Advanced Search

Study Preview



Study Title and Description

A pilot randomised controlled trial of the pelvic toner device in female stress 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 A pilot randomised controlled trial of the pelvic toner device in female stress urinary incontinence.
Author Delgado D., White P., Trochez R., Drake MJ.
Country Musculoskeletal Research Unit, Avon Orthopaedic Centre, Southmead Hospital, Bristol, BS10 5NB, UK.
Year 2013
Numbers Pubmed ID: 23640005

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Standard Treatment Group unresisted pelvic floor muscle training
  • Comments Comments (
    0
    ) |
2 Pelvic toner group pelvic training device used
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
  • Comments Comments (
    0
    ) |
Country/countries United Kingdom
  • Comments Comments (
    0
    ) |
Funding source Explicitly not industry funded
  • Comments Comments (
    0
    ) |
Inclusion criteria women > 18 with sure SUI or stress-predominant mixed UI, no previous UI surgery
  • Comments Comments (
    0
    ) |
Exclusion criteria pregnancy, <12 weels post-partum, taking duloxeting, recent or current UTI, neurological disease, post-void residual ≥ 100 ml, organ prolapse
  • Comments Comments (
    0
    ) |
UI type
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
100
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Age 49.6
  • Comments Comments (
    0
    ) |
mean
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
36-68
  • Comments Comments (
    0
    ) |
  • Comments Comments (
    0
    ) |
Men included 0
  • Comments Comments (
    0
    ) |
Special populations
  • 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
  • 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? Not reported/unclear
  • Comments Comments (
    0
    ) |
Study years nd
  • 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 Standard Treatment Group Pelvic toner group Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 24 28 52
  • Comments Comments (
    0
    ) |
19 21 40
  • Comments Comments (
    0
    ) |
5 7 12
  • Comments Comments (
    0
    ) |
Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure Standard Treatment Group Pelvic toner group Comparison Measure Standard Treatment Group vs. Pelvic toner group


Enter a numeric value or title (required) years

N Analyzed 19 21 P-Value 0.429
Counts 2 0
Percentage 10.5 0
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure Standard Treatment Group Pelvic toner group Comparison Measure Standard Treatment Group vs. Pelvic toner group


Enter a numeric value or title (required) years

N Analyzed 13 15 P-Value 0.089
Counts 0 1
Percentage 0 6.7
Outcome: Cure etc.      Population: All Participants
Time Point Measure Standard Treatment Group Pelvic toner group


16 weeks

N Analyzed 19 21
Counts 10 11


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 not possible with study interventions
  • Comments Comments (
    0
    ) |
RCT.....Intention-to-treat-analysis Low RoB
  • Comments Comments (
    0
    ) |
ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Low RoB assessors blinded
  • 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 Unclear RoB pt completing intervention at home on own over 16 weeks
  • 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
  • Comments Comments (
    0
    ) |
ALL....Were interventions adequately described? Yes
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.