- Email: [email protected]
Videothoracoscopic Sympathectomy Results after Oxybutynin Chloride Treatment Failure
Accepted Manuscript Videothoracoscopic Sympathectomy Results after Oxybutynin Chloride Treatment Failure Lucas Lembrança, Nelson Wolosker, José Ribas Milanez de Campos, Paulo Kauffman, Marcelo Passos Teivelis, Pedro Puech-Leão PII:
S0890-5096(16)31089-5
DOI:
10.1016/j.avsg.2017.01.018
Reference:
AVSG 3277
To appear in:
Annals of Vascular Surgery
Received Date: 24 October 2016 Accepted Date: 21 January 2017
Please cite this article as: Lembrança L, Wolosker N, de Campos JRM, Kauffman P, Teivelis MP, Puech-Leão P, Videothoracoscopic Sympathectomy Results after Oxybutynin Chloride Treatment Failure, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.01.018. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1
VIDEOTHORACOSCOPIC SYMPATHECTOMY RESULTS AFTER OXYBUTYNIN
2
CHLORIDE TREATMENT FAILURE.
3 Lucas Lembrança. Hospital Israelita Albert Einstein, São Paulo ([email protected])
5
Nelson Wolosker. Hospital Israelita Albert Einstein, São Paulo ([email protected])
6
José Ribas Milanez de Campos. University of São Paulo School of Medicine Hospital das
7
Clínicas, São Paulo. ([email protected])
8
Paulo Kauffman. University of São Paulo School of Medicine Hospital das Clínicas, São
9
Paulo. ([email protected])
SC
RI PT
4
Marcelo Passos Teivelis. Hospital Israelita Albert Einstein, São Paulo
11
([email protected])
12
Pedro Puech-Leão Department of Vascular Surgery, LIM 2, Faculdade de Medicina da
13
Universidade de São Paulo, Sao Paulo ([email protected])
M AN U
10
14 15
Original Article
16
Keywords: Hyperhidrosis; Thoracoscopy; VATS
18 19
TE D
17
Corresponding Author:
21
Lucas Lembrança Pinheiro
22
Email: [email protected]
23
Av Albert Einstein 627 - Bloco A1 - 4º andar - sala 423
24
Morumbi - São Paulo - SP – Brasil-CEP 05652-000
26 27 28 29
AC C
25
EP
20
ACCEPTED MANUSCRIPT 30
STRUCTURED ABSTRACT
31 INTRODUCTION: Videothoracoscopy sympathectomy (VATS) is the only definitive
33
treatment for primary hyperhidrosis (HH) . Since 2007, in our institution, patients with HH
34
were initially treated with oxybutynin chloride to avoid VATS and reduce compensatory
35
hyperhidrosis (CH) incidence with good results. The aim of this study was to analyze the
36
surgical response of patients suffering from essential hyperhidrosis after failure of oxybutynin
37
chloride treatment.
RI PT
32
SC
38
METHODS: This was an observational retrospective study that included 737 patients who
40
were diagnosed with palmar or axillary hyperhidrosis and received VATS from January of
41
2007 to January of 2014. Patients were selected for two different groups:
42
Oxybutynin Surgery group consisted of 167 patients that were initially treated with
43
oxybutynin chloride for 6 weeks and then received VATS after drug treatment failure. The
44
Primary Surgery group consisted of a historic control group of 570 patients who were referred
45
directly to surgical treatment. We evaluated the degree of improvement in symptoms thirty
46
days after surgery and Quality of Life before and after the surgical treatment
TE D
The Post-
EP
47
M AN U
39
RESULTS: All patients showed poor or very poor quality of life before surgery. The majority
49
of patients, showed a response between moderate and high after surgical treamente. However,
50
those in Primary surgery group responded better (95,1% vs 98,2%). In the quality of life after
51
surgery most of the patients reported improvement, and the primary surgery group had better
52
improvement. (92,2% vs 95,1%)
53
CONCLUSIONS: VATS showed good results in patients with palmar or axillary
54
hyperhidrosis regarding surgical response and improvement on quality of life even when the
55
previous oxybutynin chloride treatment failed.
56 57
AC C
48
ACCEPTED MANUSCRIPT 58
INTRODUCTION
59 60
Videothoracoscopy sympathectomy (VATS) is the only definitive treatment for primary
61
hyperhidrosis (HH) .
62
improvement of symptoms in the affected site. Nevertheless, its use is associated with the
63
potential development of compensatory hyperhidrosis, a condition characterized by increased
64
sweating in other areas which were previously asymptomatic(1).
65
RI PT
This technique demonstrates excellent results related to the
VATS was the mainstream treatment for HH. Nevertheless beginning 2007, patients with HH
67
were initially treated in our institution with oxybutynin chloride to avoid sympathectomy
68
and, therefore, reduce compensatory hyperhidrosis (CH) incidence (2). We verified that
69
nearly 70% of treated patients had good results in different sites: hands (3), armpits (4), face
70
(5), and feet(6), with an absence of compensatory hyperhidrosis in both short and long terms
71
(5,7). Subjects that did not improve (30%) received an indication for videothoracoscopy
72
sympathectomy. (8)
TE D
M AN U
SC
66
73
Nowadays, the majority of patients that in recent past were immediately operated, now have
75
their symptoms resolved with the use of oxybutynin chloride exclusively. Still, a portion of
76
these patients do not respond to drug treatment only and end up being referred to VATS. (9)
77
We do not know if these patients have the same positive results as those primarily referred to
78
surgery.
AC C
79
EP
74
80
The aim of this study was to analyze in a large series of patients (737) if a patient group
81
submitted to surgical treatment after failure of oxybutynin use had a different surgical
82
response than those primarily referred to surgery without previous use of oxybutynin.
83 84 85
ACCEPTED MANUSCRIPT PATIENTS AND METHODS
87
This was an observational retrospective study that included 737 patients who were diagnosed
88
with palmar or axillary hyperhidrosis and received VATS at Hospital das Clínicas da
89
Faculdade de Medicina da USP and Hospital Israelita Albert Einstein from January of 2007
90
to January of 2014. This study was approved by the ethics committee of each institution. We
91
stratified the sample by mean age, BMI, gender, quality of life before surgery and main
92
complaint site.
