Advanced Search

Study Preview



Study Title and Description

Randomized controlled trial of pelvic floor muscle training with or without biofeedback for urinary incontinence.



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 Randomized controlled trial of pelvic floor muscle training with or without biofeedback for urinary incontinence.
Author Hirakawa T., Suzuki S., Kato K., Gotoh M., Yoshikawa Y.
Country Program in Physical and Occupational Therapy, Nagoya University Graduate School of Medicine, 1-1-20, Daiko-minami, Higashi-ku, Nagoya, 461-8673, Japan.
Year 2013
Numbers Pubmed ID: 23306768

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


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

Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
  • Comments Comments (
    0
    ) |
Country/countries Japan
  • Comments Comments (
    0
    ) |
Funding source Explicitly not industry funded
  • Comments Comments (
    0
    ) |
Inclusion criteria SUI; leakage episode occurring more than once a week
  • Comments Comments (
    0
    ) |
Exclusion criteria Pelvic organ prolapse beyond the vaginal hymen; pregnancy; previous pelvic surgery for urology or gynecology in the past year, concomitant treatment for SUI during the trial period; neurological or psychiatric disease; urinary tract infection; any severe disease such as malignancy
  • 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 56.8
  • Comments Comments (
    0
    ) |
mean
  • Comments Comments (
    0
    ) |
10.6
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Men included 0
  • Comments Comments (
    0
    ) |
Special populations 46
  • 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 46
  • 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
    ) |
Study years 2008-2011
  • 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 PFMT PFMT + biofeedback Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 23 23 46
  • Comments Comments (
    0
    ) |
20 19 39
  • Comments Comments (
    0
    ) |
3 4 7
  • Comments Comments (
    0
    ) |
1 woman dropped out because of changes in her work situation, and the other 2 women dropped out because of a dislike of measuring the vaginal squeeze pressure woman dropped out because of menopausal discomfort, and the other 3 women dropped out because they disliked using the vaginal device at home; 1 woman also reported pain while inserting the vaginal device. nd
  • Comments Comments (
    0
    ) |
Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants
Time Point Measure PFMT PFMT + biofeedback


12 weeks

N Analyzed 23 23
Counts 17 16


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
  • Comments Comments (
    0
    ) |
RCT:.....Allocation concealment Low RoB
  • Comments Comments (
    0
    ) |
RCT:.....Blinding of PATIENTS High RoB unblinded
  • Comments Comments (
    0
    ) |
RCT.....Intention-to-treat-analysis Low RoB
  • Comments Comments (
    0
    ) |
ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High RoB unblinded assessors
  • 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 Dropouts due to intervention components
  • 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.