Table 2 Characteristics of primary studies included in this systematic review

Patrick et al., 1999 [39]

To report the further development of the I-QOL, including its measurement model, responsiveness, and effect size

Start: 288

End: The calculations for each anchor had a different sample size: Pad test: 270

Voiding diary: 269

PGI-I: 115

SUI, MUI

Conservative: pharmacological

I-QOL (0-100 points; higher score means a worse condition)

NA

Responsiveness statistic (mean change divided by the stadard deviation of the baseline)

PGI-I, Pad test, Voiding diary

9

Results varied from 0.4.-0.8 and a varying from 2-13% was detected by the PROM, which supports the ability of the PROM to detect change.

Yalcin et al., 2005 [40]

To determine MID for the total and subscale I-QOL scores during within- and between-treatment for women with SUI

Start: Total=1133

Placebo=45

Treatment=708

End: Not reported

SUI

Conservative treatment: pharmacological and placebo

I-QOL (0-100 points; higher score means a worse condition)

NA

Mean change

PGI-I

8

The clinical important score por I-QOL for reasons of between-treatment is 2.5 points, while the within-treatment score is 6.3

Barber et al., 2009 [41]

Estimate MID for the UDI, UDI-stress (subscale of the PFDI), and UIQ (subscale of the PFIQ)

Start: 445

End: 333

SUI

Conservative treatment: pessary, behavioral therapy

UDI

(0-300 points; higher score means a worse condition)

UDI-stress, (0-100 points; higher score means a worse condition)

UIQ (0-100 points; higher score means a worse condition)

Effect size, Standard error of measurement

Mean change

PGI-I, Incontinence Severity Index, Voiding diary

21

MIDs were provided for UDI, UDI-stress subscale and UIQ. Findings that meet or exceed these thresholds should be considered clinically important

Dyer et al., 2011 [42]

To estimate the MID for the UDI, IIQ, OAB-q and/or their selected subscales in patients with UUI and to determine whether the MID changes over time

Start: 307

End: 10 weeks = 272

8 months = 241

UUI

Conservative: pharmacological, behavioral therapy

IIQ

(0-400 points, higher score means a worse condition)

OAB-q

(0-100 points; higher score means a worse condition)

UDI (0-300 points; higher score means a worse condition)

Effect size, Standard error of measurement

Difference in the mean score between people that were “better” versus “about the same”

PSQ, GPI, Voiding diary

38

MIDs were provided for women who underwent treatment for UUI in UDI, UDI irritative and OAB-q (quality of life and symptom severity subscores)

Chan et al., 2013 [43]

To evaluate the responsiveness of the Chinese PFDI and PFIQ in women with POP and/or urodynamic SUI who were undergoing treatment by surgery

Start: Continence surgery alone: 28

End: Not reported

SUI

Non-conservative: surgery

UDI (subscale of PFDI) (0-300 points; higher score means a worse condition)

UIQ (subscale of PFIQ) (0-100 points; higher score means a worse condition)

Effect size, Standardized response mean

Mean change

Satisfaction with the treatment received, 10-cm VAS score indicating the severy of symptoms

28

The Chinese version of the PFDI and PFIQ are responsive to change in incontinent women treated by surgical procedures

Suskind et al., 2014 [44]

To develop a clinically relevant, easy to use, and validated instrument for assessing severity and bother related to urinary incontinence

Start: 447

End: 447

SUI

Non-conservative: surgery

M-ISI (1-12 points: higher score means a worse condition)

Standard deviation

NA

NA

8

M-ISI is a parsimonious measure that has established reliability and validity on several levels and complements current clinical evaluative methods for patients with urinary incontinence

Nystrom et al., 2015 [45]

To calculate the MID for ICIQ-UI SF and ICIQ-LUTSqol in women treated with PFMT for SUI

Start: 218

End: 214

SUI

Conservative: Internet-based treatment programme (information about SUI and associated lifestyle factors, PFMT, training reports)

ICIQ-SF

(0-21 points; higher score means a worse condition)

ICIQ-LUTSqol (19-76 points; higher score means a worse condition)

NA

Mean change

PGI-I

4

This study suggested that the reductions of 2.5 and 3.7, should be considered clinically relevant for ICIQ-UISF and ICIQ-LUTSqol, respectively, in women with SUI treated with PFMT by internet or postal treatment

Sirls et al., 2015 [46]

To determine the MID of the ICIQ-UI SF

Start: 597

End: 12 months: 501

24 months: 447

SUI

Non-conservative: surgery

ICIQ-SF (0-21 points; higher score means a worse condition)

Effect size

Mean change

PGI-I, UDI, IIQ, Voiding diary, Satisfaction with surgical results

14

The recommended MIDs for the ICIQ-UI SF in a population of women with stress predominant UI are -5 for assessment at 12 months and -4 for assessment at 24 months

Luz et al., 2017 [47]

To calculate KHQ scores for subjective cure and improvement rates

Start: 204

End: 6 months: objective=199; KHQ=190

12 months: objective=185, KHQ=177

24 months: objective=171; KHQ=169

SUI, MUI

Non-conservative: surgery

KHQ (0-100 points; higher score means a worse condition)

Effect size

NA

NA

1

This study determined the clinically relevant threshould scores to define subjective outcomes after surgery for urinary symptoms

Baessler et al., 2019 [49]

To establish the MID of the Australian Pelvic Floor Questionnaire in women undergoing surgery for SUI or POP using anchor-based methods

Start: 80

End: 80

SUI

Non-conservative: surgery

Australian Pelvic Floor Questionnaire (0-40 points; higher score means a worse condition)

Effect size, Standardized response mean

ROC curve

PGI-I

15

Changes of approximately 1 in the Australian Pelvic Floor Questionnaire can be considered a clinically important difference

Lim et al., 2019 [48]

To estimate the MIDs of ICIQ-UI SF and the ICIQ-LUTSqol using anchor and distribution-based methods for women with SUI undergoing nonsurgical treatment

Start: 120

End: 106

SUI

Conservative: magnetic stimulation

ICIQ-SF (0-21 points; higher score means a worse condition)

ICIQ-LUTSqol (19-76 points; higher score means a worse condition)

Effect size

Mean difference

PGI-I, Satisfaction with the treatment, 1-h pad test, Voiding diary (3-day bladder diary)

10

Reductions in 4 and 6 points at 12-month follow-up in ICIQ-UI SF and ICIQ-LUTSqol are perceived as clinically meaningful in women undergoing nonsurgical treatment for SUI

Nipa et al., 2023 [50]

To establish, for the first time, the clinically important differences for the ICIQ-UI-SF and ICIQ-FLUTS questionnaires following surgical and conservative treatments for stress-predominant urinary incontinence in women.

Start: 1200

End: 912

SUI, MUI

Non-conservative: surgery

Conservative: PFMT versus PFMT plus biofeedback

ICIQ-SF (0-21 points; higher score means a worse condition)

ICIQ-FLUTS (0-20 points: higher score means a worse condition)

NA

Linear combination of the interaction and the variable indicating a change on the anchor variable

PGI-I

13