12 year follow up: RCT for postnatal pelvic floor dysfunction ProLong Study Group Cathryn Glazener, Christine MacArthur, Suzanne Hagen, Andrew Elders, Robert Lancashire, Peter Herbison, Nicola Dean, Chris Bain, Phil Toozs-Hobson, Alison McDonald, Gladys McPherson, Karen Richardson, Don Wilson.

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The Clinical Question There is a lack of evidence for effectiveness of pelvic floor muscle training (PFMT) for postnatal incontinence in the long term. Do women with postnatal urinary incontinence benefit from PFMT teaching?

Description of Research ParticipantsWomen with urinary incontinence 3 months after an index delivery in Intervention3 one-to-one instruction sessions on PFMT (+ bladder training if necessary) at 5, 7 and 9 months after delivery ComparisonStandard postnatal care Outcomes Primary outcome: urinary incontinence at 1, 6 and 12 years Secondary outcome: Performance of PFMT Faecal incontinence at 1, 6 and 12 years Prolapse symptom score (POP-SS) (12 years only) Prolapse at hymen or beyond (POP-Q) (12 years only)

Aims and Objectives To identify the advantages and disadvantages of the clinical outcomes used in this study To recap the purpose of stratification in a randomised-controlled trial To discuss the strengths and weaknesses of different questionnaire study designs To summarise the current evidence and reflect on its potential clinical applications

Recruitment to RCT Initial screening survey women Responded 7882 (72%) Incontinent at 3 months 2632 (33%) Continent at 3 months 5247 (67%) Randomised 747 (28%) Non participants 1885 (72%) RCT

Follow up – flow chart 747 randomised Intervention 371 Control (75%) 263 (71%) 221 (60%) 245 (65%) 253 (67%) 228 (61%) FU at 1 year FU at 6 years FU at 12 years

Background Was the intervention (e.g. intensity and duration) in this clinical trial the same as in other similar studies? At your unit, how common is urinary incontinence at 3 months after childbirth?

Methods What is the purpose of stratification at randomisation in this clinical trial? Was it necessary to stratify for mode of delivery, and centre/hospital? Was the primary outcome in this study appropriate? Would you select different outcome measures?

Urinary incontinence 1 year P= years NS Percent 12 years NS 60% 69% 76% 79% 83% 80% Intervention Control

Faecal incontinence Percent 1 year P= years NS 12 years NS 4% 11 % 12% 13% 19% 15% Intervention Control

Compliance of PFMT Percent 1 year P= years NS 12 years NS 78 % 48% 50 % 52% 49% Intervention Control

Pelvic organ prolapse (POP) At 12 years: *Prolapse symptom score: 3.14 vs 3.30 (NS) POP at hymen or beyond: 30% vs 29% (NS) * POP-SS: 0 = none of 7 symptoms, to 28 = maximum 7 symptoms all the time

Outcome (PFMT vs standard care; 448 responded at 12 year) Intervention 371 Comparison Intervention Comparison Participants Source population Intervention control Eligible population Participants GATE Frame (Primary outcome- urinary incontinence)

Results Was compliance satisfactory? How could this have affected the results? Can you suggest any strategy to improve the response rate of a similar study in the future?

Authors’ summary The modest effect of the conservative intervention was not sustained at 12 years – On urinary or faecal incontinence – On use of pelvic floor muscle training – No effect seen on prolapse at 12 years Women who have urinary incontinence after delivery have a long-term problem – The majority will still be incontinent – Also have other symptoms of pelvic floor dysfunction

Take home message Can you briefly summarise the results of this study in a single sentence? Has this study changed your practice?

Suggested Reading Boyle R, Hay-Smith EJ, Cody JD, M›rkved S. Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev 2012; / CD pub2. Glazener C, Elders A, MacArthur C, Lancashire R, Herbison P, Hagen S et al. Childbirth and prolapse: long-term associations with the symptoms and objective measurement of pelvic organ prolapse. BJOG 2013; 120(2):