Urethro-raphy

October 10, 2010

The New Operation For the Treatment of Stress Urinary Incontinence, (SUI), Detrusor Instability, (DI), and Mixed Type of Urinary Incontinence; Short and Long Term Results

Synopsis
Urethro-raphy is mending the torn wall of the internal urethral sphincter and closing the rupture that causes SUI, DI, and Mixed type of urinary incontinence. The sphincter, thus regains its integrity and strength to resist sudden increases of pressure.

Abstract:Introduction: Urethro-raphy, the new operation for surgical management of SUI, DI and Mixed Type of urinary incontinence has proved its efficacy after 5 years. SUI is due to a defective internal urethral sphincter, the defect is mostly due to traumatic rupture of its wall. The internal sphincter is a collagenous tissue cylinder that extends from the bladder neck to the perineal membrane. Urethro-raphy, is a simple vaginal operation, which depends on identifying the defect (rupture) in the wall of the sphincter, causing SUI, DI & mixed type of urinary incontinence and mending the torn wall by simple interrupted sutures, thus restoring the integrity, and strength of the sphincter to withstand sudden increases of pressure.

Aim of the study: Is to evaluate short and long term results of this new operation. The patients are to be seen and assessed after surgery and for up to five years following surgery. 

Study design: Urethro-raphy operation is to be done to cases with SUI, DI, and Mixed type of urinary incontinence; and incontinent patients who had undergone previous unsuccessful surgery for SUI. The cases were followed up for continence up to 5 years after the operation. 

Results: Urethro-raphy had been done for 450 patients; immediate success rate was 92%. During the follow up period, 2% more gained continence successfully. No post-operative troubles were recorded.

Conclusion: By repairing the torn posterior wall of the internal urethral sphincter by Urethro-raphy, the integrity and strength of the sphincter are restored, providing resistance to sudden increases of intra - abdominal pressure without relevant postoperative complications. 

Introduction
Stress Urinary Incontinence is involuntary escape of urine through the urethra with sudden increases of intra-abdominal pressure.

It had been subdivided into genuine stress urinary incontinence and detrusor instability. However most of the patients have a mixed type of stress urinary incontinence and urgency incontinence.1 In addition, genuine SUI is subdivided into urethral hyper mobility and intrinsic sphincter deficiency2. The pathogenesis of SUI is attributed to several factors mostly due to descent of the bladder neck and upper part of the urethra below the pelvic floor, loss of urethro-vesical angle, shortness of the urethra, and intrinsic sphincter deficiency.2,3,4

A new concept explaining the mechanism of micturition, urinary continence and the pathogenesis of SUI, DI, and Mixed-type of urinary incontinence was introduced in 1996.5,6,7,8, 9,10,11

The mechanism of micturition in human beings, as described in 1996, can be divided into two stages:5I Stage one: 
In infancy, micturition occurs spontaneously as a spinal cord reflex. As the urinary bladder fills, afferent impulses reach the spinal cord, and when it is full, efferent impulses, through the pelvic parasympathetic (S. 2, 3 & 4) stimulate detrusor muscle contraction thus emptying the bladder irrespective of time and place.

II Stage two:
In humans (this can also be applied to some domestic animals), the mother starts to teach her infant, at the age of 18-24 months, how to hold himself. This is achieved by gaining an acquired behavior, learning how to keep a high alpha sympathetic tone (T10-L2), at the internal urethral sphincter, thus keeping it closed all the time until micturition is desired. On desire to void and/or in need the person, first through the high centers, inhibits this acquired behavior of keeping high alpha sympathetic tone, thus allowing the internal sphincter to relax and open allowing voiding to occur.

Urinary continence depends on 2 main factors, one inherent and one acquired:

I. The inherent factor, is the presence of an intact and strong internal urethral sphincter. (figures 1, 2 & 3) The internal sphincter is composed of a cylinder of a compact sheet of collagenous and elastic tissues, extending down from the bladder neck to the perineal membrane. The collagenous tissue cylinder is lined by urothelium. The muscle fibers lie on and intermingle with the collagen fibers in the middle part of this compact collagenous tissue cylinder with the collagen and elastic fibers extending beyond the muscle layer. The muscle fibers are connected with the detrusor muscle above. The collagenous and elastic tissues give the internal sphincter its high wall tension and hence the high urethral closure pressure. The muscle fibers, controlled by alpha sympathetic activity (T10-L2) are responsible for opening and closing the urethra.

II. The acquired factor, is an acquired behavior gained by learning in early childhood how to keep a high alpha sympathetic tone at the internal urethral sphincter keeping it closed until micturition is needed. 

