Int Urogynecol J (2015) 26:1369–1372 DOI 10.1007/s00192-015-2718-5
ORIGINAL ARTICLE
Decreasing transobturator sling groin pain without decreasing efficacy using TVT-Abbrevo Jonathan S. Shaw 1 & Peter C. Jeppson 2 & Charles R. Rardin 1
Received: 29 January 2015 / Accepted: 15 April 2015 / Published online: 2 June 2015 # The International Urogynecological Association 2015
Abstract Introduction and hypothesis Groin pain following a transobturator (TO) midurethral sling is not uncommon and can be difficult to manage. We sought to determine if decreasing the mesh burden in the groin would decrease pain. The primary objective was to compare the incidence of post-operative groin pain following placement of full-length TVT-Obturator versus the shorter TVT-Abbrevo. Secondarily, we aimed to compare the efficacy between both devices 6 months after surgery. Methods This is a retrospective cohort study of all women who underwent a TO midurethral sling by the division of urogynecology at one institution between 1 January 2007 and 31 October 2013. Charts were reviewed and the incidence of postoperative groin pain in the two groups dichotomized as present or absent and compared using a Chi-squared test. Validated questionnaire scores of the groups were compared using t tests. Results There were 125 patients who received a TVTObturator and 100 patients who received a TVT-Abbrevo. No differences in demographic data were present between the groups. Twelve patients (9.6 %) in the TVT-Obturator group and 1 patient (1 %) in the TVT-Abbrevo group experienced bothersome groin pain (P value=0.007). The complete pre- and 6-month post-operative ISI, UDI-6 and PFIQ-7 scores were available for 76 (61 %), 47 (38 %), and 45 (36 %) patients following TVT-Obturator and 57 (57 %), 30 * Jonathan S. Shaw [email protected] 1
Division of Urogynecology, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital of Rhode Island, 659 Eddy Street, Lower Level, Suite 12, Providence, RI, USA
2
Division of Urogynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA
(30 %), and 28 (28 %) following TVT-Abbrevo treatment. At 6 months the mean improvement in questionnaire scores for the TVT-Obturator and TVT-Abbrevo groups were as follows: 5.0 and 5.1 for ISI (P value=0.9), 8.3 and 7.9 for UDI-6 (P value=0.8), and 4.8 and 6.1 for PFIQ-7 (P value=0.4). Conclusion Use of TVT-Abbrevo reduces post-operative groin pain compared with the full-length TVT-Obturator, without any reduction in efficacy. Keywords Transobturator sling . Groin pain
Introduction Groin pain following a transobturator (TO) midurethral sling is extremely frustrating to patients and difficult to treat. It may be found in 16 % of patients at 2 months and in 3 % at 1 year [1]. In a meta-analysis comparing TO and retropubic (RP) slings, a higher rate of groin pain was seen in the TO group with an odds ratio of 8.05 (3.78–17.16) [2]. While RP and TO slings appear to have equivalent efficacy in the absence of intrinsic sphincter deficiency, RP slings carry a higher risk of bladder perforation, voiding dysfunction, and hematoma formation [3–6]. Therefore, the TO approach remains an attractive option if groin pain can be avoided. Single-incision slings negate a groin incision but a recent Cochrane review found higher failure rates compared with full-length midurethral slings (MUS; 30 vs 11 %; RR 2.55, 95 % CI 1.93 to 3.36) [7]. The Gynecare TVT Abbrevo® Continence System (Ethicon, Somerville, NJ, USA), or “TVT-Abbrevo,” was developed with the goal of decreasing the amount of mesh in the adductor compartment while retaining a design similar to the original TO approach and aiming to achieve equivalent success [8]. The TVT-Abbrevo device is placed using an identical technique to the full-length Gynecare
1370
Int Urogynecol J (2015) 26:1369–1372
TVT™ Obturator System (Ethicon), or “TVT-Obturator,” but the mesh itself is only 12 cm long, with removable positioning lines on either side to enable placement. The primary objective of this study is to compare the incidence of post-operative groin pain following placement of a full-length TVT-Obturator versus the shorter TVT-Abbrevo. We hypothesized that a reduced amount of mesh would decrease post-operative groin pain. In light of the apparent high failure rates of singleincision slings, our secondary objective is to compare the efficacy of the two devices 6 months after surgery.
