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Diane Newman: Welcome, I'm Diane Newman, and I'm the Medical Director of UroToday. And today I have with me a colleague that I'm really excited about her presentation. Dr. Suzanne Hagen is a professor in Health Sciences Research at Caledonian University in Glasgow, Scotland. And Dr. Hagen is going to present her research on pelvic organ prolapse. Welcome.

Suzanne Hagen: Thank you very much, Diane. It's really kind of you to invite me on and to have this opportunity to share some information about the research that we do. And as Diane says, I'm based at Glasgow Caledonian University. I'm a statistician by background. But I've been very lucky to be able to be working in the field of continence for 30 years almost, I think, now. So it's been a pleasure to be able to do research solely in that field and to contribute to the evidence base that is so needed for nurses and other allied health professions.

So I thought today I would share a presentation that I gave to the International Continence Society earlier this year in Madrid at their annual conference. And it relates to work on pelvic organ prolapse specifically. So you hear about some of the research about the history of the field and some of the research evidence that has been generated.

So this is a talk about primary, secondary prevention with conservative treatment of pelvic organ prolapse. And it was the state-of-the-art presentation in Madrid at the ICS conference. And I'd like to acknowledge Pauline Campbell, my co-author on some of the reviews we've published, and who helped me with the materials for these slides.

So I'm going to give you a bit of history about the background of conservative management, from the earliest ideas around conservative options for preventing and treating prolapse, to the established evidence base that we now have, and then with a bit of a detour through the evidence for pelvic floor muscle training specifically and how it can inform practice and what the challenges are that we have now.

As you possibly know, prolapse is a common problem for women with a range of distressing symptoms. And conservative management is one of the three options for the management of prolapse, including lifestyle changes and education, pelvic floor muscle training, and other pelvic floor rehabilitation approaches that are coming to the fore.

The conservative approach is often considered for women if they have a mild to moderate prolapse, with pelvic floor muscle training being the cornerstone of what women are offered today. But it was back in the late 1940s when Arnold Kegel, a gynecologist from California, first observed that if women had poor pubococcygeus function, then that was associated with them having prolapse. And if you improve the function of those muscles, then the symptoms got better. Women would feel stronger in their pelvic area, and this would allow them to get on with their usual activities. And it made sense to Kegel then that these muscles should be exercised to stave off a prolapse that would be getting worse.

So pelvic floor muscles, shown here in red in this female cross section, play a large part in supporting the pelvic organs. And if you think about a program of regular contractions, or as Kegel called them, “perineomeric exercises,” these can overload the muscles and be effective in increasing the strength and tone of the muscles to better support the organs and to give support to the pelvic floor above and all the organs.

But then it wasn't until about 40 years later that this approach started to be recognized within physiotherapy practice. And in this physio textbook by Polden and Mantle, they asserted that physiotherapy targeted at strengthening those pelvic floor muscles would be of benefit in cases of mild prolapse. And they also recognized, of course, that lifestyle factors had to be addressed too. But at this time, there was no trial evidence to support the fact that pelvic floor exercises were of benefit here. And good trial evidence did relate—so it did [INAUDIBLE] relate—to pelvic floor muscle training for urinary incontinence, but there wasn't the same type of evidence for prolapse.

What was happening then in practice? So women's health physios I was working with were asking, what are we supposed to do with women with prolapse? We can treat women with incontinence, but we don't know what to do when a woman has a prolapse. And so we conducted a UK survey of women's health physios. It was really interesting to see that the vast majority were treating prolapse but with no guidance to direct their practice. And in the absence of that guidance, they were just following the protocols that we used for stress urinary incontinence. So practice had just adapted in that way without any evidence.

And it was around that time that the first trial evidence started to emerge. And these trials were comparing pelvic floor muscle training with no treatment. And these three bodies of trials all reported the benefit of pelvic floor muscle training. Although, the Thai trial by Piya-anant—it was the largest trial, but it had quite severe limitations with it. So the trial evidence really wasn't that well established. And it made it challenging then to know what the robustness of the findings were from the trials.

