Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials

Cathryn Glazener, Charles Boachie, Brian Buckley, Claire Cochran, Grace Dorey, Adrian Grant, Suzanne Hagen, Mary Kilonzo, Alison McDonald, Gladys McPherson, Katherine Moore, John Norrie, Craig Ramsay, Luke Vale, James N'Dow

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Abstract

Background
Urinary incontinence is common immediately after prostate surgery. Men are often advised to do pelvic-floor exercises, but evidence to support this is inconclusive. Our aim was to establish if formal one-to-one pelvic floor muscle training reduces incontinence.

Methods
We undertook two randomised trials in men in the UK who were incontinent 6 weeks after radical prostatectomy (trial 1) or transurethral resection of the prostate (TURP; trial 2) to compare four sessions with a therapist over 3 months with standard care and lifestyle advice only. Randomisation was by remote computer allocation. Our primary endpoints, collected via postal questionnaires, were participants' reports of urinary incontinence and incremental cost per quality-adjusted life year (QALY) after 12 months. Group assignment was masked from outcome assessors, but this masking was not possible for participants or caregivers. We used intention-to-treat analyses to compare the primary outcome at 12 months. This study is registered, number ISRCTN87696430.

Findings
In the intervention group in trial 1, the rate of urinary incontinence at 12 months (148 [76%] of 196) was not significantly different from the control group (151 [77%] of 195; absolute risk difference [RD] −1·9%, 95% CI −10 to 6). In trial 2, the difference in the rate of urinary incontinence at 12 months (126 [65%] of 194) from the control group was not significant (125 [62%] of 203; RD 3·4%, 95% CI −6 to 13). Adjusting for minimisation factors or doing treatment-received analyses did not change these results in either trial. No adverse effects were reported. In both trials, the intervention resulted in higher mean costs per patient (£180 and £209 respectively) but we did not identify evidence of an economically important difference in QALYs (0·002 [95% CI −0·027 to 0·023] and −0·00003 [−0·026 to 0·026]).

Interpretation
In settings where information about pelvic-floor exercise is widely available, one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be effective or cost effective. The high rates of persisting incontinence after 12 months suggest a substantial unrecognised and unmet need for management in these men.
Original languageEnglish
Pages (from-to)328-337
Number of pages10
JournalThe Lancet
Volume378
Issue number9788
Early online date8 Jul 2011
DOIs
Publication statusPublished - 23 Jul 2011

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Transurethral Resection of Prostate
Pelvic Floor
Urinary Incontinence
Prostatectomy
Randomized Controlled Trials
Muscles
Quality-Adjusted Life Years
Costs and Cost Analysis
Prostate
Exercise
Control Groups
Intention to Treat Analysis
Random Allocation
Caregivers
Life Style
Therapeutics

Keywords

  • aged
  • exercise therapy
  • humans
  • male
  • middle aged
  • pelvic floor
  • prostatectomy
  • transurethral resection of prostate
  • urinary incontinence

Cite this

Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS) : two parallel randomised controlled trials. / Glazener, Cathryn; Boachie, Charles; Buckley, Brian; Cochran, Claire; Dorey, Grace; Grant, Adrian; Hagen, Suzanne; Kilonzo, Mary; McDonald, Alison; McPherson, Gladys; Moore, Katherine; Norrie, John; Ramsay, Craig; Vale, Luke; N'Dow, James.

In: The Lancet, Vol. 378, No. 9788, 23.07.2011, p. 328-337.

Research output: Contribution to journalArticle

Glazener, Cathryn ; Boachie, Charles ; Buckley, Brian ; Cochran, Claire ; Dorey, Grace ; Grant, Adrian ; Hagen, Suzanne ; Kilonzo, Mary ; McDonald, Alison ; McPherson, Gladys ; Moore, Katherine ; Norrie, John ; Ramsay, Craig ; Vale, Luke ; N'Dow, James. / Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS) : two parallel randomised controlled trials. In: The Lancet. 2011 ; Vol. 378, No. 9788. pp. 328-337.
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title = "Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials",
abstract = "BackgroundUrinary incontinence is common immediately after prostate surgery. Men are often advised to do pelvic-floor exercises, but evidence to support this is inconclusive. Our aim was to establish if formal one-to-one pelvic floor muscle training reduces incontinence.MethodsWe undertook two randomised trials in men in the UK who were incontinent 6 weeks after radical prostatectomy (trial 1) or transurethral resection of the prostate (TURP; trial 2) to compare four sessions with a therapist over 3 months with standard care and lifestyle advice only. Randomisation was by remote computer allocation. Our primary endpoints, collected via postal questionnaires, were participants' reports of urinary incontinence and incremental cost per quality-adjusted life year (QALY) after 12 months. Group assignment was masked from outcome assessors, but this masking was not possible for participants or caregivers. We used intention-to-treat analyses to compare the primary outcome at 12 months. This study is registered, number ISRCTN87696430.FindingsIn the intervention group in trial 1, the rate of urinary incontinence at 12 months (148 [76{\%}] of 196) was not significantly different from the control group (151 [77{\%}] of 195; absolute risk difference [RD] −1·9{\%}, 95{\%} CI −10 to 6). In trial 2, the difference in the rate of urinary incontinence at 12 months (126 [65{\%}] of 194) from the control group was not significant (125 [62{\%}] of 203; RD 3·4{\%}, 95{\%} CI −6 to 13). Adjusting for minimisation factors or doing treatment-received analyses did not change these results in either trial. No adverse effects were reported. In both trials, the intervention resulted in higher mean costs per patient (£180 and £209 respectively) but we did not identify evidence of an economically important difference in QALYs (0·002 [95{\%} CI −0·027 to 0·023] and −0·00003 [−0·026 to 0·026]).InterpretationIn settings where information about pelvic-floor exercise is widely available, one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be effective or cost effective. The high rates of persisting incontinence after 12 months suggest a substantial unrecognised and unmet need for management in these men.",
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author = "Cathryn Glazener and Charles Boachie and Brian Buckley and Claire Cochran and Grace Dorey and Adrian Grant and Suzanne Hagen and Mary Kilonzo and Alison McDonald and Gladys McPherson and Katherine Moore and John Norrie and Craig Ramsay and Luke Vale and James N'Dow",
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T1 - Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS)

