Guideline for the Management of Pelvic Organ Prolapse Requiring Ring Pessary Fitting/ Replacement October 2016 Page 1 of 15

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1 Policy Number LCH-111 This document has been reviewed in line with the Policy Alignment Process for Liverpool Community Health NHS Trust Services. It is a valid Mersey Care document, however due to organisational change this FRONT COVER has been added so the reader is aware of any changes to their role or to terminology which has now been superseded. When reading this document please take account of the changes highlighted in Part B and C of this form. Part A Information about this Document Policy Name Guideline for Management of Pelvic Organ Prolapse Requiring Ring Pessary Fitting or Replacement Policy Type Board Approved (Trust-wide) Trust-wide Divisional / Team / Locality Action No Change Minor Change Major Change New Policy No Longer Needed Approval As Mersey Care s Executive Director / Lead for this document, I confirm that this document: a) complies with the latest statutory / regulatory requirements, b) complies with the latest national guidance, c) has been updated to reflect the requirements of clinicians and officers, and d) has been updated to reflect any local contractual requirements Signature: Date: Part B Changes in Terminology (used with Minor Change, Major Changes & New Policy only) Terminology used in this Document New terminology when reading this Document Part C Additional Information Added (to be used with Major Changes only) Section / Paragraph No Outline of the information that has been added to this document especially where it may change what staff need to do Part D Rationale (to be used with New Policy & Policy No Longer Required only) Please explain why this new document needs to be adopted or why this document is no longer required Part E Oversight Arrangements (to be used with New Policy only) Accountable Director Recommending Committee Page 1 of 15

2 Approving Committee Next Review Date LCH Policy Alignment Process Form 1 Page 2 of 15

3 SUPPORTING STATEMENTS This document should be read in conjunction with the following statements: SAFEGUARDING IS EVERYBODY S BUSINESS All Mersey Care NHS Foundation Trust employees have a statutory duty to safeguard and promote the welfare of children and adults, including: being alert to the possibility of child / adult abuse and neglect through their observation of abuse, or by professional judgement made as a result of information gathered about the child / adult; knowing how to deal with a disclosure or allegation of child / adult abuse; undertaking training as appropriate for their role and keeping themselves updated; being aware of and following the local policies and procedures they need to follow if they have a child / adult concern; ensuring appropriate advice and support is accessed either from managers, Safeguarding Ambassadors or the trust s safeguarding team; participating in multi-agency working to safeguard the child or adult (if appropriate to your role); ensuring contemporaneous records are kept at all times and record keeping is in strict adherence to Mersey Care NHS Foundation Trust policy and procedures and professional guidelines. Roles, responsibilities and accountabilities, will differ depending on the post you hold within the organisation; ensuring that all staff and their managers discuss and record any safeguarding issues that arise at each supervision session EQUALITY AND HUMAN RIGHTS Mersey Care NHS Foundation Trust recognises that some sections of society experience prejudice and discrimination. The Equality Act 2010 specifically recognises the protected characteristics of age, disability, gender, race, religion or belief, sexual orientation and transgender. The Equality Act also requires regard to socio-economic factors including pregnancy /maternity and marriage/civil partnership. The trust is committed to equality of opportunity and anti-discriminatory practice both in the provision of services and in our role as a major employer. The trust believes that all people have the right to be treated with dignity and respect and is committed to the elimination of unfair and unlawful discriminatory practices. Mersey Care NHS Foundation Trust also is aware of its legal duties under the Human Rights Act Section 6 of the Human Rights Act requires all public authorities to uphold and promote Human Rights in everything they do. It is unlawful for a public authority to perform any act which contravenes the Human Rights Act. Mersey Care NHS Foundation Trust is committed to carrying out its functions and service delivery in line the with a Human Rights based approach and the FREDA principles of Fairness, Respect, Equality Dignity, and Autonomy Page 3 of 15

