Balloon catheter insertion for Bartholin's cyst or abscess (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Balloon catheter insertion for Bartholin’s cyst or abscess
The Bartholin’s glands are at the entrance of the vagina. A cyst or abscess can form in the Bartholin’s duct (which drains the glands) if it becomes blocked or infected. Cysts are usually treated either by ‘incision and drainage’ or ‘marsupialisation’, which involves cutting into the cyst and placing stitches to make a permanent opening so that the gland can drain freely. Insertion of a balloon catheter is a non-surgical alternative to incision and drainage or marsupialisation.
The National Institute for Health and Clinical Excellence (NICE) is examining balloon catheter insertion for Bartholin’s cyst or abscess and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about balloon catheter insertion for Bartholin’s cyst or abscess.
This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
- comments on the provisional recommendations
- the identification of factual inaccuracies
- additional relevant evidence, with bibliographic references where possible.
Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that NICE will follow after the consultation period ends is as follows.
- The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.
For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).
NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.
Closing date for comments: 20 August 2009
Target date for publication of guidance: November 2009
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of balloon catheter insertion for Bartholin’s cyst or abscess is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.
2 The procedure
2.1 Indications and current treatments
2.1.1 Bartholin’s glands are located at the vaginal entrance. During sexual arousal, they secrete a lubricant which enters the vagina through a small duct from each gland. A cyst may form if the duct becomes obstructed and if the cyst becomes infected then an abscess develops.
2.1.2 Conservative management of symptomatic cysts or abscesses may include a warm bath, compresses, analgesics, and antibiotics when appropriate. Persistent and symptomatic cysts or abscesses are often treated surgically, by incision and drainage, or by marsupialisation (the cyst is opened, and the skin edges are stitched to allow continual free drainage of the fluid from the cyst cavity).
2.2 Outline of the procedure
2.2.1 The aim of the procedure is to establish drainage of the abscess or cyst by creating a fistula or sinus track which will remain open in the long term. The underlying principle is that a foreign body reaction (to the balloon and catheter) induces formation of an epithelialised fistula.
2.2.2 With the patient under local or general anaesthesia, an incision is made into the abscess or cyst on the mucosal surface of the labia minora. A tissue specimen (biopsy) and/or swab may be taken to test for neoplasia and/or infection (including sexually transmitted diseases). The abscess or cyst is drained.
2.2.3 A specially designed balloon catheter is inserted into the abscess or cyst cavity through the incision, and the balloon is inflated with saline to secure it in place. If pain persists after the balloon is inflated, it is partially deflated, leaving enough fluid to keep the catheter in place. A suture may be used to partially close the incision and hold the catheter in place. The catheter stays in place for up to 4 weeks to allow epithelialisation of the tract.
2.2.4 After epithelialisation is judged to have occurred, the catheter is deflated and removed. A period of several weeks may be required for epithelialisation.
|Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP766overview|
2.3.1 A prospective case series of 35 women with Bartholin’s abscess treated by the balloon catheter reported operative success (defined as short-term abscess resolution with no need for marsupialisation and no recurrence) in 97% (34/35) of women. The study reported that 89% (24/27) of women who retained the catheter for 4 weeks would recommend the procedure to a friend.
2.3.2 In the case series of 35 women, catheters were successfully inserted in 34. Of these, 7 fell out: 3 after 24 hours, 3 after 1 week and 1 after 11 days. Despite their catheters falling out, 6 of the 7 women were reported as having successful operations. One woman had subsequent marsupialisation. Epithelialisation was judged to have occurred in the remaining 27 women 4 weeks after treatment.
2.3.3 A case series of 46 women with Bartholin’s cyst or abscess treated by balloon catheter reported recurrence in 17% (8/46) of women and the procedure was repeated in all patients. Another case series (68 women with Bartholin’s cyst or abscess) reported 2 cyst recurrences (without infection) 6 months and 5 years after the procedure. For the first recurrence, it was thought that the catheter was removed prematurely.
2.3.4 The Specialist Advisers listed key efficacy outcome as healing in the short term and absence of abscess recurrence 6 months after the procedure.
2.4.1 The case series of 68 women reported necrotic abscess development in 1 woman because the inflated balloon eroded the cutaneous surface of the labium (time of occurrence not stated). This was considered to be have been caused by improper insertion of the catheter. The same case series reported that another woman was admitted to hospital for 9 days because the catheter had been inserted between the vestibular mucosa and the cyst wall. One year after the operation, the cyst remained.
2.4.2 The case series of 35 women reported that 5 women complained of mild discomfort (scoring 2−3 on a pain scale from 0 [no pain] to 10 [severe pain]) on sitting at 1-week follow-up. One woman reported moderate discomfort (scoring 5 on the same scale) and a continuous sensation of labial swelling, which subsided when 2 ml of fluid was removed from the balloon (time of occurrence not stated).
2.4.3 The Specialist Advisers listed an anecdotal adverse event as pain if the catheter is overfilled, which could be relieved by slightly deflating it. They considered theoretical adverse events to include infection, abscess recurrence, bleeding, pain from having the catheter in situ, scarring, expulsion of the bulb of the catheter and dyspareunia.
Chairman, Interventional Procedures Advisory Committee
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It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 30 January 2011