RI PT
86
93 Patients:
95
Patients were selected for two different groups: the Primary Surgery group consisted historic
96
control of 570 patients who were referred directly to surgical treatment in the first medical
97
consult; the Post-Oxybutynin Surgery group consisted of 167 patients that were initially
98
treated with oxybutynin chloride for 6 weeks and then received VATS after drug treatment
99
failure. Is this group the motivation for VATS were absence of response to the drug, presence
100
of collateral effects or the desire to stop the continuous use of medication. The patients didn’t
101
receive any kind of cosmetic treatment before the VATS or before the start of oxybutynin
102
chloride use. All of them were part of an initial study group of hyperhidrosis
103
treatment and share the same demographics characteristics. Furthermore, they were treated by
104
the same group of thoracic and vascular surgeons.
105
VATS was performed under general anesthesia in a semi-sitting position with selective
106
intubation and two incisions. After fourth chain ganglion identification, thermoablation was
107
performed (sympathectomy).
109 110 111 112 113
M AN U
TE D
EP
AC C
108
SC
94
ACCEPTED MANUSCRIPT Assessment of Surgical Success and quality of life.
115
Patients were submitted to two questionnaires that evaluated response to surgery and quality
116
of life.
117
1) Surgical treatment response: this questionnaire evaluated the degree of improvement in
118
symptoms thirty days after surgery. Responses were quantified from 0 (lack of improvement)
119
to 10 (complete improvement) and afterwards were stratified as either low (0-4), moderate (5-
120
7) or high (8-10): standardized responses as the previous studies using oxybutynin chloride
121
(5,7).
122
2) Quality of Life: this questionnaire evaluated the impact on quality of life for patients with
123
HH before surgical treatment and the degree of improvement after the surgery. It consisted of
124
20 questions divided into four domains (functional-social, personal, emotional and special
125
conditions) with five answer levels, where only one answer per question was allowed,
126
resulting in values from 20 to 100 points. A sum of higher than 84 was considered a very poor
127
quality of life; 68 to 83 poor; 52 to 67 good; 36 to 51, very good and 20 to 35, excellent (10).
128
When used post-operatively, 30 days after the procedure, this questionnaire evaluates the
129
quality of life improvement. where a sum higher than 84 was considered a much worse
130
quality of life after surgery; 68 to 83, slightly worse; 52 to 67, same quality; 36 to 51, slightly
131
better and 20 to 35, much better.
132
It was not mandatory to answer all the questions in this questionnaire, for example patients
133
who were not sexually active received a maximum score of 85, as 15 points were related to
134
sexual activity. We made a rule of three to correlate their score so that all scores were
135
comparable.
137 138 139 140 141
SC
M AN U
TE D
EP
AC C
136
RI PT
114
ACCEPTED MANUSCRIPT Statistical analysis:
143
Mean and standard deviation were used to describe continuous variables, while frequency
144
was used for categorical variables. A T-test was used in the analysis to compare continuous
145
variables and Pearson’s chi-squared test and Mann-Whitney test to compare two groups. A
146
95% confidence interval was used and a P value of < 0.05 was determined as statistically
147
significant.
RI PT
142
148 149 RESULTS:
SC
150 151
Demographic data of both groups is shown in Table 1. Palmar hyperhidrosis was the main
153
complaint site in both groups, present in 58.2 % of the sample. There was no statistically
154
significant difference in the following variables: age, BMI, gender, smoking, alcohol use, and
155
primary complaint site.
M AN U
152
TE D
156
Quality of life before the procedure is shown in Table 2. All patients showed poor or very
158
poor quality of life, with no difference between groups.
159
VATS response is shown in Table 3. We noticed that more than 95% of the patients,
160
regardless of the evaluated group, showed a response between moderate and high. However,
161
those in Primary surgery group responded better.
163 164
AC C
162
EP
157
165
A similar result was demonstrated in the quality of life of groups after treatment, where more
166
than 90% of the patients reported improvement, however those in the Primary Surgery group
167
responded better. Table 4.
168 169
ACCEPTED MANUSCRIPT 170
In a subgroup analysis, after stratifying by the gender, results were different from the
171
complete sample. In men, there was no difference between groups, both in surgical treatment
172
response (92,0 vs 91,7) and improvement in quality of life (86,7 vs 86,3) after surgery. Table
173
5.
175
RI PT
174 DISCUSSION:
176
VATS is considered the definitive treatment for HH with demonstrated positive results in the
178
reduction of local sweating in main complaint sites. However, it leads to CH in most patients,
179
and it can be intense in 1% of all cases, generating great clinical repercussions (11,12).
180
Severity of CH is influenced by several factors such as BMI (13) and the level and extension
181
of sympathetic chain resection. (14)
182
M AN U
SC
177
In 2007, in an effort to reduce the incidence and severity of CH, we started studies using
184
oxybutynin chloride for HH treatment. We observed that 60% to 70% of patients
185
demonstrated significant improvement and did not require surgical intervention (2,15,16).
186
Patients that did not improve with oxybutynin chloride or had to stop the medication for other
187
reasons received an indication for surgical treatment.
188
It is already proven that VATS yields positive responses during hyperhidrosis treatment (8)
189
(17). Until now, no studies have been performed to evaluate the effects of surgery on specific
190
patient groups that were previously treated with oxybutynin chloride and did not show
191
improvement.
EP
AC C
192
TE D
183
193
We evaluated a large series of patients (737 patients) at a long time frame, when most patients
194
were operated without previous treatment with oxybutynin chloride. For this reason, our
195
sample could be split into two groups in the same institution using the same protocol: first,
196
the ones treated according to the routine protocol at the time (without oxybutynin chloride),
197
and second, patients that were treated with oxybutynin chloride without show improvement
ACCEPTED MANUSCRIPT 198
from the drug. This explains the absence of difference between the two groups, as exposed in
199
demographic characteristics. And even without a gravity score we can presume that the
200
severity of the hyperhidrosis symptoms were the same for each group.
201 Currently, in our practice, patients are no longer operated on without previous use of
203
oxybutynin chloride. Because of this, it would be impossible to perform a prospective
204
analysis that involved patients referred directly to surgery.
205
RI PT
202
Most patients were in third decade of life, are thin (BMI 22.1) and are predominantly female,
207
similar to other studies (7,16,18). The technique used in this study was thermoablation of the
208
fourth thoracic ganglion, both for patients with palmar hyperhidrosis as well as axillary. We
209
chose this technique based on positive surgical results and lower levels of severe CH as
210
observed in previous studies(19).
