Acta Obstet Gynecol Scand 1990; 69:359-360
SUMMARY OF DOCTORAL THESIS ELECTROSTIMULATION OF THE PELVIC FLOOR IN FEMALE URINARY INCONTINENCE Bjarne C. Eriksen Department of Gynecology and Obstetrics, University of Trondheim, Regional Hospital, Trondheim, Norway, 7989
PART I
PART I1
Surgical correction of urinary stress incontinence by the colposuspension procedure has a cure rate of about 70% at a 5-year follow-up. In addition, about 20% had improved significantly. The cure seems to be related to a lasting increase in the functional urethral length. The colposuspension procedure aggravates posterior vaginal wall weakness and predisposes to development of symptomatic enterocele in 7% of the patients. The long-term results d o not seem to be related to age, hormonal status or previous anterior vaginal repair. In patients with combined stress and motor urge incontinence preoperatively, the cure rate was reduced to 57% and only 29% of this subgroup were free from lower urinary tract symptoms 5 years after surgery. Conservative therapy is therefore to be recommended for patients with mixed incontinence before surgery is performed. In patients with genuine stress incontinence, 18% developed symptomatic detrusor instability following colposuspension. The incontinence problem may thus be exacerbated by surgery for stress incontinence. About 50% of the patients had some sort of lower urinary tract dysfunction at follow-up, and about 30% were in need of further incontinence therapy. These findings are probably due to the fact that a majority of patients with urodynamic abnormalities have a demonstrable neurogenic component which is not corrected by surgery. This work demonstrates the need for new therapeutic methods in female lower urinary tract dysfunction.
An integrated electronic plug device for long-term pelvic floor electrostimulation has been developed, and tested out in various kinds of female urinary incontinence. The plug device may be located anally or vaginally. It is automatically activated by the humid mucosa when the ring electrodes touch the wall of the vagina or the anal canal, and is automatically turned off when the electrodes are washed and dried. The current intensity reaches its maximum during the first minute of use, allowing the patient to adapt to the stimulation. In a study of 121 women with stress, motor urge and mixed urinary incontinence, continence was achieved in 64% of the patients with stress incontinence, in 65% of those with motor urge incontinence and in 53% of the patients with mixed stress and motor urge incontinence who had used the device regularly for at least 3 months. Continence was more difficult to achieve in patients who had undergone previous unsuccessful incontinence operations. The clinical results were verified by objective urodynamic measurements. In patients with detrusor instability, cystometry showed an increased bladder volume measured at first desire to void, increased maximum cystometric capacity, and less tendency to abortive detrusor contractions which appeared at larger bladder volumes with lower amplitude. In 45% of the patients with detrusor instability, a stable bladder with normal sensibility and capacity was found after therapy. In patients with stress incontinence, a significant increase was observed in functional urethral length. The slight increase in maximum urethral closure pressure after therapy was not significant. In patients reporting cure of stress inAcra Ohstet Gytiecol Scand 69 (1990)
360
B. C. Eriksen
continence, 94% had a positive urethral closure pressure during stress provocation after therapy. A prospective study was then performed in 55 women with stress urinary incontinence awaiting colposuspension. None of them had undergone previously surgical repair. In the complete study group, surgery was avoided in 56%. In patients who used the stimulation device regularly for at least 3 months, surgery could be avoided in 73%. A costbenefit analysis showed that the total cost of stress incontinence therapy could be reduced by 40%. Long-term stimulation is therefore recommended as primary therapy in urinary stress incontinence before surgical repair is performed. Long-term stimulation is also recommended in mixed stress and motor urge incontinence as the first choice of therapy whenever an insufficient urethral closure mechanism appears to be the main cause of incontinence. PART I11 Various types of lower urinary tract dysfunction may be treated successfully by maximal stimulation of the pelvic floor. An in-clinic device for maximal pelvic floor stimulation was developed, favoring patient security and technical quality. The maximal stimulator, MS-103, is