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Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 1 Change in pain score with Resiniferatoxin.
Figuras y tablas -
Analysis 1.1

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 1 Change in pain score with Resiniferatoxin.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 2 Change in pain score with BCG.
Figuras y tablas -
Analysis 1.2

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 2 Change in pain score with BCG.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 3 Pain reduced by at least 50% after Resiniferatoxin..
Figuras y tablas -
Analysis 1.3

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 3 Pain reduced by at least 50% after Resiniferatoxin..

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 4 Improvement in vaginal/urethral pain with BCG..
Figuras y tablas -
Analysis 1.4

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 4 Improvement in vaginal/urethral pain with BCG..

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 5 Improvement in pelvic pain with BCG.
Figuras y tablas -
Analysis 1.5

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 5 Improvement in pelvic pain with BCG.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 6 Pain relieved with cross‐over instillations.
Figuras y tablas -
Analysis 1.6

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 6 Pain relieved with cross‐over instillations.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 7 Change in bladder capacity with BCG.
Figuras y tablas -
Analysis 1.7

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 7 Change in bladder capacity with BCG.

Study

BCG

Peters 1997

Instillation

Peters 1997

BCG

Peters 1997

Placebo

Pentosanpolysulphate

Bade 1997

Instillation

Bade 1997

PPS

Bade 1997

Placebo

Figuras y tablas -
Analysis 1.8

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 8 Urodynamic capacity after instillation.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 9 Maximum Cystometric Capacity after cross‐over instillations.
Figuras y tablas -
Analysis 1.9

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 9 Maximum Cystometric Capacity after cross‐over instillations.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 10 Change in frequency after Resiniferatoxin.
Figuras y tablas -
Analysis 1.10

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 10 Change in frequency after Resiniferatoxin.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 11 Change in frequency after BCG.
Figuras y tablas -
Analysis 1.11

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 11 Change in frequency after BCG.

Study

Instillation

Subjects(n)

Pre‐treatment

Post‐treatment

Change

BCG

Peters 1997

BCG

15

14 voids/24hr
median
(range: 7‐36)

‐1.4
(decrease)

Peters 1997

Placebo

15

16 voids/24hr
median
(range: 6‐22)

2.5
(increase)

Pentosanpolysulphate

Bade 1997

PPS

9

18voids/24hr

18voids/24hr

0

Bade 1997

Placebo

10

22voids/24hr

24voids/24hr

2 (increase)

Figuras y tablas -
Analysis 1.12

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 12 Change in frequency after instillation.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 13 Change in nocturia with Resiniferatoxin.
Figuras y tablas -
Analysis 1.13

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 13 Change in nocturia with Resiniferatoxin.

Study

Instillation

Subjects(n)

Pre‐treatment

Post‐treatment

Change

Pentosanpolysulphate

Bade 1997

Pentosan‐
polysulphate

9

4 episodes/24hr

2.8 episodes/24hr

‐1.2 episodes/24hr

Bade 1997

Placebo

10

5 episodes/24hr

5 episodes/24hr

no change

Figuras y tablas -
Analysis 1.14

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 14 Change in nocturia.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 15 Change in Symptom Index (SI) after Resiniferatoxin.
Figuras y tablas -
Analysis 1.15

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 15 Change in Symptom Index (SI) after Resiniferatoxin.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 16 Change in Symptom Index (SI) after BCG.
Figuras y tablas -
Analysis 1.16

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 16 Change in Symptom Index (SI) after BCG.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 17 Change in Problem Index (PI) after Resiniferatoxin.
Figuras y tablas -
Analysis 1.17

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 17 Change in Problem Index (PI) after Resiniferatoxin.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 18 Change in Problem Index (PI) after BCG instillation.
Figuras y tablas -
Analysis 1.18

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 18 Change in Problem Index (PI) after BCG instillation.

