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Female Stress Urinary Incontinence: Clinical Efficacy and Satisfaction After Transobturator Adjustable Tape Sling. An Observational Longitudinal Cohort Study Tito Silvio Patrelli, Salvatore Gizzo, Marco Noventa, Andrea Dall'Asta, Andrea Musarò, Raffaele Faioli, Giuliano Carlo Zanni, Giovanni Piantelli, Adolf Lukanovic, Alberto Bacchi Modena and Roberto Berretta SURG INNOV published online 29 May 2014 DOI: 10.1177/1553350614535855 The online version of this article can be found at: http://sri.sagepub.com/content/early/2014/05/29/1553350614535855
Published by: http://www.sagepublications.com
On behalf of:
Institute for Research into Cancer of the Digestive System
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>> OnlineFirst Version of Record - May 29, 2014 What is This?
Downloaded from sri.sagepub.com at TEXAS SOUTHERN UNIVERSITY on November 11, 2014
535855
research-article2014
SRIXXX10.1177/1553350614535855Surgical InnovationPatrelli et al
Article
Female Stress Urinary Incontinence: Clinical Efficacy and Satisfaction After Transobturator Adjustable Tape Sling. An Observational Longitudinal Cohort Study
Surgical Innovation 1–6 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350614535855 sri.sagepub.com
Tito Silvio Patrelli, PhD, MD1,2, Salvatore Gizzo, MD3, Marco Noventa, MD3, Andrea Dall’Asta, MD1, Andrea Musarò, MD1, Raffaele Faioli, MD1, Giuliano Carlo Zanni, MD2, Giovanni Piantelli, MD1, Adolf Lukanovic, MD4, Alberto Bacchi Modena, MD1, and Roberto Berretta, MD, PhD1
Abstract We performed an observational longitudinal cohort study on patients affected by stress urinary incontinence (SUI) and surgically treated with a transobturator adjustable tape sling (TOA) in order to evaluate this surgical procedure in terms of efficacy, safety, quality of life (QoL) improvement, and patient satisfaction. For all patients, we recorded: general features, preoperative SUI risk factors, obstetrics history, preoperative urodynamic tests, intraoperative/ postoperative complications, number of postoperative sling regulations, postmicturition residue, and hospital stay. All patients were asked to complete the validated short version of the Urogenital Distress Inventory (UDI-6) questionnaire 18 months after discharge to evaluate the efficacy of the TOA system. We added 2 adjunctive items to the UDI-6 in order to evaluate patient satisfaction and QoL. All 77 surgical procedures were performed under locoregional anesthesia without complications. Postoperative TOA regulations were performed in 46.8% of patients immediately after the procedure and in 14.3% during hospitalization. Before discharge, postmicturition residue was negative in 67 cases and less than 50 cc in 10 cases. Mean hospital stay was 2.18 days. From the questionnaire evaluation, we found that after the procedure, 90.9% of patients showed a complete regression of urinary symptoms, 1.3% obtained considerable relief from preoperative symptoms, and 6.6% reported poor or absent symptom improvements; 75.3% of patients were totally satisfied and 5.2% totally disappointed. The possibility of modulating postoperative sling tension and reusing the surgical materials in association with short hospitalization as well as high patient satisfaction render TOA a safe, effective, and low-cost technique for the treatment of female SUI. Keywords transobturator adjustable tape, stress urinary incontinence, quality of life, patient satisfaction, UDI-6 questionnaire.
