Accepted Manuscript A novel implantation technique for pudendal nerve stimulation for treatment of overactive bladder and urgency incontinence Marc Possover, MD, PhD PII:
S1553-4650(14)00245-3
DOI:
10.1016/j.jmig.2014.03.026
Reference:
JMIG 2293
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 30 December 2013 Revised Date:
14 March 2014
Accepted Date: 30 March 2014
Please cite this article as: Possover M, A novel implantation technique for pudendal nerve stimulation for treatment of overactive bladder and urgency incontinence, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/j.jmig.2014.03.026. 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.
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT 1
A novel implantation technique for pudendal nerve stimulation for treatment of overactive
2
bladder and urgency incontinence.
3
Marc Possover, MD, PhD
4
Department of Surgical Gynecology & Neuropelveology, Hirslanden Clinic, CH- 8032 Zürich
5
RI PT
6 7
No financial support was received for this study.
8
Conflict of interest: MP has a provisional patent pending for an implantation system.
SC
9 Authors’contributions to the manuscript:
11
Marc Possover: Project development, data collection and management, data analysis, manuscript writing/editing
M AN U
10
12 13
Corresponding Author:
Univ. Prof. Prof. Dr. med. Marc Possover, MD, PhD.
15
Department of Surgical Gynaecology/Oncology& Neuropelveology
16
Prof. for Neuropelveology – University of Aarhus - DK
17
Hirslanden Clinic
18
Witellikerstrasse 40
19
CH- 8032 Zürich
20
Tel: +41- (0)443872830 Fax: +41 (0) 443872831
21
E-mail: [email protected]
22
Web: www.possover.com
24 25
EP
AC C
23
TE D
14
26 27 28 29 30 31 1
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT 32 Abbrevations:
34
OAB: overactive bladder
35
PN: pudendal nerve
36
UUI: urgency incontinence
37
SNS: sacral nerve stimulation
38
LION procedure: laparoscopic implantation of neuroprothesis
RI PT
33
39
SC
40 41
M AN U
42 43 44 45 46
TE D
47 48 49
52 53 54 55
AC C
51
EP
50
56 57 58 59 60 2
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT 61
A novel implantation technique for pudendal nerve stimulation for treatment of overactive
62
bladder and urgency incontinence.
63
Marc Possover, MD, PhD
64
Abstract
66
Study Objective: To report about the laparoscopic implantation of neuroprothesis to the pudendal nerve (PN)
67
for treatment for non-neurogenic bladder overactivity.
68
Design: Case series
69
Design Classification: Level I
70
Setting: Tertiary referral unit specialized in advanced gynaecological surgery and neuropelveology.
71
Patients: 14 consecutive male and female patients
72
Interventions: Laparoscopic implantation of electrode to endopelvic portion of the pudendal nerve (PN) for
73
pudendal neuromodulation.
74
Measurements and Main Results: All procedures were performed successfully by laparoscopy without any
75
complications. The mean operative time for the entire procedure was 18 minutes. After a successfully test-phase
76
of external stimulation, 11 patients underwent implantation of permanent generator (78.57%). These patients had
77
presented a reduction of micturition frequency from 25 per day in average (±11.7;13-50) to 10.18 (±2.7; 7-15) at
78
final evaluation (mean follow-up 18 months, range 9-49 months). Nocturia decreased from 5.82 (±4.2;3-18) to
79
2.18 (±1.08; 1-5) micturitions per night. Cystometric bladder capacities increased from a mean of 159ml (±53;
80
80-230ml) to 312ml (±104.9;160ml-500ml). Mean incontinence episodes at the initial evaluation based on a 3-
81
days voiding diary were 8.1 comparing; at final evaluation 6 patients were completely dry. Average pads used
82
per days reduced from 7.3 (±4.2) to 1.6 (±2.3). No any lead dislocation or migration did occurred.
83
Conclusions: Laparoscopic implantation of neuroprothesis to the PN is an effective, safe and reproducible day-
84
procedure for treatment for intractable non-neurogenic OAB with UUI.
SC
M AN U
TE D
EP
AC C
85
RI PT
65
86 87
Key words: OAB – pudendal nerve stimulation – urgency incontinence – overactive bladder
88 89 90
3
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT INTRODUCTION
92
First-line conservative treatments, such as antimuscarinics, do not always lead to sufficient improvement of the
93
complaints of OAB and/or are often associated with disabling adverse effects leading to treatment failure.
