NIHR Signal Pelvic floor exercises may reduce need for further treatments for pelvic organ prolapse

Published on 6 June 2017

Pelvic floor muscle training reduced symptoms at two years slightly more than the improvement seen in women who just received a leaflet with lifestyle advice. In addition to this 1 point change on a 28 point scale, 8% fewer women who had training needed further treatment for prolapse.

This randomised controlled trial included 412 women with relatively minor prolapse but who had not had any previous treatment. The basic training was provided by physiotherapists in five treatment sessions with added pilates classes and a DVD.

Pelvic floor exercises are safe and can be carried out easily by most women with this common condition. They may be helpful even before women have any troublesome symptoms of prolapse. The researchers are planning longer-term follow-up, which will help to determine whether it is a cost-effective option.

Pelvic floor exercises may reduce need for further treatments for pelvic organ prolapse

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Why was this study needed?

Pelvic organ prolapse is common, occurring in 40 to 60% of women who have given birth. Eight in every 100 UK women in the community report symptoms. Surgery to treat a prolapse is relatively common – about one in ten women will have this treatment by the time they reach 80 years.

Non-surgical options include pelvic floor muscle exercises and there is evidence that these can help reduce prolapse severity and symptoms. However, there has been little research about whether pelvic floor muscle training can help to prevent prolapse symptoms and reduce the need for other, more costly, treatment such as surgery.

What did this study do?

This randomised controlled trial, PREVPROL, recruited 412 women from three centres in the UK and New Zealand who had given birth in 1993 to 1994. The women could be any age, with evidence of prolapse, who had not already undergone treatment.

Researchers randomly allocated 206 women to pelvic floor muscle training and 206 women to the control group. The training group were offered five appointments with a physiotherapist, given an individualised training programme and advice, and given a lifestyle advice leaflet. They also had pilates classes and physiotherapy review appointments after one and two years. At two years 77% of women in the treatment group were still doing their pelvic floor exercises. The control group received the lifestyle advice leaflet in the post. The results were measured after two years, comparing symptoms and cost effectiveness.

The results of this large multicentre trial are likely to be reliable, although the participants and physiotherapists knew which group they were in. This could have introduced some bias when reporting symptoms.

What did it find?

  • The main outcome was severity of prolapse symptoms at two years, measured using the Pelvic Organ Prolapse Symptom Score (POP-SS). This has a scale of 0 to 28, with 0 meaning no symptoms in the previous four weeks, and 28 meaning all symptoms were present all the time. Average POP-SS reduced from a baseline of 4.4 to 3.2 at two years in those who had pelvic floor muscle training compared to increasing from 3.9 to 4.2 in the control group (mean difference [MD] ‑1.01, 95% confidence interval [CI] ‑1.70 to ‑0.33).
  • Using the ICIQ-Urinary Incontinence form (a scale of 0 to 21 which combines frequency of urine leakage, amount and associated bother, with a higher score indicating more problems), the training group average score decreased from 4.8 to 3.3 after two years while it remained the same for the control group, 4.2 to 4.1(MD ‑0.83, 95% CI ‑1.44 to ‑0.22).
  • Fewer women in the training group had any further treatment for prolapse symptoms during the two-year follow-up (6%) than those in the control group (14.4%). Odds Ratio 0.29 (95% CI 0.12 to 0.71).  In particular, women in the training group were less likely to see their GP: 3% versus 12%.

Uptake of further treatment for prolapse symptoms within 2 years of pelvic floor muscle training

What does current guidance say on this issue?

NICE is developing a guideline on the management of urinary incontinence and pelvic organ prolapse (due in February 2019).  NICE has produced a number of pieces of guidance on surgical techniques to treat different types of prolapse – these all list pelvic floor muscle training as an option for treatment.

What are the implications?

This high quality study suggests that pelvic floor muscle training could be a useful option for managing minor pelvic organ prolapse. It may also reduce the need for further treatment such as surgery. It is a safe option that could be done easily learned by most women and started once prolapse is first recognised and before they symptoms become more troublesome.

The effects seen in this study are small, and as a research study involved a lot of input from specialist physiotherapists.  The researcher’s planned long-term follow-up would allow us to see if there would be real cost-savings or if there are simpler ways of delivering the intervention.

Citation and Funding

Hagen S, Glazener C, McClurg D, et al. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial. Lancet. 2017;389(10067):393-402.

This study was funded by the Wellbeing of Women charity, the New Zealand Continence Association, and the Dean’s Bequest Fund of Dunedin School of Medicine. One of the authors was part-funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West Midlands.

Bibliography

Cooper J, Annappa M, Dracocardos D, et al. Prevalence of genital prolapse symptoms in primary care: a cross-sectional survey. Int Urogynecol J. 2015;26(4):505-10.

NHS Choices. Pelvic organ prolapse. London: Department of Health; 2015.

NICE. Urinary incontinence (update) and pelvic organ prolapse in women: management. GID-NG10035. London: National Institute for Health and Care Excellence; in development.

Why was this study needed?

Pelvic organ prolapse is common, occurring in 40 to 60% of women who have given birth. Eight in every 100 UK women in the community report symptoms. Surgery to treat a prolapse is relatively common – about one in ten women will have this treatment by the time they reach 80 years.

Non-surgical options include pelvic floor muscle exercises and there is evidence that these can help reduce prolapse severity and symptoms. However, there has been little research about whether pelvic floor muscle training can help to prevent prolapse symptoms and reduce the need for other, more costly, treatment such as surgery.

What did this study do?