Study

Domain

BCG (n = 15)

Placebo (n = 15)

p value

Mean improvement in Rand‐36 questionnaire after BCG

Peters 1997

Pain

16

0

0.097

Peters 1997

Social function

21

‐7

0.036*

Peters 1997

Fatigue

24

1

0.007*

Peters 1997

Emotional limitation

22

3

0.414

Peters 1997

Physical function

10

‐9

0.423

Peters 1997

Physical limitation

22

4

0.399

Peters 1997

General health

10

2

0.431

Peters 1997

Well‐being

8

2

0.520

Figuras y tablas -
Analysis 1.19

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 19 Quality of Life.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 20 Subjective improvement in symptoms after Pentosanpolysulphate.
Figuras y tablas -
Analysis 1.20

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 20 Subjective improvement in symptoms after Pentosanpolysulphate.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 21 Subjective improvement in symptoms after Resiniferatoxin.
Figuras y tablas -
Analysis 1.21

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 21 Subjective improvement in symptoms after Resiniferatoxin.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 22 Subjective improvement in symptoms after BCG.
Figuras y tablas -
Analysis 1.22

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 22 Subjective improvement in symptoms after BCG.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 23 Pain with instillation of Resiniferatoxin.
Figuras y tablas -
Analysis 1.23

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 23 Pain with instillation of Resiniferatoxin.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 24 Unable to tolerate prescribed instillation.
Figuras y tablas -
Analysis 1.24

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 24 Unable to tolerate prescribed instillation.

Study

Instillation

Subjects(n)

At least 1 AE

Serious AE*

Withdrawn due to AE

AEs during instilln.

AEs during f/up.

Mayer 2005

BCG

129

123 (95%)

64 (50%)

1
(BCG sensitivity rxn)

Mayer 2005

Placebo

132

126 (95%)

63 (48%)

1
(prostatis/UTI)

Peters 1997

BCG

17

(* Grade 3/5 on
Common
Toxicity Criteria)

66

37

Peters 1997

Placebo

15

61

38

Figuras y tablas -
Analysis 1.25

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 25 Adverse Events with BCG or placebo instillation..

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 26 Bladder pain with BCG.
Figuras y tablas -
Analysis 1.26

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 26 Bladder pain with BCG.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 27 Bladder symptoms with instillation.
Figuras y tablas -
Analysis 1.27

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 27 Bladder symptoms with instillation.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 28 Haematuria with BCG instillation..
Figuras y tablas -
Analysis 1.28

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 28 Haematuria with BCG instillation..

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 29 Arthralgia/Myalgia with BCG.
Figuras y tablas -
Analysis 1.29

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 29 Arthralgia/Myalgia with BCG.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 30 Arthralgia with BCG.
Figuras y tablas -
Analysis 1.30

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 30 Arthralgia with BCG.

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 31 Inflammatory change on cystoscopy..
Figuras y tablas -
Analysis 1.31

Comparison 1 Intravesical treatment vs placebo or no treatment., Outcome 31 Inflammatory change on cystoscopy..

Study

Treatment.

Number

Baseline Capacity.

Post‐Rx Capacity.

Barbalias 2000

Bladder drill with instilled Oxybutinin solution.

24

174.5 ml

276.5 ml

Barbalias 2000

Bladder drill with instilled saline
solution.

12

179.4 ml

216.8 ml

Figuras y tablas -
Analysis 5.1

Comparison 5 Intravesical treatment combined with another treatment vs the other treatment alone., Outcome 1 Mean cystometric bladder capacity.

Study

Treatment

Number

Baseline frequency

Frequency Post‐Rx

Barbalias 2000

Bladder training with instilled Oxybutinin solution.

24

15 (voids/24hr)

13 (voids/24hr)

Barbalias 2000

Bladder training with instilled saline solution.

12

14.7

13.75

Figuras y tablas -
Analysis 5.2

Comparison 5 Intravesical treatment combined with another treatment vs the other treatment alone., Outcome 2 Mean frequency.

Study

Treatment

Number

PI (range) pre‐Rx.

PI (range) post‐Rx.

Barbalias 2000

Bladder training with instilled Oxybutinin solution.

24

13‐15

10‐8

Barbalias 2000

Bladder training with instilled saline solution.

12

13.08‐15.4

12.5‐14

Figuras y tablas -
Analysis 5.3

Comparison 5 Intravesical treatment combined with another treatment vs the other treatment alone., Outcome 3 Scores on symptom Problem Index (PI)..

