Rationale and impact
- Organisation of specialist services
- Collecting data on surgery and surgical complications
- Urodynamic testing
- Pelvic floor muscle training
- Absorbent containment products
- Medicines for overactive bladder
- Botulinum toxin type A injection
- Surgical management of stress urinary incontinence
- Assessing pelvic organ prolapse
- Non-surgical management of pelvic organ prolapse
- Surgical management of pelvic organ prolapse
- Surgery for women with both stress urinary incontinence and pelvic organ prolapse
- Assessing complications associated with mesh surgery
- Managing complications associated with mesh surgery
These sections briefly explain why the committee made the 2019 recommendations and how they might affect practice. They link to details of the evidence and a full description of the committee's discussion.
Recommendations 1.1.1 to 1.1.7
The committee agreed, based on their experience, that women with stress urinary incontinence, overactive bladder or primary prolapse would benefit from the broad range of expertise provided by a local multidisciplinary team (MDT). They agreed that a local MDT working within a regional clinical network could refer women to other services within the network for treatments that are not available locally, thus providing a broader choice of treatments.
The committee thought that women with complications related to mesh surgery, or with complex pelvic floor problems, should have access to a specialist MDT working at the regional level. The regional MDT could provide expert assessment and ensure that women are offered all available treatment options.
The committee acknowledged that membership of local and regional MDTs needs to be flexible and will vary in line with local and regional arrangements.
The recommendations on the different levels of MDTs, their composition, and how they should work together might affect how local and regional MDTs are commissioned and how services are currently organised.
Recommendations 1.2.1 to 1.2.4
The committee were concerned about the lack of reliable evidence on adverse events after surgery for urinary incontinence and pelvic organ prolapse, especially those that occur 2 years or more after surgery. They were also aware of the widespread public concern about the use of synthetic mesh to treat these conditions in women. The wording of the recommendations reflects the committee's strong support for the collection of data in a national registry of surgery for urinary incontinence and pelvic organ prolapse in women.
The committee agreed that it would be helpful to provide a broad indication of the types of information that should be included in the registry, rather than specifying this in detail. The data in the registry will be analysed in the future to provide more reliable evidence than is available currently on the use of the various procedures in England and Wales and their long-term effects. This could be used to inform future guidance. The recommendations support the findings of the Mesh Oversight Group Report on reporting procedures in a national database.
The committee also agreed to highlight the importance of obtaining consent from women to include their data in the registry, and giving women a copy of their own data.
The recommendations are likely to have an impact on healthcare professionals and providers who are not already doing this because additional time and resource will be needed to report data to the registry and because of the cost of maintaining the registry and analysing the data.
Recommendations 1.3.15 and 1.3.16
The evidence did not show any benefit from urodynamic testing to assess stress urinary incontinence or stress-predominant mixed urinary incontinence in women who have demonstrable stress urinary incontinence before primary surgery. The committee concluded that urodynamic testing is not necessary for most women in this situation.
However, based on their experience the committee agreed that urodynamic testing can be beneficial if the diagnosis is unclear or if the woman has symptoms of voiding dysfunction, anterior or apical prolapse, or a history of surgery for stress urinary incontinence.
The recommendations are likely to reduce variation in practice, which is largely caused by uncertainty about the clinical value of urodynamic testing before surgery. They are also expected to reduce the number of women having urodynamic testing before surgery, and avoid unnecessary use of a procedure that some women find unpleasant.
Although there was some good evidence showing that surgery is more effective than pelvic floor muscle training to manage stress urinary incontinence, the committee also took into account the risks associated with surgery and the absence of side effects from pelvic floor muscle training. They noted that the 2006 guideline committee had recommended pelvic floor muscle training, and had looked at evidence on both stress urinary incontinence and mixed urinary incontinence. The 2019 committee looked at evidence on stress urinary incontinence alone. The evidence showed that pelvic floor muscle training is just as effective as surgery for around half of women with stress urinary incontinence. The committee therefore decided to retain the 2006 recommendation for pelvic floor muscle training as a first-line treatment for stress urinary incontinence.
The 2019 recommendation is unchanged from 2006 and so should not lead to changes in clinical practice in most services. However, there might still be services in which pelvic floor muscle training is not routinely offered, so the recommendation might lead to a change in practice in those areas.
