- Email: [email protected]
Evaluation of female urinary incontinence device
EVALUATION
OF FEMALE URINARY
INCONTINENCE
DEVICE
LINDA
M.B.,
STUART
D. CARDOZO, L. STANTON,
CH.B.
M.R.C.O.G.,
F.R.C.S.
From the Urodynamic Unit, Department of Obstetrics Gynecology, St. George’s Hospital, London, England
and
-A new silicone rubber injatable vaginal pessary has been evaluated in 33 patients with stress incontinence due to urethral sphincter dysfunction (genuine stress incontinence), confirmed by urodynamic assessment. Nine of 20 patients who used the device for one month showed subjective improvement and 2 patients have continued to use the device. Urodynamic changes include a marked increase in maximum urethral closure pressure and elevation of the bladder neck.
ABSTRACT
A mechanical device, designed by Bonnar in 1977,’ for the control of incontinence in women, has recently been marketed in England (Fig. 1). It is moulded in soft silicone rubber to fit the shape of the vagina, with the two horns seated in the lateral fomices on either side of the cervix. After insertion of the device, the balloon, which lies anteriorly, is inflated by means of a small, finger pump with a one-way nonreturn valve. The pump may then be removed leaving the device in situ. The other end of the pump is used to deflate the balloon prior to micturition or removal. Continence is produced by elevation of the bladder neck and compression of the urethra by the balloon, the volume being altered to suit the person’s requirements.
Material
and Methods
Thirty-three patients, whose age, parity, and number of previous vaginal operations are shown in Table I, attended the urodynamic unit with a primary complaint of stress incontinence. A full history was taken and a clinical examination performed. A midstream specimen of urine was taken for culture and sensitivity, and an independent peak flow rate was measured. Videocystourethrography with pressure and flow studies’ was performed, and a diagnosis of urethral sphincter dysfunction (genuine stress incontinence) was made if there was demonstrable stress incontinence in the absence of detrusor contractions, and with a detrusor pressure rise of less than 15 cm. of water during the provocative tests of fast bladder filling, coughing, passive posture change, catheter withdrawal, and coughing when erect. If stress incontinence was not demonstrated on videocystourethrography, a Urilos nappy test was performed.3 TABLE I.
FIGURE 1. and de&ted.
398
Bonnar incontinence device,
inflated
Clinical data
Data
Mean
Age (years)
48.5 2.6
Parity Previous vaginal operations
0.3
Standard Deviation 12.0 1.4 0.7
Range 30-79 O-6 o-3
UROLOGY / APRIL1979 / VOLUMEXIII, NUMBER4
While waiting to undergo surgery, those patients with objective evidence of stress incontinence due to urethral sphincter dysfunction attended the urodynamic unit for assessment of the incontinence device. Urethral closure pressure measurements were made using a microtip pressure transducer (Gaeltec). The probe was withdrawn and reintroduced into the urethra three times to ensure consistency of results. The first measurements were taken with the bladder empty. It was then filled with 300 ml. of 0.9 per cent saline at body temperature, and the urethral pressure measurements were repeated. The incontinence device was then introduced into the vagina and the urethral pressure measured before and after inflation. (Simultaneous intravesical pressure measurements were not made, but all the patients
had undergone videocystourethrography with provocative tests and had been shown to have stable bladders.) Twenty of the patients, all of whom were manually dextrous, were instructed in the use of the device. They were allowed to take it home and to use it daily (removing it at night) for one month, after which they returned to the urodynamic unit for review. This included questionnaires completed by the patient on the usefulness of the device, and by the doctor on any problems encountered. If the device had been useful, the patient was encouraged to keep it and was reviewed two months later. Ten of the patients with positive Urilos nappy tests had the tests repeated with the device in situ. Results
TABLE II. Changes in maximum urethral closure pressure (cm. water) Data
Mean
Standard Deviation
Range
Bladder empty Bladder full (300 ml. 0.9% saline) Device deflated Device inflated
55.6 58.7
17.4 17.3
29-93 26- 102
77.3 107.1
25.6 56.2
30- 155 45-320
Table II shows the changes in mean maximum urethral closure pressure before and after the device was inserted. The outcome of the home trial of the device is shown in Table III. The device was easy to insert in all but 2 of the patients, both of whom found the device uncomfortable to wear. One was a nulliparous woman with no previous surgery, and the other had undergone three anterior repairs. After one month none of the devices had broken and all the pumps still worked. There was no vaginal
TABLE III. Results of home trial of incontinence device Age (Years)
Parity
50 65 45 50 56 41 48 45 48 79 41 43 30 56 59 51 62 59 60 41
1 2 4 3 2 2 1 3 4 1 6 5 4 1 0 0 1 1 1 2
UROLOGY
Previous Vaginal Operations
Effect on Incontinence
Problems
1
Nil
0
0 0 0 0 0 0 t 01
Always “aware” of device Nuisance inflating/deflating Difficult to insert/remove Esthetic objections Made urgency worse Uncomfortable after 3 or 4 hours Backache
Helphrl
Some help
Device too small (fen out)
2 0 3 1 1 0
/ APRIL 1979 / VOLUME XIII. NUMBER4
No help Device too large (uncomfortable) I t
Device “distasteful” Nil
399
FIGURE 2. (A) Bladd er x-ray film of stress incontinent patient coughing; there is marked descent of bladder base, bladder neck is open, and urine has escaped into urethra. (B) Incontinence device in situ. (Balloon has been in&ted with 30 ml. of Hypaque.) Bladder neck has been elevated and is closed. (C) Device in situ. With patient bearing down and coughing, bladder neck remains closed.