4 Guideline for Management of Pelvic Organ Prolapse Requiring Ring Pessary Fitting / Replacement Page 4 of 15

5 Guideline reference number Aim and purpose of clinical document Author Type 111 To give guidance to clinical staff of the Liverpool Community Health Urogynaecology Service to manage women presenting with pelvic organ prolapse requiring ring pessary fitting/ replacement Clinical Director Liverpool Community Sexual Health New document Reviewed document Review Date Person/gro up accountabl e for review Type of Evidence base used October 2018 Clinical Standards Group Level C: Evidence which includes published and /or unpublished studies and expert opinion Issue date November 2016 Authorised by Clinical Standards group 25 th October 2016 Equality Analysis Yes date when undertaken 22/11/2016 Evidence collated Yes No Page 5 of 15

6 Version Number: 2 Ratified by: Clinical Standards Group Date of Approval: 25 th October 2016 Name of originator/author: Approving Body / Committee: Clinical Director, Sexual Health Clinical Standards Group Date issued: November 2016 Review date: October 2018 Target audience: Director Responsible Changes / Alterations Made To Previous Version: Clinical Staff of Liverpool Community Health Urogynaecology Service Medical Director 1. Introduction. Included the name of the grading system used in this guideline for uterine prolapse as there are other grading systems present 2. Section assess quality of life using electronic assessment questionnaire (see-paq) has been deleted because this electronic assessment package has not been purchased by LCH 3. Conservative management. Changed 6-8 months to 6 months as usual UK practice Page 6 of 15

7 Contents Page Purpose and Scope of the guideline 4 Definitions 4 Development, contributors and peer review 4 Equality Analysis 4 Distribution/ Dissemination 4 Monitoring 4 Pelvic Organ Prolapse 5 Appendix 1 9 References 11 Page 7 of 15

8 Purpose and scope of the guideline The purpose of this guideline is to give guidance to clinical staff working for the Liverpool Community Health Urogynaecology Service to manage women presenting with pelvic organ prolapse requiring ring pessary fitting/ replacement. It is based on the Liverpool Women s Hospital Ring Pessary Guideline. Definitions CEU - Clinical Effectiveness Unit of Faculty of Sexual & Reproductive Healthcare. CHD - Coronary artery disease CVA - Cerebrovascular accident fpa - Family Planning Association LARC - Long acting reversible contraception. MI - Myocardial infarction NHS - National Health Service POP - Progestogen - only pill UK - United Kingdom WHO - World Health Organization Development, Contributors and Peer review. This guideline was developed by the Clinical Director for Liverpool Community Sexual Health. It was peer reviewed and contributed to by Consultant, Specialty Doctor, Specialist Registrar and Advanced Registered Practitioners. Equality Analysis Equality analysis was conducted on 22/11/2016 using Liverpool Community Health Equality Impact Equality Analysis Screening Tool and the findings were forwarded to the Equality and Diversity Lead. Distribution/ Dissemination This document will be distributed electronically to all clinical staff of the Liverpool Community Health Urogynaecology Service. A copy will also be available on the Abacus Common Drive. Monitoring Adherence to this guideline will be monitored by audit of key aspects and review of incidents, complaints and near misses. Page 8 of 15

9 PELVIC ORGAN PROLAPSE Introduction Pelvic organ prolapse refers to the herniation of pelvic organs through the vagina due to loss of pelvic support. This may involve one or more pelvic organs including Uterus Anterior vaginal wall (urethrocele, cystocele) Posterior vaginal wall (rectocele) Peritoneum with or without small bowel involvement (enterocele) Post-hysterectomy prolapse Uterine prolapse has the cervix at its leading edge. This in turn may pull down the vagina (uterovaginal prolapse) Grading using the pelvic organ prolapse quantification (POPQ) system: The four stages of uterine prolapse Stage 1- the most distal portion of the prolapse is >1cm above the level of the hymen Stage 2 the most distal portion of the prolapse is <1cm proximal or distal to the hymen Stage 3 the most distal portion of the prolapse is >1cm below the hymen but protrudes no further than 2cm less than the total length of the vagina Stage 4 complete eversion of the vagina Vaginal prolapse is classified according to the region of the vaginal wall affected Cystocele involves the upper anterior vaginal wall Urethrocele involves the lower anterior vaginal wall Rectocele involves the lower posterior vaginal wall Enterocele involves the upper posterior vaginal wall Post hysterectomy vaginal prolapse is defined as the descent of the vaginal cuff scar below a point that is 2cm less than the total length above the plane of the hymen. Conservative management of pelvic organ prolapse includes the use of supporting vaginal pessaries. A pessary is a device inserted into the vagina to support the walls and related pelvic organs (Hay-Smith et al 2009). Pessaries restore prolapsed pelvic organs to their normal position, relieving most symptoms. They can significantly improve the quality of patients lives. Page 9 of 15

