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Surgical treatment for primary premature ejaculation with an inner condom technique

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To explore a novel surgical treatment for primary premature ejaculation using an inner condom technique. A total of 20 males with premature ejaculation, who admitted our andrology clinic from June 2016 to July 2017, were enrolled. By surgery, an inner condom made of acellular dermal matrix (ADM) was transferred to the subcutaneous pocket of the penis. The prolongation of intravaginal ejaculatory latency time (IELT) after the surgery was examined. The perioperative complications were also studied. The surgical intervention significantly increased the average IELT in patients, from 0.67 to 2.37 min (P = .009). No serious perioperative complications and adverse psychosexual effects were seen. Patients could resume sexual activity 6 weeks after the surgery. The novel inner condom using ADM is an effective and safe surgical treatment for males with premature ejaculation. The efficacy of this new treatment modality warrants further investigation in independent cohorts.
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Surgical treatment for primary premature
ejaculation with an inner condom technique
Hai Wang, MD
a
, Ming Bai, MD
b
, Hai-Lin Zhang, MD
b
, Ang Zeng, MD
b,
Abstract
To explore a novel surgical treatment for primary premature ejaculation using an inner condom technique.
A total of 20 males with premature ejaculation, who admitted our andrology clinic from June 2016 to July 2017, were enrolled. By
surgery, an inner condom made of acellular dermal matrix (ADM) was transferred to the subcutaneous pocket of the penis. The
prolongation of intravaginal ejaculatory latency time (IELT) after the surgery was examined. The perioperative complications were also
studied.
The surgical intervention signicantly increased the average IELT in patients, from 0.67 to 2.37 min (P=.009). No serious
perioperative complications and adverse psychosexual effects were seen. Patients could resume sexual activity 6 weeks after the
surgery.
The novel inner condom using ADM is an effective and safe surgical treatment for males with premature ejaculation. The efcacy of
this new treatment modality warrants further investigation in independent cohorts.
Abbreviations: ADM =acellular dermal matrix, IELT =intravaginal ejaculatory latency time.
Keywords: acellular dermal matrix, inner condom technique, intravaginal ejaculatory latency time (IELT), premature ejaculation
1. Introduction
Premature ejaculation is one of the common male sexual
problems, with the reported prevalence rate of 20% to 30%
in China.
[1]
Subjects with premature ejaculation would have
short intravaginal ejaculatory latency time (IELT) of less than 1
min. Personal distress and interpersonal difculty were often
experienced along with ejaculatory dysfunction.
[2]
The cause of
premature ejaculation could be multi-factorial, both physiologi-
cally and psychologically. Penile hypersensitivity was proposed
to be 1 of the key pathologic mechanism of premature
ejaculation.
[3]
Reducing the sensitivity of skin and mucous
membrane of penis is therefore believed to prolong the IELT in
males with premature ejaculation.
In this study, we examined the efcacy of the penile
implantation of acellular dermal matrix (ADM) in prolonging
IELT. The ndings would provide novel insights into the
management of premature ejaculation.
2. Patients and methods
2.1. Patient characteristics
The present study recruited 20 males with premature ejaculation
who admitted to our clinic between June 2016 and January 2017.
All cases were diagnosed as primary (premature ejaculation
occurred upon rst sexual activity), and were refractory to
conventional treatment administered by specialist clinics.
Primary premature ejaculation was dened as the premature
ejaculation occurred upon rst sexual activity. Conventional
therapy, serotonin reuptake inhibitors (eg, sertraline, Prozac,
etc.), was used for more than a month in these patients and was
ineffective. All patients showed no abnormalities at external
genitals, testis, epididymis, and spermatic cord. The urine and
prostatic uid tests of all patients were normal. Blood tests were
performed to assess various blood hormone levels (eg, luteinizing
hormone, follicle-stimulating hormone, estriol, testosterone,
prolactin, etc.). Patients with disorders in endocrine system
(eg, thyroid or hypothalamus disorder), prostatitis, unstable
psychological state, or mental illness like depression were
excluded. patients with chronic disease or erectile dysfunctions
were also excluded.