94
Electrical stimulation of pelvic nerves has emerged as an alternative and attractive treatment for refractory cases
95
of bladder overactivity. Pudendal Nerve Stimulation has shown better results than Sacral Nerve Stimulation, but
96
difficulties for lead placement and high rate for secondary lead migration make alternative necessary. A novel
97
technique of laparoscopic implantation of an electrode to the supralevator portion of the pudendal nerve (PN)
98
within the protection of the pelvis has been developed for pudendal neuromodulation. The endopelvic portion of
99
the PN is simply exposed by laparoscopic detachment of the pelvic lymph-tissue from the pelvic sidewall. The
100
electrode is implanted retroperitoneally in direct contact to the PN through the less sciatic notch using a
101
tunneling-applicator introduced transcutaneously from outside the body. Neither extensive dissection of the PN
102
nor electrophysiological guidance is required. The procedure is followed by a screening phase of several weeks
103
that performs test stimulation using a temporary external pulse generator to evaluate if a patient is a suitable
104
candidate for extended placement of the implantable pulse generator. The primary objective of this report was to
105
demonstrate of the technique for safety, reproducibility and feasibility for gynecologists and urologists trained in
106
laparoscopic surgery. The second objective was to evaluate PN neuromodulation in reducing UUI in patients that
107
had previously failed or refused other therapies, including at least one anti-cholinergic drug. The data on subjects
108
considered responders to the therapy is presented in this report.
TE D
M AN U
SC
RI PT
91
109
METHODS
111
This pilot group-study was performed in female and male subjects with documented symptoms of OAB with
112
UUI for at least one year.
113
Implantation of the implant system entailed a two-stage surgical procedure. The first stage consisted in the
114
laparoscopic implantation of an electrode to the PN including the postoperative test screening phase of several
115
weeks, and a second step, the subcutaneous implantation of a generator in local anesthesia. Laparoscopy is
116
performed under general anaesthesia avoiding any myo-relaxation. The patients are given a single intraoperative
117
antibiotic prophylaxis. For laparoscopy, one 10mm trocar were placed in the umbilicus to introduce a 10mm/0°
118
optic, and two 3mm-trocars in the lower abdomen for introduction 3mm scissors and bipolar forceps.
AC C
EP
110
119
For exposure of the endopelvic portion of the sciatic nerve and of the PN, the “transperitoneal
120
lumbosacral way” is used: After wide opening of the retroperitoneal space laterally to the external iliac artery,
121
the lumbosacral space is expanded downwards to the lumbosacral trunk. By following this nerve distally, the 4
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT sciatic nerve is identified just before its entry through the great sciatic notch (figure 1). By further gentle
123
detachment of the pelvic fat-lymph-tissue covering the nerve, the sacrospinous ligament and the caudal border of
124
the sciatic nerve are exposed. At the lesser sciatic foramen, the pudendal nerve (PN) is identified just before it
125
leaves the pelvis. No dissection of the PN is required. A curve tunneling-applicator tool designed for
126
laparoscopic implantation, with a stump tip and a sleeve is then introduced just above the anterior iliac crest
127
through the lateral abdominal wall until the top is identified behind the peritoneum by laparoscopy (figure 2). By
128
following the peritoneum and rotating the tunneling-applicator tool downwards, it is passes laterally from the
129
external iliac artery into the previously dissected space (figure 3). All steps are safe since the top of the
130
tunneling-applicator tool is permanently under control of the endoscopic vision. Using the applicator tool, an
131
electrode lead can be placed in direct contact to the sciatic nerve, and/or the pudendal nerve. In implantation of
132
the electrode to the PN, the top of the tunneling-applicator is pushed under the sacrospinous ligament along the
133
PN through the lesser sciatic foramen on about 1cm (figure 4). Risk for damages of the pudendal vessels is
134
extremely low since the vessels are located on the opposite side of the PN. Removal of the tunneling/applicator
135
tool leaves the sleeve in place to the PN, allows the physician to pass the electrode from outside through the
136
sleeve to the nerve. The removal of the sleeve completely out of the body leaves the electrode in direct contact to
137
the PN and the sciatic nerve (figure 5). The lead electrode is fixed laparoscopically with a non-resorbable suture
138
to the abdominal fascia before the peritoneum is closed. The test stimulator is coupled to the lead electrode
139
outside the body via a sterile cable to apply stimulation pulses trough the electrode, to confirm that the electrode
