A study comparing pelvic floor muscle exercises with and without the use of computer feedback for women with urine leakage (OPAL)

Conditions

Female stress or mixed urinary incontinence Urological and Genital Diseases Stress incontinence

Suzanne Hagen, Carol Bugge, Sarah Dean, Andrew Elders, Jean Hay‐Smith et al. (24 authors)

Health Technology Assessment2020-12-0149 citations

10.3310/hta24700

Designing process evaluations using case study to explore the context of complex interventions evaluated in trials.

Grant A, Bugge C, Wells M.

2020-11-2727 citations

10.1186/s13063-020-04880-4

Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial

Suzanne Hagen, Doreen McClurg, Carol Bugge, Jean Hay‐Smith, Sarah Dean et al. (19 authors)

BMJ Open2019-02-0124 citations

10.1136/bmjopen-2018-024153

Effectiveness and cost-effectiveness randomised controlled trial of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL (optimising pelvic floor exercises to achieve long-term benefits) trial mixed methods longitudinal qualitative case study and process evaluation

Aileen Grant, Sarah Dean, Jean Hay‐Smith, Suzanne Hagen, Doreen McClurg et al. (8 authors)

BMJ Open2019-02-0112 citations

10.1136/bmjopen-2018-024152

Interventions

1. PFMT intensified with use of electromyography biofeedback both at home and in clinic. 2. Basic PFMT. Both groups will be seen for six appointments and intervention

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women 18 years of age or above, presenting with a new episode of stress or mixed urinary incontinence (UI) 2. Who are willing and eligible to be randomised

Exclusion criteria

Exclusion criteria: 1. Women who have urge UI alone 2. Women who cannot contract their pelvic floor muscles 3. Women who had formal instruction in PFMT in the last three years 4. Women who are pregnant or less than one year postnatal 5. Women who have prolapse greater than stage II, who have pelvic cancer, cognitive impairment or neurological disease

Design outcomes

Primary

Measure	Time frame
International Consultation on Incontinence short form questionnaire (ICIQ-UI SF) measured at baseline, 6, 12 and 24 months	—

Secondary

Measure	Time frame
Urinary outcomes 1. Number of episodes of UI per day, recorded by women in a bladder diary [Locher et al 2001] 2. Impression of global improvement in UI (PGI-I) [Yalcin and Bump 2003] 3. Number of women with UI cured and number with UI improved, derived from the ICIQ-UI ShortForm (cured is a negative response to both 'how often do you leak urine?' and 'how much urine do you usually leak (whether you wear protection or not)?' 4. Uptake of surgery for UI 5. Uptake of other treatment for UI 6. Other urinary symptoms (ICIQ-FLUTS) [Brookes et al 2004] Quality of life outcomes 1. UI-specific quality of life (Kings Health Questionnaire) [Kelleher et al 1997] 2. General health (EQ-5D-3L) [EuroQol Group] Pelvic floor related outcomes 1. Prolapse symptoms (POP-SS - Hagen et al 2009) 2. Bowel symptoms (early version of ICIQ Bowel Short Form) 3. Pelvic floor muscle function (Oxford scale - Laycock 2008, ICS method - Messelink et al 2005) 4. Self-efficacy for PFMT (PFME self-efficacy scale) [Chen 2004] 5. Adherence to PFMT (exercise diary/follow-up questionnaire) Economic outcomes 1. Cost and use of NHS services 2. Cost to the women and their families/carers 3. The incremental costs, QALYs and incremental cost per QALY derived by the economic model.	—

Measure

Time frame

Urinary outcomes 1. Number of episodes of UI per day, recorded by women in a bladder diary [Locher et al 2001] 2. Impression of global improvement in UI (PGI-I) [Yalcin and Bump 2003] 3. Number of women with UI cured and number with UI improved, derived from the ICIQ-UI ShortForm (cured is a negative response to both 'how often do you leak urine?' and 'how much urine do you usually leak (whether you wear protection or not)?' 4. Uptake of surgery for UI 5. Uptake of other treatment for UI 6. Other urinary symptoms (ICIQ-FLUTS) [Brookes et al 2004] Quality of life outcomes 1. UI-specific quality of life (Kings Health Questionnaire) [Kelleher et al 1997] 2. General health (EQ-5D-3L) [EuroQol Group] Pelvic floor related outcomes 1. Prolapse symptoms (POP-SS - Hagen et al 2009) 2. Bowel symptoms (early version of ICIQ Bowel Short Form) 3. Pelvic floor muscle function (Oxford scale - Laycock 2008, ICS method - Messelink et al 2005) 4. Self-efficacy for PFMT (PFME self-efficacy scale) [Chen 2004] 5. Adherence to PFMT (exercise diary/follow-up questionnaire) Economic outcomes 1. Cost and use of NHS services 2. Cost to the women and their families/carers 3. The incremental costs, QALYs and incremental cost per QALY derived by the economic model.

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Countries

United Kingdom

Outcome results

None listed