medicolegal aspects of vesicovaginal fistulae

Medicolegal aspects of vesicovaginal ®stulaeK. THOMAS and G. WILLIAMS

Department of Urology, Hammersmith Hospital, London

Introduction

Vesicovaginal ®stulae (VVF) are a common ®nding in

developing countries, because there is a high incidence of

prolonged obstructed labour [1±4]. In the Western world

VVF are less common and usually associated with

iatrogenic injury, especially obstetric and gynaecological

procedures [5±8]. VVF may also result from pelvic

malignancy and its treatment by radiotherapy [6,9].

The subsequent urinary incontinence caused by VVF has

a profound affect on the patient's quality of life and is a

common cause of medicolegal claims. This is frequently

compounded by an unnecessary delay in repair of up to 3

months from the time of injury [5,6].

For a small ®stula, the treatment is initially con-

servative, as a small percentage will heal spontaneously;

however, most will require surgery [10,11]. Operative

intervention is associated with an 80±90% primary cure

rate [1±7,12]. Surgery can be undertaken by either a

gynaecologist or urologist, provided they are a specialist

in the ®eld. The timing and type of repair used depend on

the experience of the surgeon and the aetiology of the

®stula [13].

The incidence of medicolegal claims is increasing,

especially in the ®eld of obstetrics and gynaecology.

Urological injury occurring during obstetric and gynae-

cological procedures accounts for 10% of all claims and

represents 19.6% of claims actually settled, with VVF

accounting for the second highest cause of claims within

gynaecology [14,15]. The avoidance, recognition and

treatment of these ®stulae is therefore a signi®cant issue

given the associated morbidity and medicolegal implica-

tions [16]. This review discusses the aetiology, presenta-

tion, management and prevention of obstetric, iatrogenic

and radiotherapy-induced VVF [17].

Surgical ®stulae

Aetiology

In developed countries iatrogenic injury during pelvic

surgery is the commonest cause of VVF. Abdominal

hysterectomy is the procedure most commonly impli-

cated, with the risk of ®stula formation quoted as 1 in

1300 hysterectomies [5±8]. The ®stula is usually found

in the vaginal vault [7,8,18]. The risk of causing VVF is

known to be increased by a variety of causes including:

anatomical distortion by ®broids or ovarian tumours,

adhesions between bladder and cervix after previous

surgery, sepsis, endometriosis or malignancy and pre-

vious radiotherapy [8,10]. Abnormal bladder function, in

particular a poor voiding pattern, has been implicated as

increasing the risk of ®stula formation through post-

operative urinary retention, which is often not

recognized early [10].

Presentation and diagnosis

Injuries may be recognized during surgery or present up

to 3 weeks later [5,6]. If iatrogenic injury to the bladder is

noticed at the time of surgery, then a senior clinician

should be informed and a urologist involved immediately

to repair the damage. If a urologist is not available, the

defect should be closed with an absorbable suture

(chromic catgut, polyglactin or polydioxanone) in two

or three layers, a catheter inserted, left on free

drainage and a urology review obtained after surgery.

Unfortunately, the injury is often not noticed intra-

operatively and the subsequent ®stula is not diagnosed

until later, despite persistent discharge through the

vagina after surgery. Fistulae are diagnosed a mean of

3 weeks after surgery, as the history is often subtle and

the opening of the ®stula small and dif®cult to ®nd [5,6].

A pelvic examination is mandatory and biochemical

con®rmation of the presence of urine advisable. IVU is

essential as concurrent ureteric damage is common [6]. If

it is dif®cult to establish the presence of a ®stula the three-

swab test can be used, but this does not identify multiple

®stulae. If the three-swab test is positive, methylene blue

should again be instilled into the bladder and a Sims

speculum used to identify the site(s) of the ®stulae. It is

important to adequately distend the bladder with

methylene blue and stop any leakage around the

catheter. If the swabs are soaked with clear ¯uid this

implies a ureteric injury which was not detected on IVU.