10 Purpose Currently, there is little evidence on which to base treatment of women with pelvic organ prolapse through the use of pessaries. There is no consensus on the use of different types of device, the indications, nor the pattern of replacement and follow up care (Adams et al 2004). The aim of this guideline is to offer a standardised approach to assessing women with pelvic organ prolapse following the Liverpool Map of Medicine pathway managing women requiring fitting/ replacement of ring pessaries following the Liverpool Women s Hospital Guideline First Visit for Assessment of Pelvic Organ Prolapse At the first visit the following need to be known: Age Can she see or feel the vagina or cervix protrude through the vaginal opening Is there a sensation of bulging, pressure, fullness, or heaviness Urinary symptoms: urgency, frequency, incontinence, voiding dysfunction Lower back pain Bowel emptying difficulties Sexual dysfunction Examination Examine the patient when they are resting and straining in both supine and standing positions to define the extent of the prolapse and to establish the segments of the vagina that are affected (anterior, posterior, or apical). Inspect the tissues for signs of vaginal atrophy. Complete a speculum and bimanual examination to assess uterus size and cervical length. Palpate vaginal mass on digital examination. Identify all pelvic floor defects Conservative Management of Pelvic Organ Prolapse using Vaginal Pessaries Only for women for whom surgery is not appropriate Restore prolapsed organs to their normal position Should discuss the option of pessary use with all women who have prolapse that warrants treatment based on symptoms Pessary use should be considered before surgical intervention in women with symptomatic prolapse Can be fitted in most women with prolapse, regardless of stage or site of predominant prolapse Require changing every 6 months to prevent ulceration of the vaginal vault. If left for a long time there is risk of o Calcium deposition o Erosion o Fistula formation Page 10 of 15

11 Reserved for women who Are physically frail Are unfit for surgery Have declined surgery or have preference for non-surgical management Who have not yet completed their family Ring pessaries tend to fail in women with deficient perineum, who may require shelf pessaries instead such women should be referred into secondary care. Fitting first pessary Sizing of the pessary is often trial and error (McIntosh 2005). Comparing the distance between first and second fingers when fully abducted during bimanual examination, to an approximately similar diameter pessary can be used as a starting point. Doshani et al. (2007) recommends: 1. Ensure patient s bladder and bowel are empty and vaginal epithelium is healthy. 2. The pessary fits well if a finger can be swept between the pessary and the walls of the vagina 3. The aim is to fit the smallest pessary that does not cause discomfort. 4. The patient should be asked to walk around, bend, and micturate to ensure the pessary is retained. A full procidentia will probably gain best support from a shelf pessary or other chosen device. There are occasions where 2 pessaries are utilised to gain support. To fit the ring pessary Confirm details and gain consent for removal and refit of pessary. Check for any change in medication or medical history on each visit. Check whether had any episodes of discomfort, bleeding, increase in discharge or problems with toileting Check whether she wishes to reconsider surgery Ensure happy to proceed with pessary fitting The ring pessary should be coated in a lubricating jelly or if indicated oestrogen cream. Check the patient has no nut allergy before using oestrogen cream Part labia with the non-dominant hand; grasp ring with dominant hand and squeeze to form a narrow oval shape or a twisted figure of 8. Page 11 of 15