140
resides in the location previously found: electrical stimulation of PN induce a strong contraction of the external
141
anal sphincter confirmed by rectal touch. At last, a subcutaneous tunnel is formed for connecting the lead
142
electrode to an extension cable. The same tunneling/applicator tool with a sharp tip and sleeve is introduced
143
through the incision site where the lead electrode was passed transcutaneously, and pushed toward away from
144
the primary incision to the contralateral side of the pelveo-abdominal wall. In this configuration, should infection
145
occur in the region where the percutaneous extension cable extends from the skin, the infection occurs away
146
from the region where the pocket for the implanted pulse generator will be formed. The pocket incision site and
147
the lead tunnel all the way to the electrode are thereby shielded from channel infection during the first stage, in
148
anticipation of forming a sterile pocket for the implantable generator in the second stage. Stimulation parameters
149
were fixed at 15 Hz, pulse width at 210µs and lowest perceptible amplitude. Operative data and complications as
150
well as secondary endpoints included the number of dry subjects (zero episodes of urgency leaks) and validated
151
patient reported outcomes (number of incontinence/24h, number of micturition per day7night, number of
152
pad/24h, cystometric bladder capacity) were collected.
AC C
EP
TE D
M AN U
SC
RI PT
122
5
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT Indication for implantation a permanent generator - patients “responders” – is indicated when at last 50%
154
improvement in UUI episodes could be achieved during the test-phase. Permanent generators are then implanted
155
subcutaneously in local anesthesia, in the lower abdominal to avoid subcutaneous passage of cables.
156
All the trial was done in accordance with the 1975 Declaration of Helsinki and every patient provided written
157
informed consent. All patients were highly motivated and asking for any kind of procedure that would improve
158
them in their autonomy and quality of life.
RI PT
153
159
RESULTS
161
14 eligible subjects (2 males, 12 females) were enrolled. The mean age of the patients was 46.5 years (±12.6). At
162
the time of evaluation, 3 women were menopausal. All patients of this series were treated by anticholinergics but
163
have stopped this treatment because of side effects. 9 patients had previously failed sacral neuromodulation. Four
164
patients refused further botulinum toxine A injections because of recurrent cystitis and/or need for self-
165
catheterization. 10 patients refused primarily and categorically the option with botulinum because of systematic
166
need for repetition of injections every 6-9 months but also because of fear for possible deterioration of bladder
167
functions.
168
All procedures were performed by laparoscopy without conversion to laparotomy. The first seven procedures
169
were performed without the “curve applicator tool”, the last seven with this tool; mean operative times were
170
respectively 79 minutes (49-93 minutes) and 18 minutes (9 -29 minutes). No any peri- or postoperative
171
complications occurred. In three patients, because of failure of neuromodulation, electrodes were simply
172
removed by traction in local anesthesia. The further eleven patients underwent implantation of a permanent
173
generator because of successfully testing phase (78.57%). After a period of several months of adaptation, all
174
patients were stimulated with constant current 15Hz/210µs with amplitudes not exceeding 1.5 Volts. At time of
175
this manuscript no any lead dislocation or migration or cable rupture had occurred.
176
Implanted patients had 25 micturitions in average per day (±11.7;13-50) at the initial evaluation and 10.2 (±2.75;
177
7-15) at the final evaluation ( mean follow-up 18 months, min 9- max 49 months). Nocturia decreased from 5.82
178
(±4.2;3-18) to 2.18 (±1.08; 1-5) micturitions per night. Cystometric bladder capacities increased from a mean of
179
159ml (±53; 80-230ml) to 312ml (±104.9;160ml-500ml). Mean incontinence episodes at the initial evaluation
180
based on a 3-days voiding diary were 8.1 comparing; at final evaluation 6 patients were completely dry. Average
181
pads used per days reduced from 7.3 (±4.2) to 1.6 (±2.3). Postvoid residual volume measured by sonography
182
were
S1553-4650(14)00245-3
DOI:
10.1016/j.jmig.2014.03.026
Reference:
JMIG 2293
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 30 December 2013 Revised Date:
14 March 2014
Accepted Date: 30 March 2014
Please cite this article as: Possover M, A novel implantation technique for pudendal nerve stimulation for treatment of overactive bladder and urgency incontinence, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/j.jmig.2014.03.026. 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.