Oral pyridium is useful in these cases to colour the renal

urine (double-dye test) [19]. An examination under

anaesthesia can occasionally be necessary to detect

the track and plan the type of repair required more

accurately [20].

Recently there has been interest in documenting the

stability of the bladder before and after repair using

BJU International (2000), 86, 354±359

# 2000 BJU International354

urodynamics [21]. Hilton [21] suggested that the

incidence of detrusor instability and stress incontinence

in patients with vaginal vault ®stulae is lower than in

those with urethral or bladder neck ®stulae. Most of the

symptoms were found to resolve after repair, although an

element of detrusor instability requiring further treat-

ment persisted in some women. This contrasts with a

study based on the urodynamic assessment of women in

Nigeria after repair, 44% of whom were found to have

signi®cant stress incontinence despite a successful repair

[22]. This was a smaller study in patients who had

large ®stulae secondary to obstructed labour, requiring

more extensive surgery and bladder mobilization [22].

However, it is important to document any instability

before undertaking the repair, to prevent later allegations

suggesting that the repair has caused the problem [21].

Clinicians involved in surgery at risk of producing

these ®stulae must maintain a high index of suspicion

and refer any patient with a ®stula to a specialist unit for

her repair.

Management

If VVF are noticed < 24 h after surgery there is a case for

immediate repair; most ®stulae are diagnosed later and

thus the initial treatment is conservative, as some small

®stulae will heal spontaneously [8,10,11]. The bladder is

kept empty with an indwelling urethral catheter on free

drainage for 4±6 weeks. A suprapubic catheter should be

used for low ®stulae around the bladder neck or trigone,

to prevent pressure on the repair. Antibiotics are given to

prevent infection further jeopardising the health of the

tissues and complicating the ®stula. Steroid creams have

been claimed to improve healing but there is insuf®cient

evidence for routine use [23]. If after this time the ®stula

appears to have closed a cystogram should be performed

before the catheter is removed.

Most patients will require surgery, although the timing

and type of repair is controversial. The traditional

approach to the treatment of VVF is to delay surgery to

allow the tissues to re-vascularize [7]. This view has been

challenged by recent studies which show that if the

®stula had been caused by iatrogenic injury there is no

bene®t to delaying surgery, as the tissues are not unduly

indurated. Results for immediate repair are comparable

with those from previous reports favouring delayed repair

[5,24,25]. Obviously the advantage of an early repair is

an immediate improvement in quality of life. However, in

trying to achieve this the ef®cacy of the repair must not

be compromised, as the best chance of success is with the

®rst repair [1].

The approach depends on the site of the ®stula and the

preference of the surgeon. Gynaecologists often favour a

vaginal approach, whereas urologists tend to prefer an

abdominal approach. A vaginal approach, although

suitable for most ®stulae, is not recommended for high

®stulae, those with extensive surrounding induration

and those with involvement of the ureteric ori®ces [6,26].

The repair is also in¯uenced by previous surgery and any

associated injury requiring simultaneous repair. For

example, if a coexisting ureteric injury is present, an

abdominal approach would be more appropriate [27].

The most important factor is that the repair is performed

by a specialist in a specialist centre with appropriately

trained staff.

Speci®c operative measures are wide mobilization of

the scar and bladder using sharp dissection, and

emptying the bladder and opening the peritoneum

superiorly by sharp dissection (blunt dissection or

stretching of the wound can lead to bladder damage,

particularly in the presence of adhesions) [10]. The

ureters are protected by the passage of ureteric stents.

