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Pre-pubic TVT: an alternative to classic TVT in selected patients with urinary stress incontinence
European Journal of Obstetrics & Gynecology and Reproductive Biology 107 (2003) 205–207
Pre-pubic TVT: an alternative to classic TVT in selected patients with urinary stress incontinence N. Dahera,*, J.C. Boulangera, U. Ulmstenb a
Department of Obstetrics and Gynaecology, University of Amiens, 124 rue Camille Desmoulins, 80000 Amiens, France b Department of Obstetrics and Gynaecology, University of Uppsala, Uppsala, Sweden Received 21 January 2003; accepted 23 January 2003
Abstract Objectives: To evaluate in a prospective open study a pre-pubic route of TVT for surgical treatment of female stress incontinence. Study design: Consecutively, 74 patients were operated using a pre-pubic TVT tape application. All women were suffering subjectively and objectively from female stress urinary incontinence. The mean post-operative follow-up time was 5 months (range 2–10 months). The pre- and post-operative evaluations were performed according to a standard protocol. Results: According to the protocol, 60 patients (81%) were cured of their stress incontinence symptoms. Another 10 patients (13%) were improved. Four patients (6%) were considered failures. There were no significant intra- or post-operative complications. Conclusion: The short-term results of pre-pubic TVT are consonant with those of classic TVT. The risks of intra-operative complications should be reduced by the pre-pubic route. If the long-term results of pre-pubic TVT are the same as those after classic TVT, then this surgical approach may be a tentative alternative in selected high-risk patients. # 2003 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Female stress incontinence; Surgery; Pre-pubic TVT
1. Introduction
2. Materials and Methods
Tension-free vaginal tape (TVT) has within a few years become one of the most popular surgical procedures for treatment of female urinary stress incontinence. So far, approximately 300,000 operations have been carried out. Several reports have confirmed a high cure rate (85%) with low morbidity [1]. Even though TVT is claimed to be a safe and easy procedure, it is not without risks of complications. In particular, there is a risk during the blind passage of the needle behind the retropubic space that can perforate the bladder and, if the needle is introduced too laterally or cranially, vessels, nerves or bowels can be injured. At particular risk are patients who have been operated before in the lower pelvis with subsequent adhesions. To avoid these intra-operative complications, a pre-pubic TVT alternative has been developed and previously a small number of patients have been operated using this route in France and the Scandinavian countries (unpublished observations). To our knowledge, the present article is the first report on a large number of patients who have been operated with the new pre-pubic TVT technique.
2.1. Patients In all, 74 patients were consecutively operated using the pre-pubic TVT technique. All patients suffered from typical symptoms of stress urinary incontinence (SUI) grades II and III, according to the Ingelman-Sundbergs scale [2]. In 22 patients, there were also signs and symptoms of prolapse, necessitating surgical intervention. Before operation, all women had undergone extensive pre-operative evaluation including endoscopic and urodynamic assessment, stress test, pad test, gynaecologic examination and a quality of life evaluation according to previously described techniques [1]. Mean age was 58 years (range 34–79 years), mean parity 3 (1–8). Twenty-seven patients had been operated previously (one–three times) for incontinence. The mean follow-up time was 6 months (range 3–11 months). The post-operative evaluation was similar to that performed pre-operatively, including also a questionnaire evaluating possible sexual dysfunction.
* Corresponding author. Tel.: þ33-322-533600; fax: þ33-322-533690. E-mail address: [email protected] (N. Daher).
The surgical procedure was carried out under local anaesthesia in 4 patients, under spinal anaesthesia in 64 patients
2.2. Surgical procedure
0301-2115/03/$ – see front matter # 2003 Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S0301-2115(03)00051-4
206
N. Daher et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 107 (2003) 205–207
Fig. 1. Incision under the mid-urethra with minimal and lateral dissection in the deep perineal space to achieve preformed canals as far as the ischiopubic bone.