technically reliable, safe for the patients and has been used successfully without any serious side effects in 48 women with idiopathic detrusor instability and urge incontinence; 85% were cured or much improved. A stable bladder was found in about 50% of the patients immediately after therapy and at the one-year follow-up. The urodynamic results were not correlated to the hormonal status of the patient. No serious side effects were observed in any patient who received an average of seven stimulation sessions (range 2-16) using low-frequent (5-10 Hz), intermittent stimulation (1.5 s on, 3 s off), and monophasic square pulses with a pulse width of 1 ms. The mean total current intensity varied from 43-162 mA o n both plugs simultaneously. Acute maximal pelvic floor stimulation is recommended as primary therapy in patients with idiopathic detrusor instability before pharmacotherapy is started. In mixed stress and motor urge inconti-
nence, a period of maximal stimulation may eliminate the component of urge incontinence before long-term electrostimulation is started and should therefore b e initiated parallel to the long-term stiniulation in these patients. It should not be applied in patients with on-demand pacemaker, or in pregnant women. Following maximal stimulation of the pelvic floor, there will be some recurrences, necessitating periods of repeated stimulation in some patients to keep them continent. A one-channel maximal stimulator for home treatment, MS-105, with a disposable or permanent, vaginal or anal electrode has recently been tested, and is now available in clinical practice. CONCLUSION The new stimulators for long-term and acute maximal electrical stimulation of the pelvic floor have made possible new and improved routines for incontinence therapy in women. Considering their low cost and lack of serious side effects, a trial of electrostimulation should be recommended as primary therapy in stress-, motor urge-, and mixed stress and motor urge incontinence in women. Further studies are necessary to evaluate the potential therapeutic effect of maximal stimulation in diurnal and nocturnal enuresis, urge incontinence at intercourse, sensory dysfunction of the urinary bladder (pain conditions), non-ulcerous interstitial cystitis, and in selected patients with neurogenic bladder and detrusor hyporeflexia. Due to the simplicity of this kind of therapy, information about both types of pelvic floor stimulation should be offered personnel in primary health care services. Electrostimulation therapy should b e tried before admitting the patient to expensive specialist care in hospitals. Doctors, nurses, physiotherapists and midwives can easily learn the methods, and may cure many patients with urinary incontinence at a lower cost for the community compared with surgery and pharmacotherapy. Bjarnc Chr. Eriksen Department of Obstetrics and Gynecology University of Trondheim N-7006 Trondheim Norway
SUMMARY OF DOCTORAL THESIS ELECTROSTIMULATION OF THE PELVIC FLOOR IN FEMALE URINARY INCONTINENCE Bjarne C. Eriksen Department of Gynecology and Obstetrics, University of Trondheim, Regional Hospital, Trondheim, Norway, 7989
PART I
PART I1
Surgical correction of urinary stress incontinence by the colposuspension procedure has a cure rate of about 70% at a 5-year follow-up. In addition, about 20% had improved significantly. The cure seems to be related to a lasting increase in the functional urethral length. The colposuspension procedure aggravates posterior vaginal wall weakness and predisposes to development of symptomatic enterocele in 7% of the patients. The long-term results d o not seem to be related to age, hormonal status or previous anterior vaginal repair. In patients with combined stress and motor urge incontinence preoperatively, the cure rate was reduced to 57% and only 29% of this subgroup were free from lower urinary tract symptoms 5 years after surgery. Conservative therapy is therefore to be recommended for patients with mixed incontinence before surgery is performed. In patients with genuine stress incontinence, 18% developed symptomatic detrusor instability following colposuspension. The incontinence problem may thus be exacerbated by surgery for stress incontinence. About 50% of the patients had some sort of lower urinary tract dysfunction at follow-up, and about 30% were in need of further incontinence therapy. These findings are probably due to the fact that a majority of patients with urodynamic abnormalities have a demonstrable neurogenic component which is not corrected by surgery. This work demonstrates the need for new therapeutic methods in female lower urinary tract dysfunction.