The basic principles of ®stula repair apply. The ®stulous

tract is excised to healthy, well-vascularized tissue and

the repair should be tension-free and multilayered

using absorbable sutures [6,16]. Various techniques to

improve the viability of the tissue have been described,

interposing well-vascularized tissues between the blad-

der and vagina. Examples of these are the Martius ¯ap

using a ¯ap of labial ®brofatty tissue, and the omental

¯ap [16,28±33]. The role of prophylactic antibiotics is

unclear, with most surgeons using a single dose of a

broad-spectrum agent at the time of repair. Thrombo-

embolic precautions (subcutaneous heparin and

stockings) must be taken, as this is high-risk pelvic

surgery.

After surgery patients are left with a urethral and/or

suprapubic catheter in situ for 4±6 weeks to allow

adequate healing. Patients with a ®stula at the bladder

neck or trigone should not be left with a urethral catheter

because of the risk of pressure on the repair. Nursing care

during this period is extremely important. The catheter

must be secure and not allowed to kink; often this is

easiest to ensure by placing the patient on bed rest.

Obviously if bed rest is imposed, thrombo-embolic

precautions should be continued. Accurate ¯uid charts

are essential; input and output should be charted hourly

in the ®rst few days, with urine output maintained at

100 mL/h until the urine becomes clear. Staff must be

alert to any evidence of a urethral or vaginal leak

indicating that the catheter is being bypassed. If this

occurs the catheter should be gently ¯ushed with a small

volume of sterile saline. Only in rare cases and with

appropriate medical consultation is the catheter changed

[10]. Well-trained nurses and vigilant nursing care are so

crucial to the success of the repair that if there is under-

staf®ng or no trained staff available then this type of

surgery should not be attempted.

VESICOVAGINAL FISTULAE 355

# 2000 BJU International, 86, 354±359

At 10±14 days after surgery a cystogram is performed

to ensure that there is no leak before removing the

catheter. If there is a persistent leak the catheter is left on

free drainage for 6 weeks to encourage healing and the

cystogram repeated. After removing the catheter, the

bladder capacity will be reduced by prolonged drainage.

Patients are encouraged to void hourly to avoid over-

distension of the bladder and compromise of the repair.

They can aim to resume a normal voiding pattern by one

month. Tampons, douches and sexual intercourse are to

be avoided until the patients are followed up 3 months

later [10,11].

Speci®c complications after repair of a ®stula include

ureteric injury, especially if the ®stula is close to the

ureteric ori®ces. This can be minimized by placing

ureteric stents during surgery [5]. Patients may develop

stress incontinence, although the results of recent studies

using urodynamics suggest this may have been present

before the repair was undertaken [21]. Vaginal stenosis

resulting in dyspareunia is a recognized but uncommon

complication [22]. To avoid any medicolegal problems

the patients should be informed of these speci®c

complications when consent is obtained for the repair.

It must also be made clear to the patient before surgery

that even in a specialist centre these repairs can have a

10% failure rate. In the event of a failed repair further

surgery is possible but the chance of success is diminished

to 60% [3]. This must be discussed with the patient and

the discussion documented in the notes.

Prevention

Given the association of VVF with hysterectomy, certain

simple measures can be adopted to reduce the risks of the

procedure. A hysterectomy identi®ed as high risk should

be performed by an experienced surgeon. If a high-risk

procedure is scheduled, involvement of a urologist

beforehand will ensure that the necessary expertise is

available quickly if required during surgery [34].

Speci®c operative techniques to minimize the risks of

®stula formation should be taken during any hyster-

ectomy regardless of whether the case is perceived as

high or low risk [26]. In particular, sharp dissection to

mobilize the bladder away from the cervix is preferable to

the use of swabs to develop the plane, as this also

increases the risk of damage to the bladder [8,22]. Before

clamping the ureterosacral ligaments, mobilization of the

inferior and lateral aspects of the bladder must be

completed and the ligaments taken close to the uterus to

avoid accidental damage to the bladder [20].

