HCP Clinical Data

CLINICAL DATA

RCT COMPLETED BY WELLCOME TRUST CLINICAL RESEARCH CENTRE, MANCHESTER

STUDY SUMMARY

In a randomised, single-blind controlled trial, 123 women with stress, urgency or mixed urinary incontinence were randomised between an active control group and an active group.

Active control group (Exercise)

Followed an on-line Pelvic Floor muscle exercise programme.

Active group (Pelviva)

Followed the on-line exercise programme with the addition of using Pelviva for 12 weeks.

Results

Women in the active group reported statistically significant improvements in quality of life with 84% reporting improved symptoms of bladder leakage.

PRIMARY OUTCOME MEASURE

ICIQ-UI

A condition specific quality of life tool for urinary incontinence

Statistically significant 4x greater improvement in ICIQ-UI scores in Pelviva group (p exact = 0.014)

Pelviva group (median decrease) – 5 points (45%)

Exercise group (median decrease) – 1 point (10%)

3 ICIQ-UI SUB DOMAINS

  • Leak frequency
  • Leak interference
  • Leak amount

LEAK FREQUENCY

Scored out of 6

Where 0 is ‘never’ leaking and 5 is leaking ‘all the time’

  • 66% significant 2-point improvement for the Pelviva group
  • 33% 1-point improvement for the exercise group

p exact = 0.005

Equates to an improvement from leaking about once per day to once or less per week for the Pelviva group and 3 times per week for the exercise group.

LEAK INTERFERENCE

Scored out of 10

Where 10 is interfering a ‘great deal’ with your everyday life

  • 40% significant 2-point improvement for the Pelviva group
  • 20% 1-point improvement for the exercise group

p exact = 0.018

SECONDARY OUTCOME MEASURE

Patient Global Impression of Severity and of Improvement (PGIS / PGII)

PGI Severity is measured on a 4-point scale 1 = normal, 2 = mild, 3 = moderate, 4 = severe

PGI improvement is measured on a 7-point scale 1 = very much better, 4 = no change and 7 = very much worse

84% of women in the Pelviva group reported an improvement compared to 69.6% in the exercise only group.

4.6% of women in the exercise group reported that their symptoms got worse, no women in the Pelviva group reported worsening of symptoms.

WOMEN IN THE PELVIVA GROUP DESCRIBED A SIGNIFICANTLY GREATER PERCEPTION OF IMPROVEMENT THAN THE EXERCISE GROUP (P=0.007).

FLUTsex

A questionnaire specific to the relationship of urinary incontinence and sexual function, developed and validated by the Bristol Urological Institute.

Both groups reported that their incontinence did not spoil or cause discomfort during sex. For those that did find incontinence ‘bothersome during sex’ the Pelviva group had a significant improvement (p= 0.026) with the majority of women affected in this group reporting that their incontinence was ‘no longer bothersome’ post treatment.

Usability data

During the study women were asked to fill in a ‘user diary’. This captured data with regard to comfort, ease of use and side effects. The majority of women found the device comfortable and easy to use and there were no apparent adverse incidents (e.g., allergic reactions, bleeding, undue pain, inability to remove the device) associated with using the device.

References

PEL/000016/UK September 2018