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT 1
A novel implantation technique for pudendal nerve stimulation for treatment of overactive
2
bladder and urgency incontinence.
3
Marc Possover, MD, PhD
4
Department of Surgical Gynecology & Neuropelveology, Hirslanden Clinic, CH- 8032 Zürich
5
RI PT
6 7
No financial support was received for this study.
8
Conflict of interest: MP has a provisional patent pending for an implantation system.
SC
9 Authors’contributions to the manuscript:
11
Marc Possover: Project development, data collection and management, data analysis, manuscript writing/editing
M AN U
10
12 13
Corresponding Author:
Univ. Prof. Prof. Dr. med. Marc Possover, MD, PhD.
15
Department of Surgical Gynaecology/Oncology& Neuropelveology
16
Prof. for Neuropelveology – University of Aarhus - DK
17
Hirslanden Clinic
18
Witellikerstrasse 40
19
CH- 8032 Zürich
20
Tel: +41- (0)443872830 Fax: +41 (0) 443872831
21
E-mail: [email protected]
22
Web: www.possover.com
24 25
EP
AC C
23
TE D
14
26 27 28 29 30 31 1
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT 32 Abbrevations:
34
OAB: overactive bladder
35
PN: pudendal nerve
36
UUI: urgency incontinence
37
SNS: sacral nerve stimulation
38
LION procedure: laparoscopic implantation of neuroprothesis
RI PT
33
39
SC
40 41
M AN U
42 43 44 45 46
TE D
47 48 49
52 53 54 55
AC C
51
EP
50
56 57 58 59 60 2
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT 61
A novel implantation technique for pudendal nerve stimulation for treatment of overactive
62
bladder and urgency incontinence.
63
Marc Possover, MD, PhD
64
Abstract
66
Study Objective: To report about the laparoscopic implantation of neuroprothesis to the pudendal nerve (PN)
67
for treatment for non-neurogenic bladder overactivity.
68
Design: Case series
69
Design Classification: Level I
70
Setting: Tertiary referral unit specialized in advanced gynaecological surgery and neuropelveology.
71
Patients: 14 consecutive male and female patients
72
Interventions: Laparoscopic implantation of electrode to endopelvic portion of the pudendal nerve (PN) for
73
pudendal neuromodulation.
74
Measurements and Main Results: All procedures were performed successfully by laparoscopy without any
75
complications. The mean operative time for the entire procedure was 18 minutes. After a successfully test-phase
76
of external stimulation, 11 patients underwent implantation of permanent generator (78.57%). These patients had
77
presented a reduction of micturition frequency from 25 per day in average (±11.7;13-50) to 10.18 (±2.7; 7-15) at
78
final evaluation (mean follow-up 18 months, range 9-49 months). Nocturia decreased from 5.82 (±4.2;3-18) to
79
2.18 (±1.08; 1-5) micturitions per night. Cystometric bladder capacities increased from a mean of 159ml (±53;
80
80-230ml) to 312ml (±104.9;160ml-500ml). Mean incontinence episodes at the initial evaluation based on a 3-
81
days voiding diary were 8.1 comparing; at final evaluation 6 patients were completely dry. Average pads used
82
per days reduced from 7.3 (±4.2) to 1.6 (±2.3). No any lead dislocation or migration did occurred.
83
Conclusions: Laparoscopic implantation of neuroprothesis to the PN is an effective, safe and reproducible day-
84
procedure for treatment for intractable non-neurogenic OAB with UUI.
SC
M AN U
TE D
EP
AC C
85
RI PT
65
86 87
Key words: OAB – pudendal nerve stimulation – urgency incontinence – overactive bladder
88 89 90
3
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT INTRODUCTION
92
First-line conservative treatments, such as antimuscarinics, do not always lead to sufficient improvement of the
93
complaints of OAB and/or are often associated with disabling adverse effects leading to treatment failure.