211
M AN U
SC
206
More than 90% of the patients of both groups obtained a positive response to treatment.
213
However, in the Post Oxybutynin Surgery group, we observed lower results compared to the
214
Primary Surgery group (95% vs. 98%). Although there is a statistical difference, from a
215
clinical view, an improvement higher than 90% is determined to be an overall positive
216
response to treatment (8,17,20).
EP
AC C
217
TE D
212
218
The evaluation of quality of life has been shown to be the most reliable technique to assess
219
essential hyperhidrosis treatment (21). Hyperhidrosis is a disease that greatly affects the
220
completion of daily activities. Because of this, the evaluation of symptoms’ impact on day-to-
221
day life is as important as the evaluation of the degree of sweating(22). As such, standardized
222
questionnaires were implemented to evaluate patients on a day-to-day basis. In our group, we
223
used a protocol developed exclusively for HH, the Amir and Cols questionnaire translated to
224
Portuguese by Campos et al. (10,23) and we think that these kind of evaluation are better
225
correlate with the consequences of Essential Hyperhidrosis in the activities of theses patients.
ACCEPTED MANUSCRIPT 226 227
All patients from our study showed poor or very poor quality of life before VATS, in similar
228
proportions between groups. This is because only patients with a poor quality of life are
229
operated on. No provider will operate on patients with a good quality of life (17),(2).
RI PT
230 In this study we observed that there was improvement of HH symptoms and quality of life
232
after surgery in all subjects were excellent, above 90%, although improvements were slightly
233
worse in the Post Oxybutynin Surgery group (92,2% vs 95.1%).
SC
231
234
Regarding gender, when we selected only male patients the results were different in
236
comparison with total amount of cases. This differs from previous studies that have shown no
237
difference in results regarding gender (24).
M AN U
235
238
The main limitation of this study is the fact that it was retrospective, however all patients had
240
their data prospectively collected following institutional protocol, which allowed insignificant
241
data loss.
EP
242
TE D
239
Our group was the pioneer to develop a protocol using initial medical treatment for HH. The
244
protocol offers the possibility of improvement in sweating symptoms and subsequent quality
245
of life in 70% of patients (2) (3,7). However, patients that do not improve and are surgically
246
treated have very good results, but slightly worse than those referred directly to surgery. The
247
reason for this difference still unknown. It could be and psychological effect of a redo
248
treatment. We think that the patients who needed a second method of treatment are more
249
concerned with the hyperhidrosis. Nonetheless, even seeing these improvements patients must
250
be warned about the risks and the results of this study should be offered to them.
251
AC C
243
ACCEPTED MANUSCRIPT 252
This research did not receive any specific grant from funding agencies in the public,
253
commercial, or not-for-profit sectors .
254 255
RI PT
256 257 CONCLUSION
259
VATS showed good results in patients with palmar or axillary hyperhidrosis regarding
260
surgical response and improvement on quality of life even when the previous oxybutynin
261
chloride treatment failed.
M AN U
262 263 264
SC
258
REFERENCES
TE D
265 1.
Chwajol M, Barrenechea IJ, Chakraborty S, Lesser JB, Connery CP, Perin NI. Impact of compensatory hyperhidrosis on patient satisfaction after endoscopic thoracic sympathectomy. Neurosurgery. 2009 Mar;64(3):511–8–discussion518.
269 270 271
2.
Wolosker N, de Campos JR, Kauffman P, Neves S, Yazbek G, Jatene FB, et al. An alternative to treat palmar hyperhidrosis: use of oxybutynin. Clin Auton Res. 2011 Jun 19;21(6):389–93.
272 273 274
3.
Wolosker N, Teivelis MP, Krutman M, de Paula RP, de Campos JRM, Kauffman P, et al. Long-term results of oxybutynin treatment for palmar hyperhidrosis. Clin Auton Res. 2014 Nov 27;24(6):297–303.
275 276 277
4.
278 279 280
5.
Wolosker N, Teivelis MP, Krutman M, Campbell TPD de A, Kauffman P, Campos JR de, et al. Long-term results of oxybutynin use in treating facial hyperhidrosis. An bras dermatol. 2014;89(6):912–6.
281 282 283
6.
Wolosker N, de Campos JRM, Kauffman P, Yazbek G, Neves S, Puech-Leão P. Use of oxybutynin for treating plantar hyperhidrosis. International Journal of Dermatology. 2013 Apr 17;52(5):620–3.
284
7.
Wolosker N, Teivelis MP, Krutman M, de Paula RP, de Campos JRM, Kauffman P, et
AC C
EP
266 267 268
Wolosker N, Teivelis MP, Krutman M, de Paula RP, Kauffman P, de Campos JRM, et al. Long-term Results of the Use of Oxybutynin for the Treatment of Axillary Hyperhidrosis. Annals of Vascular Surgery. Elsevier Inc; 2014 Jul 1;28(5):1106–12.
ACCEPTED MANUSCRIPT 285 286
al. Long-term results of oxybutynin treatment for palmar hyperhidrosis. Clin Auton Res. 2014 Nov 27;24(6):297–303. 8.
Ibrahim M, Menna C, Andreetti C, Ciccone AM, D'Andrilli A, Maurizi G, et al. Bilateral Single-Port Sympathectomy: Long-Term Results and Quality of Life. BioMed Research International. 2013;2013(5, supplement):1–6.
290 291 292
9.
Hynes CF, Seevaratnam S, Gesuwan K, Margolis M, Marshall MB. The efficacy of oral anticholinergics for sympathetic overactivity in a thoracic surgery clinic. The Journal of Thoracic and Cardiovascular Surgery. Elsevier; 2016 Apr 14;152(2):565–8.
293 294 295
10.
de Campos JRM, Kauffman P, Werebe E de C, Andrade Filho LO, Kusniek S, Wolosker N, et al. Quality of life, before and after thoracic sympathectomy: report on 378 operated patients. Ann Thorac Surg. 2003 Sep;76(3):886–91.
296 297 298 299
11.
de Andrade Filho LO, Kuzniec S, Wolosker N, Yazbek G, Kauffman P, de Campos JRM. Technical Difficulties and Complications of Sympathectomy in the Treatment of Hyperhidrosis: An Analysis of 1731 Cases. Annals of Vascular Surgery. Elsevier Inc; 2013 Feb 9;:1–7.
300 301 302
12.