Recommendations 1.4.16 to 1.4.18
There was no evidence available on the use of absorbent containment products to manage urinary incontinence. In the committee's experience, these products are often used for long-term management, with no review of their ongoing suitability or discussion of other possible management options. The committee were particularly concerned about the effect that long-term use of these products can have on skin integrity if urine absorption is not adequate, noting that breakdown of vulval skin is uncomfortable and distressing. They agreed that a review of absorbent containment products should be done at least once a year to ensure that problems are identified more promptly and management can be tailored to women's changing clinical and lifestyle needs.
The committee noted that standard medical reviews often do not include absorbent containment product use, and therefore agreed that reviews of absorbent containment products should be conducted or overseen by a continence-trained healthcare professional. They thought this would ensure that reviews are consistent and thorough, and offer women a full range of management options, including referral to specialist services if needed.
The recommendations will result in an increase in reviews for women using absorbent containment products. This might reduce the overall use of these products and lead to more referrals for alternative treatment. Although short‑term costs might rise, long-term costs can be expected to fall through reduction in the use of absorbent containment products.
Recommendations 1.4.25 to 1.4.27 and 1.4.30
The committee noted that there is very little evidence about how anticholinergic medicines prescribed for overactive bladder affect cognitive function in women. They were aware that some anticholinergic medicines have been associated with dementia and Alzheimer's disease. They also noted that large numbers of women are prescribed anticholinergic medicines, with some estimates suggesting that one‑third of women aged over 65 have some degree of incontinence. Because the long-term effects of anticholinergic medicines are uncertain, the committee stressed the importance of a full discussion with the woman, taking account of the woman's total anticholinergic load and carrying out regular reviews. They also decided to make a research recommendation on anticholinergic medicines to inform future guidance.
The effectiveness of anticholinergic and other medicines for overactive bladder was not reviewed in this guideline update.
The recommendations might raise awareness of the potential adverse effects of anticholinergic medicines, especially on cognitive function, and result in women being able to make better informed choices about managing their overactive bladder. The recommendations should also ensure that healthcare professionals regularly review women who remain on long-term medication.
Recommendations 1.4.44 to 1.4.51
The evidence on botulinum toxin type A injections for overactive bladder was limited, especially on the long-term effectiveness, dosage and frequency of injections, and the risks of adverse effects. The committee decided to make a research recommendation on the long-term effectiveness of botulinum toxin type A to inform future guidance.
The committee discussed starting doses and agreed that there was not enough evidence on the benefits and risks to recommend starting treatment with a higher dose than 100 units. The committee were aware from their own experience that there may be an increased risk of self-catheterisation with 200 units and that women usually wish to avoid this if possible. Although starting with the lower dose (100 units) may result in some women needing more injections, the committee agreed that there was not enough evidence to support starting at the higher dose.
Despite the limited evidence, the committee agreed that increasing the dose to 200 units might be effective for women who have not had a satisfactory response to 100 units. The committee also agreed that an increase in dose to 200 units should be considered for women who had a response to 100 units that lasted less than 6 months. These recommendations were based on the committee's clinical experience.
The committee discussed follow‑up in clinical practice. They noted that the 2013 guideline recommended follow‑up at 6 months, or sooner if symptoms return. However, based on their experience, the committee agreed that 6 months might be too late for some women, and recommended a telephone call or a clinic appointment within 12 weeks of their first injection.
The recommendations are expected to reduce variation in practice by giving clear guidance on the initial dose of botulinum toxin A for treating women with idiopathic overactive bladder.
Changes in practice are unlikely because services are already in place to support botulinum toxin type A treatment. There will be a cost saving by having a starting dose of 100 units. There may also be savings because the recommendations no longer specify that women need training in self-catheterisation before treatment.
Recommendations 1.5.1 to 1.5.18
The evidence showed that there were no important differences in the short- and medium-term effectiveness of colposuspension, retropubic mid-urethral mesh slings and autologous rectus fascial slings, so the committee agreed that women should be offered a choice of these 3 procedures.
However, they emphasised that there is substantial uncertainty about the long-term complications associated with each procedure, and agreed that women should be made aware of this when choosing a procedure. They also made a research recommendation on the long-term risks of surgery with and without mesh to help inform future guidance.
The committee acknowledged the public concern about the risks of these procedures, especially those involving the insertion of mesh products. However, they agreed that women should not be denied effective surgical options. Instead, women should be fully informed and supported by their doctor to make the right decision about their treatment, taking into account the benefits and risks of all the options as well as any individual social or psychological factors that might affect their decision. The committee agreed that a patient decision aid could help women better understand the different surgical options and promote shared decision making.
The committee also noted variation in the amount of information and level of detail given to women before surgery and agreed that key information should be included in the recommendations, with more detailed information provided in the patient decision aid. The committee noted the importance of giving women full information about the benefits and risks of these procedures.
