| Methods |
Design: three group parallel trial
Purpose: study the effect TENS for pain associated with cystoscopy |
| Participants |
Patients: outpatients needing flexible cystoscopy
Baseline comparability: yes (age, gender) |
| Interventions |
Placebo: sessions with TENS device not producing nerve stimulation
Untreated: no sessions
Experimental: sessions TENS device not producing nerve stimulation
(Co‐intervention: lidocaine gel) |
| Outcomes |
Pain (VAS)
Vital signs
International prostate symptom score |
| Notes |
It is unclear wether the spread of the mean VAS pain score refer to standard errors or standard deviations. We assume that they are standard deviations as their size (1.50 and 2.05) are comparable to the standard deviations for other mean VAS pain scores. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
No protocol available. It is unclear wether the spread of the mean VAS pain score refer to standard errors or standard deviations. We assume that they are standard deviations as their size (1.50 and 2.05) are comparable to the standard deviations for other mean VAS pain scores. |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 100 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