excoriation, but one woman had an offensive vaginal discharge. Two of the patients chose to keep the device, one because she was unwilling to have further surgery, and the other because she was looking after an invalid relative whom she felt she could not leave for a hospital stay. Both said that the device completely cured their stress incontinence and could find no faults with it. Four other patients found that the device cured their incontinence but that it had various drawbacks. In the other 14 patients the problems encountered outweighed the usefulness of the device. All 10 patients in whom the Urilos nappy test was repeated with the device in situ (some of whom had previously lost up to 50 ml. of urine on coughing alone) proved to be completely dry in spite of vigorous exercises during the test. Comment Stress incontinence due to urethral sphincter dysfunction may be treated by surgery, drugs, or appliances. There are various surgical procedures which seek to elevate the bladder neck and render the urethral pressure higher than the intravesical pressure even in stressful situations. The results are good, suprapubic procedures producing a higher cure rate than vaginal repairs.4 However, there is a group of patients in whom surgery is inappropriate or has failed. Antispasmodic preparations and estrogens have been tried, and the latter have been shown to be beneficial in some postmenopausal women.5 The commonly used anticholinergic prepa-
400
rations are of more value in the management of incontinence due to detrusor instability. Various types of device have been invented to control incontinence. They are either electrical or mechanical. The former comprise anal plugs and vaginal pessaries which are thought to work by stimulating the striated portion of the urethral sphincter mechanism to contract. Up to 50 per cent of incontinent patients have had improvement with an anal pluga Vaginal pessaries come in different shapes: ring, Hodge, and the Vitalograph Continator which is cylindrical with a narrow middle, for better retention. The latter device has been found to be the most successful producing an improvement in 53 per cent of patients. ’ Pelvic floor stimulator implants have been tried, but are no longer commonly used since the long-term results have not proved satisfactory, and they produce morbidity due to infection and fibrosis and are prone to mechanical faults. Mechanical devices are thought to act by compression of the urethra and elevation of the bladder neck. Edwards and Malverr? found a 70 per cent improvement using a pubovaginal spring, with only one attendant complication a vaginal ulcer. g Crowley et al. lo claimed a 96 per cent improvement using a suction device, however most of the patients in whom it was tried had normal bladder function. Neither device appears to be in widespread use at present. The Bonnar device has been shown to produce continence by elevation of the bladder neck which is maintained during stressful actions (Fig. 2). It also produces a marked
UROLOGY
/
APRIL 1979
/
VOLUME
XIII,
NUMBER
4
increase in the maximum urethral closure pressure. In many cases the urethral pressure was sufficiently elevated by the device before inflation to produce continence; and when varying amounts of air (20 to 40 ml.) had been introduced into the balloon, the urethral closure pressure was increased in all cases. Objective evidence of continence was produced by the Urilos nappy test which was negative in all 10 patients. The advantages of this silicone vaginal incontinence device are that it is effective in producing continence, easy to use, free from complications, and moderately well tolerated. Its disadvantages are: (I) it is made in one size only; (2) it needs to be deflated and reinflated for micturition and removed regularly for cleaning; (3) it requires manual dexterity; (4) it is esthetically distasteful to some patients; and (5) it is unsuitable for patients in whom previous vaginal surgery had markedly altered vaginal shape or size. Conclusion This device has a place in the management of female urinary incontinence due to urethral sphincter dysfunction. It is likely to be of most use in those patients who are unfit for surgery (but still have good use of their hands), those who are unwilling to undergo an operative procedure, and as an immediate solution for those patients with severe stress incontinence who are