Introduction Stress urinary incontinence (SUI) is defined as the involuntary leakage of urine on effort, exertion, or coughing.1,2 These symptoms have a negative impact on the quality of life (QoL), in terms of physical, psychological, and social well-being. Surgical approach seems to be the most suitable and effective treatment for symptom resolution.3 Petros and Ulmsten4 first proposed and developed intravaginal slingplasty (IVS) for the treatment of SUI: it consists of a surgical technique in which a synthetic mesh is inserted beneath the midurethra. Later, this technique was revised by Ulmsten et al5 who introduced the tension
free technique (TVT) that uses a polypropylene mesh, which differs from the previous one in that it does not require sutures at any anatomical region. 1
University of Parma, Parma, Italy Vicenza General Hospital, Vicenza, Italy 3 University of Padua, Padua, Italy 4 University of Ljubljana, Ljubljana, Slovenia 2
Corresponding Author: Salvatore Gizzo, Dipartimento della Salute della Donna e del Bambino, U. O. C. di Ginecologia e Ostetricia, Via Giustiniani 3, 35128 Padova, Italy. Email: [email protected]
Downloaded from sri.sagepub.com at TEXAS SOUTHERN UNIVERSITY on November 11, 2014
2
Surgical Innovation
In 2001, Delorme6 described an attempt to reduce the morbidity of the retropubic needle passage (as described in the TVT technique), using an alternative approach involving a transobturator tape (TOT). The TOT procedure became more popular because it significantly reduced the overall complications rate, particularly bladder and nerve injury.7 With the TOT procedure, however, it is difficult to apply the correct degree of tension during surgery. The transobturator adjustable tape (TOA), a recent version of the midurethral sling system, allows the surgeon to adjust the tension applied both during surgery and in the postoperative period.8 Because the data related to this procedure are still fragmentary in the current literature, the first aim of this study is to evaluate the efficacy and safety of the TOA sling in the surgical treatment of SUI. Additionally, the second aim of the study is to evaluate the QoL and patient satisfaction after SUI surgical treatment using the TOA sling.
Materials and Methods We performed an observational longitudinal cohort study on patients referred to the Gynecologic and Obstetric Clinic, Parma University, in the period between January 2008 and June 2011. Among all patients with SUI who underwent a surgical procedure, we recruited only women treated by the TOA technique. Patients with a concomitant uterine prolapse and/or cystocele were excluded. All the enrolled patients were properly informed about the aim of the study, and they consented (through a written consent form) to the use of data respecting their privacy (Italian law 675/96). After verbal consultation with the local ethical committee (Local Ethical Committee for Clinical Experimentation, Parma University, Parma, Italy), our study was defined as exempt by the institutional review board. Approval from the local institutional review board for health sciences was not required for observational studies because the clinical management and/or surgical approach were not modified by the investigators. All patient data were anonymized. For each patient, the following data were recorded: •• Age, height, body weight (kg), body mass index (BMI) •• Known SUI risk factors (constipation, diverticulosis, chronic obstructive pulmonary disease, chronic coughing, asthma, neurological disease) •• Parity, considering vaginal deliveries and cesarean deliveries only if performed during labor (elective cesarean section was excluded because of the absence of intrapartum perineal injuries) •• Hormonal status (considering both fertile and menopausal women)
•• •• •• •• ••
Preoperative urodynamic tests (when performed) Intraoperative and postoperative complications Number of effective sling regulations Postmicturition residue Hospital stay
All eligible patients underwent the preoperative evaluation consisting of an accurate medical history and a urogynecological physical examination. Urethral hypermobility was evaluated with the Q-tip test and transperineal ultrasound scan.9 Urinary incontinence was always clinically ascertained and also confirmed by a urodynamic test, when performed. For surgical treatment, we used TOA system slings (Agency for Medical Innovations, AMI, Austria). The system comprises sling-like implants (polypropylene mesh, adjustment threads, and detachable pull-in aid) and reusable tunnelers (reusable helicoidal stainless steel tunneler and paired instruments, specific to the left and right sides). The surgical procedure was performed as follows. The anterior vaginal wall was suspended with 2 Allis clamps on either side of the midline, proximally 0.5 cm to the urethral meatus. A vertical midline incision of the vaginal wall was performed. Using scissors, dissection of the paraurethral space was done bilaterally. The external tunneler entry point was made in the genitofemoral fold, and the helicoidal tunneler was introduced. Once the tunneler passed through the obturator membrane, it reached the fingertip inserted in the paraurethral space. The tape was then connected to the tunneler. Next, with a rotating wrist motion, the tape was guided through the tunnel and exited the skin incision. The same procedure was carried out on the contralateral side. Then, the 2 threads per side, located laterally at 1.5 cm from the mesh midline, were crossed and exteriorized through the anterior vaginal surface, whereas the 3 threads in each branch of the mesh were exteriorized through the cutaneous incisions. If necessary, in the postoperative period, the sling tension was regulated to obtain
Female Stress Urinary Incontinence: Clinical Efficacy and Satisfaction After Transobturator Adjustable Tape Sling. An Observational Longitudinal Cohort Study Tito Silvio Patrelli, Salvatore Gizzo, Marco Noventa, Andrea Dall'Asta, Andrea Musarò, Raffaele Faioli, Giuliano Carlo Zanni, Giovanni Piantelli, Adolf Lukanovic, Alberto Bacchi Modena and Roberto Berretta SURG INNOV published online 29 May 2014 DOI: 10.1177/1553350614535855 The online version of this article can be found at: http://sri.sagepub.com/content/early/2014/05/29/1553350614535855
Published by: http://www.sagepublications.com
On behalf of:
Institute for Research into Cancer of the Digestive System
Additional services and information for Surgical Innovation can be found at: Email Alerts: http://sri.sagepub.com/cgi/alerts Subscriptions: http://sri.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav
>> OnlineFirst Version of Record - May 29, 2014 What is This?