The intravaginal ejaculation latency time (IELT) of all patients
before and after the surgical treatment were recorded using
stopwatch. Generally, the initiation of sexual activity was
recommended 8 weeks after surgery, but the condition of the
fusion of acellular allogeneic dermis and self-tissue would also be
considered to determine the time.
Perioperative parameters were also collected for analysis.
Written informed consents were obtained from all participants,
with the study design and protocol approved by the ethic
committee of Peking Union Medical College Hospital.
2.2. Surgical treatment
Surgery was performed under local anesthesia with 2%
Lidocaine. After the incision area was marked, a 2 cm transverse
Editor: Giuseppe Lucarelli.
The authors have no conicts of interest to disclose.
a
Department of Urologic Surgery,
b
Department of Plastic and Reconstructive
Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical
Sciences and Peking Union Medical College, Beijing 100730, Peoples Republic
of China.
Correspondence: Ang Zeng, Department of Plastic and Reconstructive Surgery,
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
and Peking Union Medical College, No. 41 Damucang Hutong, Xicheng District,
Beijing 100730, Peoples Republic of China (e-mail: 13683507962@qq.com).
Copyright ©2019 the Author(s). Published by Wolters Kluwer Health, Inc.
This is an open access article distributed under the terms of the Creative
Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-
ND), where it is permissible to download and share the work provided it is
properly cited. The work cannot be changed in any way or used commercially
without permission from the journal.
Medicine (2019) 98:3(e14109)
Received: 10 August 2018 / Received in nal form: 28 November 2018 /
Accepted: 18 December 2018
http://dx.doi.org/10.1097/MD.0000000000014109
Observational Study Medicine®
OPEN
1
incision was made 1.5 cm proximal to the coronal sulcus, through
which a sharp dissection was then carried out under the Buck
fascia (Fig. 1A&B). To form the inner condom, a sheet of type J-1
ADM (4 6 cm) (Jayyalife Biological Technology, Beijing,
China), was transferred to the subcutaneous pocket and xed
with vicryl sutures (Fig. 1C). The penis was immobilized with an
elastic bandage for 7 days, with the sutures subsequently removed
after 10 days (Fig. 1D).
2.3. Statistical analyses
The IELT before and after the surgical treatment was compared
using student ttest, with the signicant difference indicated by a P
value <.05.
3. Results
3.1. Patient enrolment
A total of 20 males diagnosed with primary premature
ejaculation was recruited. The average age of the cohort was
33 years old (ranging 1852 years), with an average course of
disease of 12 years (ranging 132 years). Four males received
circumcision.
3.2. Outcomes of the treatment
The average follow-up length was 6 months (ranging 212
months). Penile edema was observed at the rst 2 to 4 weeks post-
surgery. Except that, all males presented no other complications
like abnormal incision healing, exposure of the implant,
infection, hematoma, and seroma.
The surgical treatment signicantly increased the IELT of the
patients (P=.009). The IELT before and after the treatment was
0.67 min (ranging 0.181.1 min) and 2.37 min (ranging 0.828.4
min), respectively.
4. Discussion
The present study demonstrated for the rst time the penile
implantation of ADM could signicantly prolong the IELT in
males with clinically-diagnosed premature ejaculation. Patients
did not show any serious perioperative complications and could
resume sexual activity in a limited period as short as 6 weeks.
The etiology of premature ejaculation is multi-factorial,
involving psychological factors, genetics, endocrinological and
neuromodulating etiology.
[4,5]
Among the different factors, the
penile hypersensitivity is a key mechanism.
[3]
As such, both
pharmacological and surgical interventions originally aimed to
make the glans penis less sensitive during intercourse have
emerged as potential treatment modalities. For pharmacological
intervention, topical anesthetic is the oldest known one with well-
documented efcacy in prolonging the latency time of ejacula-
tion. Despite its efcacy, the use of topical anesthetics was
associated with penile hypoanesthesia and transvaginal absorp-
tion, leading to vaginal numbness and female anorgasmia.