UROLOGY
/
APRIL 1979
/
VOLUME
XIII,
NUMBER
4
on a long waiting list for surgery. The device would have further potential if it were available in a range of sizes. London SW17 ORE, England (DR. CARDOZO) ACKNOWLEDGMENT. To Mrs. V. Allan, Miss L. Bickaroo, and Mrs. S. Mullings for help with this study. Eschmann Bros., West Sussex, England, provided the incontinence devices. References 1. Bonnar J: Silicone vaginal appliance for control of stress incontinence, Lancet 2: 8049, 1161(1977). 2. Bates CP, and Comey CE: Synchronous tine/pressure/flow cystography: a method of routine urodynamic investigations, Br. J. Radiol. 44: 44 (1971). 3. Stanton SL, and Ritchie D: Urilos: The practical detection of urine loss, Am. J. Obstet Gynecol. 128: 461 (1977). 4. Hodgkinson CP: Stress urinary incontinence, Am. J. Obstet. Gynecol. 108: 1141(1970). 5. Caine M, and Rax S: The role of female hormones in stress incontinence, Communications to the 16th Congress of the International Society of Urology, Amsterdam, 1973. 6. Hopkinson BR: Electrical treatment of incontinence using an external stimulator with intra anal electrodes, Ann. R. Coll. Surg. 50: 92 (1972). 7. Doyle PT, et al: Treatment of urinary incontinence by external stimulating devices, Urologe (Basel) 29: 450 (1974). 8. Edwards L, and Malvem J: Long-term follow-up results with the pubovaginal spring device in incontinence of urine in women: comparison with electronic methods of control, Br. J. Urol. 45: 193 (1973). 9. Edwards L: Control of incontinence of urine in women with a pubo-vaginal spring device: objective and subjective results, ibid. 43: 211 (1971). 10. Crowley I, Cardozo L, and Lawrence L: Female incontinence: a new approach, ibid. 43: 492 (1971).
401
OF FEMALE URINARY
INCONTINENCE
DEVICE
LINDA
M.B.,
STUART
D. CARDOZO, L. STANTON,
CH.B.
M.R.C.O.G.,
F.R.C.S.
From the Urodynamic Unit, Department of Obstetrics Gynecology, St. George’s Hospital, London, England
and
-A new silicone rubber injatable vaginal pessary has been evaluated in 33 patients with stress incontinence due to urethral sphincter dysfunction (genuine stress incontinence), confirmed by urodynamic assessment. Nine of 20 patients who used the device for one month showed subjective improvement and 2 patients have continued to use the device. Urodynamic changes include a marked increase in maximum urethral closure pressure and elevation of the bladder neck.
ABSTRACT
A mechanical device, designed by Bonnar in 1977,’ for the control of incontinence in women, has recently been marketed in England (Fig. 1). It is moulded in soft silicone rubber to fit the shape of the vagina, with the two horns seated in the lateral fomices on either side of the cervix. After insertion of the device, the balloon, which lies anteriorly, is inflated by means of a small, finger pump with a one-way nonreturn valve. The pump may then be removed leaving the device in situ. The other end of the pump is used to deflate the balloon prior to micturition or removal. Continence is produced by elevation of the bladder neck and compression of the urethra by the balloon, the volume being altered to suit the person’s requirements.
Material
and Methods
Thirty-three patients, whose age, parity, and number of previous vaginal operations are shown in Table I, attended the urodynamic unit with a primary complaint of stress incontinence. A full history was taken and a clinical examination performed. A midstream specimen of urine was taken for culture and sensitivity, and an independent peak flow rate was measured. Videocystourethrography with pressure and flow studies’ was performed, and a diagnosis of urethral sphincter dysfunction (genuine stress incontinence) was made if there was demonstrable stress incontinence in the absence of detrusor contractions, and with a detrusor pressure rise of less than 15 cm. of water during the provocative tests of fast bladder filling, coughing, passive posture change, catheter withdrawal, and coughing when erect. If stress incontinence was not demonstrated on videocystourethrography, a Urilos nappy test was performed.3 TABLE I.
FIGURE 1. and de&ted.