Lin TS, Fang HY. Transthoracic endoscopic sympathectomy in the treatment of palmar hyperhidrosis--with emphasis on perioperative management (1,360 case analyses). Surg Neurol. 1999 Nov;52(5):453–7.
303 304 305
13.
Ribas Milanez de Campos J, Wolosker N, Takeda FR, Kauffman P, Kuzniec S, Biscegli Jatene FB, et al. The body mass index and level of resection. Clin Auton Res. 2005 Apr;15(2):116–20.
306 307 308
14.
Yano M, Kiriyama M, Fukai I, Sasaki H, Kobayashi Y, Mizuno K, et al. Endoscopic thoracic sympathectomy for palmar hyperhidrosis: efficacy of T2 and T3 ganglion resection. Surgery. Elsevier; 2005 Jul;138(1):40–5.
309 310 311
15.
Wolosker N, de Campos JRM, Kauffman P, Puech-Leão P. A randomized placebocontrolled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis. YMVA. Elsevier Inc; 2012 Jun 1;55(6):1696–700.
312 313 314
16.
Schollhammer M, Brenaut E, Menard-Andivot N, Pillette-Delarue M, Zagnoli A, Chassain-Le Lay M, et al. Oxybutynin as a treatment for generalized hyperhidrosis: a randomized, placebo-controlled trial. Br J Dermatol. 2015 Oct 14;173(5):1163–8.
315 316 317 318
17.
Milanez de Campos JR, Kauffman P, de Campos Werebe E, Andrade Filho LO, Kusniek S, Wolosker N, et al. Quality of life, before and after thoracic sympathectomy: report on 378 operated patients. Ann Thorac Surg. Elsevier; 2003 Sep;76(3):886–91.
319 320 321
18.
Millán-Cayetano JF, del Boz J, Rivas-Ruiz F, Blázquez-Sánchez N, Hernández Ibáñez C, de Troya-Martín M. Oral oxybutynin for the treatment of hyperhidrosis: outcomes after one-year follow-up. Australas J Dermatol. 2016 Mar 30;:n/a–n/a.
322 323 324 325
19.
Wolosker N, Yazbek G, Ishy A, de Campos JRM, Kauffman P, Puech-Leão P. Is Sympathectomy at T4 Level Better Than at T3 Level for Treating Palmar Hyperhidrosis? Journal of Laparoendoscopic & Advanced Surgical Techniques. 2008 Feb;18(1):102–6.
326
20.
Neves S, Uchoa PC, Wolosker N, Munia MA, Kauffman P, de Campos JRM, et al.
AC C
EP
TE D
M AN U
SC
RI PT
287 288 289
ACCEPTED MANUSCRIPT 327 328 329
Long-Term Comparison of Video-Assisted Thoracic Sympathectomy and Clinical Observation for the Treatment of Palmar Hyperhidrosis in Children Younger Than 14. Pediatric Dermatology. 2012 Apr 4;29(5):575–9. 21.
Wolosker N, de Campos JRM, Kauffman P, de Oliveira LA, Munia MAS, Jatene FB. Evaluation of quality of life over time among 453 patients with hyperhidrosis submitted to endoscopic thoracic sympathectomy. YMVA. Elsevier Inc; 2012 Jan 1;55(1):154–6.
334 335 336
22.
Krogstad A-L, Skymne BSA, Göran Pegenius BS, Elam M, Wallin BG. Evaluation of objective methods to diagnose palmar hyperhidrosis and monitor effects of botulinum toxin treatment. Clin Neurophysiol. Elsevier; 2004 Aug;115(8):1909–16.
337 338 339
23.
de Campos JRM, Kauffman P, Werebe E de C, Andrade Filho LO, Kusniek S, PhD NWM, et al. Questionário de qualidade de vida em pacientes com hiperidrose primária. Jornal de Pneumologia. 2003 Aug 11;:1–4.
340 341 342
24.
Wolosker N, Munia MAS, Kauffman P, Campos JRM de, Yazbek G, Puech-Leão P. Is gender a predictive factor for satisfaction among patients undergoing sympathectomy to treat palmar hyperhidrosis? Clinics. 2010;65(6):1–4.
M AN U
SC
RI PT
330 331 332 333
343
AC C
EP
TE D
344
ACCEPTED MANUSCRIPT Table 1. Demographics data. Post-Oxybutynin Surgery N
Primary Surgery
%
N
%
p 0,200**
average (DP)
25,7 (6,6)
24,9 (8,1)
RI PT
Age (years)
0,070**
BMI (Kg/m2) average (DP)
22,1 (2,5)
21,7 (2,7)
0,166*
SC
Gender 43
26,7
183
32,4
Female
118
73,3
381
67,6
Smokers
M AN U
Male
Yes
5
3,0
31
5,4
No
159
97,0
538
94,6
Primary Complaint 91
54.5
338
59,3
76
45,5
232
40,7
TE D
Palmar Axilary
BMI: Body Mass Index ** Student T-Test
AC C
EP
*Qui-Square Test
0,210*
0,286*
ACCEPTED MANUSCRIPT
Primary
Surgery
Surgery
n
%
n
%
Excellent
0
0
0
0
Very Good
0
0
0
0
Good
0
0
0
0
Poor
40
24,2
132
25,2
Very Poor
125
75,8
369
74,8
AC C
EP
TE D
M AN U
Mann-Whitney Test p=0,206
SC
Post-Oxybutynin
RI PT
Table 2. Qualitfy of Life Before Surgery
ACCEPTED MANUSCRIPT
Post-Oxybutynin
Primary
Surgery
Surgery %
n
%
Low
8
4,9
10
1,8
Moderate
11
6,7
29
5,1
High
145
88,4
527
93,1
SC
n %a
RI PT
Table 3. Surgical treatment response
AC C
EP
TE D
M AN U
Mann-Whitney Test p=0,044
ACCEPTED MANUSCRIPT
Post-Oxybutynin
Primary
Surgery
Surgery
%
n
%
Excellent
126
75,4
473
83,0
Very Good
28
16,8
69
12,1
Good
7
4,2
22
3,9
Poor
5
3,0
4
0,7
Very Poor
1
0,6
2
0,4
AC C
EP
TE D
M AN U
Mann-Whitney Test p=0,025
SC
n
RI PT
Table 4. Improvement of Quality of Life After Surgery
ACCEPTED MANUSCRIPT
Post-Oxybutynin
Primary
Surgery
Surgery %
n
%
Low
1
2,4
4
2,2
Moderate
2
4,8
11
6,1
High
39
92,9
165
91,7
SC
n %a
RI PT
Table 5. Surgical treatment response in men
AC C
EP
TE D
M AN U
Mann-Whitney Test p=0,942
S0890-5096(16)31089-5
DOI:
10.1016/j.avsg.2017.01.018
Reference:
AVSG 3277
To appear in:
Annals of Vascular Surgery
Received Date: 24 October 2016 Accepted Date: 21 January 2017
Please cite this article as: Lembrança L, Wolosker N, de Campos JRM, Kauffman P, Teivelis MP, Puech-Leão P, Videothoracoscopic Sympathectomy Results after Oxybutynin Chloride Treatment Failure, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.01.018. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1
VIDEOTHORACOSCOPIC SYMPATHECTOMY RESULTS AFTER OXYBUTYNIN
2
CHLORIDE TREATMENT FAILURE.