94
Electrical stimulation of pelvic nerves has emerged as an alternative and attractive treatment for refractory cases
95
of bladder overactivity. Pudendal Nerve Stimulation has shown better results than Sacral Nerve Stimulation, but
96
difficulties for lead placement and high rate for secondary lead migration make alternative necessary. A novel
97
technique of laparoscopic implantation of an electrode to the supralevator portion of the pudendal nerve (PN)
98
within the protection of the pelvis has been developed for pudendal neuromodulation. The endopelvic portion of
99
the PN is simply exposed by laparoscopic detachment of the pelvic lymph-tissue from the pelvic sidewall. The
100
electrode is implanted retroperitoneally in direct contact to the PN through the less sciatic notch using a
101
tunneling-applicator introduced transcutaneously from outside the body. Neither extensive dissection of the PN
102
nor electrophysiological guidance is required. The procedure is followed by a screening phase of several weeks
103
that performs test stimulation using a temporary external pulse generator to evaluate if a patient is a suitable
104
candidate for extended placement of the implantable pulse generator. The primary objective of this report was to
105
demonstrate of the technique for safety, reproducibility and feasibility for gynecologists and urologists trained in
106
laparoscopic surgery. The second objective was to evaluate PN neuromodulation in reducing UUI in patients that
107
had previously failed or refused other therapies, including at least one anti-cholinergic drug. The data on subjects
108
considered responders to the therapy is presented in this report.
TE D
M AN U
SC
RI PT
91
109
METHODS
111
This pilot group-study was performed in female and male subjects with documented symptoms of OAB with
112
UUI for at least one year.
113
Implantation of the implant system entailed a two-stage surgical procedure. The first stage consisted in the
114
laparoscopic implantation of an electrode to the PN including the postoperative test screening phase of several
115
weeks, and a second step, the subcutaneous implantation of a generator in local anesthesia. Laparoscopy is
116
performed under general anaesthesia avoiding any myo-relaxation. The patients are given a single intraoperative
117
antibiotic prophylaxis. For laparoscopy, one 10mm trocar were placed in the umbilicus to introduce a 10mm/0°
118
optic, and two 3mm-trocars in the lower abdomen for introduction 3mm scissors and bipolar forceps.
AC C
EP
110
119
For exposure of the endopelvic portion of the sciatic nerve and of the PN, the “transperitoneal
120
lumbosacral way” is used: After wide opening of the retroperitoneal space laterally to the external iliac artery,
121
the lumbosacral space is expanded downwards to the lumbosacral trunk. By following this nerve distally, the 4
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT sciatic nerve is identified just before its entry through the great sciatic notch (figure 1). By further gentle
123
detachment of the pelvic fat-lymph-tissue covering the nerve, the sacrospinous ligament and the caudal border of
124
the sciatic nerve are exposed. At the lesser sciatic foramen, the pudendal nerve (PN) is identified just before it
125
leaves the pelvis. No dissection of the PN is required. A curve tunneling-applicator tool designed for
126
laparoscopic implantation, with a stump tip and a sleeve is then introduced just above the anterior iliac crest
127
through the lateral abdominal wall until the top is identified behind the peritoneum by laparoscopy (figure 2). By
128
following the peritoneum and rotating the tunneling-applicator tool downwards, it is passes laterally from the
129
external iliac artery into the previously dissected space (figure 3). All steps are safe since the top of the
130
tunneling-applicator tool is permanently under control of the endoscopic vision. Using the applicator tool, an
131
electrode lead can be placed in direct contact to the sciatic nerve, and/or the pudendal nerve. In implantation of
132
the electrode to the PN, the top of the tunneling-applicator is pushed under the sacrospinous ligament along the
133
PN through the lesser sciatic foramen on about 1cm (figure 4). Risk for damages of the pudendal vessels is
134
extremely low since the vessels are located on the opposite side of the PN. Removal of the tunneling/applicator
135
tool leaves the sleeve in place to the PN, allows the physician to pass the electrode from outside through the
136
sleeve to the nerve. The removal of the sleeve completely out of the body leaves the electrode in direct contact to
137
the PN and the sciatic nerve (figure 5). The lead electrode is fixed laparoscopically with a non-resorbable suture