and under general anaesthesia in 6 patients. The anaesthetic techniques used were similar to those previously described when performing classic TVT [1,3]. The same instrument kit was used as in classic TVT, except that the handle was not used when the TVT needles were introduced. The operation begins with a small (1.5 cm long) sagittal incision under the mid-urethra (Fig. 1). This incision is made about 0.5–1 cm more proximal to the mid-urethra compared to when classic TVT is performed. As in classic TVT, minimal paraurethral dissections are performed using closed scissors. The aim is to enter the deep perineal space limited by the superior and inferior fascias of the urogenital diaphragm, then to penetrate the superficial perineal space arriving finally into the subvulvar space. Unlike classic TVT, the dissection to achieve the preformed canals for the TVT needles is directed more laterally or horizontally towards the mid-ischiopubic bone (Fig. 2). When the bone is reached, the TVT needle is introduced into the preformed canals. With the needle tip aiming laterally, the ischiocavernous muscle is perforated together with the superficial perineal fascia. This is done with the needle tip in close
Fig. 2. The needle reaches the bone in the preformed canal while the superficial perineal space is not yet touched (1). The needle tip is translated antero-laterally and kept in close contact with the bone when the ischiocavernous muscle is perforated (2).
Fig. 3. Just as the needle tip has passed the muscle (2), an angulated double movement (3 and 4) has to be achieved by an anterior directed pendular movement (3), continued by a pushing movement of the needle straight upward under vulvae (4).
contact with the pubic bone (Fig. 2). When the muscle has been perforated, the needle tip is angulated straight upwards and the needle is passed under the vulva to reach the small skin incision made near the superior part of the pubic bone in the mid between the genitoinguinal fold and the midline of the symphysis (see Fig. 3). The other needle is then introduced on the other side of the urethra. When both needles have reached the abdominal incisions, the ends of the tape are cut. To adjust the tension of the tape under the mid-urethra, the plastic sheet on only one side is removed from the tape. To facilitate that removal, it is important to separate the ends of the plastic sheets under the mid-urethra so that they do not overlap. Similar to classic TVT, one has to place a scissors or forceps between the urethra and the tape during this manoeuvre and simultaneously ensure a correct mid-urethral position of the tape, below the lower part of the pubic bone. When the plastic sheet has been removed on one side, the tape can be adjusted by pulling on the tape on the other side where the tape is still covered by the plastic sheet. It is important to understand that in pre-pubic TVT, it is not possible to adjust the tension of the tape under the mid-urethra in the same way as in classic TVT, since the pulling forces on the tape will act much more horizontally and frontally. Therefore, pulling on the tape during ‘‘fine-tuning’’ has to be stronger at pre-pubic TVT compared to classic TVT. Nevertheless, the final tension under mid-urethra should be the same. Cough tests are strongly recommended during ‘‘fine-tuning’’ of the tape. The adjustment of the tape is done at a bladder volume to 250–300 ml. Since the bladder cannot be perforated, cystoscopy is not necessary when performing pre-pubic TVT. When leakage has been minimised during the cough test, the remaining plastic sheet is removed and the tape ends are cut in the subcutaneous layer and the abdominal and vaginal incisions are closed. If the operation is not performed under local anaesthesia, an indwelling catheter is used post-operatively according to local recommendations. The post-opera-
N. Daher et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 107 (2003) 205–207
tive instructions to the patients are similar to those given after classic TVT.
3. Results The mean post-operative follow-up time was 5 months (range 2–10 months). According to the protocol, the postoperative evaluation showed that 60 patients (81%) were cured of stress incontinence. Another 10 patients (13%) were improved and there were 4 failures (6%). All failures occurred in the patients either operated under general anaesthesia or in whom a uretrocele was observed. In two of these four patients, a urethrocele was observed both pre- and postoperatively. Patients not cured by the procedure were incontinent directly after the procedure. No late recurrences (>2 months) were observed. Post-operative void residual urine of >100 ml was recognised in three patients. No de novo instability occurred. Significant (>200 ml) intra-operative bleeding did not occur. Eleven patients complained directly after the procedure that they had some pain or discomfort when sitting. This symptom abated within 7 days. In nine patients, some ecchymoses were noticed after the procedure. No symptoms of sexual dysfunction were reported after the procedure. In two patients, the vaginal wall was perforated when introducing the needle tip lateral to the pubic bone. This was discovered intra-operatively and the needles could be reinserted properly without any post-operative healing problems. The mean total operating time was 18 min (range 12– 26 min). Patients with TVT operations only were hospitalised for a mean of 2 days (range 1–5 days). Those who had TVT combined with prolapse surgery had to be hospitalised for a mean of 5 days (range 4–8 days).