3 Lucas Lembrança. Hospital Israelita Albert Einstein, São Paulo ([email protected])
5
Nelson Wolosker. Hospital Israelita Albert Einstein, São Paulo ([email protected])
6
José Ribas Milanez de Campos. University of São Paulo School of Medicine Hospital das
7
Clínicas, São Paulo. ([email protected])
8
Paulo Kauffman. University of São Paulo School of Medicine Hospital das Clínicas, São
9
Paulo. ([email protected])
SC
RI PT
4
Marcelo Passos Teivelis. Hospital Israelita Albert Einstein, São Paulo
11
([email protected])
12
Pedro Puech-Leão Department of Vascular Surgery, LIM 2, Faculdade de Medicina da
13
Universidade de São Paulo, Sao Paulo ([email protected])
M AN U
10
14 15
Original Article
16
Keywords: Hyperhidrosis; Thoracoscopy; VATS
18 19
TE D
17
Corresponding Author:
21
Lucas Lembrança Pinheiro
22
Email: [email protected]
23
Av Albert Einstein 627 - Bloco A1 - 4º andar - sala 423
24
Morumbi - São Paulo - SP – Brasil-CEP 05652-000
26 27 28 29
AC C
25
EP
20
ACCEPTED MANUSCRIPT 30
STRUCTURED ABSTRACT
31 INTRODUCTION: Videothoracoscopy sympathectomy (VATS) is the only definitive
33
treatment for primary hyperhidrosis (HH) . Since 2007, in our institution, patients with HH
34
were initially treated with oxybutynin chloride to avoid VATS and reduce compensatory
35
hyperhidrosis (CH) incidence with good results. The aim of this study was to analyze the
36
surgical response of patients suffering from essential hyperhidrosis after failure of oxybutynin
37
chloride treatment.
RI PT
32
SC
38
METHODS: This was an observational retrospective study that included 737 patients who
40
were diagnosed with palmar or axillary hyperhidrosis and received VATS from January of
41
2007 to January of 2014. Patients were selected for two different groups:
42
Oxybutynin Surgery group consisted of 167 patients that were initially treated with
43
oxybutynin chloride for 6 weeks and then received VATS after drug treatment failure. The
44
Primary Surgery group consisted of a historic control group of 570 patients who were referred
45
directly to surgical treatment. We evaluated the degree of improvement in symptoms thirty
46
days after surgery and Quality of Life before and after the surgical treatment
TE D
The Post-
EP
47
M AN U
39
RESULTS: All patients showed poor or very poor quality of life before surgery. The majority
49
of patients, showed a response between moderate and high after surgical treamente. However,
50
those in Primary surgery group responded better (95,1% vs 98,2%). In the quality of life after
51
surgery most of the patients reported improvement, and the primary surgery group had better
52
improvement. (92,2% vs 95,1%)
53
CONCLUSIONS: VATS showed good results in patients with palmar or axillary
54
hyperhidrosis regarding surgical response and improvement on quality of life even when the
55
previous oxybutynin chloride treatment failed.
56 57
AC C
48
ACCEPTED MANUSCRIPT 58
INTRODUCTION
59 60
Videothoracoscopy sympathectomy (VATS) is the only definitive treatment for primary
61
hyperhidrosis (HH) .
62
improvement of symptoms in the affected site. Nevertheless, its use is associated with the
63
potential development of compensatory hyperhidrosis, a condition characterized by increased
64
sweating in other areas which were previously asymptomatic(1).
65
RI PT
This technique demonstrates excellent results related to the
VATS was the mainstream treatment for HH. Nevertheless beginning 2007, patients with HH
67
were initially treated in our institution with oxybutynin chloride to avoid sympathectomy
68
and, therefore, reduce compensatory hyperhidrosis (CH) incidence (2). We verified that
69
nearly 70% of treated patients had good results in different sites: hands (3), armpits (4), face
70
(5), and feet(6), with an absence of compensatory hyperhidrosis in both short and long terms
71
(5,7). Subjects that did not improve (30%) received an indication for videothoracoscopy
72
sympathectomy. (8)
TE D
M AN U
SC
66
73
Nowadays, the majority of patients that in recent past were immediately operated, now have
75
their symptoms resolved with the use of oxybutynin chloride exclusively. Still, a portion of
76
these patients do not respond to drug treatment only and end up being referred to VATS. (9)
77
We do not know if these patients have the same positive results as those primarily referred to
78
surgery.
AC C
79
EP
74
80
The aim of this study was to analyze in a large series of patients (737) if a patient group
81
submitted to surgical treatment after failure of oxybutynin use had a different surgical
82
response than those primarily referred to surgery without previous use of oxybutynin.
83 84 85
ACCEPTED MANUSCRIPT PATIENTS AND METHODS
87
This was an observational retrospective study that included 737 patients who were diagnosed
88
with palmar or axillary hyperhidrosis and received VATS at Hospital das Clínicas da
89
Faculdade de Medicina da USP and Hospital Israelita Albert Einstein from January of 2007
90
to January of 2014. This study was approved by the ethics committee of each institution. We
91
stratified the sample by mean age, BMI, gender, quality of life before surgery and main
92
complaint site.