This randomised controlled trial, PREVPROL, recruited 412 women from three centres in the UK and New Zealand who had given birth in 1993 to 1994. The women could be any age, with evidence of prolapse, who had not already undergone treatment.

Researchers randomly allocated 206 women to pelvic floor muscle training and 206 women to the control group. The training group were offered five appointments with a physiotherapist, given an individualised training programme and advice, and given a lifestyle advice leaflet. They also had pilates classes and physiotherapy review appointments after one and two years. At two years 77% of women in the treatment group were still doing their pelvic floor exercises. The control group received the lifestyle advice leaflet in the post. The results were measured after two years, comparing symptoms and cost effectiveness.

The results of this large multicentre trial are likely to be reliable, although the participants and physiotherapists knew which group they were in. This could have introduced some bias when reporting symptoms.

What did it find?

  • The main outcome was severity of prolapse symptoms at two years, measured using the Pelvic Organ Prolapse Symptom Score (POP-SS). This has a scale of 0 to 28, with 0 meaning no symptoms in the previous four weeks, and 28 meaning all symptoms were present all the time. Average POP-SS reduced from a baseline of 4.4 to 3.2 at two years in those who had pelvic floor muscle training compared to increasing from 3.9 to 4.2 in the control group (mean difference [MD] ‑1.01, 95% confidence interval [CI] ‑1.70 to ‑0.33).
  • Using the ICIQ-Urinary Incontinence form (a scale of 0 to 21 which combines frequency of urine leakage, amount and associated bother, with a higher score indicating more problems), the training group average score decreased from 4.8 to 3.3 after two years while it remained the same for the control group, 4.2 to 4.1(MD ‑0.83, 95% CI ‑1.44 to ‑0.22).
  • Fewer women in the training group had any further treatment for prolapse symptoms during the two-year follow-up (6%) than those in the control group (14.4%). Odds Ratio 0.29 (95% CI 0.12 to 0.71).  In particular, women in the training group were less likely to see their GP: 3% versus 12%.

Uptake of further treatment for prolapse symptoms within 2 years of pelvic floor muscle training

What does current guidance say on this issue?

NICE is developing a guideline on the management of urinary incontinence and pelvic organ prolapse (due in February 2019).  NICE has produced a number of pieces of guidance on surgical techniques to treat different types of prolapse – these all list pelvic floor muscle training as an option for treatment.

What are the implications?

This high quality study suggests that pelvic floor muscle training could be a useful option for managing minor pelvic organ prolapse. It may also reduce the need for further treatment such as surgery. It is a safe option that could be done easily learned by most women and started once prolapse is first recognised and before they symptoms become more troublesome.

The effects seen in this study are small, and as a research study involved a lot of input from specialist physiotherapists.  The researcher’s planned long-term follow-up would allow us to see if there would be real cost-savings or if there are simpler ways of delivering the intervention.

Citation and Funding

Hagen S, Glazener C, McClurg D, et al. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial. Lancet. 2017;389(10067):393-402.

This study was funded by the Wellbeing of Women charity, the New Zealand Continence Association, and the Dean’s Bequest Fund of Dunedin School of Medicine. One of the authors was part-funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West Midlands.

Bibliography

Cooper J, Annappa M, Dracocardos D, et al. Prevalence of genital prolapse symptoms in primary care: a cross-sectional survey. Int Urogynecol J. 2015;26(4):505-10.

NHS Choices. Pelvic organ prolapse. London: Department of Health; 2015.

NICE. Urinary incontinence (update) and pelvic organ prolapse in women: management. GID-NG10035. London: National Institute for Health and Care Excellence; in development.

Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial

Published on 25 December 2016

Hagen, S.,Glazener, C.,McClurg, D.,Macarthur, C.,Elders, A.,Herbison, P.,Wilson, D.,Toozs-Hobson, P.,Hemming, C.,Hay-Smith, J.,Collins, M.,Dickson, S.,Logan, J.

Lancet , 2016

BACKGROUND: Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. METHODS: We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1-3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. FINDINGS: Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3.2 (SD 3.4) in the intervention group versus 4.2 (SD 4.4) in the control group (adjusted mean difference -1.01, 95% CI -1.70 to -0.33; p=0.004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath). INTERPRETATION: Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies. FUNDING: Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine.

Pelvic organ prolapse is the bulging of one or more of the pelvic organs (the uterus, vagina, bowel or bladder) into the vagina. This may be due to pregnancy, childbirth, hysterectomy or the menopause. The pelvic floor muscles wrap beneath the bladder and rectum. If these muscles are weak or damaged, there is a greater chance of prolapse. These muscles can be strengthened by carrying out exercises, which include squeezing and holding the muscles repeatedly.

The Pelvic Organ Prolapse Symptom Score measures the following symptoms: feeling of something coming down from or in the vagina; discomfort worse when standing; abdominal pain when standing; lower back heaviness; strain to empty bladder; feel bladder not empty; feel bowel not empty.

Expert commentary

Secondary prevention aims to reduce the impact of a condition that has already occurred, in this instance to slow the progression of pelvic floor prolapse in women with mild prolapse. The assumption is that women in this study were at increased risk of developing severe prolapse and associated problems.

However, symptoms of women in the control group did not worsen after two-years. This makes me question whether women in the study were the most at risk and most likely to benefit from the intervention. Further research is needed to better understand the course and risk factors associated with severe prolapse.

Sarah Harrisson, Clinical Specialist Physiotherapist, NIHR Clinical Doctoral Research Fellow, Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University

Categories

  •   Fertility and childbirth, Gynaecological disorders, Musculo-skeletal disorders, Physical therapy