Evidence showed that open and laparoscopic colposuspension were equally effective procedures. Although there is a slightly increased risk of bladder injury with the laparoscopic approach, the committee thought this risk was not sufficient to exclude this option.
The committee recommended the retropubic, rather than the transobturator, route because the evidence showed that retropubic mesh slings are more likely to cure incontinence in the short term and less likely to cause complications in the medium and short term. In addition, the committee agreed that the retropubic mesh slings are easier to remove if complications do occur. However, there is evidence of a greater risk of bladder injury and need for temporary catheterisation with a retropubic procedure.
The committee agreed that porcine dermis slings should not be offered because they are less likely to result in a cure and more likely to lead to repeat surgery than a retropubic mesh sling.
The committee noted the lack of evidence on the long-term use of intramural bulking agents and uncertainty about the risks. However, in the committee's experience, some women, particularly those who are older or frail, find them beneficial. The committee agreed that intramural bulking agents should be considered if other surgery is unsuitable for, or unacceptable to, the woman. They emphasised that women who choose an intramural bulking agent should be fully advised of the risks, the lack of evidence for long-term effectiveness and adverse events, and that other surgical procedures may be more effective.
More thorough and detailed discussion with women before they have surgery for stress urinary incontinence is likely to moderately increase the time spent in consultations.
Synthetic mesh slings, colposuspension, autologous rectus fascial slings and intramural bulking agents are offered in current practice. However, all surgical options are not available at every hospital and women may require referral to another centre (regional centre) if they choose to have a procedure that is not available locally. Regional centres may require extra resources to meet this need. There might also be an increase in the number of colposuspensions and autologous rectus fascial sling procedures carried out.
Recommendations 1.6.1 to 1.6.7
The evidence indicated that self-reported symptoms can accurately identify pelvic organ prolapse, although the committee noted that prolapse is often an incidental finding. They agreed, based on the evidence and their clinical experience, that accurate assessment of suspected pelvic organ prolapse depends on a thorough clinical history and examination.
The committee thought that secondary care clinicians who suspect or identify vaginal prolapse could consider referral to a clinician with expertise in prolapse.
Evidence showed that the POP‑Q (Pelvic Organ Prolapse Quantification) system produces an accurate assessment of pelvic organ prolapse, and the committee agreed that it provides an objective and standardised measure that will ensure consistency of assessment.
Based on their experience, the committee agreed that it is important to assess pelvic floor muscles and vaginal atrophy, and to rule out a pelvic mass or other pathology. They also agreed that a validated pelvic floor symptom questionnaire could aid assessment.
The committee noted evidence showing that imaging does not provide any additional benefit in the assessment of vaginal prolapse diagnosed by physical examination. They agreed that imaging would delay management, and should not be routinely carried out in this situation.
Based on their experience, the committee agreed that symptoms of pelvic floor prolapse can become more prominent when the woman is straining or changes her position. They concluded that repeating the physical examination with the woman in a different position could be helpful if her symptoms are not explained by the physical examination. They also agreed, based on their experience, that other pelvic floor symptoms, including symptoms that remain unexplained after physical examination, should also be investigated.
The recommendations reflect current good practice, so the committee agreed there should be little change in practice.
Recommendations 1.7.1 to 1.7.9
Based on their experience, the committee agreed that there should be an initial discussion of the management options with women who have pelvic organ prolapse, including no treatment, non-surgical treatment and all surgical options.
There was no evidence available on lifestyle modification to manage pelvic organ prolapse, so the committee used their knowledge and clinical experience to make this recommendation. They thought that advice on aspects of lifestyle that directly affect the pelvic organs is most useful for women with pelvic organ prolapse. The committee agreed that obesity, heavy lifting and constipation all exacerbate the symptoms of pelvic organ prolapse by increasing intra-abdominal pressure.
There was no evidence available on topical oestrogen to manage pelvic organ prolapse. In the committee's experience, women with urogenital atrophy have more pronounced symptoms of pelvic organ prolapse. Treatment with a vaginal oestrogen reduces the effect of the atrophy and improves symptoms. The committee noted that vaginal oestrogen is available in a pessary, a cream or an oestrogen-releasing ring.
A small amount of evidence suggests that pelvic floor muscle training is beneficial for women with pelvic organ prolapse.