Areas identi®ed by the Medical Defence Union as

important in medicolegal claims were communication,

consent and case notes [14]. It is important for all doctors

to communicate with their patients both before and after

surgery, as patients who feel adequately informed are less

likely to claim in the event of an injury. Consent should

be obtained by a doctor suf®ciently familiar with the

procedure to accurately describe its complications. A

record of the explanation given and complications should

be recorded in the case notes, in addition to a signed

consent form [14]. Good documentation helps to avoid

litigation and provides good defence in the event of a

claim. Detailed operative notes should be made by the

surgeon who performed the operation and not by his

assistant. Any deviation from normality should be noted

and the use of words such as `routine, uncomplicated,

uneventful and straightforward' avoided [35]. Inade-

quate case notes were cited as the cause for settlement in

several claims [14,15,36].

Obstetric ®stulae

Aetiology

Obstructed labour is uncommon in the developed world

and obstetric-related ®stulae are usually secondary to an

instrumental delivery or injury to the bladder during a

lower segment Caesarean section [37]. In the developing

world, especially Africa, the main cause of VVF is

pressure necrosis secondary to obstructed labour [1±4].

During labour the bladder is displaced upwards whilst the

anterior vaginal wall, bladder base and urethra are

compressed between the fetal head and the pubis. If this

stage is prolonged the resultant ischaemia can cause

devitalization of tissues, leading to the formation of VVF

[1,2]. Women are usually poorly educated and live far

from medical facilities, with many having their ®rst child

at a young age, often before the pelvis is fully developed

[12]. This can lead to women being in labour for days

before seeking medical help. The risk is compounded in

women who have been circumcised, as this causes a

reduction in the size of the introitus, leading to obstructed

labour [38].


The diagnosis of a ®stula is usually obvious as the patient

constantly leaks urine at about 10 days after injury. A

pelvic examination often reveals slough in the area

caused by extensive tissue loss [2,7]. In addition to the

investigations mentioned in the surgical section, IVU is

essential where the ureters may be damaged, e.g. after

Caesarean section.

Management

A ®stula caused during vaginal delivery can be treated

conservatively with a catheter initially, as a minority of

356 K. THOMAS and G. WILLIAMS


small ®stulae will heal this way [8,10,11]. Conservative

management is the same as described for surgical ®stulae,

with a catheter left on free drainage to allow the ®stula to

heal. Most ®stulae will require surgical repair. In these

®stulae this should be delayed for 3 months to allow the

tissues to re-vascularize. Obstetric ®stulae should be dealt

with in specialist centres, as even in experienced hands

the repairs have a 10% recurrence rate [1±7,12]. The

approach depends on the site of the ®stula and the

preference of the surgeon, as discussed for surgical

®stulae; the management during and after surgery is the

same, with nursing care being a critical factor in the

success of the repair.

Prevention

As well as taking precautions to prevent a ®stula it is

important to take measures to minimize the risk of

litigation if a ®stula is caused. The risk of ®stula formation

as a consequence of obstructed labour can be reduced by

appropriate training of staff, and following guidelines in

the management of the second stage of labour. Factors

such as congenital uterine abnormality, ®broids, primi-

gravida, scoliosis, small pelvis, large fetus and malposi-

tion are known to increase the risk of an obstructed

labour, and should be established during antenatal visits.

Appropriate precautions can then be taken, i.e. an

elective Caesarean section booked, or a trial of labour

closely monitored with staff available to proceed to

Caesarean section.

Forceps should only be used by a skilled operator who

understands the indications for using forceps [39]. If

junior staff are using forceps they must be trained when

to use them and how to apply them. Incorrect application

of forceps can cause lacerations to the anterior vaginal

wall extending into the bladder as a ®stula, as well as

causing fetal trauma. If forceps are considered during a

delivery it is important to document the indication and

preferably obtain written consent (although verbal

consent is adequate) [39]. After the procedure a

thorough description should be written in the notes

and any trauma, whether maternal or fetal, noted and

the patient informed.