398
Bonnar incontinence device,
inflated
Clinical data
Data
Mean
Age (years)
48.5 2.6
Parity Previous vaginal operations
0.3
Standard Deviation 12.0 1.4 0.7
Range 30-79 O-6 o-3
UROLOGY / APRIL1979 / VOLUMEXIII, NUMBER4
While waiting to undergo surgery, those patients with objective evidence of stress incontinence due to urethral sphincter dysfunction attended the urodynamic unit for assessment of the incontinence device. Urethral closure pressure measurements were made using a microtip pressure transducer (Gaeltec). The probe was withdrawn and reintroduced into the urethra three times to ensure consistency of results. The first measurements were taken with the bladder empty. It was then filled with 300 ml. of 0.9 per cent saline at body temperature, and the urethral pressure measurements were repeated. The incontinence device was then introduced into the vagina and the urethral pressure measured before and after inflation. (Simultaneous intravesical pressure measurements were not made, but all the patients
had undergone videocystourethrography with provocative tests and had been shown to have stable bladders.) Twenty of the patients, all of whom were manually dextrous, were instructed in the use of the device. They were allowed to take it home and to use it daily (removing it at night) for one month, after which they returned to the urodynamic unit for review. This included questionnaires completed by the patient on the usefulness of the device, and by the doctor on any problems encountered. If the device had been useful, the patient was encouraged to keep it and was reviewed two months later. Ten of the patients with positive Urilos nappy tests had the tests repeated with the device in situ. Results
TABLE II. Changes in maximum urethral closure pressure (cm. water) Data
Mean
Standard Deviation
Range
Bladder empty Bladder full (300 ml. 0.9% saline) Device deflated Device inflated
55.6 58.7
17.4 17.3
29-93 26- 102
77.3 107.1
25.6 56.2
30- 155 45-320
Table II shows the changes in mean maximum urethral closure pressure before and after the device was inserted. The outcome of the home trial of the device is shown in Table III. The device was easy to insert in all but 2 of the patients, both of whom found the device uncomfortable to wear. One was a nulliparous woman with no previous surgery, and the other had undergone three anterior repairs. After one month none of the devices had broken and all the pumps still worked. There was no vaginal
TABLE III. Results of home trial of incontinence device Age (Years)
Parity
50 65 45 50 56 41 48 45 48 79 41 43 30 56 59 51 62 59 60 41
1 2 4 3 2 2 1 3 4 1 6 5 4 1 0 0 1 1 1 2
UROLOGY
Previous Vaginal Operations
Effect on Incontinence
Problems
1
Nil
0
0 0 0 0 0 0 t 01
Always “aware” of device Nuisance inflating/deflating Difficult to insert/remove Esthetic objections Made urgency worse Uncomfortable after 3 or 4 hours Backache
Helphrl
Some help
Device too small (fen out)
2 0 3 1 1 0
/ APRIL 1979 / VOLUME XIII. NUMBER4
No help Device too large (uncomfortable) I t
Device “distasteful” Nil
399
FIGURE 2. (A) Bladd er x-ray film of stress incontinent patient coughing; there is marked descent of bladder base, bladder neck is open, and urine has escaped into urethra. (B) Incontinence device in situ. (Balloon has been in&ted with 30 ml. of Hypaque.) Bladder neck has been elevated and is closed. (C) Device in situ. With patient bearing down and coughing, bladder neck remains closed.
