure, leakage, complication rate, UISS, DIS, VAS, IIQ-7, UDI-6. | No significant difference in EQ-5D | Agreement with some clinical outcomes and not others. | Yes | |
Haywood et al 2008 [7] | Comparison of means for responders and non-responders | 6 week data: | 6 week data: | 6 week data: | 6 week data: |
SSI and I-QoL index had difference in expected direction but not statistically significant (at p=0.01). Two of the I-QoL domains had significant difference. | EQ-5D had difference in expected direction but not statistically significant (at p=0.01). | Yes | Not consistent with all | ||
5 mth data: | 5 mth data: | 5 mth data: | 5 mth data: | ||
As for 6 weeks except only one of the I-QoL domains had significant (p<0.01) difference. | EQ-5D had difference in expected direction and statistically significant (p=0.01). | Yes | Not consistent with all. | ||
Mean change scores for patients reporting improvement | 6 week data: | 6 week data: | 6 week data: | 6 week data: | |
Expected direction and significant (at p=0.05) for SSI, I-QoL index, I-QoL domains | Expected direction but p>0.05 | Yes | No | ||
5 mth data: | 5 mth data: | 5 mth data: | 5 mth data: | ||
As for 6 weeks but larger changes. | Expected direction and p<0.05. | Yes | Yes | ||
MSRM for patients reporting improvement | 6 week data: | 6 week data: | 6 week data: | 6 week data: | |
SSI, 0.70 | 0.07 | Yes | No | ||
I-QoL index, 1.01 | |||||
I-Qol domains, 0.40 to 0.94 | |||||
5 mth data: | 5 mth data: | 5 mth data: | 5 mth data: | ||
SSI, 0.67 | 0.26 | Yes | Yes | ||
I-QoL index, 1.17 | |||||
I-Qol domains, 0.80 to 1.25 | |||||
Kobelt et al, 2006 [21] | Median incontinence episodes per day for clinical outcome but change from baseline for EQ-5D | All patients: | All patients: | All patients | All patients |
3.0 at baseline, 0.7 at 3mths and 0.9 at 12 mths (p<0.0001 and p<0.001 for differences) | 3 mths: 0.048 (p<0.001)6 mths: 0.014 (not significant) | 3 mths: Yes | 3 mths: Yes | ||
12 mths: “gain remained evident” | 12 mths: Yes | 12 mths: Yes | |||
Patients with utility<1 at baseline: | Patients with utility <1 at baseline: | Patients with utility <1 at baseline: | |||
3 mths: 0.099 (p<0.01) | |||||
6 mths: 0.065 (p<0.001) | |||||
12 mths: “significant improvements” | As for all patients | As for all patients | |||
Dumville et al, 2006 [17] | Difference between treatment arms: | Objective and subjective cure rates and SF-36 scores showed no significant difference | QALY gain based on EQ-5D utility scores showed no significant difference (CrI crossed zero) | No change in either clinical, generic HRQoL or utility | Yes |
Manca et al, 2003 [18] | Differences from baseline to 6mths | Pad weight decreased significantly for both groups. | Utility increased in both arms (significance not reported) | Yes | Not reported |
Significant reduction in leakage episodes in both groups (P<0.0001) | |||||
Significant reduction in 21/30 symptoms (BFLUTS) in both groups (P<0.0001) | |||||
Differences between trial arms: | No significant difference in objective or subjective cure rate between trial arms | QALY difference between arms based on EQ-5D scores non significant at p=0.05 | Agreement with clinical outcomes but didn’t detect differences between arms in some SF-36 domains | Yes for clinical outcomes, no for some SF-36 domains | |
SF-36 scores had significantly smaller improvement/ greater decline lower for colposuspension group vs TVT in four domains at 6 weeks and four domains (three same and one different) at 6 mths. | |||||
Noble et al, 2002 [11] | Change from baseline: | Improvements in I-PSS, maximum urine flow, and residual volume were significant (p=0.05) for laser and resection but not conservative. | Means increased for laser and resection but not conservative (p values not reported) | Yes | Not reported |
Improvements in I-PSS QoL were significant for all three interventions. | |||||
Differences between trial arms: | Resection vs conservative and laser vs conservative showed significant difference in all four outcomes. | Gains were greater for resection than laser therapy (p values not reported) | Yes | Not reported | |
Laser vs resection showed significant difference in only one outcome which was in favour of resection (maximum flow) | |||||
Mihaylova et al, 2010 [23] | Comparison between active treatment arms and no treatment: | Number of leaks avoided per week was significantly (p<0.01) better for Duloxetine alone, conservative alone and duloxetine plus conservative (all relative to no treatment). | QALY gains based on EQ-5D utility were significant for Duloxetine alone (p<0.01) and duloxetine plus conservative treatment (p<0.05) but conservative alone was not significant and was negative (all compared to no treatment) | Yes for two of three comparisons against no treatment | Yes for two of three comparisons against no treatment |
Comparison between the three active treatment arms: | No significant reduction in number of leaks for 3 comparisons between active treatment arms. | Significant (p<0.05) QALY gains for 2 of 3 comparisons between active treatment arms. | Yes for 2 of 3 comparisons between active treatment arms. | No for 2 of 3 comparisons between active treatment arms. |