Comparison 5 Intravesical treatment combined with another treatment vs the other treatment alone., Outcome 4 Dropouts during study..
Figuras y tablas -
Analysis 5.4

Comparison 5 Intravesical treatment combined with another treatment vs the other treatment alone., Outcome 4 Dropouts during study..

Comparison 1. Intravesical treatment vs placebo or no treatment.

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in pain score with Resiniferatoxin Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.1 Four weeks after treatment.

1

22

Mean Difference (IV, Fixed, 95% CI)

0.57 [‐2.17, 3.31]

1.2 Twelve weeks after treatment.

1

21

Mean Difference (IV, Fixed, 95% CI)

‐0.29 [‐2.79, 2.21]

2 Change in pain score with BCG Show forest plot

1

246

Mean Difference (IV, Fixed, 95% CI)

‐0.50 [‐1.06, 0.06]

2.1 At 34 weeks after starting instillations

1

246

Mean Difference (IV, Fixed, 95% CI)

‐0.50 [‐1.06, 0.06]

3 Pain reduced by at least 50% after Resiniferatoxin. Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 0.01microMol/L Rtx.

1

87

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.36, 1.88]

3.2 0.05microMol/L Rtx.

1

85

Risk Ratio (M‐H, Fixed, 95% CI)

1.40 [0.69, 2.83]

3.3 0.1microMol/L Rtx.

1

79

Risk Ratio (M‐H, Fixed, 95% CI)

0.50 [0.17, 1.47]

4 Improvement in vaginal/urethral pain with BCG. Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

5 Improvement in pelvic pain with BCG Show forest plot

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

1.76 [0.78, 4.00]

6 Pain relieved with cross‐over instillations Show forest plot

1

OR (Fixed, 95% CI)

0.22 [‐1.10, 1.55]

6.1 DMSO

1

OR (Fixed, 95% CI)

0.22 [‐1.10, 1.55]

7 Change in bladder capacity with BCG Show forest plot

1

222

Mean Difference (IV, Fixed, 95% CI)

‐9.0 [‐44.83, 26.83]

8 Urodynamic capacity after instillation Show forest plot

Other data

No numeric data

8.1 BCG

Other data

No numeric data

8.2 Pentosanpolysulphate

Other data

No numeric data

9 Maximum Cystometric Capacity after cross‐over instillations Show forest plot

1

Mean difference (Fixed, 95% CI)

17.0 [‐11.22, 45.22]

9.1 Dimethyl Sulfoxide

1

Mean difference (Fixed, 95% CI)

17.0 [‐11.22, 45.22]

10 Change in frequency after Resiniferatoxin Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

10.1 Four weeks after treatment

1

22

Mean Difference (IV, Fixed, 95% CI)

‐0.77 [‐4.58, 3.04]

10.2 Twelve weeks after treatment

1

21

Mean Difference (IV, Fixed, 95% CI)

‐2.63 [‐7.23, 1.97]

11 Change in frequency after BCG Show forest plot

1

246

Mean Difference (IV, Fixed, 95% CI)

‐1.2 [‐3.42, 1.02]

11.1 At 34 weeks after starting instillations

1

246

Mean Difference (IV, Fixed, 95% CI)

‐1.2 [‐3.42, 1.02]

12 Change in frequency after instillation Show forest plot

Other data

No numeric data

12.1 BCG

Other data

No numeric data

12.2 Pentosanpolysulphate

Other data

No numeric data

13 Change in nocturia with Resiniferatoxin Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

13.1 Four weeks after treatment

1

22

Mean Difference (IV, Fixed, 95% CI)

‐0.29 [‐1.56, 0.98]

13.2 Twelve weeks after treatment

1

21

Mean Difference (IV, Fixed, 95% CI)

‐1.85 [‐5.10, 1.40]

14 Change in nocturia Show forest plot

Other data

No numeric data

14.1 Pentosanpolysulphate

Other data

No numeric data

15 Change in Symptom Index (SI) after Resiniferatoxin Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

15.1 Four weeks after treatment

1

22

Mean Difference (IV, Fixed, 95% CI)