SUI, DI, and Mixed-type of urinary Incontinence are caused by weakness of the internal urethral sphincter. The weakness is mostly caused by traumatic rupture and/or split of the collagenous tissue cylinder, the essential constituent of the internal sphincter. The torn weak internal urethral sphincter will have a low urethral closing pressure on sudden forces that increase the intra-abdominal pressure resulting in leakage of urine. 

Other causes of weakness of the internal urethral sphincter include atrophy, and degeneration of the collagenous tissue caused by other factors, e.g., infection and/or estrogen deficiency.

The traumatic rupture may affect, mainly the upper part of the internal urethral sphincter, the lower part, or the whole length of the sphincter (Fig. 4-7). 

The rupture and its extent can be nicely demonstrated using trans-vaginal three dimensions ultrasound (3DUS). 3-D Ultrasonic examinations of patients with SUI reveal the rupture in the wall with irregular thickness, with areas of echolucency denoting defective wall. The urethral lumen is open and irregularly dilated due to weakness of the wall. 

The extent and the site of the damage in the internal sphincter wall will determine the type and degree of the urinary incontinence. When the rupture affects mainly the upper part of the internal urethral sphincter, this will lead to funnelling of the bladder neck with false impression of urethral hyper mobility and descent of the bladder neck below the pelvic floor. With sudden increases of intra-abdominal, intra-vesical pressures, urine is forced into the upper part of the urethra stimulating detrusor contractions and leads to detrusor instability alone or mixed type of urinary incontinence, DI+SUI. 

When the rupture affects mainly the lower part of the internal urethral sphincter, this will lead to "genuine stress urinary incontinence". In such condition the upper part of the sphincter is more intact and narrow, while the torn lower part is wide and dilated, appearing on 3DUS as a "flask shape”. 

If the whole length of the internal urethral sphincter is damaged this will lead to mixed type of urinary incontinence which is more prevalent. The urethra would appear irregular in shape, collapsed with apparent shortness. 

A new operation “urethro-raphy” was developed to treat SUI, DI, and mixed types of urinary incontinence. It is a simple vaginal operation, which depends on identifying the rupture in the wall of the internal urethral sphincter and mending the torn wall with simple interrupted sutures. Urethro-raphy is different from Kelly, Kelly-Kennedy plication operation in the pathogenesis of the condition, aim of the surgery and the technique of the operation. Stress urinary incontinence has been claimed to be caused by descent of the bladder neck below the pelvic floor, and also due to funnelling of the bladder neck with loss of the urethro-vesical angle. So, the aim of Kelly, Kelly-Kennedy plication operations is elevation of the bladder neck to a high retro-pubic position above the pelvic floor, and narrowing the funnelled bladder-neck by plication sutures. The objective of urethro-raphy is to reconstruct the torn wall by mending the torn edges, and thus restore a strong intact internal urethral sphincter which can resist sudden increases of intra-abdominal pressure.

Objectives
This paper reports and evaluates the results of the urethro-raphy operation in the treatment of SUI, DI, and mixed type of urinary incontinence soon after surgery and for up to five years of follow up.

Patients and Methods:

  • All patients in this study gave informed consent to the operation, and the study was approved by the local ethics committee.
  • Four hundreds and fifty (450) patients suffering from SUI, DI, and mixed- type of urinary incontinence were included in the study. 

Patients included in the study are:

  • Three hundreds patients with grade 2 and 3 SUI and mixed type of urinary incontinence who had no previous surgery.
  • Also one hundred and fifty patients, who had previous unsuccessful surgery for SUI e.g. Kelly, Burch, peri-urethral injections, sling operations.12,13,14,15,16 One hundred patients of them had unsuccessful Kelly, Kelly-Kennedy plication operation, 10-30 months ago. Thirty patients of the 150 patients, had Burch operation, 12-25 months ago, 16 patients had Sling operations, 12-24 months ago; four patients had peri-urethral injection, 10-18 months ago. 

Preoperative assessment:

  • All the 450 patients had been evaluated at the Urogynaecology clinic. Evaluation include special questionnaire that inquire about lower urinary tract function and its social impact. The questionnaire ends in identifying either stress urinary incontinence, detrusor instability or mixed type of incontinence. 
  • Frequency and nocturia were defined as voiding more than seven times during the day and more than once during night respectively.
  • Following recruitment, each patient was asked to keep a voiding diary to assess the severity of the leakage, and to monitor the results in the pre-operative and the post-operative follow up period.
  • Then, physical examination, measurement of any residual urine, urinalysis and tests for bacteriological culture and sensitivity were done.
  • Urodynamic studies, namely cystometry, leak-point pressure, urethral pressure profile, and stress cysto- urethral pressure profilometry were done before surgery and after surgery at the follow up periods. 
  • Three-Dimension Ultrasonic assessment of the internal urethral sphincter was done for each patient using trans-vaginal route by a vaginal probe multi-frequent 5-7.5 MHz, Kretz 530 machine. 
  • Urethro-raphy operation8 was done for each patient, (figures 8-10).