Downloaded from sri.sagepub.com at TEXAS SOUTHERN UNIVERSITY on November 11, 2014
535855
research-article2014
SRIXXX10.1177/1553350614535855Surgical InnovationPatrelli et al
Article
Female Stress Urinary Incontinence: Clinical Efficacy and Satisfaction After Transobturator Adjustable Tape Sling. An Observational Longitudinal Cohort Study
Surgical Innovation 1–6 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350614535855 sri.sagepub.com
Tito Silvio Patrelli, PhD, MD1,2, Salvatore Gizzo, MD3, Marco Noventa, MD3, Andrea Dall’Asta, MD1, Andrea Musarò, MD1, Raffaele Faioli, MD1, Giuliano Carlo Zanni, MD2, Giovanni Piantelli, MD1, Adolf Lukanovic, MD4, Alberto Bacchi Modena, MD1, and Roberto Berretta, MD, PhD1
Abstract We performed an observational longitudinal cohort study on patients affected by stress urinary incontinence (SUI) and surgically treated with a transobturator adjustable tape sling (TOA) in order to evaluate this surgical procedure in terms of efficacy, safety, quality of life (QoL) improvement, and patient satisfaction. For all patients, we recorded: general features, preoperative SUI risk factors, obstetrics history, preoperative urodynamic tests, intraoperative/ postoperative complications, number of postoperative sling regulations, postmicturition residue, and hospital stay. All patients were asked to complete the validated short version of the Urogenital Distress Inventory (UDI-6) questionnaire 18 months after discharge to evaluate the efficacy of the TOA system. We added 2 adjunctive items to the UDI-6 in order to evaluate patient satisfaction and QoL. All 77 surgical procedures were performed under locoregional anesthesia without complications. Postoperative TOA regulations were performed in 46.8% of patients immediately after the procedure and in 14.3% during hospitalization. Before discharge, postmicturition residue was negative in 67 cases and less than 50 cc in 10 cases. Mean hospital stay was 2.18 days. From the questionnaire evaluation, we found that after the procedure, 90.9% of patients showed a complete regression of urinary symptoms, 1.3% obtained considerable relief from preoperative symptoms, and 6.6% reported poor or absent symptom improvements; 75.3% of patients were totally satisfied and 5.2% totally disappointed. The possibility of modulating postoperative sling tension and reusing the surgical materials in association with short hospitalization as well as high patient satisfaction render TOA a safe, effective, and low-cost technique for the treatment of female SUI. Keywords transobturator adjustable tape, stress urinary incontinence, quality of life, patient satisfaction, UDI-6 questionnaire.