And then we first did a Cochrane review in 2006. So there were three trials, two comparing pelvic floor muscle training with no treatment. And that meant really there was limited evidence and no practice recommendations that came from that. With the next update of that review, there were six trials included, and the review had broadened to include trials not just of treatment, but also of prevention of prolapse.

And when we come right up to date—this is the review that we are in the process of finishing off to submit for publication—we've got 79 trials involving almost 14,000 women in these trials, 48 trials looking at treatment for prolapse and 31 looking at prevention. And what we've decided to do with this review is actually to split it into two reviews because it's becoming so large. So we'll have two reviews in due course.

Two Cochrane reviews and the systematic reviews. And as you know, they take results from completed trials gathered from a systematic search. And they'll appraise that evidence, synthesize it, if possible, with a meta-analysis to give us overall effect sizes for interventions.

And this is the up-to-date PRISMA diagram that shows the searches that we've been doing recently. It's a large job to try and bring the evidence together now because there's so much of it. And we're searching across six databases and numerous clinical trial registries. We found over 21,000 records, screened 16,000 titles and abstracts, looked at almost 700 full papers, and found 79 eligible trials. So that's where we're at at the moment in terms of the bulk of evidence.

This shows you the risk of bias. So this is about the quality of the trials—these 79 trials. Green areas show you where we've got low risk of bias, which is a good thing. Yellow is where it's unclear—maybe they haven't reported so well. And red is where we've got some high risk of bias.

So the quality of the trials varies a lot. You can see the majority of trials had low risk of bias for random sequence generation. However, allocation concealment was not clearly reported in over half of the trials. There was a high risk of bias due to blinding, which comes with these types of trials because it's very difficult to blind patients and to clinicians about the group allocation for interventions such as pelvic floor muscle training. And only 50% of trials had complete data. So there's a way to go with the quality of the evidence still.

The trials have been conducted across the globe, which is good—and shown here in the dark blue and the orange areas, there were 23 trials that contributed trial data. The majority, 45 out of the 79, were from China, the US, Australia, the UK, and Brazil. Women, however, from the poorer countries are underrepresented in the trials, which is a gap in the evidence that really needs to be carefully thought about, and how do we address that, because we want the treatments that we have evidence for to be accessible and acceptable to all women, not just those from the wealthier countries.

The outcome measures in the reviews were very diverse, which presents quite a challenge. So we found a total of 379 measures had been used across the trials. Mostly, they were functional status measures and physiological measures. And what we did was classify these using the COMET standards. And what you can see on the slide is the upshot of what that looks like in terms of the different types of measures that we came across.

But it causes difficulty in pooling the data across different trials. So even if you have a large number of trials, now the opportunity to pull the data into a meta-analysis becomes limited if everyone's measured things in different ways. So I say that's a challenge.

Overall, most of the trials are focused on the effectiveness of pelvic floor muscle training. So that's really where most of the evidence is. But the trials have started to diversify. We've got pelvic floor muscle training with different adjuncts such as biofeedback. There's trials of hypopressive exercises, which are seen as a sort of alternative to pelvic floor muscle training. Trials where women are given lifestyle advice and education are definitely becoming more apparent in the literature.

There are trials looking at interventions to prevent prolapse. And we look at these both in terms of primary prevention, where it's usually trials that are including younger women who are in the antenatal and postnatal periods where the aim of the trial is to prevent postnatal prolapse. And then the secondary prevention is more where the women tend to be older. They might have some early symptoms of pelvic organ prolapse, but they've not actually sought treatment. And those tend to be trials with women around the menopause.

Of the 48 treatment comparisons, trials of pelvic floor muscle training alone make up almost half of the evidence we've got. And then that's followed by trials of pelvic floor muscle training plus an adjunct. And that might range from lifestyle advice to pessaries. There are trials of pre and post-operative pelvic floor muscle training, training women to do the exercises before they have their prolapse surgery and afterwards.

And then if we move away from pelvic floor muscle training a bit, then we get trials of electrical stimulation, hypopressive exercises, trials of education and lifestyle advice after prolapse surgery, as well as a trial of education in a general population in a workplace population.