RI PT
86
93 Patients:
95
Patients were selected for two different groups: the Primary Surgery group consisted historic
96
control of 570 patients who were referred directly to surgical treatment in the first medical
97
consult; the Post-Oxybutynin Surgery group consisted of 167 patients that were initially
98
treated with oxybutynin chloride for 6 weeks and then received VATS after drug treatment
99
failure. Is this group the motivation for VATS were absence of response to the drug, presence
100
of collateral effects or the desire to stop the continuous use of medication. The patients didn’t
101
receive any kind of cosmetic treatment before the VATS or before the start of oxybutynin
102
chloride use. All of them were part of an initial study group of hyperhidrosis
103
treatment and share the same demographics characteristics. Furthermore, they were treated by
104
the same group of thoracic and vascular surgeons.
105
VATS was performed under general anesthesia in a semi-sitting position with selective
106
intubation and two incisions. After fourth chain ganglion identification, thermoablation was
107
performed (sympathectomy).
109 110 111 112 113
M AN U
TE D
EP
AC C
108
SC
94
ACCEPTED MANUSCRIPT Assessment of Surgical Success and quality of life.
115
Patients were submitted to two questionnaires that evaluated response to surgery and quality
116
of life.
117
1) Surgical treatment response: this questionnaire evaluated the degree of improvement in
118
symptoms thirty days after surgery. Responses were quantified from 0 (lack of improvement)
119
to 10 (complete improvement) and afterwards were stratified as either low (0-4), moderate (5-
120
7) or high (8-10): standardized responses as the previous studies using oxybutynin chloride
121
(5,7).
122
2) Quality of Life: this questionnaire evaluated the impact on quality of life for patients with
123
HH before surgical treatment and the degree of improvement after the surgery. It consisted of
124
20 questions divided into four domains (functional-social, personal, emotional and special
125
conditions) with five answer levels, where only one answer per question was allowed,
126
resulting in values from 20 to 100 points. A sum of higher than 84 was considered a very poor
127
quality of life; 68 to 83 poor; 52 to 67 good; 36 to 51, very good and 20 to 35, excellent (10).
128
When used post-operatively, 30 days after the procedure, this questionnaire evaluates the
129
quality of life improvement. where a sum higher than 84 was considered a much worse
130
quality of life after surgery; 68 to 83, slightly worse; 52 to 67, same quality; 36 to 51, slightly
131
better and 20 to 35, much better.
132
It was not mandatory to answer all the questions in this questionnaire, for example patients
133
who were not sexually active received a maximum score of 85, as 15 points were related to
134
sexual activity. We made a rule of three to correlate their score so that all scores were
135
comparable.
137 138 139 140 141
SC
M AN U
TE D
EP
AC C
136
RI PT
114
ACCEPTED MANUSCRIPT Statistical analysis:
143
Mean and standard deviation were used to describe continuous variables, while frequency
144
was used for categorical variables. A T-test was used in the analysis to compare continuous
145
variables and Pearson’s chi-squared test and Mann-Whitney test to compare two groups. A
146
95% confidence interval was used and a P value of < 0.05 was determined as statistically
147
significant.
RI PT
142
148 149 RESULTS:
SC
150 151
Demographic data of both groups is shown in Table 1. Palmar hyperhidrosis was the main
153
complaint site in both groups, present in 58.2 % of the sample. There was no statistically
154
significant difference in the following variables: age, BMI, gender, smoking, alcohol use, and
155
primary complaint site.
M AN U
152
TE D
156
Quality of life before the procedure is shown in Table 2. All patients showed poor or very
158
poor quality of life, with no difference between groups.
159
VATS response is shown in Table 3. We noticed that more than 95% of the patients,
160
regardless of the evaluated group, showed a response between moderate and high. However,
161
those in Primary surgery group responded better.
163 164
AC C
162
EP
157
165
A similar result was demonstrated in the quality of life of groups after treatment, where more
166
than 90% of the patients reported improvement, however those in the Primary Surgery group
167
responded better. Table 4.
168 169
ACCEPTED MANUSCRIPT 170
In a subgroup analysis, after stratifying by the gender, results were different from the
171
complete sample. In men, there was no difference between groups, both in surgical treatment
172
response (92,0 vs 91,7) and improvement in quality of life (86,7 vs 86,3) after surgery. Table
173
5.
175
RI PT
174 DISCUSSION:
176
VATS is considered the definitive treatment for HH with demonstrated positive results in the
178
reduction of local sweating in main complaint sites. However, it leads to CH in most patients,
179
and it can be intense in 1% of all cases, generating great clinical repercussions (11,12).
180
Severity of CH is influenced by several factors such as BMI (13) and the level and extension
181
of sympathetic chain resection. (14)
182
M AN U
SC
177
In 2007, in an effort to reduce the incidence and severity of CH, we started studies using
184
oxybutynin chloride for HH treatment. We observed that 60% to 70% of patients
185
demonstrated significant improvement and did not require surgical intervention (2,15,16).
186
Patients that did not improve with oxybutynin chloride or had to stop the medication for other
187
reasons received an indication for surgical treatment.
188
It is already proven that VATS yields positive responses during hyperhidrosis treatment (8)
189
(17). Until now, no studies have been performed to evaluate the effects of surgery on specific
190
patient groups that were previously treated with oxybutynin chloride and did not show
191
improvement.
EP
AC C
192
TE D
183
193
We evaluated a large series of patients (737 patients) at a long time frame, when most patients
194
were operated without previous treatment with oxybutynin chloride. For this reason, our
195
sample could be split into two groups in the same institution using the same protocol: first,
196
the ones treated according to the routine protocol at the time (without oxybutynin chloride),
197
and second, patients that were treated with oxybutynin chloride without show improvement
ACCEPTED MANUSCRIPT 198
from the drug. This explains the absence of difference between the two groups, as exposed in
199
demographic characteristics. And even without a gravity score we can presume that the
200
severity of the hyperhidrosis symptoms were the same for each group.
201 Currently, in our practice, patients are no longer operated on without previous use of
203
oxybutynin chloride. Because of this, it would be impossible to perform a prospective
204
analysis that involved patients referred directly to surgery.
205
RI PT
202
Most patients were in third decade of life, are thin (BMI 22.1) and are predominantly female,
207
similar to other studies (7,16,18). The technique used in this study was thermoablation of the
208
fourth thoracic ganglion, both for patients with palmar hyperhidrosis as well as axillary. We
209
chose this technique based on positive surgical results and lower levels of severe CH as
210
observed in previous studies(19).
211
M AN U
SC
206
More than 90% of the patients of both groups obtained a positive response to treatment.
213
However, in the Post Oxybutynin Surgery group, we observed lower results compared to the
214
Primary Surgery group (95% vs. 98%). Although there is a statistical difference, from a
215
clinical view, an improvement higher than 90% is determined to be an overall positive
216
response to treatment (8,17,20).