Limited evidence suggests that pessaries are an important alternative to surgical intervention for women with all stages of prolapse including advanced prolapse. The committee agreed that pessaries are an easily available option for women and that many women prefer them as an alternative to surgery. However, there is little evidence so the committee made a research recommendation on pessaries or surgery for pelvic organ prolapse to inform future practice.
The committee discussed the complications that can develop with pessary use and agreed that women should be advised of these, and of the importance of the pessary being removed at regular intervals. Serious complications such as pessary incarceration necessitating removal under anaesthetic, or the development of fistulae, can occur if pessaries are not changed regularly. The committee noted that women who have difficulty managing long-term pessary care because of physical or cognitive impairments are at higher risk of these complications. They therefore recommended regular appointments for these women.
The recommendation generally reflects current practice, so the committee agreed there should be no major impact on practice.
The committee concluded that these recommendations can be expected to increase the use of vaginal oestrogen, especially in primary care, and decrease the number of referrals for specialist advice and use of other interventions.
The recommendation is current practice in some services but not all, and the committee suspects that the recommendation may result in the need for some increase in resources.
The recommendations are current practice in some services and the committee does not expect it to result in significant resource increases.
Recommendations 1.8.1 to 1.8.25
The evidence on surgery for pelvic organ prolapse was limited, making it difficult for the committee to draw definite conclusions about the benefits and risks of the different types of surgery. In particular, they noted a lack of long-term evidence on the effectiveness of different types of mesh surgery. In view of this, the committee agreed that it is important to give women information on all the treatment options, including no treatment, physiotherapy, pessaries and the range of surgical options, so that they can decide which is their preferred treatment.
The committee emphasised that there is substantial uncertainty about the long-term success and complications associated with each procedure, and agreed that women should be made aware of this when choosing a procedure. They also made a research recommendation on the long-term risks of surgery with and without mesh to help inform future guidance.
The committee acknowledged the public concern about the risks of procedures involving the insertion of mesh products. However, they agreed that women should not be denied effective surgical options. Instead, they should be fully informed and supported by their doctor to make the right decision about their treatment. They agreed that a patient decision aid could help women better understand the benefits and risks of the different treatment options and promote shared decision making.
The committee agreed informed choice is of great importance in making decisions about surgery, and that a woman should be provided with information on all her potential options for management. The committee were aware that multiple factors (for example, comorbidities and lifestyle) affect the choice of treatment, many of which were not captured by the evidence, and that these should be taken into account when discussing surgery with women.
The committee also noted variation in the amount of information and level of detail given to women before surgery and agreed that key information should be included in the recommendations, with more detailed information provided in the NICE patient decision aids. The committee noted the importance of providing full information about the benefits and risks of these procedures.
The committee noted that for some women, the full extent of prolapse in all compartments can only be evaluated during surgery. Therefore it is important to discuss with women the surgical plan if prolapse is found to be more severe than anticipated from clinic examination.
The committee agreed that surgical options, including surgery that will preserve the uterus, should be discussed with the woman.
Based on their clinical experience, they agreed that women who wish to preserve their uterus should be offered a choice of 3 types of surgery. There was no evidence available that compared these 3 procedures.
For women who have no preference about preserving their uterus, the committee used their clinical experience to agree that women should be offered a choice of 4 surgical options. There was a very small amount of evidence showing that vaginal hysterectomy might be slightly better than sacrospinous hysteropexy, but there was not enough evidence to justify a preference for any of the 4 options.
The committee noted that the evidence showed no difference in cure and quality of life between sacrocolpopexy and sacrospinous fixation. Based on the evidence and their clinical experience, the committee agreed that women with vault prolapse should be offered a choice of 2 types of surgery. The committee noted that sacrocolpopexy can be performed either as open surgery or laparoscopically.
Based on their clinical experience, the committee agreed that colpocleisis should be considered a potential surgical option for managing symptoms of vault or uterine prolapse in some groups of women. There was no evidence comparing colpocleisis with other management options. However, the committee thought that colpocleisis should be considered for women who have no other surgical options or for whom the other procedures would carry a higher risk of a serious complication. They made a research recommendation on colpocleisis compared with sacrospinous fixation for pelvic organ prolapse to help inform future guidance.
The evidence suggested that mesh surgery has higher cure rates, fewer repeat surgeries for pelvic organ prolapse, and lower recurrence rates compared with anterior colporrhaphy. However, the committee were aware of the potential complications associated with mesh exposure and erosion, and that these may increase over time. This is particularly relevant for younger women having surgery, but there was no evidence specifically for these women. Based on the evidence of risks associated with mesh surgery, the committee agreed that anterior repair without mesh should be offered.
