Extraction form for project: Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update

Arms

Arm NameArm Description
magnetic stimulation
Placebo

Arm Details

1. Type of intervention
IF "OTHER", DISCUSS WITH TEAM SO THAT MAYBE WE CAN ADD TO THE LIST. IDEALLY, IN THE END WE WANT NO "OTHERS".
magnetic stimulation
Placebo
2. Intervention description (non-pharmacological)
Brief description. You can put the whole description here (except duration of intervention)
magnetic stimulation
Placebo
3. Dose or regimen
Dose for pharmacological, regimen for nonpharmacological (as appropriate)
magnetic stimulation
Placebo
4. Frequency
Number of times taken, used, or done per day (or week etc.)
magnetic stimulation
Placebo
5. Duration
Duration of the intervention, not duration of the study. Only for "short-course" interventions. Otherwise, leave blank.
magnetic stimulation
Placebo
6. Notes
magnetic stimulation
Placebo

Outcomes

TypeDomainSpecific MeasurementPopulationsTimepoints
ContinuousIncontinence count/frequency (stress)Incontinent episodes in 24 hours
  • All Participants
  • 12 (Weeks)
ContinuousLeakage test: Pad testPad Test gram
  • All Participants
  • 12 (Weeks)
Categoricalquality of life
  • All Participants
  • 12 (Weeks)

Design

1. Men included
If there is a subgroup analysis of just women that we can use, then ignore the men, so men = 0%. IF >10% THEN STOP, REJECT STUDY, AND DELETE THIS SRDR ENTRY
%
Men
2. Trial name (if given)
3. Does this paper cite a previous paper from the same study?
If yes and all are in Evidence Map, make sure all are listed in Publications tab. If some are "new" to us, stop and check with Gaelen first.
4. Study type
5. Directionality
Skip if RCT
6. Country/countries
7. Study years
give in the following format 2010-2012; do not include months or days
8. Funding source
9. Inclusion criteria
10. Exclusion criteria
11. Did participants fail previous treatment?
If yes, extract what the prior treatments were. If "some" extract the % and what the prior treatments were.
12. UI type
Overall, across arms. Mixed = urge and stress in individual woman
%Definition
Urge UI
Stress UI
Mixed UI
Unclassified/nd
Other UI
13. Age
If there is a subgroup analysis of just women that we can use, then ignore the age data for the men. If age is mixed men and women, say that in the notes ("men and women")
mean/mediantypeSD/IQRrangenotes
Age
14. Special populations
n%notes/definition
None/not reported
athletes
older women
military/veterans
15. Race
n%notes
Not reported
White
Black
Hispanic
Asian
other
16. Notes

Outcome Details

1. Scale range
Incontinence count/frequency (stress)
Leakage test: Pad test
quality of life
2. Scale direction
Incontinence count/frequency (stress)
Leakage test: Pad test
quality of life

Baselines

1. Participant flow
If there is a subgroup analysis of just women that we can use, then ignore (do not count) the men. Ignore "Reasons" boxes for N enrolled and analyzed.
NReasons
N enrolled
N analyzed
Dropouts
2. Notes

Results

Categorical


quality of life

All Participants
Descriptive StatisticsBetween Arm Comparisons
magnetic stimulationPlacebo
12 (Weeks)
Within Arm ComparisonsNet Comparisons
magnetic stimulationPlacebo

Continuous


Incontinence count/frequency (stress) (Incontinent episodes in 24 hours)

All Participants
Descriptive StatisticsBetween Arm Comparisons
magnetic stimulationPlacebo
vs.
12 (Weeks)
N Analyzed
Net P value
IQR
Median
Within Arm ComparisonsNet Comparisons
magnetic stimulationPlacebo
vs.