EP
AC C
217
TE D
212
218
The evaluation of quality of life has been shown to be the most reliable technique to assess
219
essential hyperhidrosis treatment (21). Hyperhidrosis is a disease that greatly affects the
220
completion of daily activities. Because of this, the evaluation of symptoms’ impact on day-to-
221
day life is as important as the evaluation of the degree of sweating(22). As such, standardized
222
questionnaires were implemented to evaluate patients on a day-to-day basis. In our group, we
223
used a protocol developed exclusively for HH, the Amir and Cols questionnaire translated to
224
Portuguese by Campos et al. (10,23) and we think that these kind of evaluation are better
225
correlate with the consequences of Essential Hyperhidrosis in the activities of theses patients.
ACCEPTED MANUSCRIPT 226 227
All patients from our study showed poor or very poor quality of life before VATS, in similar
228
proportions between groups. This is because only patients with a poor quality of life are
229
operated on. No provider will operate on patients with a good quality of life (17),(2).
RI PT
230 In this study we observed that there was improvement of HH symptoms and quality of life
232
after surgery in all subjects were excellent, above 90%, although improvements were slightly
233
worse in the Post Oxybutynin Surgery group (92,2% vs 95.1%).
SC
231
234
Regarding gender, when we selected only male patients the results were different in
236
comparison with total amount of cases. This differs from previous studies that have shown no
237
difference in results regarding gender (24).
M AN U
235
238
The main limitation of this study is the fact that it was retrospective, however all patients had
240
their data prospectively collected following institutional protocol, which allowed insignificant
241
data loss.
EP
242
TE D
239
Our group was the pioneer to develop a protocol using initial medical treatment for HH. The
244
protocol offers the possibility of improvement in sweating symptoms and subsequent quality
245
of life in 70% of patients (2) (3,7). However, patients that do not improve and are surgically
246
treated have very good results, but slightly worse than those referred directly to surgery. The
247
reason for this difference still unknown. It could be and psychological effect of a redo
248
treatment. We think that the patients who needed a second method of treatment are more
249
concerned with the hyperhidrosis. Nonetheless, even seeing these improvements patients must
250
be warned about the risks and the results of this study should be offered to them.
251
AC C
243
ACCEPTED MANUSCRIPT 252
This research did not receive any specific grant from funding agencies in the public,
253
commercial, or not-for-profit sectors .
254 255
RI PT
256 257 CONCLUSION
259
VATS showed good results in patients with palmar or axillary hyperhidrosis regarding
260
surgical response and improvement on quality of life even when the previous oxybutynin
261
chloride treatment failed.
M AN U
262 263 264
SC
258
REFERENCES
TE D
265 1.
Chwajol M, Barrenechea IJ, Chakraborty S, Lesser JB, Connery CP, Perin NI. Impact of compensatory hyperhidrosis on patient satisfaction after endoscopic thoracic sympathectomy. Neurosurgery. 2009 Mar;64(3):511–8–discussion518.
269 270 271
2.
Wolosker N, de Campos JR, Kauffman P, Neves S, Yazbek G, Jatene FB, et al. An alternative to treat palmar hyperhidrosis: use of oxybutynin. Clin Auton Res. 2011 Jun 19;21(6):389–93.
272 273 274
3.
Wolosker N, Teivelis MP, Krutman M, de Paula RP, de Campos JRM, Kauffman P, et al. Long-term results of oxybutynin treatment for palmar hyperhidrosis. Clin Auton Res. 2014 Nov 27;24(6):297–303.
275 276 277
4.
278 279 280
5.
Wolosker N, Teivelis MP, Krutman M, Campbell TPD de A, Kauffman P, Campos JR de, et al. Long-term results of oxybutynin use in treating facial hyperhidrosis. An bras dermatol. 2014;89(6):912–6.
281 282 283
6.
Wolosker N, de Campos JRM, Kauffman P, Yazbek G, Neves S, Puech-Leão P. Use of oxybutynin for treating plantar hyperhidrosis. International Journal of Dermatology. 2013 Apr 17;52(5):620–3.
284
7.
Wolosker N, Teivelis MP, Krutman M, de Paula RP, de Campos JRM, Kauffman P, et
AC C
EP
266 267 268
Wolosker N, Teivelis MP, Krutman M, de Paula RP, Kauffman P, de Campos JRM, et al. Long-term Results of the Use of Oxybutynin for the Treatment of Axillary Hyperhidrosis. Annals of Vascular Surgery. Elsevier Inc; 2014 Jul 1;28(5):1106–12.
ACCEPTED MANUSCRIPT 285 286
al. Long-term results of oxybutynin treatment for palmar hyperhidrosis. Clin Auton Res. 2014 Nov 27;24(6):297–303. 8.
Ibrahim M, Menna C, Andreetti C, Ciccone AM, D'Andrilli A, Maurizi G, et al. Bilateral Single-Port Sympathectomy: Long-Term Results and Quality of Life. BioMed Research International. 2013;2013(5, supplement):1–6.
290 291 292
9.
Hynes CF, Seevaratnam S, Gesuwan K, Margolis M, Marshall MB. The efficacy of oral anticholinergics for sympathetic overactivity in a thoracic surgery clinic. The Journal of Thoracic and Cardiovascular Surgery. Elsevier; 2016 Apr 14;152(2):565–8.
293 294 295
10.
de Campos JRM, Kauffman P, Werebe E de C, Andrade Filho LO, Kusniek S, Wolosker N, et al. Quality of life, before and after thoracic sympathectomy: report on 378 operated patients. Ann Thorac Surg. 2003 Sep;76(3):886–91.
296 297 298 299
11.
de Andrade Filho LO, Kuzniec S, Wolosker N, Yazbek G, Kauffman P, de Campos JRM. Technical Difficulties and Complications of Sympathectomy in the Treatment of Hyperhidrosis: An Analysis of 1731 Cases. Annals of Vascular Surgery. Elsevier Inc; 2013 Feb 9;:1–7.
300 301 302
12.
Lin TS, Fang HY. Transthoracic endoscopic sympathectomy in the treatment of palmar hyperhidrosis--with emphasis on perioperative management (1,360 case analyses). Surg Neurol. 1999 Nov;52(5):453–7.
303 304 305
13.