Materials and methods This is a retrospective cohort study of all women who underwent a TO midurethral sling by the division of urogynecology at one institution between 1 January 2007 and 31 Oct 2013. Surgeons in the study switched from the TVTObturator to the TVT-Abbrevo device exclusively in January 2011. Patients before this event serve as historical controls to which outcomes in subsequent patients may be compared. The surgical technique, patient positioning, and mesh tensioning were not altered. Patients with intrinsic sphincter deficiency (ISD; by maximal urethral closure pressure, MUCP, less than 30 or abdominal leak point pressure, ALPP, less than 60) were not considered candidates for TO slings. Patient charts were
identified by surgical device codes. Patients were routinely asked if they have any groin pain, or inner thigh pain at the follow-up visits. Charts were then reviewed for complaints of post-operative groin pain, interventions for groin pain, removal of mesh because of groin pain, exposure/erosion, and reoperation for exposure or recurrence of SUI at any stage of followup. Patient demographics were recorded, including age, race, parity, prior surgery for urinary stress incontinence or pelvic organ prolapse, concomitant prolapse surgery, and the current use of anti-cholinergic medications. The incidence of postoperative groin pain was dichotomized as present or absent and compared in the two groups using a Chi-squared test. Pre-operative and 6-month post-operative Incontinence Severity Index (ISI), Urodynamic Distress Inventory-6 (UDI-6), and Pelvic Floor Impact Questionnaire-7 (PFIQ-7) scores of the groups were compared using t tests. Demographic information was reported with descriptive statistics using a t test for continuous data and Chi-squared test for categorical data. Institutional Review Board approval was granted for this study.
Results There were 125 patients who received TVT-Obturator and 100 patients who received TVT-Abbrevo during the study period (Table 1). Twelve patients (9.6 %) in the TVT-Obturator group
Table 1 Patient demographics and baseline characteristics Total, n (row %) Mean age (range) Race, n (col %) White Hispanic Black Native American Unknown Median parity (range) Current tobacco use Current anticholinergic use Previous hysterectomy Previous incontinence surgery Previous prolapse surgery Concomitant surgery Pre-operative ALPP (mean cm H20, SD) Pre-operative MUCP (mean cm H20, SD) Intra-operative complications Reoperation Mesh excision for groin pain SUI recurrence Revision for erosion/retention
TVT-Obturator
TVT-Abbrevo
P value
125 (55.6) 54.1 (30–93)
100 (44.4) 56.5 (32–90)
– 0.2
100 (80.0) 17 (13.6) 3 (2.4) 1 (0.8) 4 (3.2) 2 (0–9) 19 (15.3) 22 (17.6) 41 (32.8) 7 (5.6)
89 (89.0) 8 (8.0) 1 (1.0) 1 (1.0) 1 (1.0) 2 (0–6) 7 (7.2) 14 (14.0) 32 (32.0) 6 (6.0)
0.4
0.7 0.09 0.6 1.0 1.0
9 (7.2) 57 (46 %) 120.0 (39.6) 77.4 (29.7) 1 (0.8)
6 (6.0) 49 (49 %) 132.4 (85.9) 64.3 (20.3) 0
0.8 0.7 0.3
ORIGINAL ARTICLE
Decreasing transobturator sling groin pain without decreasing efficacy using TVT-Abbrevo Jonathan S. Shaw 1 & Peter C. Jeppson 2 & Charles R. Rardin 1
Received: 29 January 2015 / Accepted: 15 April 2015 / Published online: 2 June 2015 # The International Urogynecological Association 2015
Abstract Introduction and hypothesis Groin pain following a transobturator (TO) midurethral sling is not uncommon and can be difficult to manage. We sought to determine if decreasing the mesh burden in the groin would decrease pain. The primary objective was to compare the incidence of post-operative groin pain following placement of full-length TVT-Obturator versus the shorter TVT-Abbrevo. Secondarily, we aimed to compare the efficacy between both devices 6 months after surgery. Methods This is a retrospective cohort study of all women who underwent a TO midurethral sling by the division of urogynecology at one institution between 1 January 2007 and 31 October 2013. Charts were reviewed and the incidence of postoperative groin pain in the two groups dichotomized as present or absent and compared using a Chi-squared test. Validated questionnaire scores of the groups were compared using t tests. Results There were 125 patients who received a TVTObturator and 100 patients who received a TVT-Abbrevo. No differences in demographic data were present between the groups. Twelve patients (9.6 %) in the TVT-Obturator group and 1 patient (1 %) in the TVT-Abbrevo group experienced bothersome groin pain (P value=0.007). The complete pre- and 6-month post-operative ISI, UDI-6 and PFIQ-7 scores were available for 76 (61 %), 47 (38 %), and 45 (36 %) patients following TVT-Obturator and 57 (57 %), 30 * Jonathan S. Shaw [email protected] 1
Division of Urogynecology, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital of Rhode Island, 659 Eddy Street, Lower Level, Suite 12, Providence, RI, USA
2
Division of Urogynecology, University of New Mexico Health Sciences Center, Albuquerque, NM, USA