[6,7]
For surgical intervention, selective resection of dorsal nerves of
penis demonstrated an efcacy rate of 90%, and compared to
pharmacologic agents, the effect of a single surgery was more
long-lasting.
[8,9]
Disappointedly, perioperative complications
such as paraesthesia on the glans penis and erectile dysfunction
were reported.
[10,11]
Furthermore, given that the procedure is
invasive and irreversible, and because the safety of this treatment
modality remains to be determined, the International Society of
Sexual Medicines Guidelines for the Diagnosis and Treatment of
Premature Ejaculation did not recommend the resection of dorsal
nerves in premature ejaculation treatment.
[12]
New treatments for
premature ejaculation are urgently needed.
Figure 1. The original surgery implanting ADM as an inner condom for treatment of premature ejaculation is depicted. (A) The incision region on the penis was
marked. (B) A 2 cm incision was made 1.5 cm proximal to the coronal sulcus, through which a sharp dissection was then carried out under the Buck fascia. (C) ADM
was implanted into the subcutaneous pocket. (D) After the completion of the surgery the penis was immobilized with elastic bandage. ADM =acellular dermal
matrix.
Wang et al. Medicine (2019) 98:3 Medicine
2
To fulll the unmet medical needs, we developed the penile
implantation of ADM as a promising approach to delay
premature ejaculation. We utilized ADM because it is a human
skin-derived biomaterial that shows a higher degree of
biocompatibility than heterologous materials. The basement
membrane complex of ADM also facilitates the attachment of
broblasts and endothelial cells for vascular ingrowth, allowing
excellent graft integration in the recipient tissue and neodermis
formation. Furthermore, ADM elicits no immune responses
because it does not express any major histocompatibility
antigens, either class I or II. With these advantages, ADM is
widely used in breast reconstruction,
[13]
hernia repair, plastic
surgery, such as rhinoplasty
[14]
and lip augmentation,
[15]
and
penile surgery. Phalloplasty with ADM resulted in satisfactory
penile augmentation with minimal morbidity.
[16]
In another
study consisting of 69 males, the penile girth enlargement with
ADM demonstrated advantages in the elimination of donor site
morbidity and a signicantly reduction in operation time.
[17]
The surgical technique of the present study shared some
similarities with circumcision in the site of incision and layer
separation. Despite this, the delayed ejaculation was apparently
not resulted from circumcision. A systematic meta-analysis
showed that circumcision had no effect on premature ejacula-
tion.
[18]
We, therefore, believed it was the implanted ADM that
reduced the cutaneous sensation of penis, preventing the
hypersensitivity and so premature ejaculation.
The key advantage of our surgery is that it involved only the
loose connective tissue of the supercial layer of tunica albuginea.
Unlike dorsal nerve neurectomy, the process caused nearly no
damages to blood vessel and nerve, eliminating the risk of
developing paraesthesia of the glans, and preventing erectile
dysfunction.
[19]
Our surgery also allowed fast recovery. Males
could resume sexual activity in 6 weeks after the surgery.
Nevertheless, the long-term treatment outcome of the penile
ADM implantation remains to be examined. In addition, the
impact of the surgical intervention on the psychological status of
males needs to be explored. The detailed underlying mechanism
by which the penile ADM implantation prolonged IELT also has
to be further studied.
[20]
The present study has several limitations. This was a single-
center study, with a relatively small sample size. To validate this
technique for application in clinical setting, a further study is
needed. Additionally, patients satisfaction was not evaluated in
this study.
To summarize, we present encouraging results suggesting the
penile implantation of ADM could signicantly prolong the IELT
in males clinically diagnosed with premature ejaculation. The
surgery was associated with no serious perioperative complica-
tions, with patients could resume sexual activity in a short period
after surgery. The usefulness of this new surgical intervention will
be comprehensively explored in an independent cohort of the
larger population.
Author contributions
Conceptualization: Ang Zeng.
Data curation: Hai Wang, Ming Bai, and Hai-Lin Zhang.
Formal analysis: Hai Wang, Ming Bai, and Hai-Lin Zhang.
Writing original draft: Ang Zeng.
Writing review & editing: Hai-Lin Zhang.
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