They agreed that mesh surgery could be considered, but only for recurrent prolapse in a very limited number of women for whom there is no alternative treatment. The committee noted that evidence supports the effectiveness of mesh placement for anterior prolapse. They discussed the balance between the risks associated with mesh surgery and the potential harms of no treatment, which include persistent prolapse, problems with bladder emptying, ulceration of vaginal skin, recurrent urinary tract infections, pain and discomfort, sexual dysfunction, and problems with working and social life. The committee agreed that some women with recurrent prolapse after a non-mesh repair might be prepared to accept the risks associated with mesh surgery, and that these women should have the option to make an informed choice.
There was no evidence showing that mesh surgery is better than non-mesh surgery for posterior prolapse, and mesh surgery is associated with an increased risk of complications. The committee therefore agreed that vaginal repair without mesh should be offered to women with posterior prolapse.
Based on their experience, the committee agreed that a review 6 months after any type of surgery for prolapse will help to establish the effectiveness and rate of short-term complications. In view of the concern regarding long-term complications, the committee considered that it was important that women should be referred for specialist advice if they experience recurrent symptoms or complications after 6 months.
More thorough and detailed discussion with women before they have surgery for pelvic organ prolapse is likely to moderately increase time spent in consultations. Sacro-hysteropexy with mesh is not available at all centres so this might increase referrals between centres. However, because fewer women are choosing mesh surgery, the increase in this type of referral is likely to be negligible. Similarly, there could be a small increase in referrals for laparoscopic sacrocolpopexy and colpocleisis, but this is not expected to have a significant impact on practice.
Recommendations 1.9.1 and 1.9.2
The evidence did not show any clear benefits for concurrent surgery for stress urinary incontinence and pelvic organ prolapse, but the committee agreed that it should be considered in women with anterior and/or apical prolapse and stress urinary incontinence. They agreed that women should be told about the uncertainty of the benefits and risks of concurrent surgery compared with sequential surgery, to ensure that they are equipped to make an informed decision. The committee made a research recommendation on the most effective surgical management for women with both stress urinary incontinence and pelvic organ prolapse.
The committee expect these recommendations to reduce variations in care and improve the information women are given when choosing between sequential and concurrent surgery for stress urinary incontinence and pelvic organ prolapse.
Recommendations 1.10.1 to 1.10.6
The committee noted, based on their experience, that there can be delays in the diagnosis of mesh-related complications. They therefore highlighted the importance of considering mesh as a possible cause of pain, vaginal problems, or urinary or bowel problems in women who have had mesh inserted.
The committee were unable to make generalised recommendations on assessing possible mesh-related complications because of the wide variety of procedures and implanted materials used, and the many different complications that might result from these. They therefore agreed that women with suspected mesh-related complications should be referred to a specialist centre unless they have an uncomplicated, small mesh exposure that can be treated with topical oestrogen.
There was little evidence available on the use of specific investigations to assess suspected mesh-related complications, so the committee decided to outline a range of possible investigations. They also made a research recommendation on assessing complications associated with mesh surgery to inform future guidance.
The recommendations reflect current good practice and the committee did not expect them to result in changes in practice.
Recommendations 1.11.1 to 1.11.18
The available evidence was very limited and so the committee made recommendations based on their experience. They noted that women often have multiple complications from mesh surgery and that these complications can be long lasting. They also noted that the success of mesh removal varies widely depending on the specific mesh-related complication. In addition, some women who have complete mesh removal will have further complications and recurrence of stress urinary incontinence, pelvic organ prolapse, or both. The committee therefore agreed that healthcare professionals should have a full discussion with women who are considering having partial or complete mesh removal. They also agreed that mesh should be removed only after a review by the regional MDT.
Based on their experience, the committee agreed that topical oestrogen is only likely to be effective for small exposures of mesh and should be discussed with the woman as an option that could be tried before surgery is considered. They noted that some women who present with mesh exposure or extrusion with vaginal discharge may have a mesh infection, and imaging should be considered to assist in the diagnosis.
The committee acknowledged the impact that mesh perforation in the lower urinary tract has on women's quality of life, and agreed that women with this complication should be referred for further assessment. Similarly, women who have pain or painful sexual intercourse should be offered specialist assessment. The committee reiterated the need to tell women about the possible benefits and risks of mesh removal surgery. The committee also noted the lack of evidence in this area and made a recommendation for research on pain management after mesh surgery.
The committee thought that these recommendations will reduce delays in treatment for mesh-related complications, although they might increase the number of referrals.