(30 %), and 28 (28 %) following TVT-Abbrevo treatment. At 6 months the mean improvement in questionnaire scores for the TVT-Obturator and TVT-Abbrevo groups were as follows: 5.0 and 5.1 for ISI (P value=0.9), 8.3 and 7.9 for UDI-6 (P value=0.8), and 4.8 and 6.1 for PFIQ-7 (P value=0.4). Conclusion Use of TVT-Abbrevo reduces post-operative groin pain compared with the full-length TVT-Obturator, without any reduction in efficacy. Keywords Transobturator sling . Groin pain
Introduction Groin pain following a transobturator (TO) midurethral sling is extremely frustrating to patients and difficult to treat. It may be found in 16 % of patients at 2 months and in 3 % at 1 year [1]. In a meta-analysis comparing TO and retropubic (RP) slings, a higher rate of groin pain was seen in the TO group with an odds ratio of 8.05 (3.78–17.16) [2]. While RP and TO slings appear to have equivalent efficacy in the absence of intrinsic sphincter deficiency, RP slings carry a higher risk of bladder perforation, voiding dysfunction, and hematoma formation [3–6]. Therefore, the TO approach remains an attractive option if groin pain can be avoided. Single-incision slings negate a groin incision but a recent Cochrane review found higher failure rates compared with full-length midurethral slings (MUS; 30 vs 11 %; RR 2.55, 95 % CI 1.93 to 3.36) [7]. The Gynecare TVT Abbrevo® Continence System (Ethicon, Somerville, NJ, USA), or “TVT-Abbrevo,” was developed with the goal of decreasing the amount of mesh in the adductor compartment while retaining a design similar to the original TO approach and aiming to achieve equivalent success [8]. The TVT-Abbrevo device is placed using an identical technique to the full-length Gynecare
1370
Int Urogynecol J (2015) 26:1369–1372
TVT™ Obturator System (Ethicon), or “TVT-Obturator,” but the mesh itself is only 12 cm long, with removable positioning lines on either side to enable placement. The primary objective of this study is to compare the incidence of post-operative groin pain following placement of a full-length TVT-Obturator versus the shorter TVT-Abbrevo. We hypothesized that a reduced amount of mesh would decrease post-operative groin pain. In light of the apparent high failure rates of singleincision slings, our secondary objective is to compare the efficacy of the two devices 6 months after surgery.
Materials and methods This is a retrospective cohort study of all women who underwent a TO midurethral sling by the division of urogynecology at one institution between 1 January 2007 and 31 Oct 2013. Surgeons in the study switched from the TVTObturator to the TVT-Abbrevo device exclusively in January 2011. Patients before this event serve as historical controls to which outcomes in subsequent patients may be compared. The surgical technique, patient positioning, and mesh tensioning were not altered. Patients with intrinsic sphincter deficiency (ISD; by maximal urethral closure pressure, MUCP, less than 30 or abdominal leak point pressure, ALPP, less than 60) were not considered candidates for TO slings. Patient charts were
identified by surgical device codes. Patients were routinely asked if they have any groin pain, or inner thigh pain at the follow-up visits. Charts were then reviewed for complaints of post-operative groin pain, interventions for groin pain, removal of mesh because of groin pain, exposure/erosion, and reoperation for exposure or recurrence of SUI at any stage of followup. Patient demographics were recorded, including age, race, parity, prior surgery for urinary stress incontinence or pelvic organ prolapse, concomitant prolapse surgery, and the current use of anti-cholinergic medications. The incidence of postoperative groin pain was dichotomized as present or absent and compared in the two groups using a Chi-squared test. Pre-operative and 6-month post-operative Incontinence Severity Index (ISI), Urodynamic Distress Inventory-6 (UDI-6), and Pelvic Floor Impact Questionnaire-7 (PFIQ-7) scores of the groups were compared using t tests. Demographic information was reported with descriptive statistics using a t test for continuous data and Chi-squared test for categorical data. Institutional Review Board approval was granted for this study.
Results There were 125 patients who received TVT-Obturator and 100 patients who received TVT-Abbrevo during the study period (Table 1). Twelve patients (9.6 %) in the TVT-Obturator group
Table 1 Patient demographics and baseline characteristics Total, n (row %) Mean age (range) Race, n (col %) White Hispanic Black Native American Unknown Median parity (range) Current tobacco use Current anticholinergic use Previous hysterectomy Previous incontinence surgery Previous prolapse surgery Concomitant surgery Pre-operative ALPP (mean cm H20, SD) Pre-operative MUCP (mean cm H20, SD) Intra-operative complications Reoperation Mesh excision for groin pain SUI recurrence Revision for erosion/retention
TVT-Obturator
TVT-Abbrevo
P value
125 (55.6) 54.1 (30–93)
100 (44.4) 56.5 (32–90)
– 0.2
100 (80.0) 17 (13.6) 3 (2.4) 1 (0.8) 4 (3.2) 2 (0–9) 19 (15.3) 22 (17.6) 41 (32.8) 7 (5.6)
89 (89.0) 8 (8.0) 1 (1.0) 1 (1.0) 1 (1.0) 2 (0–6) 7 (7.2) 14 (14.0) 32 (32.0) 6 (6.0)
0.4
0.7 0.09 0.6 1.0 1.0
9 (7.2) 57 (46 %) 120.0 (39.6) 77.4 (29.7) 1 (0.8)
6 (6.0) 49 (49 %) 132.4 (85.9) 64.3 (20.3) 0
0.8 0.7 0.3