207
route, there is not a blind passage of the needle and, in fact, it can be more or less seen or recognised during the procedure. In patients with ‘‘loose vaginal walls’’, perforations of the wall may occur as recognised in two of our patients. This complication is, however, easy to detect intra-operatively and can be easily readjusted. An important observation is the fact that in two out of four patients in whom the operation did not bring about continence, a urethrocele was observed both pre- and postoperatively. It may be that in these patients the urethra could not be kinked-off in situations liable to cause stress incontinence. In this context, it is also important to make sure that the tape is located at the mid-urethra and not too distally when pre-pubic TVT operations are performed. Possibly, due to the lack of dynamic cough tests during ‘‘fine-tuning’’ of the tape, operations under general anaesthesia turned out to be less effective in our hands. An interesting observation is the low frequency of postoperative urinary retention. This may be explained by the fact that the tension forces of the tape are directed more laterally or horizontally when pre-pubic TVT is performed compared to classic TVT. By the same token, it is necessary to use more power when adjusting the tape as indicated above. The value of cough tests should be emphasised. The short-term results of pre-pubic TVT in terms of cure of incontinence seem to be similar to classic TVT. More extensive long-term studies, however, have to be performed before definitive general recommendations can be given on whether and when to use pre-pubic TVT. However, in our opinion, the positive results from this study suggest that prepubic TVT may be considered a possible future alternative procedure to classic TVT in specific high-risk patients like those who have been operated before in the lower pelvis with subsequent adhesions and those who for some reasons constitute particular surgical risks, such as elderly frail patients.
4. Comments For obvious reasons, the pre-pubic route will avoid complications like injuries to bowels, nerves and vessels in the lower pelvis as well as bladder perforations. One risk with the pre-pubic route may be interference with the clitoral area and injuries to pre-pubic nerves and vessels (Fig. 3). These possible complications did not occur in our patients but still such complications have to be considered at pre-pubic TVT. Injuries may also occur if the needle is introduced too lateral to the inguinal area. However, compared to the retropubic
References [1] Tension-free vaginal tape—a minimally invasive surgical procedure for treatment of female urinary incontinence. Stuart Stenton (Ed.) Int Urogynecol J 2001;12(Suppl 2):1–29. [2] Ingelman-Sundberg A, Ulmsten U. Surgical treatment of female urinary stress incontinence. Contrib Gynecol Obstet 1983;10:51– 69. [3] Ulmsten U, Henriksson L, Johnson P, et al. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996;7:81–6.
Pre-pubic TVT: an alternative to classic TVT in selected patients with urinary stress incontinence N. Dahera,*, J.C. Boulangera, U. Ulmstenb a
Department of Obstetrics and Gynaecology, University of Amiens, 124 rue Camille Desmoulins, 80000 Amiens, France b Department of Obstetrics and Gynaecology, University of Uppsala, Uppsala, Sweden Received 21 January 2003; accepted 23 January 2003
Abstract Objectives: To evaluate in a prospective open study a pre-pubic route of TVT for surgical treatment of female stress incontinence. Study design: Consecutively, 74 patients were operated using a pre-pubic TVT tape application. All women were suffering subjectively and objectively from female stress urinary incontinence. The mean post-operative follow-up time was 5 months (range 2–10 months). The pre- and post-operative evaluations were performed according to a standard protocol. Results: According to the protocol, 60 patients (81%) were cured of their stress incontinence symptoms. Another 10 patients (13%) were improved. Four patients (6%) were considered failures. There were no significant intra- or post-operative complications. Conclusion: The short-term results of pre-pubic TVT are consonant with those of classic TVT. The risks of intra-operative complications should be reduced by the pre-pubic route. If the long-term results of pre-pubic TVT are the same as those after classic TVT, then this surgical approach may be a tentative alternative in selected high-risk patients. # 2003 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Female stress incontinence; Surgery; Pre-pubic TVT
1. Introduction
2. Materials and Methods
Tension-free vaginal tape (TVT) has within a few years become one of the most popular surgical procedures for treatment of female urinary stress incontinence. So far, approximately 300,000 operations have been carried out. Several reports have confirmed a high cure rate (85%) with low morbidity [1]. Even though TVT is claimed to be a safe and easy procedure, it is not without risks of complications. In particular, there is a risk during the blind passage of the needle behind the retropubic space that can perforate the bladder and, if the needle is introduced too laterally or cranially, vessels, nerves or bowels can be injured. At particular risk are patients who have been operated before in the lower pelvis with subsequent adhesions. To avoid these intra-operative complications, a pre-pubic TVT alternative has been developed and previously a small number of patients have been operated using this route in France and the Scandinavian countries (unpublished observations). To our knowledge, the present article is the first report on a large number of patients who have been operated with the new pre-pubic TVT technique.