Introduction Stress urinary incontinence (SUI) is defined as the involuntary leakage of urine on effort, exertion, or coughing.1,2 These symptoms have a negative impact on the quality of life (QoL), in terms of physical, psychological, and social well-being. Surgical approach seems to be the most suitable and effective treatment for symptom resolution.3 Petros and Ulmsten4 first proposed and developed intravaginal slingplasty (IVS) for the treatment of SUI: it consists of a surgical technique in which a synthetic mesh is inserted beneath the midurethra. Later, this technique was revised by Ulmsten et al5 who introduced the tension
free technique (TVT) that uses a polypropylene mesh, which differs from the previous one in that it does not require sutures at any anatomical region. 1
University of Parma, Parma, Italy Vicenza General Hospital, Vicenza, Italy 3 University of Padua, Padua, Italy 4 University of Ljubljana, Ljubljana, Slovenia 2
Corresponding Author: Salvatore Gizzo, Dipartimento della Salute della Donna e del Bambino, U. O. C. di Ginecologia e Ostetricia, Via Giustiniani 3, 35128 Padova, Italy. Email: [email protected]
Downloaded from sri.sagepub.com at TEXAS SOUTHERN UNIVERSITY on November 11, 2014
2
Surgical Innovation
In 2001, Delorme6 described an attempt to reduce the morbidity of the retropubic needle passage (as described in the TVT technique), using an alternative approach involving a transobturator tape (TOT). The TOT procedure became more popular because it significantly reduced the overall complications rate, particularly bladder and nerve injury.7 With the TOT procedure, however, it is difficult to apply the correct degree of tension during surgery. The transobturator adjustable tape (TOA), a recent version of the midurethral sling system, allows the surgeon to adjust the tension applied both during surgery and in the postoperative period.8 Because the data related to this procedure are still fragmentary in the current literature, the first aim of this study is to evaluate the efficacy and safety of the TOA sling in the surgical treatment of SUI. Additionally, the second aim of the study is to evaluate the QoL and patient satisfaction after SUI surgical treatment using the TOA sling.
Materials and Methods We performed an observational longitudinal cohort study on patients referred to the Gynecologic and Obstetric Clinic, Parma University, in the period between January 2008 and June 2011. Among all patients with SUI who underwent a surgical procedure, we recruited only women treated by the TOA technique. Patients with a concomitant uterine prolapse and/or cystocele were excluded. All the enrolled patients were properly informed about the aim of the study, and they consented (through a written consent form) to the use of data respecting their privacy (Italian law 675/96). After verbal consultation with the local ethical committee (Local Ethical Committee for Clinical Experimentation, Parma University, Parma, Italy), our study was defined as exempt by the institutional review board. Approval from the local institutional review board for health sciences was not required for observational studies because the clinical management and/or surgical approach were not modified by the investigators. All patient data were anonymized. For each patient, the following data were recorded: •• Age, height, body weight (kg), body mass index (BMI) •• Known SUI risk factors (constipation, diverticulosis, chronic obstructive pulmonary disease, chronic coughing, asthma, neurological disease) •• Parity, considering vaginal deliveries and cesarean deliveries only if performed during labor (elective cesarean section was excluded because of the absence of intrapartum perineal injuries) •• Hormonal status (considering both fertile and menopausal women)
•• •• •• •• ••
Preoperative urodynamic tests (when performed) Intraoperative and postoperative complications Number of effective sling regulations Postmicturition residue Hospital stay
All eligible patients underwent the preoperative evaluation consisting of an accurate medical history and a urogynecological physical examination. Urethral hypermobility was evaluated with the Q-tip test and transperineal ultrasound scan.9 Urinary incontinence was always clinically ascertained and also confirmed by a urodynamic test, when performed. For surgical treatment, we used TOA system slings (Agency for Medical Innovations, AMI, Austria). The system comprises sling-like implants (polypropylene mesh, adjustment threads, and detachable pull-in aid) and reusable tunnelers (reusable helicoidal stainless steel tunneler and paired instruments, specific to the left and right sides). The surgical procedure was performed as follows. The anterior vaginal wall was suspended with 2 Allis clamps on either side of the midline, proximally 0.5 cm to the urethral meatus. A vertical midline incision of the vaginal wall was performed. Using scissors, dissection of the paraurethral space was done bilaterally. The external tunneler entry point was made in the genitofemoral fold, and the helicoidal tunneler was introduced. Once the tunneler passed through the obturator membrane, it reached the fingertip inserted in the paraurethral space. The tape was then connected to the tunneler. Next, with a rotating wrist motion, the tape was guided through the tunnel and exited the skin incision. The same procedure was carried out on the contralateral side. Then, the 2 threads per side, located laterally at 1.5 cm from the mesh midline, were crossed and exteriorized through the anterior vaginal surface, whereas the 3 threads in each branch of the mesh were exteriorized through the cutaneous incisions. If necessary, in the postoperative period, the sling tension was regulated to obtain