If damage to the bladder is noticed during a Caesarean

section, senior advice should be sought and a urologist

contacted. If there is no urologist available the defect

should be closed with an absorbable suture in two or

three layers, a catheter inserted, left on free drainage and

a urology review obtained afterward. Obstetric trainees

should be aware of basic urological principles and be able

to perform a simple repair of a hole in the bladder if a

urologist is unavailable [40]. The injury must be

documented in the notes and a full explanation given

to the patient of the possible complications of a ®stula

[35].

From a medicolegal aspect the same principles of

thorough documentation, consent and communication

also apply to these ®stulae as to those of surgical

aetiology.

Radiotherapy

Aetiology

Whether used therapeutically or as an adjuvant, radio-

therapy increases the risk of VVF [9,10]. Before treatment

it decreases the vascularity of tissue, rendering it friable,

and impairs healing. Therapeutic radiotherapy causes

obliterative endoarteritis which progresses over years

and caused the late presentations of some ®stulae [10].

The presence of radiation damage also makes any

attempt to repair the ®stula less successful because of

poor healing.


It is important to be aware that these ®stulae can present

many years after radiotherapy [5,10]. Therefore, if a

patient with a past history of radiotherapy presents with

incontinence, a ®stula must be included in the differential

diagnosis. The principles of investigation are as discussed

earlier.

Management

These ®stulae are often complex and must be managed in

a specialist centre. An abdominal approach is preferable

as they are often high ®stulae. The use of an omental ¯ap

is essential as the tissues are often poorly vascularized

[30±33]. Patients must be made aware of the high risk of

failure caused by poor tissue healing and given the option

of urinary diversion [6].

Prevention

The risk of producing these ®stulae can be reduced by

limiting the ®eld of exposure and the dose of radiation

given. During consent for radiotherapy the patient must

be warned of the risk of a late-onset ®stula and the

subsequent surgery this would involve, with the

possibility of a urinary diversion. This explanation

must be documented in the notes. It is then for the

patient and the radiotherapist to weigh the bene®ts of

treatment against the long-term risks. As always, good

documentation, consent and communication are impor-

tant in preventing and managing medicolegal claims.



Discussion

The number of medicolegal claims continues to increase,

particularly within the ®eld of obstetrics and gynaecol-

ogy. This speciality accounts for 23.7% of the total claims

settled in hospital practice [14]. Individual payments are

increasing, with a total annual cost to the NHS estimated

at >£50 million. This has obvious implications for

budgets to clinical areas [41]. Doctors have a responsi-

bility to minimize the numbers of such claims and when

an injury occurs, to manage the patient's complaint in an

appropriate manner.

Injury to the genitourinary tract was found to be the

second major malpractice claim in gynaecology in a

study of 500 claims in Atlanta, with VVF ranking as the

second most common injury [15]. A worrying feature of

these claims was the failure by the surgeon to recognize

the signs and symptoms arising as a consequence of the

injury, with subsequent delays in treatment. Such errors

in management cause claims to be considered legally

indefensible and are therefore settled out of court. A

similar study in Britain by Lynch et al. [36] examined

500 medicolegal claims in obstetrics and gynaecology,

and found that 6% of claims in gynaecology were for

urinary tract injuries. The main causes for claims were

inexperienced surgeons and clumsy instrumentation. An

important point from both papers is the importance

of accurate documentation. Claims where notes are

missing or insuf®cient are extremely dif®cult to defend

[14,15,36]. In this review, we have attempted to address

these issues and give guidance about the medicolegal

aspects of VVF; by addressing these issues, doctors may

avoid many future claims.

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AuthorsK. Thomas, FRCS, Research Fellow.

G. Williams, MS, FRCS, Consultant Urologist.

Correspondence: Miss K. Thomas, Research Fellow, Royal

College of Surgeons of England, 35±43 Lincoln's Inn Fields,

London WC2A 3PN.



medicolegal aspects of vesicovaginal fistulae

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