2.1. Patients In all, 74 patients were consecutively operated using the pre-pubic TVT technique. All patients suffered from typical symptoms of stress urinary incontinence (SUI) grades II and III, according to the Ingelman-Sundbergs scale [2]. In 22 patients, there were also signs and symptoms of prolapse, necessitating surgical intervention. Before operation, all women had undergone extensive pre-operative evaluation including endoscopic and urodynamic assessment, stress test, pad test, gynaecologic examination and a quality of life evaluation according to previously described techniques [1]. Mean age was 58 years (range 34–79 years), mean parity 3 (1–8). Twenty-seven patients had been operated previously (one–three times) for incontinence. The mean follow-up time was 6 months (range 3–11 months). The post-operative evaluation was similar to that performed pre-operatively, including also a questionnaire evaluating possible sexual dysfunction.
* Corresponding author. Tel.: þ33-322-533600; fax: þ33-322-533690. E-mail address: [email protected] (N. Daher).
The surgical procedure was carried out under local anaesthesia in 4 patients, under spinal anaesthesia in 64 patients
2.2. Surgical procedure
0301-2115/03/$ – see front matter # 2003 Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S0301-2115(03)00051-4
206
N. Daher et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 107 (2003) 205–207
Fig. 1. Incision under the mid-urethra with minimal and lateral dissection in the deep perineal space to achieve preformed canals as far as the ischiopubic bone.
and under general anaesthesia in 6 patients. The anaesthetic techniques used were similar to those previously described when performing classic TVT [1,3]. The same instrument kit was used as in classic TVT, except that the handle was not used when the TVT needles were introduced. The operation begins with a small (1.5 cm long) sagittal incision under the mid-urethra (Fig. 1). This incision is made about 0.5–1 cm more proximal to the mid-urethra compared to when classic TVT is performed. As in classic TVT, minimal paraurethral dissections are performed using closed scissors. The aim is to enter the deep perineal space limited by the superior and inferior fascias of the urogenital diaphragm, then to penetrate the superficial perineal space arriving finally into the subvulvar space. Unlike classic TVT, the dissection to achieve the preformed canals for the TVT needles is directed more laterally or horizontally towards the mid-ischiopubic bone (Fig. 2). When the bone is reached, the TVT needle is introduced into the preformed canals. With the needle tip aiming laterally, the ischiocavernous muscle is perforated together with the superficial perineal fascia. This is done with the needle tip in close
Fig. 2. The needle reaches the bone in the preformed canal while the superficial perineal space is not yet touched (1). The needle tip is translated antero-laterally and kept in close contact with the bone when the ischiocavernous muscle is perforated (2).
Fig. 3. Just as the needle tip has passed the muscle (2), an angulated double movement (3 and 4) has to be achieved by an anterior directed pendular movement (3), continued by a pushing movement of the needle straight upward under vulvae (4).
contact with the pubic bone (Fig. 2). When the muscle has been perforated, the needle tip is angulated straight upwards and the needle is passed under the vulva to reach the small skin incision made near the superior part of the pubic bone in the mid between the genitoinguinal fold and the midline of the symphysis (see Fig. 3). The other needle is then introduced on the other side of the urethra. When both needles have reached the abdominal incisions, the ends of the tape are cut. To adjust the tension of the tape under the mid-urethra, the plastic sheet on only one side is removed from the tape. To facilitate that removal, it is important to separate the ends of the plastic sheets under the mid-urethra so that they do not overlap. Similar to classic TVT, one has to place a scissors or forceps between the urethra and the tape during this manoeuvre and simultaneously ensure a correct mid-urethral position of the tape, below the lower part of the pubic bone. When the plastic sheet has been removed on one side, the tape can be adjusted by pulling on the tape on the other side where the tape is still covered by the plastic sheet. It is important to understand that in pre-pubic TVT, it is not possible to adjust the tension of the tape under the mid-urethra in the same way as in classic TVT, since the pulling forces on the tape will act much more horizontally and frontally. Therefore, pulling on the tape during ‘‘fine-tuning’’ has to be stronger at pre-pubic TVT compared to classic TVT. Nevertheless, the final tension under mid-urethra should be the same. Cough tests are strongly recommended during ‘‘fine-tuning’’ of the tape. The adjustment of the tape is done at a bladder volume to 250–300 ml. Since the bladder cannot be perforated, cystoscopy is not necessary when performing pre-pubic TVT. When leakage has been minimised during the cough test, the remaining plastic sheet is removed and the tape ends are cut in the subcutaneous layer and the abdominal and vaginal incisions are closed. If the operation is not performed under local anaesthesia, an indwelling catheter is used post-operatively according to local recommendations. The post-opera-
N. Daher et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 107 (2003) 205–207
tive instructions to the patients are similar to those given after classic TVT.