12 Gently insert pessary into the vagina, in a clockwise direction in the saggital plane. The most posterior part of the ring should lie in the posterior fornix; with the anterior portion lying immediately behind and above the symphysis pubis. The cervix should be palpable within the central deficit of the ring (if not had previous hysterectomy). There may be a vague sensation of discomfort or irritation from the actual fitting procedure Encourage patient to void after fit as pessary should not dislodge or prevent voiding (once pessary is established then they would not be encouraged to void after each fitting) Ring pessary removal Apply traction to the anterior portion of the ring with first finger and thumb. Whilst rotating the ring; ask the patient to cough lightly this will ease removal. Asking the patient to put her hands under her buttocks or a pillow beneath the hips can help to make the removal of pessary easier Ensure that pessary details are recorded in notes. Aftercare and follow up. There is no consensus about the optimal frequency of care. Routine care is mandatory due to the potential side-effects and complications. Therefore the patient s needs should be addressed individually and reviewed as clinically indicated usual follow up would be between 3-6 months. Patients who wish to consider surgical correction of prolapse will be referred for review by a Consultant Urogynaecologist at the Women s. Fitting a pessary can unmask symptoms of urinary incontinence Complications arising from pessary use Erosion, ulceration, abrasion and contact bleeding of the vaginal epithelium are a common complication of pessary usage. Below is a list of recommended management of this complication It can be minimised by teaching the patient to remove the pessary and re-insert it herself at regular intervals if able to do this Local oestrogen can be used to improve atrophic changes A short term course of topical oestrogen cream/pessaries should be prescribed, with the pessary removed. This will encourage healing of erosions to the epithelia. Page 12 of 15

13 It is also possible to still treat with pessary in-situ depending on severity of erosion and prolapse symptoms. Treat with Gynest cream/ Vagifem 10mcg pessary per vaginum nightly for two weeks then twice weekly for six weeks then review in clinic. If epithelium healthy then can have refit of pessary and routine follow up. Sometimes continued use of gynest/ vagifem pessaries may be required for 3-6 months if treating for symptoms of vaginal atrophy with careful review by clinician. Increased vaginal discharge and or odour are also common it is worth advising on own personal hygiene and if still concerned speak to clinician for advice on symptom control. Ring pessaries tend to fail in women with a deficient perineum, who may require shelf pessary instead These women will need to be referred into the nurse led ring pessary clinic at the Liverpool Women s Hospital Rarely, vesicovaginal, rectovaginal fistula or incarceration of pessary occurs. References Adams EJ et al (2004) Mechanical devices for pelvic organ prolapse in women. Cochrane database of systemic reviews (ISSN X article no CD004010). Doshani A et al (2007) Uterine prolapse. BMJ. 355, Hagen S. et al (2006) Conservative management of pelvic organ prolapse in women.cochrane database of systemic reviews (ISSN X article no CD003882). Haylen et al (2010). An international Urogynaecological Association (IUGA/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics. 2010; 29: Hay-Smith et al (2009) Adult conservative management in Incontinence 4 th International Consultation, Paris July (4 th ed). Health Publications Ltd: McIntosh L. (2005) The role of the nurse in the use of vaginal pessaries to treat pelvic organ prolapse and/or urinary incontinence. Urology Nurse. 25 (1), Page 13 of 15

14 Appendix 1: Competencies for Management of Pelvic Organ Prolapse Requiring Ring Pessary Fitting/ Replacement Competencies Knowledge of terminology and classification of pelvic organ prolapse Knowledge of staging system for pelvic organ prolapse Take a history for symptoms suggestive of or associated with pelvic organ prolapse Be aware of red flag conditions requiring urgent referral Carry out a gynaecological examination when resting and straining to define extent of prolapse and segment of vagina affected Assess tissues for signs of atrophy Carry out a bimanual examination to assess uterus size and cervical length and digitally palpate a vaginal COMPETENCY Mentor Signature COMPETENCY Advanced Registered Practitioner Signature Page 14 of 15

15 mass Correctly identify women for whom a pessary is appropriate Examine patient to assess size of ring pessary required Successfully insert ring pessary Successfully remove ring pessary Arrange appropriate follow up for individual patient Manage complications arising from pessary use Refer appropriately into secondary care when indicated Page 15 of 15