T2 - two parallel randomised controlled trials

AU - Glazener, Cathryn

AU - Boachie, Charles

AU - Buckley, Brian

AU - Cochran, Claire

AU - Dorey, Grace

AU - Grant, Adrian

AU - Hagen, Suzanne

AU - Kilonzo, Mary

AU - McDonald, Alison

AU - McPherson, Gladys

AU - Moore, Katherine

AU - Norrie, John

AU - Ramsay, Craig

AU - Vale, Luke

AU - N'Dow, James

N1 - Copyright © 2011 Elsevier Ltd. All rights reserved.

PY - 2011/7/23

Y1 - 2011/7/23

N2 - BackgroundUrinary incontinence is common immediately after prostate surgery. Men are often advised to do pelvic-floor exercises, but evidence to support this is inconclusive. Our aim was to establish if formal one-to-one pelvic floor muscle training reduces incontinence.MethodsWe undertook two randomised trials in men in the UK who were incontinent 6 weeks after radical prostatectomy (trial 1) or transurethral resection of the prostate (TURP; trial 2) to compare four sessions with a therapist over 3 months with standard care and lifestyle advice only. Randomisation was by remote computer allocation. Our primary endpoints, collected via postal questionnaires, were participants' reports of urinary incontinence and incremental cost per quality-adjusted life year (QALY) after 12 months. Group assignment was masked from outcome assessors, but this masking was not possible for participants or caregivers. We used intention-to-treat analyses to compare the primary outcome at 12 months. This study is registered, number ISRCTN87696430.FindingsIn the intervention group in trial 1, the rate of urinary incontinence at 12 months (148 [76%] of 196) was not significantly different from the control group (151 [77%] of 195; absolute risk difference [RD] −1·9%, 95% CI −10 to 6). In trial 2, the difference in the rate of urinary incontinence at 12 months (126 [65%] of 194) from the control group was not significant (125 [62%] of 203; RD 3·4%, 95% CI −6 to 13). Adjusting for minimisation factors or doing treatment-received analyses did not change these results in either trial. No adverse effects were reported. In both trials, the intervention resulted in higher mean costs per patient (£180 and £209 respectively) but we did not identify evidence of an economically important difference in QALYs (0·002 [95% CI −0·027 to 0·023] and −0·00003 [−0·026 to 0·026]).InterpretationIn settings where information about pelvic-floor exercise is widely available, one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be effective or cost effective. The high rates of persisting incontinence after 12 months suggest a substantial unrecognised and unmet need for management in these men.

AB - BackgroundUrinary incontinence is common immediately after prostate surgery. Men are often advised to do pelvic-floor exercises, but evidence to support this is inconclusive. Our aim was to establish if formal one-to-one pelvic floor muscle training reduces incontinence.MethodsWe undertook two randomised trials in men in the UK who were incontinent 6 weeks after radical prostatectomy (trial 1) or transurethral resection of the prostate (TURP; trial 2) to compare four sessions with a therapist over 3 months with standard care and lifestyle advice only. Randomisation was by remote computer allocation. Our primary endpoints, collected via postal questionnaires, were participants' reports of urinary incontinence and incremental cost per quality-adjusted life year (QALY) after 12 months. Group assignment was masked from outcome assessors, but this masking was not possible for participants or caregivers. We used intention-to-treat analyses to compare the primary outcome at 12 months. This study is registered, number ISRCTN87696430.FindingsIn the intervention group in trial 1, the rate of urinary incontinence at 12 months (148 [76%] of 196) was not significantly different from the control group (151 [77%] of 195; absolute risk difference [RD] −1·9%, 95% CI −10 to 6). In trial 2, the difference in the rate of urinary incontinence at 12 months (126 [65%] of 194) from the control group was not significant (125 [62%] of 203; RD 3·4%, 95% CI −6 to 13). Adjusting for minimisation factors or doing treatment-received analyses did not change these results in either trial. No adverse effects were reported. In both trials, the intervention resulted in higher mean costs per patient (£180 and £209 respectively) but we did not identify evidence of an economically important difference in QALYs (0·002 [95% CI −0·027 to 0·023] and −0·00003 [−0·026 to 0·026]).InterpretationIn settings where information about pelvic-floor exercise is widely available, one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be effective or cost effective. The high rates of persisting incontinence after 12 months suggest a substantial unrecognised and unmet need for management in these men.

KW - aged

KW - exercise therapy

KW - humans

KW - male

KW - middle aged

KW - pelvic floor

KW - prostatectomy

KW - transurethral resection of prostate

KW - urinary incontinence

U2 - 10.1016/S0140-6736(11)60751-4

DO - 10.1016/S0140-6736(11)60751-4

M3 - Article

C2 - 21741700

VL - 378

SP - 328

EP - 337

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9788

ER -