3. Results The mean post-operative follow-up time was 5 months (range 2–10 months). According to the protocol, the postoperative evaluation showed that 60 patients (81%) were cured of stress incontinence. Another 10 patients (13%) were improved and there were 4 failures (6%). All failures occurred in the patients either operated under general anaesthesia or in whom a uretrocele was observed. In two of these four patients, a urethrocele was observed both pre- and postoperatively. Patients not cured by the procedure were incontinent directly after the procedure. No late recurrences (>2 months) were observed. Post-operative void residual urine of >100 ml was recognised in three patients. No de novo instability occurred. Significant (>200 ml) intra-operative bleeding did not occur. Eleven patients complained directly after the procedure that they had some pain or discomfort when sitting. This symptom abated within 7 days. In nine patients, some ecchymoses were noticed after the procedure. No symptoms of sexual dysfunction were reported after the procedure. In two patients, the vaginal wall was perforated when introducing the needle tip lateral to the pubic bone. This was discovered intra-operatively and the needles could be reinserted properly without any post-operative healing problems. The mean total operating time was 18 min (range 12– 26 min). Patients with TVT operations only were hospitalised for a mean of 2 days (range 1–5 days). Those who had TVT combined with prolapse surgery had to be hospitalised for a mean of 5 days (range 4–8 days).
207
route, there is not a blind passage of the needle and, in fact, it can be more or less seen or recognised during the procedure. In patients with ‘‘loose vaginal walls’’, perforations of the wall may occur as recognised in two of our patients. This complication is, however, easy to detect intra-operatively and can be easily readjusted. An important observation is the fact that in two out of four patients in whom the operation did not bring about continence, a urethrocele was observed both pre- and postoperatively. It may be that in these patients the urethra could not be kinked-off in situations liable to cause stress incontinence. In this context, it is also important to make sure that the tape is located at the mid-urethra and not too distally when pre-pubic TVT operations are performed. Possibly, due to the lack of dynamic cough tests during ‘‘fine-tuning’’ of the tape, operations under general anaesthesia turned out to be less effective in our hands. An interesting observation is the low frequency of postoperative urinary retention. This may be explained by the fact that the tension forces of the tape are directed more laterally or horizontally when pre-pubic TVT is performed compared to classic TVT. By the same token, it is necessary to use more power when adjusting the tape as indicated above. The value of cough tests should be emphasised. The short-term results of pre-pubic TVT in terms of cure of incontinence seem to be similar to classic TVT. More extensive long-term studies, however, have to be performed before definitive general recommendations can be given on whether and when to use pre-pubic TVT. However, in our opinion, the positive results from this study suggest that prepubic TVT may be considered a possible future alternative procedure to classic TVT in specific high-risk patients like those who have been operated before in the lower pelvis with subsequent adhesions and those who for some reasons constitute particular surgical risks, such as elderly frail patients.
4. Comments For obvious reasons, the pre-pubic route will avoid complications like injuries to bowels, nerves and vessels in the lower pelvis as well as bladder perforations. One risk with the pre-pubic route may be interference with the clitoral area and injuries to pre-pubic nerves and vessels (Fig. 3). These possible complications did not occur in our patients but still such complications have to be considered at pre-pubic TVT. Injuries may also occur if the needle is introduced too lateral to the inguinal area. However, compared to the retropubic
References [1] Tension-free vaginal tape—a minimally invasive surgical procedure for treatment of female urinary incontinence. Stuart Stenton (Ed.) Int Urogynecol J 2001;12(Suppl 2):1–29. [2] Ingelman-Sundberg A, Ulmsten U. Surgical treatment of female urinary stress incontinence. Contrib Gynecol Obstet 1983;10:51– 69. [3] Ulmsten U, Henriksson L, Johnson P, et al. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996;7:81–6.