An integrated electronic plug device for long-term pelvic floor electrostimulation has been developed, and tested out in various kinds of female urinary incontinence. The plug device may be located anally or vaginally. It is automatically activated by the humid mucosa when the ring electrodes touch the wall of the vagina or the anal canal, and is automatically turned off when the electrodes are washed and dried. The current intensity reaches its maximum during the first minute of use, allowing the patient to adapt to the stimulation. In a study of 121 women with stress, motor urge and mixed urinary incontinence, continence was achieved in 64% of the patients with stress incontinence, in 65% of those with motor urge incontinence and in 53% of the patients with mixed stress and motor urge incontinence who had used the device regularly for at least 3 months. Continence was more difficult to achieve in patients who had undergone previous unsuccessful incontinence operations. The clinical results were verified by objective urodynamic measurements. In patients with detrusor instability, cystometry showed an increased bladder volume measured at first desire to void, increased maximum cystometric capacity, and less tendency to abortive detrusor contractions which appeared at larger bladder volumes with lower amplitude. In 45% of the patients with detrusor instability, a stable bladder with normal sensibility and capacity was found after therapy. In patients with stress incontinence, a significant increase was observed in functional urethral length. The slight increase in maximum urethral closure pressure after therapy was not significant. In patients reporting cure of stress inAcra Ohstet Gytiecol Scand 69 (1990)
360
B. C. Eriksen
continence, 94% had a positive urethral closure pressure during stress provocation after therapy. A prospective study was then performed in 55 women with stress urinary incontinence awaiting colposuspension. None of them had undergone previously surgical repair. In the complete study group, surgery was avoided in 56%. In patients who used the stimulation device regularly for at least 3 months, surgery could be avoided in 73%. A costbenefit analysis showed that the total cost of stress incontinence therapy could be reduced by 40%. Long-term stimulation is therefore recommended as primary therapy in urinary stress incontinence before surgical repair is performed. Long-term stimulation is also recommended in mixed stress and motor urge incontinence as the first choice of therapy whenever an insufficient urethral closure mechanism appears to be the main cause of incontinence. PART I11 Various types of lower urinary tract dysfunction may be treated successfully by maximal stimulation of the pelvic floor. An in-clinic device for maximal pelvic floor stimulation was developed, favoring patient security and technical quality. The maximal stimulator, MS-103, is technically reliable, safe for the patients and has been used successfully without any serious side effects in 48 women with idiopathic detrusor instability and urge incontinence; 85% were cured or much improved. A stable bladder was found in about 50% of the patients immediately after therapy and at the one-year follow-up. The urodynamic results were not correlated to the hormonal status of the patient. No serious side effects were observed in any patient who received an average of seven stimulation sessions (range 2-16) using low-frequent (5-10 Hz), intermittent stimulation (1.5 s on, 3 s off), and monophasic square pulses with a pulse width of 1 ms. The mean total current intensity varied from 43-162 mA o n both plugs simultaneously. Acute maximal pelvic floor stimulation is recommended as primary therapy in patients with idiopathic detrusor instability before pharmacotherapy is started. In mixed stress and motor urge inconti-
nence, a period of maximal stimulation may eliminate the component of urge incontinence before long-term electrostimulation is started and should therefore b e initiated parallel to the long-term stiniulation in these patients. It should not be applied in patients with on-demand pacemaker, or in pregnant women. Following maximal stimulation of the pelvic floor, there will be some recurrences, necessitating periods of repeated stimulation in some patients to keep them continent. A one-channel maximal stimulator for home treatment, MS-105, with a disposable or permanent, vaginal or anal electrode has recently been tested, and is now available in clinical practice. CONCLUSION The new stimulators for long-term and acute maximal electrical stimulation of the pelvic floor have made possible new and improved routines for incontinence therapy in women. Considering their low cost and lack of serious side effects, a trial of electrostimulation should be recommended as primary therapy in stress-, motor urge-, and mixed stress and motor urge incontinence in women. Further studies are necessary to evaluate the potential therapeutic effect of maximal stimulation in diurnal and nocturnal enuresis, urge incontinence at intercourse, sensory dysfunction of the urinary bladder (pain conditions), non-ulcerous interstitial cystitis, and in selected patients with neurogenic bladder and detrusor hyporeflexia. Due to the simplicity of this kind of therapy, information about both types of pelvic floor stimulation should be offered personnel in primary health care services. Electrostimulation therapy should b e tried before admitting the patient to expensive specialist care in hospitals. Doctors, nurses, physiotherapists and midwives can easily learn the methods, and may cure many patients with urinary incontinence at a lower cost for the community compared with surgery and pharmacotherapy. Bjarnc Chr. Eriksen Department of Obstetrics and Gynecology University of Trondheim N-7006 Trondheim Norway