excoriation, but one woman had an offensive vaginal discharge. Two of the patients chose to keep the device, one because she was unwilling to have further surgery, and the other because she was looking after an invalid relative whom she felt she could not leave for a hospital stay. Both said that the device completely cured their stress incontinence and could find no faults with it. Four other patients found that the device cured their incontinence but that it had various drawbacks. In the other 14 patients the problems encountered outweighed the usefulness of the device. All 10 patients in whom the Urilos nappy test was repeated with the device in situ (some of whom had previously lost up to 50 ml. of urine on coughing alone) proved to be completely dry in spite of vigorous exercises during the test. Comment Stress incontinence due to urethral sphincter dysfunction may be treated by surgery, drugs, or appliances. There are various surgical procedures which seek to elevate the bladder neck and render the urethral pressure higher than the intravesical pressure even in stressful situations. The results are good, suprapubic procedures producing a higher cure rate than vaginal repairs.4 However, there is a group of patients in whom surgery is inappropriate or has failed. Antispasmodic preparations and estrogens have been tried, and the latter have been shown to be beneficial in some postmenopausal women.5 The commonly used anticholinergic prepa-
400
rations are of more value in the management of incontinence due to detrusor instability. Various types of device have been invented to control incontinence. They are either electrical or mechanical. The former comprise anal plugs and vaginal pessaries which are thought to work by stimulating the striated portion of the urethral sphincter mechanism to contract. Up to 50 per cent of incontinent patients have had improvement with an anal pluga Vaginal pessaries come in different shapes: ring, Hodge, and the Vitalograph Continator which is cylindrical with a narrow middle, for better retention. The latter device has been found to be the most successful producing an improvement in 53 per cent of patients. ’ Pelvic floor stimulator implants have been tried, but are no longer commonly used since the long-term results have not proved satisfactory, and they produce morbidity due to infection and fibrosis and are prone to mechanical faults. Mechanical devices are thought to act by compression of the urethra and elevation of the bladder neck. Edwards and Malverr? found a 70 per cent improvement using a pubovaginal spring, with only one attendant complication a vaginal ulcer. g Crowley et al. lo claimed a 96 per cent improvement using a suction device, however most of the patients in whom it was tried had normal bladder function. Neither device appears to be in widespread use at present. The Bonnar device has been shown to produce continence by elevation of the bladder neck which is maintained during stressful actions (Fig. 2). It also produces a marked
UROLOGY
/
APRIL 1979
/
VOLUME
XIII,
NUMBER
4
increase in the maximum urethral closure pressure. In many cases the urethral pressure was sufficiently elevated by the device before inflation to produce continence; and when varying amounts of air (20 to 40 ml.) had been introduced into the balloon, the urethral closure pressure was increased in all cases. Objective evidence of continence was produced by the Urilos nappy test which was negative in all 10 patients. The advantages of this silicone vaginal incontinence device are that it is effective in producing continence, easy to use, free from complications, and moderately well tolerated. Its disadvantages are: (I) it is made in one size only; (2) it needs to be deflated and reinflated for micturition and removed regularly for cleaning; (3) it requires manual dexterity; (4) it is esthetically distasteful to some patients; and (5) it is unsuitable for patients in whom previous vaginal surgery had markedly altered vaginal shape or size. Conclusion This device has a place in the management of female urinary incontinence due to urethral sphincter dysfunction. It is likely to be of most use in those patients who are unfit for surgery (but still have good use of their hands), those who are unwilling to undergo an operative procedure, and as an immediate solution for those patients with severe stress incontinence who are
UROLOGY
/
APRIL 1979
/
VOLUME
XIII,
NUMBER
4
on a long waiting list for surgery. The device would have further potential if it were available in a range of sizes. London SW17 ORE, England (DR. CARDOZO) ACKNOWLEDGMENT. To Mrs. V. Allan, Miss L. Bickaroo, and Mrs. S. Mullings for help with this study. Eschmann Bros., West Sussex, England, provided the incontinence devices. References 1. Bonnar J: Silicone vaginal appliance for control of stress incontinence, Lancet 2: 8049, 1161(1977). 2. Bates CP, and Comey CE: Synchronous tine/pressure/flow cystography: a method of routine urodynamic investigations, Br. J. Radiol. 44: 44 (1971). 3. Stanton SL, and Ritchie D: Urilos: The practical detection of urine loss, Am. J. Obstet Gynecol. 128: 461 (1977). 4. Hodgkinson CP: Stress urinary incontinence, Am. J. Obstet. Gynecol. 108: 1141(1970). 5. Caine M, and Rax S: The role of female hormones in stress incontinence, Communications to the 16th Congress of the International Society of Urology, Amsterdam, 1973. 6. Hopkinson BR: Electrical treatment of incontinence using an external stimulator with intra anal electrodes, Ann. R. Coll. Surg. 50: 92 (1972). 7. Doyle PT, et al: Treatment of urinary incontinence by external stimulating devices, Urologe (Basel) 29: 450 (1974). 8. Edwards L, and Malvem J: Long-term follow-up results with the pubovaginal spring device in incontinence of urine in women: comparison with electronic methods of control, Br. J. Urol. 45: 193 (1973). 9. Edwards L: Control of incontinence of urine in women with a pubo-vaginal spring device: objective and subjective results, ibid. 43: 211 (1971). 10. Crowley I, Cardozo L, and Lawrence L: Female incontinence: a new approach, ibid. 43: 492 (1971).
401