For prevention, we've now got a higher number of women who've participated in trials of prevention—around 8,500 women in 31 trials. And a lot of these trials have come from China, where they tend to have very large sample sizes, so that boosts the numbers of women in the trials. Pelvic floor muscle training features in over half of the trials. Again, it's very dominant in the prevention literature. But there are several trials now of electrical stimulation alone or with an adjunct of yoga and lifestyle educational interventions.

There's much more evidence in the pipeline, which is a good thing. We've got 40 ongoing trials—or part of those are trials that have yet to be reported on. And you can see even greater diversity here with various different stimulation modalities, traditional medicine interventions even, and interventions relating to pushing during labor—so whether a different regimen of pushing actually has a benefit on women's pelvic floor outcomes after labor.

So as you can see, there's a lot of trial information to summarize and many outcomes. And within each trial, you'll find there'll be different time points as well. So a trial might have measured outcomes at 6 months, 12 months, 18 months. So a lot of data to try and work with.

So just for today, I'll focus on that sort of fundamental question about the effectiveness of pelvic floor muscle training. Keeping it simple, just focus on pelvic floor muscle training on its own and try and unpack some of that information for you.

So you might be familiar with these kinds of plots, forest plots, which show you the results of a systematic review where you see lines for individual trials and then diamonds which summarize the pooling together of the information from the individual trials.

So these are what we call meta-analysis. So these are the treatment trials. And firstly, I've looked at the trials where they've reported on the cure or improvement of the main prolapse symptoms. And we pooled the findings from 6 trials, just over 700 women, where the trials had reported on symptoms like a feeling of a bulge or something coming down, a pelvic heaviness. And we found there was significant benefit in favor of pelvic floor muscle training. So women were more likely to report a cure or improvement after pelvic floor muscle training compared to the women who had not.

But you notice the number of women is quite small compared to the total of almost 1,800 that we have for these trial populations, as not all the trials reported the outcomes or reported them separately. So back to that challenge of outcome measurement and what it does in terms of limiting what you can analyze with the data.

And secondly here, these are data on prolapse symptom scores—so where the trials have used an actual validated symptom or questionnaire instrument. So from 3 trials in 555 women who all used the POP-SS tool, you can see here the clear benefit for women post-pelvic floor muscle training in terms of their prolapse symptoms compared to the no pelvic floor muscle training group. So you see trials' results fall into the left-hand side, which favors pelvic floor muscle training.

And then finally, looking in these treatment trials, we pooled together 4 trials in 500 women. And on the improvement that the women had in their prolapse severity—so the POP-Q stage measurement—we found a small significant benefit for women who had pelvic floor muscle training in terms of improvement in their POP-Q post-intervention compared to a no treatment group.

So I've summarized here the trial evidence relating to the prevention trials. That was treatment. These are the prevention ones. Because there's so much of it, I've summarized it into one slide here. And essentially, in summary, we found no effect of pelvic floor muscle training for any outcome in primary prevention trials. These were the trials that focused on the prevention of prolapse postnatally.

Similarly, we found no effect of pelvic floor muscle training in the secondary prevention trials for cure or improvement or prolapse symptom scores. But there was a small significant benefit found in one trial for anterior prolapse severity—so where these were women from GP practices who had been given pelvic floor muscle training versus watchful waiting. And we did find a benefit for their anterior prolapse.

Interestingly, another place where we did see some evidence of effectiveness for prevention prolapse was in trials of education, which are the newer types of trial that we've been seeing. So there are three trials, 219 women, and both prolapse symptom scores and prolapse-specific quality of life are better in the women who had received pelvic floor education. Although, we do see that effect in secondary prevention trials but not in the primary prevention trials. So interesting that even giving women education about pelvic floor seems to have a benefit for their symptoms.

So in terms of the evidence base, we know pelvic floor muscle training is effective for treating prolapse symptoms. We know that now from the reviews. But where have we got to with the implementation? Because it's all very well knowing about evidence; it's what you do with it.

Well, in some respects we've done well because the evidence relating to the effectiveness of PFMT is widely referenced in the guidelines internationally, with PFMT recommended as first-line management for prolapse. And this means that women across the globe should be offered this evidence-based treatment.