Ribas Milanez de Campos J, Wolosker N, Takeda FR, Kauffman P, Kuzniec S, Biscegli Jatene FB, et al. The body mass index and level of resection. Clin Auton Res. 2005 Apr;15(2):116–20.
306 307 308
14.
Yano M, Kiriyama M, Fukai I, Sasaki H, Kobayashi Y, Mizuno K, et al. Endoscopic thoracic sympathectomy for palmar hyperhidrosis: efficacy of T2 and T3 ganglion resection. Surgery. Elsevier; 2005 Jul;138(1):40–5.
309 310 311
15.
Wolosker N, de Campos JRM, Kauffman P, Puech-Leão P. A randomized placebocontrolled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis. YMVA. Elsevier Inc; 2012 Jun 1;55(6):1696–700.
312 313 314
16.
Schollhammer M, Brenaut E, Menard-Andivot N, Pillette-Delarue M, Zagnoli A, Chassain-Le Lay M, et al. Oxybutynin as a treatment for generalized hyperhidrosis: a randomized, placebo-controlled trial. Br J Dermatol. 2015 Oct 14;173(5):1163–8.
315 316 317 318
17.
Milanez de Campos JR, Kauffman P, de Campos Werebe E, Andrade Filho LO, Kusniek S, Wolosker N, et al. Quality of life, before and after thoracic sympathectomy: report on 378 operated patients. Ann Thorac Surg. Elsevier; 2003 Sep;76(3):886–91.
319 320 321
18.
Millán-Cayetano JF, del Boz J, Rivas-Ruiz F, Blázquez-Sánchez N, Hernández Ibáñez C, de Troya-Martín M. Oral oxybutynin for the treatment of hyperhidrosis: outcomes after one-year follow-up. Australas J Dermatol. 2016 Mar 30;:n/a–n/a.
322 323 324 325
19.
Wolosker N, Yazbek G, Ishy A, de Campos JRM, Kauffman P, Puech-Leão P. Is Sympathectomy at T4 Level Better Than at T3 Level for Treating Palmar Hyperhidrosis? Journal of Laparoendoscopic & Advanced Surgical Techniques. 2008 Feb;18(1):102–6.
326
20.
Neves S, Uchoa PC, Wolosker N, Munia MA, Kauffman P, de Campos JRM, et al.
AC C
EP
TE D
M AN U
SC
RI PT
287 288 289
ACCEPTED MANUSCRIPT 327 328 329
Long-Term Comparison of Video-Assisted Thoracic Sympathectomy and Clinical Observation for the Treatment of Palmar Hyperhidrosis in Children Younger Than 14. Pediatric Dermatology. 2012 Apr 4;29(5):575–9. 21.
Wolosker N, de Campos JRM, Kauffman P, de Oliveira LA, Munia MAS, Jatene FB. Evaluation of quality of life over time among 453 patients with hyperhidrosis submitted to endoscopic thoracic sympathectomy. YMVA. Elsevier Inc; 2012 Jan 1;55(1):154–6.
334 335 336
22.
Krogstad A-L, Skymne BSA, Göran Pegenius BS, Elam M, Wallin BG. Evaluation of objective methods to diagnose palmar hyperhidrosis and monitor effects of botulinum toxin treatment. Clin Neurophysiol. Elsevier; 2004 Aug;115(8):1909–16.
337 338 339
23.
de Campos JRM, Kauffman P, Werebe E de C, Andrade Filho LO, Kusniek S, PhD NWM, et al. Questionário de qualidade de vida em pacientes com hiperidrose primária. Jornal de Pneumologia. 2003 Aug 11;:1–4.
340 341 342
24.
Wolosker N, Munia MAS, Kauffman P, Campos JRM de, Yazbek G, Puech-Leão P. Is gender a predictive factor for satisfaction among patients undergoing sympathectomy to treat palmar hyperhidrosis? Clinics. 2010;65(6):1–4.
M AN U
SC
RI PT
330 331 332 333
343
AC C
EP
TE D
344
ACCEPTED MANUSCRIPT Table 1. Demographics data. Post-Oxybutynin Surgery N
Primary Surgery
%
N
%
p 0,200**
average (DP)
25,7 (6,6)
24,9 (8,1)
RI PT
Age (years)
0,070**
BMI (Kg/m2) average (DP)
22,1 (2,5)
21,7 (2,7)
0,166*
SC
Gender 43
26,7
183
32,4
Female
118
73,3
381
67,6
Smokers
M AN U
Male
Yes
5
3,0
31
5,4
No
159
97,0
538
94,6
Primary Complaint 91
54.5
338
59,3
76
45,5
232
40,7
TE D
Palmar Axilary
BMI: Body Mass Index ** Student T-Test
AC C
EP
*Qui-Square Test
0,210*
0,286*
ACCEPTED MANUSCRIPT
Primary
Surgery
Surgery
n
%
n
%
Excellent
0
0
0
0
Very Good
0
0
0
0
Good
0
0
0
0
Poor
40
24,2
132
25,2
Very Poor
125
75,8
369
74,8
AC C
EP
TE D
M AN U
Mann-Whitney Test p=0,206
SC
Post-Oxybutynin
RI PT
Table 2. Qualitfy of Life Before Surgery
ACCEPTED MANUSCRIPT
Post-Oxybutynin
Primary
Surgery
Surgery %
n
%
Low
8
4,9
10
1,8
Moderate
11
6,7
29
5,1
High
145
88,4
527
93,1
SC
n %a
RI PT
Table 3. Surgical treatment response
AC C
EP
TE D
M AN U
Mann-Whitney Test p=0,044
ACCEPTED MANUSCRIPT
Post-Oxybutynin
Primary
Surgery
Surgery
%
n
%
Excellent
126
75,4
473
83,0
Very Good
28
16,8
69
12,1
Good
7
4,2
22
3,9
Poor
5
3,0
4
0,7
Very Poor
1
0,6
2
0,4
AC C
EP
TE D
M AN U
Mann-Whitney Test p=0,025
SC
n
RI PT
Table 4. Improvement of Quality of Life After Surgery
ACCEPTED MANUSCRIPT
Post-Oxybutynin
Primary
Surgery
Surgery %
n
%
Low
1
2,4
4
2,2
Moderate
2
4,8
11
6,1
High
39
92,9
165
91,7
SC
n %a
RI PT
Table 5. Surgical treatment response in men
AC C
EP
TE D
M AN U
Mann-Whitney Test p=0,942