138
to the abdominal fascia before the peritoneum is closed. The test stimulator is coupled to the lead electrode
139
outside the body via a sterile cable to apply stimulation pulses trough the electrode, to confirm that the electrode
140
resides in the location previously found: electrical stimulation of PN induce a strong contraction of the external
141
anal sphincter confirmed by rectal touch. At last, a subcutaneous tunnel is formed for connecting the lead
142
electrode to an extension cable. The same tunneling/applicator tool with a sharp tip and sleeve is introduced
143
through the incision site where the lead electrode was passed transcutaneously, and pushed toward away from
144
the primary incision to the contralateral side of the pelveo-abdominal wall. In this configuration, should infection
145
occur in the region where the percutaneous extension cable extends from the skin, the infection occurs away
146
from the region where the pocket for the implanted pulse generator will be formed. The pocket incision site and
147
the lead tunnel all the way to the electrode are thereby shielded from channel infection during the first stage, in
148
anticipation of forming a sterile pocket for the implantable generator in the second stage. Stimulation parameters
149
were fixed at 15 Hz, pulse width at 210µs and lowest perceptible amplitude. Operative data and complications as
150
well as secondary endpoints included the number of dry subjects (zero episodes of urgency leaks) and validated
151
patient reported outcomes (number of incontinence/24h, number of micturition per day7night, number of
152
pad/24h, cystometric bladder capacity) were collected.
AC C
EP
TE D
M AN U
SC
RI PT
122
5
Pudendal nerve stimulation for treatment OAB
Possover
ACCEPTED MANUSCRIPT Indication for implantation a permanent generator - patients “responders” – is indicated when at last 50%
154
improvement in UUI episodes could be achieved during the test-phase. Permanent generators are then implanted
155
subcutaneously in local anesthesia, in the lower abdominal to avoid subcutaneous passage of cables.
156
All the trial was done in accordance with the 1975 Declaration of Helsinki and every patient provided written
157
informed consent. All patients were highly motivated and asking for any kind of procedure that would improve
158
them in their autonomy and quality of life.
RI PT
153
159
RESULTS
161
14 eligible subjects (2 males, 12 females) were enrolled. The mean age of the patients was 46.5 years (±12.6). At
162
the time of evaluation, 3 women were menopausal. All patients of this series were treated by anticholinergics but
163
have stopped this treatment because of side effects. 9 patients had previously failed sacral neuromodulation. Four
164
patients refused further botulinum toxine A injections because of recurrent cystitis and/or need for self-
165
catheterization. 10 patients refused primarily and categorically the option with botulinum because of systematic
166
need for repetition of injections every 6-9 months but also because of fear for possible deterioration of bladder
167
functions.
168
All procedures were performed by laparoscopy without conversion to laparotomy. The first seven procedures
169
were performed without the “curve applicator tool”, the last seven with this tool; mean operative times were
170
respectively 79 minutes (49-93 minutes) and 18 minutes (9 -29 minutes). No any peri- or postoperative
171
complications occurred. In three patients, because of failure of neuromodulation, electrodes were simply
172
removed by traction in local anesthesia. The further eleven patients underwent implantation of a permanent
173
generator because of successfully testing phase (78.57%). After a period of several months of adaptation, all
174
patients were stimulated with constant current 15Hz/210µs with amplitudes not exceeding 1.5 Volts. At time of
175
this manuscript no any lead dislocation or migration or cable rupture had occurred.
176
Implanted patients had 25 micturitions in average per day (±11.7;13-50) at the initial evaluation and 10.2 (±2.75;
177
7-15) at the final evaluation ( mean follow-up 18 months, min 9- max 49 months). Nocturia decreased from 5.82
178
(±4.2;3-18) to 2.18 (±1.08; 1-5) micturitions per night. Cystometric bladder capacities increased from a mean of
179
159ml (±53; 80-230ml) to 312ml (±104.9;160ml-500ml). Mean incontinence episodes at the initial evaluation
180
based on a 3-days voiding diary were 8.1 comparing; at final evaluation 6 patients were completely dry. Average
181
pads used per days reduced from 7.3 (±4.2) to 1.6 (±2.3). Postvoid residual volume measured by sonography
182
were