However, there are several implementation challenges. Staffing to support the delivery of this recommendation is limited. So specialist physiotherapists, who are usually the main provider of supervised pelvic floor muscle training, are in short supply. Definitely in the UK, for instance, the professional network there has specialist physiotherapists. But there are 1,400, and although they've run lots of courses on prolapse and trained over 800 physiotherapists now, it really is only going to scratch the surface in a population of 27 million adult women.

We have really long waiting lists for pelvic floor muscle training. And there's also an issue of inequity relating to accessing prolapse treatment more generally, with low income countries and some ethnic groups really at a disadvantage here. So implementation is not without quite a lot of challenge.

Another challenge you'll probably be familiar with or can imagine is adherence to pelvic floor muscle training. And this was illustrated in a paper and a study by Toye, which I've presented here. It's a meta-ethnographic review—so qualitative studies being pulled together—and as well as highlighting very important issues for the women relating to the physical and emotional loss associated with having a prolapse, and the taboo, and the misunderstanding, and distress round about that.

There were familiar reports of women finding it difficult to do pelvic floor muscle exercises regularly, and not being confident, worrying that they weren't doing it correctly, and just other things in life getting in the way and being a higher priority. So implementation is key and is problematic for women.

Other ways that we can overcome these challenges: I think we have to tackle this head on. We've done some research that looks at different staffing models for delivering pelvic floor muscle training for prolapse. And in a study we did, we found that involving a mix of staff in the service for delivery can give good outcomes for women.

So in some models, we had physiotherapists who were non-specialists. We had nurses with special interests in incontinence and pelvic floor who came together in the delivery of the pelvic floor muscle training and were able to triage women in an effective way.

Post-COVID, we've seen pelvic floor muscle training services move to virtual appointments and hybrid-type models. And there is systematic review evidence that e-health interventions can be effective in improving pelvic floor symptoms. So that's good news as well. Group teaching in advance of one-to-one appointments where they're necessary is another pragmatic way of using scarce resources that we have for delivering PFMT.

In terms of prevention of prolapse, there really is scope for building in pelvic floor muscle training around childbirth, for example, training midwives to teach pelvic floor muscle exercises antenatally, which we've seen happen in the APPEAL research that's been going on in the UK. And giving women access to perinatal pelvic health care is currently another thing that is being rolled out in the UK, a bit like the model that we've had in France for a long time.

Primary care is also another place or opportunity for early intervention. So brief pelvic health interventions would be useful for women when they attend for routine appointments, or for screening and for follow-up appointments such as smears, family planning. That really is a missed opportunity. And it's an area of research; I think it would be really good to try and fill some of that gap because I think it could be very useful to start as far upstream as we can with prevention.

And we can look at evidence from low resource countries where there have been some trials. It's found that even brief information and lifestyle intervention can be effective in improving prolapse symptoms and quality of life. So, for example, the work that's been done in Nepal.

I mentioned the gap in trial evidence for the low income countries and how do we tackle that—how do we crack that nut—well, it's not easy. And this is something we've tried to do and will continue to try to do. And hopefully, others might follow our lead.

But we've been working with staff in the Pacific Islands. And we managed to get some Global Challenges Research Funding. And we set out to try and build a prolapse research network in the Pacific Islands. And our aim was to be able to build on that network so we could eventually do trials in those Pacific Islands, which is really important for them to have evidence about conservative management because there are countries where they have really poor access to surgery, and knowing how to teach pelvic floor muscle training, knowing how to [INAUDIBLE], would really go a long way to helping a lot of the women in these countries like Samoa and Fiji.

But we had to do this incrementally, as you can see here from some of the publications we've got. So there were no prevalence studies. We don't know how common prolapse is in the populations. We didn't have outcome measures. And we found that even awareness about prolapse as a condition amongst women and even healthcare professionals was very low.

So far we've done some translation work to facilitate prevalence studies and run training workshops for healthcare professionals and develop some public health videos and materials to raise awareness. So it's a slow process to get towards building that evidence that's needed.