‐2.19 [‐5.34, 0.96]

15.2 Twelve weeks after treatment

1

21

Mean Difference (IV, Fixed, 95% CI)

‐2.07 [‐5.09, 0.95]

16 Change in Symptom Index (SI) after BCG Show forest plot

1

246

Mean Difference (IV, Fixed, 95% CI)

‐0.70 [‐1.70, 0.30]

16.1 At 34 weeks after starting instillations

1

246

Mean Difference (IV, Fixed, 95% CI)

‐0.70 [‐1.70, 0.30]

17 Change in Problem Index (PI) after Resiniferatoxin Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

17.1 Four weeks after treatment

1

22

Mean Difference (IV, Fixed, 95% CI)

‐2.67 [‐5.13, ‐0.21]

17.2 Twelve weeks after treatment

1

21

Mean Difference (IV, Fixed, 95% CI)

‐3.12 [‐6.67, 0.43]

18 Change in Problem Index (PI) after BCG instillation Show forest plot

1

246

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐1.56, 0.36]

18.1 At 34 weeks after starting instillations

1

246

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐1.56, 0.36]

19 Quality of Life Show forest plot

Other data

No numeric data

19.1 Mean improvement in Rand‐36 questionnaire after BCG

Other data

No numeric data

20 Subjective improvement in symptoms after Pentosanpolysulphate Show forest plot

1

20

Risk Ratio (M‐H, Fixed, 95% CI)

2.0 [0.47, 8.56]

21 Subjective improvement in symptoms after Resiniferatoxin Show forest plot

1

163

Risk Ratio (M‐H, Fixed, 95% CI)

0.74 [0.43, 1.27]

22 Subjective improvement in symptoms after BCG Show forest plot

2

295

Risk Ratio (M‐H, Fixed, 95% CI)

1.83 [1.12, 2.99]

23 Pain with instillation of Resiniferatoxin Show forest plot

2

185

Risk Ratio (M‐H, Fixed, 95% CI)

1.53 [1.13, 2.07]

24 Unable to tolerate prescribed instillation Show forest plot

2

185

Risk Ratio (M‐H, Fixed, 95% CI)

5.18 [1.29, 20.83]

24.1 Resiniferatoxin

2

185

Risk Ratio (M‐H, Fixed, 95% CI)

5.18 [1.29, 20.83]

25 Adverse Events with BCG or placebo instillation. Show forest plot

Other data

No numeric data

26 Bladder pain with BCG Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

26.1 During instillation

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.44, 2.39]

26.2 During follow‐up

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.21, 3.73]

27 Bladder symptoms with instillation Show forest plot

1

261

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.90, 1.17]

27.1 BCG

1

261

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.90, 1.17]

28 Haematuria with BCG instillation. Show forest plot

2

293

Risk Ratio (M‐H, Fixed, 95% CI)

1.78 [1.19, 2.66]

29 Arthralgia/Myalgia with BCG Show forest plot

1

261

Risk Ratio (M‐H, Fixed, 95% CI)

0.53 [0.30, 0.92]

30 Arthralgia with BCG Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

30.1 During instillation

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.06, 12.91]

30.2 During follow‐up

1

32

Risk Ratio (M‐H, Fixed, 95% CI)

2.65 [0.31, 22.82]

31 Inflammatory change on cystoscopy. Show forest plot

1

22

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.34, 2.95]

31.1 Resiniferatoxin.

1

22

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.34, 2.95]

Figuras y tablas -
Comparison 1. Intravesical treatment vs placebo or no treatment.
Comparison 5. Intravesical treatment combined with another treatment vs the other treatment alone.

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mean cystometric bladder capacity Show forest plot

Other data

No numeric data

2 Mean frequency Show forest plot

Other data

No numeric data

3 Scores on symptom Problem Index (PI). Show forest plot

Other data

No numeric data

4 Dropouts during study. Show forest plot

1

36

Risk Ratio (M‐H, Fixed, 95% CI)

0.13 [0.02, 1.00]

Figuras y tablas -
Comparison 5. Intravesical treatment combined with another treatment vs the other treatment alone.