The Urethro-raphy operation had been explained to the patient and every patient gave a written consent before surgery. General or regional (spinal or epidural) anesthesia is used. The urethro-raphy operation entails dissecting the anterior vaginal wall separately from the posterior wall of the urethra, visualizing the rupture in the internal urethral sphincter and its extent. It is important to dissect the urethral wall clearly free from the vaginal wall and not to dissect through the urethral wall. When clearly dissected the urethral wall would be obvious with the rupture nicely demonstrated either affecting the whole length of the sphincter or part of it. The muscle fibers with its brownish color are seen through the rupture. The repair is done in the torn collagenous tissue cylinder. Mending the rupture with fine slowly absorbable suture material, this is achieved by putting ten or more interrupted stitches. Good "bite" of the torn edges of the collagenous tissue cylinder is taken and sutures are tied with enough strength to bring the torn edges together. No harm is done to the muscle fibers and no narrowing of the urethral lumen, as we do not put plicatory stitches, and so there are no voiding troubles after surgery (Fig. 8, 9 & 10). 

Postoperative care
The catheter and the vaginal pack were removed on the second postoperative day. Patients were allowed to void freely for one day and discharged with an outpatient appointment after 4 weeks, 6 months, 12 months and then every year for up to five years.

Post-operative follow up, the patient is assessed clinically, by 3DUS examination and by urodynamic studies. 

Postoperative evaluation includes:

  • Subjective assessment was done by recording symptoms, assessment of urinary incontinence, SUI, DI, or both, frequency, nocturia, and any voiding troubles. 
  • Subjective cure is defined as no urine loss on provocation. In addition, the patient should not have any voiding problems, e.g. urine retention, urge nor residual urine, more than 50 ml. 
  • Objective cure depends on clinical, urodynamic, and 3DUS assessment.
  • There should no demonstrable urine leakage on coughing, significant increase in urethral closure pressure and bladder capacity, no significant detrusor contractions during filling the bladder, an increase of the level of first sensation to void, correction of the transmission ratio to more than one, elevation of abdominal leak-point pressure and reduction of post voiding residual urine to less than 50ml. On 3DUS there should be disappearance of defects with the appearance of compact thick wall, the restoration of the urethro-vesical angles and correction of the apparent urethral collapse. 
  • Improvement is defined as marked reduction in the number of leakage episodes, more than 50% the number before the operation, also not having voiding problems. There should significant improvement in the urodynamic and 3DUS parameters. Failure is defined as post operative leakage episode more than 50% the number before the operation. Urodynamic and 3DUS parameters are not improved significantly.
  • The statistical methods employed were X2 test, Z. test, paired sample "t" test and repeated measure analysis with its post Hoc test using Statistical Package for the Social Science (SPSS) version 10 with a level of significance of 5%.

Results
(Figures 11&12 and tables 1-5).

  • The mean age of the patients was 50.7years, S.D. 31.82 a range from 35 to 70 years.
  • The mean parity was 5.8, S.D. 6.08, a range from 3-10.The mean body weight is 77.50 Kg, S.D. 44.23, a range from 55 to 110 Kg. 
  • All patients needed pads, mean 7 pads per day, S.D. 2.29, a range from 4 to 11 pads per day. 
  • Assessment of the condition of each patient after surgery is done by the subjective, objective, urodynamic tests and the 3DUS assessment described before.
  • Using these subjective criteria, in addition to objective clinical signs, 3DUS, and urodynamic parameters; 414 patients, (92%), gained continence successfully. 
  • The success rate was more seen in patients who had no previous surgery. 288 out of 300 were continent (96%). While of the 150 patients who had previous surgery for SUI, 126 gained continence (84 %) 
  • There was improvement in 14 patients from the 450 patients a rate of (3.1%).
  • Failure was recorded in 22 women, 4.9%. Seven women of them had no previous surgery for urinary incontinence and 15 women had previous surgery.
  • During the follow up period which extended up to 5 years, 9 patients who, at first showed improvement became continent successfully about 3-6 months after operation, a rate of 2% of the total number of 450 patients. 
  • As seen in the tables, there has been high cure rate and improvement as proved by subjective and objective parameters. The urodynamic parameters improved significantly. This significant improvement persisted along the follow up periods.

Discussion
Stress urinary incontinence, detrusor instability, and mixed-type of urinary incontinence had been big problems to manage. So many different trials to understand the pathogenesis of the conditions, and many different operations are introduced to treat such ambiguous troublesome conditions.