So I will summarize then, and thinking about the state-of-the-art for conservative management of prolapse as a whole, I think we can see that we now have a large amount of trial evidence addressing prevention and treatment of prolapse. Predominantly, it's about pelvic floor muscle training at the moment, although that's diversifying.

However, we are limited in what meta-analysis of published trials we can do and how much that can tell us. And what would be really good is if we could do more analysis of the individual patient data from these trials, which is really a gold standard. It's the gold standard method, really. Rather than just taking the findings from the individual trials, if we can gather all the data together into one place and re-analyze, then that is going to be so much more powerful and tell us so much more.

And in order for that to happen, trials have to work together. We have to collaborate with each other. We have to share our data. And that's really key to make the most of this data and then to give us more evidence so that we can support women and practice better.

The trial quality has improved over the years as we’ve been doing the Cochrane reviews. And the women are more at the center of the reviews in terms of patient-reported outcome measures that are more to the fore. But the reporting of the trials could still be better. And I think if the trials could comply with different new standard reporting frameworks that we know of now and are used in a standard fashion, then that would make a big difference. Using the same outcome measures from trial to trial would be good. So that really maximizes the amount of data that we've got to work with.

I think just to finish off then, it's a fairly positive picture in this field of research. And we've got a wealth of data. And we've got lots of opportunities that I think we have to make the most of. A healthy pipeline of trials is coming through. So there's more for us to learn, more for us to base the practice on. And the community of researchers is growing, which is good. We've got a lot of experience to learn from the research that's been done to date, which will help us ensure that in the future, we do get the best evidence base to inform practice in this area. And I'll stop there. Thank you very much.

Diane Newman: Thank you very much, Dr. Hagen. That was wonderful. Whenever you did, though, the review, did they talk about the degree of prolapse? Because depending on the degree, the pelvic floor muscle training might be much more effective.

And it was interesting when you said the primary prevention was postnatal. I guess I was thinking that prevention should be prior because having the child, of course, can start causing the prolapse. So I'm just wondering what you think of that as far as the degree of prolapse? Because I would think if you've got a significant prolapse, particularly on the introitus, I don't know what muscle training is really going to do.

Suzanne Hagen: Yeah. I think in our own research, we did do subgroup analysis by the state of prolapse. And we had included women with stage I, II, or III. And we did some subgroup analysis. And although because the subgroups aren't really technically large enough to give you statistically robust findings, the indication was that it was more effective in stage I and stage II prolapse.

Other trials have probably not been as big as ours. So there's not been as much room to do that kind of subgroup analysis. But I think, like yourself, Diane, I think it would be unusual for a severe stage III prolapse to be referred for pelvic floor muscle training, that that woman is not going to be a good candidate.

Diane Newman: Well, and the thing is—

Suzanne Hagen: And I think that the antenatal, postnatal thing—definitely working with women prenatally is the ideal.

Diane Newman: Yeah. And then, of course, we have to follow them. So the question is, who's going to do that study if you started prenatally, then follow them through their pregnancies? And there's all types of factors—the way the child, the delivery, all that type of thing that we really don't know. And like you say in your funding, when you're going to other countries, it's a very hidden problem, and women just live with it. And they don't really view it until it's really a significant issue.

Where do you see in the research where the pessary, though? Because some of the studies here in the US have been surgery versus the use of a pessary. And I think that if you go back to some of the vaginal weight research, that when women had something in the vagina, the pelvic floor muscle almost had a proprioceptive response to contracting. So they may not have formal pelvic floor muscle training, but they may be doing, quote-unquote, “a kegel.” And I was wondering where the pessary fits within your Cochrane review.

Suzanne Hagen: So there's a separate Cochrane review actually that deals with pessaries separately from pelvic floor muscle training. But as you say, there are trials that have got both pessary and pelvic floor muscle training in them. And I agree with the idea that having the pessary in place does actually or potentially give that training effect.

