Laparoscopic augmentation cystoplasty (including clam cystoplasty) (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Laparoscopic augmentation cystoplasty (including clam cystoplasty)
An ‘overactive bladder’ or detrusor hyper-reflexia causes symptoms of urgent need to urinate, urge incontinence, frequent urination and waking at night to urinate. One of the causes is bladder muscle (detrusor) overactivity, in which the detrusor contracts unexpectedly during bladder filling. Laparoscopic augmentation cystoplasty (including clam cystoplasty) is reconstructive surgery to increase the size of the bladder and is done via small incisions. The procedure involves sewing or stapling a tissue graft from a section of the small intestine (ileum), colon or other substitutes to the urinary bladder.
The National Institute for Health and Clinical Excellence (NICE) is examining laparoscopic augmentation cystoplasty (including clam cystoplasty) 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 laparoscopic augmentation cystoplasty (including clam cystoplasty).
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- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 23 September 2009
Target date for publication of guidance: December 2009
1 Provisional recommendations
1.1 Current evidence on the safety and efficacy of laparoscopic augmentation cystoplasty (including clam cystoplasty) is limited in quantity and quality but raises no major safety concerns, and the open procedure is well established. This procedure may therefore be used with normal arrangements for clinical governance, consent and audit.
1.2 Patient selection and treatment should be carried out by a multidisciplinary team with specialist expertise in the management of urinary incontinence and experience in complex laparoscopic reconstructive surgery.
1.3 Clinicians undertaking laparoscopic augmentation cystoplasty (including clam cystoplasty) should submit data on all patients to the Female and Reconstructive Urology database run by the British Association of Urological Surgeons (available from www.sarahfowler.org/bsfru.htm) to allow monitoring of safety outcomes in the long term.
2 The procedure
2.1 Indications and current treatments
2.1.1 Laparoscopic augmentation cystoplasty (including clam cystoplasty) is indicated for a number of conditions including anatomically/structurally contracted bladder, neurogenic bladder and overactive bladder.
2.1.2 Current treatment options include bladder training, anticholinergic drugs, intravesical botulinum toxin injections, intermittent
self-catheterisation (ISC) and sacral neuromodulation. In patients whose condition is refractory to non-surgical treatment, open augmentation cystoplasty is an established procedure.
2.1.3 Proposed advantages of a laparoscopic approach are less intraoperative blood loss, quicker recovery, less pain, a shorter stay in hospital and smaller scars.
2.2 Outline of the procedure
2.2.1 Laparoscopic augmentation cystoplasty (including clam cystoplasty) (also known as ileocystoplasty, sigmoidocystoplasty, enterocystoplasty or bladder augmentation) increases bladder size and reduces intravesical pressure. Its aims are to reduce urgency and urge incontinence, prevent nocturia and reduce voiding frequency.
2.2.2 The procedure is typically carried out, through 4 or 5 laparoscopic ports, with the patient under general anaesthesia. The bladder is incised and an isolated piece of bowel, usually ileum, is sutured to this opening. A urethral catheter is left in the reconstructed bladder.
2.2.3 Once a ‘watertight’ reservoir has been demonstrated, 2–3 weeks after surgery, the urethral catheter is removed. Many patients require ISC and bladder washouts to prevent development of infection or stones in the augmented part of the bladder. Patients need to empty the bladder frequently (by passing urine or by ISC) to prevent bladder rupture.
|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/IP779overview|
2.3.1 Case series of 23 and 6 patients treated by laparoscopic cystoplasty reported significant increases in mean postoperative bladder volume compared with preoperative volume – from 111 ml to 778 ml and 48 ml to 260 ml at 12-month follow-up (p < 0.01) and 13- to 16-month follow-up (significance not stated). Two case reports of 1 patient each reported increases in bladder volume from 85 ml preoperatively to 250 ml at 4-week follow-up and from 150 ml preoperatively to 315 ml at 3-month follow-up
2.3.2 A case series of 17 patients reported a significant improvement in bladder control on the Bladder Control Scale (scoring system not described) from a mean preoperative score of 14.9 to 1.6 at an average 17-month follow-up (p = 0.0002).
2.3.3 The case series of 23 and 6 patients reported postoperative decreases in mean maximum detrusor pressure from 92 to 15 cm H2O at 12-month follow-up and from 35 to 12 cm H2O at an average of 13- to 16-month follow-up respectively (significance not stated).
2.3.4 The case series of 23 patients reported that all 19 patients with 12-month follow-up data were dry while performing ISC every 4–5 hours. The case series of 6 patients reported that all patients were generally dry for 2–3 hours between catheterisations within 1 month of the procedure.
2.3.5 The Specialist Advisers listed key efficacy outcomes as symptom relief, rapid recovery and shorter duration of hospital stay (compared with the open procedure), reduced need for analgesia and cosmesis.
2.4.1 Multiple bladder stones in the augmented pouch 13 months after surgery were reported in 1 patient in the case series of 23 patients; (these were treated by cystolithotomy).
2.4.2 In the same case series of 23 patients, spontaneous rupture of the pouch 15 months after augmentation was reported in 1 patient who neglected to undertake ISC as recommended. The rupture was repaired and a urethral catheter was inserted for 4 weeks.
2.4.3 In the case series of 17 patients, a trocar-induced rectus sheath haematoma was reported in 1 patient during a sigmoidocystoplasty (this was controlled laparoscopically). Paralytic ileus (managed conservatively) was reported in another patient in the case series of 17 patients (timing of event not stated).
2.4.4 Leakage from the suture line occurred in 1 patient in the case series of 6 patients: this resolved with conservative management.
2.4.5 The Specialist Advisers considered theoretical adverse events to include bleeding, sepsis, infection, damage to the bowel, intestinal anastomotic leaks (bowel or bladder) and metabolic disturbance.
3 Further information
3.1 For related NICE guidance see www.nice.org.uk
Chairman, Interventional Procedures Advisory Committee
Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.
It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 30 March 2010