We claim that urinary incontinence is due to a weak internal urethral sphincter.6 Weakness of the sphincter is due to a defect in the collagenous tissue cylinder, the essential constituent of the internal urethral sphincter and which is responsible for the high wall tension necessary to create the high urethral closure pressure. The most common cause of the defect is traumatic rupture, and/or split of the collagenous cylinder. Other causes include atrophy, and degeneration caused by other factors, e.g., infection and/or estrogen deficiency.

Weakness of the internal sphincter would reduce the wall tension and subsequently the urethral closure pressure, so that sudden increases of the intra-abdominal pressure would overcome the weak sphincter leading to leakage of urine. This leakage of urine will initiate a quick reactive sympathetic response that increases the internal sphincter tone preventing further leakage.6

Collagen is the most abundant protein in humans. Collagen sheets are usually found in bundles of fibers and provide strength to the tissues. Each fiber is made up of fibrils, chemically it has a high content of hydroxy-proline and hydroxy-lysine. Many different types of collagen are identified on the basis of their molecular structure.

Type I is the most abundant being found in the dermis, bone, dentin, tendons, fascia, sclera, and organ capsules.

Urethro-raphy,8 a new operation had been developed to treat SUI, DI and mixed type of urinary incontinence. It is a simple vaginal operation which depends on restoring the normal anatomy to allow the internal urethral sphincter to maintain urinary continence. 

It is worthwhile mentioning that Urethro-raphy is different from Kelly, Kelly- Kennedy plication operation in the pathogenesis of the incontinence, the aim of the procedure, the technique of the operation and the post-operative sequel. Kelly and Kelly-Kennedy plication operations aim at elevating the bladder neck to a high retro-pubic position; and narrowing the funnelled bladder neck by plication sutures. This is done by deeply infolding, plicating and suturing together the adjacent pelvic, sub-pubic and peri--urethral fasciae by several mattress sutures.13,14 On the other hand we claim that SUI, DI and mixed type of urinary incontinence are due to a weak torn internal urethral sphincter. The aim of Urethro-raphy operation is to restore a strong and sound internal urethral sphincter with compact, thick walls with high wall tension. This is achieved by identifying the rupture in the wall of the internal sphincter and mending it by approximating the torn edges together by simple sutures. The false impression of urethral hyper mobility and funnelling of the bladder neck is caused by the damaged torn weak wall of the upper part of the internal urethral sphincter. Also the false impression of shortness of the urethra is due to the collapse of the torn damaged whole length of the internal urethral sphincter. Reconstruction and repair of the torn wall will restore the normal shape and station of the bladder neck and urethra.

In some patients suffering from SUI, the urodynamic studies show high urethral closure pressure at rest. This can be present in cases where there is just splitting of the compact collagenous tissue cylinder, without any observable defective rupture in this compact layer, leaving the internal sphincter with high wall tension at rest. However, on stress the split weak wall yields leading to leakage of urine. This defect can be better assessed by 3DUS studies.

We evaluated our patients pre, and post operative by clinical assessment, by urodynamic studies, and by transvaginal 3DUS for up to 5 years. There are highly significant differences in the symptoms, signs, urodynamic, and 3DUS parameters as seen in the tables, 1-5. 

The immediate results are encouraging, and in the follow up period, further improvement occurred. This can be explained by later healing of the collagenous tissue cylinder in some patients. The healing of the repaired wall of the internal sphincter is affected by many factors, e.g. by the patient age, the tissues state, its vascular supply, any infection, and the trophic effects of estrogen. 

Slow, but complete healing of the internal sphincter may explain the late success, after initial improvement, in some cases.

Senility and hormone deficiency weakens the collagenous tissue, and this may explain the failure in some patients. In a trial to improve the results, we tried local application of estrogen but we are, still analyzing the results. Theoretically, local estrogen application will promote pelvic tissue healing, as pelvic tissues are hormone dependant, with minimal systemic effects. The dose and the duration of application have to be determined. 

Patients with SUI who had no previous surgery are expected to have a torn wall with no degeneration and no fibrosis and will benefit more from urethro-raphy. While those who had more extensive wall damage and defects may do better with collagen injection.16

Urethro-raphy is a simple effective vaginal operation that corrects and repairs the torn wall of the internal urethral sphincter, thus, it regains its integrity and strength. This allows the internal sphincter to perform its physiological function in keeping urinary continence. 

Acknowledgement
The authors wish to thank very much professor I. Z. Mackenzie, reader in obstetrics and gynecology, Oxford University, U.K. for the kind help he offered in reviewing, and correcting the manuscript.

References:

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