Leakage test: Pad test (Pad Test gram)

All Participants
Descriptive StatisticsBetween Arm Comparisons
magnetic stimulationPlacebo
magnetic stimulation
vs.
Placebo
12 (Weeks)
N Analyzed
Net P value
IQR
Median
Within Arm ComparisonsNet Comparisons
magnetic stimulationPlacebo
magnetic stimulation
vs.
Placebo

Quality

1. RCT:.....Adequate generation of a randomized sequence
There is a low risk of selection bias if the investigators describe a random component in the sequence generation process such as: referring to a random number table, using a computer random number generator, coin tossing, shuffling cards or envelopes, throwing dice, drawing of lots, minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random). There is a high risk of selection bias if the investigators describe a non-random component in the sequence generation process, such as: sequence generated by odd or even date of birth, date (or day) of admission, hospital or clinic record number; or allocation by judgement of the clinician, preference of the participant, results of a laboratory test or a series of tests, or availability of the intervention.
Value:
Notes:
2. RCT:.....Allocation concealment
There is a low risk of selection bias if the participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomization); sequentially numbered drug containers of identical appearance; or sequentially numbered, opaque, sealed envelopes. There is a high risk of bias if participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; or other explicitly unconcealed procedures.
Value:
Notes:
3. RCT:.....Blinding of PATIENTS
There is a low risk of performance bias if blinding of participants was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.
Value:
Notes:
4. RCT.....Intention-to-treat-analysis
There is low risk of bias if all randomized patients were reported/analyzed in the group to which they were allocated by randomization. I.e., no dropouts or they state analyzed as ITT (unless there's an obvious problem).
Value:
Notes:
5. ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND")
There is low risk of detection bias if the blinding of the outcome assessment was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.; or: >> for patient-reported outcomes in which the patient was the outcome assessor (e.g., pain, disability): there is a low risk of bias for outcome assessors if there is a low risk of bias for participant blinding. >> for outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care providers (e.g., co-interventions, length of hospitalization, treatment failure), in which the care provider is the outcome assessor: there is a low risk of bias for outcome assessors if there is a low risk of bias for care providers. >> for outcome criteria that are assessed from data from medical forms: there is a low risk of bias if the treatment or adverse effects of the treatment could not be noticed in the extracted data.
Value:
Notes:
6. ALL.....Incomplete results data (attrition bias)
There is a low risk of attrition bias if there were no missing outcome data; reasons for missing outcome data wre unlikely to be related to the true outcome (for survival data, censoring unlikely to be introducing bias); missing outcome data were balancd in numbers, with similar reasons for missing data across groups (The percentage of withdrawals and drop-outs should not exceed 20% for short-term follow-up and 30% for long-term follow-up and should not lead to substantial bias. Note: these percentages are commonly used but arbitrary, not supported by the literature). For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk was not enough to have a clinically relevant impact on the intervention effect estimate. For continuous outcome data, the plausible effect size (difference in means or standardized difference in means) among missing data were imputed using appropriate methods. Note: if drop-outs are very large, imputation using even ‘acceptable’ methods may still suggest a high risk of bias.
Value:
Notes:
7. ALL....Group similarity at baseline (selection bias)
There is low risk of selection bias if groups are similar at baseline for demographic factors, value of main outcome measure(s), and important prognostic factors (examples in the field of back and neck pain are duration and severity of complaints, vocational status, percentage of patients with neurological symptoms).
Value:
Notes:
8. ALL.....Compliance with interventions
There is low risk of bias if compliance with the interventions was acceptable, based on the reported intensity/dosage, duration, number and frequency for both the index and control intervention(s).
Value:
Notes:
9. NRCS.....Patients in different intervention groups selected in an equivalent manner
Value:
Notes:
10. NRCS....Baseline differences between groups accounted for (Adjusted analysis)?
For RCT, Yes, unless there are important baseline differences that are not adjusted for. For nRCS, No if unadjusted or adjusted only for age and sex; Yes if multivariate adjustment (more than age/sex) or propensity score analysis. There is low risk of selection bias if groups are similar at baseline for demographic factors, value of main outcome measure(s), and important prognostic factors (examples in the field of back and neck pain are duration and severity of complaints, vocational status, percentage of patients with neurological symptoms).
Value:
Notes:
11. ALL.....Other issues
Value:
Notes:
12. ALL....Were interventions adequately described?
Do you understand in enough detail what's being done?
Value:
Notes:
13. Adjust Quality Rating (for Key Questions: 1)
Quality Guideline Used:
Select Current Overall Rating:
Notes on this Rating: