Advanced Search

Study Preview



Study Title and Description

Outpatient biofeedback in addition to home pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial.



Key Questions Addressed
1 KQ 1: What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? KQ 2: What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? KQ 3: What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? KQ 4: What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Outpatient biofeedback in addition to home pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial.
Author Fitz FF., Stüpp L., da Costa TF., Bortolini MA., Girão MJ., Castro RA.
Country Department of Gynaecology, Federal University of São Paulo, São Paulo, Brazil.
Year 2017
Numbers Pubmed ID: 28169458

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: All studies
Arms
Number Title Description Comments
1 BF
  • Comments Comments (
    0
    ) |
2 PFMT
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
  • Comments Comments (
    0
    ) |
Country/countries Brazil
  • Comments Comments (
    0
    ) |
Funding source Explicitly not industry funded
  • Comments Comments (
    0
    ) |
Inclusion criteria Predominance of SUI symptoms and≥2 g leakage measured by pad test and with capability to contract the PFM properly.
  • Comments Comments (
    0
    ) |
Exclusion criteria Younger than 18 years old, had chronic degenerative diseases, pelvic organ prolapse greater than stage I by POP-Q, neurologic or psychiatric diseases, inability to contract PFMs, had previous pelvic floor re-education programs and/or pelvic floor surgeries
  • Comments Comments (
    0
    ) |
UI type
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
100
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Age 56.4
  • Comments Comments (
    0
    ) |
mean
  • Comments Comments (
    0
    ) |
11.3
  • Comments Comments (
    0
    ) |
nd
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Men included 0
  • Comments Comments (
    0
    ) |
Special populations 72
  • Comments Comments (
    0
    ) |
100
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Race 72
  • Comments Comments (
    0
    ) |
100
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Notes
  • Comments Comments (
    0
    ) |
Did participants fail previous treatment? No (explicitly treatment naive)
  • Comments Comments (
    0
    ) |
Study years 2011-2014
  • Comments Comments (
    0
    ) |
Trial name (if given)
  • Comments Comments (
    0
    ) |
Does this paper cite a previous paper from the same study?
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question BF PFMT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 35 37 72
  • Comments Comments (
    0
    ) |
25 24 49
  • Comments Comments (
    0
    ) |
10 13 23
  • Comments Comments (
    0
    ) |
Changes in work situation, family issues, no symptoms, not available Changes in work situation, family issues, other health issues, no symptoms, not available, moved to a different city Changes in work situation, family issues, other health issues, no symptoms, not available, moved to a different city
  • Comments Comments (
    0
    ) |
Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure BF PFMT Comparison Measure BF vs. PFMT


9 months

N Analyzed 35 37 Odds Ratio (OR) 1.55
Counts 17 14 95% CI low 0.61
Proportion 0.486 0.378 95% CI high 3.97
P-Value 0.358
Outcome: Leakage test: Pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure BF PFMT Comparison Measure ERROR vs. ERROR


9 months

N Analyzed 25 24 P-Value 0.158
Mean 2.0 5.5
95% CI low 0.7 0.9
95% CI high 3.3 10.1
Outcome: Leakage test: Other (placeholder)      Population: All Participants Between-Arm Comparisons
Time Point Measure BF PFMT Comparison Measure BF vs. PFMT


9 months

N Analyzed 25 24 P-Value 0.212
Mean 0.5 0.9
95% CI low 0.2 0.4
95% CI high 0.8 1.4


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
  • Comments Comments (
    0
    ) |
RCT:.....Allocation concealment High RoB
  • Comments Comments (
    0
    ) |
RCT:.....Blinding of PATIENTS High RoB
  • Comments Comments (
    0
    ) |
RCT.....Intention-to-treat-analysis Low RoB
  • Comments Comments (
    0
    ) |
ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High RoB
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data (attrition bias) Low RoB
  • Comments Comments (
    0
    ) |
ALL....Group similarity at baseline (selection bias) Low RoB
  • Comments Comments (
    0
    ) |
ALL.....Compliance with interventions High RoB
  • Comments Comments (
    0
    ) |
NRCS.....Patients in different intervention groups selected in an equivalent manner
  • Comments Comments (
    0
    ) |
NRCS....Baseline differences between groups accounted for (Adjusted analysis)?
  • Comments Comments (
    0
    ) |
ALL.....Other issues No
  • Comments Comments (
    0
    ) |
ALL....Were interventions adequately described? Yes
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.