We've just launched a trial, actually. We were comparing pelvic floor muscle training alone with pelvic floor muscle training with a pessary in place. So you can have the answer for that question in a few years’ time, hopefully. I don't know how things are in the US, but in the UK, there's very little surgery going on now and very long waiting lists. So women tend to be offered pelvic floor muscle training or a pessary because they will wait for three years if they want to have surgery. So clinically, those are really the options that women have got. And younger women are much more—they're much more receptive to that now than the idea of having surgery.

Diane Newman: Yeah, it's interesting because it's kind of pushed your population into utilizing conservative because you have a long wait. Whereas here in the US, they may get to that surgeon and be able to have it. And there are issues. There's some research that people are looking at maybe using a vaginal support device post-surgery to actually support the surgical—

Suzanne Hagen: The healing?

Diane Newman: Yeah. So I mean, we may see some of that. And the other issue you brought up as far as how many specialists do we have in this area. Because you're very much into that, the physiotherapist in the UK. But in the US, that's another referral. And so that's not often done. So we do look at more conservative treatments.

But then again, you have the issue of who can fit a pessary. And that's not necessarily an easy thing for clinicians. So I do think that some of it's because of what's going on within the health system. And we've brought that up as far as the numbers that you need. So you are moving into more midwives training for pelvic floor muscle training, and then nurses. Is that really the trend?

Suzanne Hagen: The midwifery work has really been successful. In terms of pelvic floor muscle training, I think the models that we worked on, and researched, and found as good outcomes with—we did quite a lot of implementation work in delivering that research around the UK to healthcare managers and staff.

I don't actually know what the uptake of that would be. I think there were lots of good plans to take those ideas and to use those models at local levels. But I don't know that that's happened. I think COVID hit just after that and everything just went a bit nuts.

But there are some areas—some of our rural areas—where they don't have access to specialist physiotherapists. Then it's a nurse with special interests. And it's interesting to see where you have those areas where you just have to do something; these different models that can be very successful just emerge.

Our system is the GPs now refer straight to physiotherapy in most places. So the women won't even see a gynecologist or a urogynecologist. And there's a training program now for physiotherapists so that not only the nurses can fit pessaries, but also the physiotherapists. So the pessaries are really taking off, which is good.

And there's a lot more self-management of pessaries going on now because younger women are using them, and they can just remove them, insert them to fit in with their lifestyle. And I think it's probably a good thing that women can avoid surgery for as long as possible then.

Diane Newman: And I agree with you 100%. That's a really good thing. When you say GPs, were gynecologists being there? Were they the ones that are assessing for prolapse? That's really surprising to me.

Suzanne Hagen: So sorry. When I say GP, I mean primary care.

Diane Newman: Right. That's what I mean—so primary care. So that would include the gynecologists too then in primary care or no?

Suzanne Hagen: No, just general practitioners. So when women go to see their normal GP in the community, if they've got a prolapse, they would refer them into the physiotherapy therapist service at the hospital.

Diane Newman: That's impressive because our GPs are not assessing for a prolapse, I don't think. I mean that's really where it should start. I agree with you 100%. And then they would—

Suzanne Hagen: So in general practice, you could see, when someone's having a smear or if there's a—we get some training interventions and therefore the general practitioners and the practice nurses at the early stages, they could be directing to some good materials about pelvic floor health, and apps, and things like that could support them in.

Diane Newman: That's really impressive. And that's really where prevention will start or some type of push to actually improve the progression of the prolapse. And then I like what you said. And then the end result was, OK, they may need surgery down the road, but at least we start with some prevention, conservative treatments, which makes a lot of sense, doesn't it?

Suzanne Hagen: Yeah. Because when you have one operation, then high chances you'll have another and then a third.

Diane Newman: And every time you have the surgery, the outcomes are—I know. They decrease. Well, thank you very much. And when is the Cochrane going to come out? You said there's going to be two parts to it, you think?

Suzanne Hagen: Yes, so the treatment—well, I don't quite know we've decided which one will come first. But probably one of them will be submitted in January. And then it will be a while—it goes through publication processes.

Diane Newman: Well, thanks. That's really wonderful work. And I really appreciate you presenting this because this is just a really big growing area for women. And getting out the word about what is out there and what can be done. So thanks for this.

Suzanne Hagen: No problem. Thank you. It's lovely to speak to you.