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Brief Report  |   September 2016
Retropubic Dilation With a Foley Catheter Balloon: A Novel Technique for Penile Prosthesis Reservoir Placement
Author Notes
  • From the Departments of Urological Surgery (Drs Szell, McIntosh, DiMatteo, and Campbell) and Medical Education and Research (Dr Shaw) at St John Providence Health System in Warren, Michigan. 
  •  * Address correspondence to Nicole M. Szell, DO, Department of Urological Surgery, St John Providence Health System, 11800 E 12 Mile Rd, Warren, MI 48093-3472. E-mail: szellnic@gmail.com
     
Article Information
Brief Report   |   September 2016
Retropubic Dilation With a Foley Catheter Balloon: A Novel Technique for Penile Prosthesis Reservoir Placement
The Journal of the American Osteopathic Association, September 2016, Vol. 116, 594-598. doi:10.7556/jaoa.2016.118
The Journal of the American Osteopathic Association, September 2016, Vol. 116, 594-598. doi:10.7556/jaoa.2016.118
Abstract

Background: The 3-piece inflatable penile prosthesis was introduced in 1973 as a treatment for men with erectile dysfunction. Consisting of 2 corporal cylinders, 1 pump, and a fluid-filled reservoir, the prosthesis is placed by blunt dissection into the retropubic space. The dissection for the reservoir is performed blindly into a space juxtaposed with nerves, vessels, and the bladder.

Objective: To propose a novel approach for inflatable penile prosthesis reservoir placement involving gentle dilation of the retropubic space using a Foley catheter balloon.

Methods: Patient medical records from 1 surgeon were reviewed. Patients did not have a history of pelvic surgery or prostatectomy. Each implant was approached using a penoscrotal incision, and the retropubic space was dilated with a 30-mL Foley catheter balloon filled to 100-mL capacity before reservoir placement. The postoperative visits were examined for complications, including reservoir infection and herniation. A literature search of penile prosthesis reservoir placement technique and complications (eg, herniation, infection) of reservoir placement was also performed.

Results: Fifteen patient records were examined. The reservoir herniation rate was 0% and the infection rate was 7%. The average reservoir herniation rate is reported to be 1% to 3%, and the average infection rate is reported to be 1% to 5%.

Conclusion: The use of a Foley catheter balloon is a safe, atraumatic, cost-effective, and easily performed method of dilating the retropubic space for subsequent inflatable penile prosthesis reservoir placement.

The 3-piece inflatable penile prosthesis (IPP) was introduced in 1973 as a treatment for men with erectile dysfunction.1 The IPP consists of 2 corporal cylinders, 1 pump, and a reservoir that retains sterile fluid until it is cycled into the cylinders by depressing the pump. Over the past 40 years, the IPP has undergone considerable enhancements and refinements. Patients with erectile dysfunction have reported that IPP is a satisfying and functional operative treatment2 and in one study were more satisfied with IPP than with medication or injections.3 
Typically the IPP is placed using either an infrapubic or penoscrotal approach. The penoscrotal approach allows surgeons to easily place all components of the IPP through a well-hidden incision and then tuck the reservoir into the retropubic space while carefully avoiding the juxtaposed nerves and blood vessels. The infrapubic approach allows for the placement of the reservoir under direct visualization, but it may be technically more difficult than scrotal pump placement. This technique is used less frequently. 
The reservoir has been modified in the past 10 years to include a lock-out valve that inhibits autoinflation of the cylinders within the corpora. The reservoir has also undergone more ergonomic construction to ensure that it remains hidden and flattened in the retropubic space. Despite these improvements, herniation can occur and most commonly happens in the immediate postoperative period. It is often a result of sustained intra-abdominal pressure or surgical error.4 
The most common and severe complication of IPP insertion is infection, which can be precipitated by pressure on and inflammation of the tissues confining the individual components.5 Various modifications of the device, including antibiotic-impregnated and bacteriostatic coatings, have been used to combat infection. Variations in surgical technique, including the no-touch technique, have also been implicated in the decrease of surgical infections with IPPs.6 Nonetheless, infection of the implant region remains the most difficult complication, especially in patients needing several revision procedures throughout their lifetimes.5,7 
With the aim of decreasing the rate of reservoir herniation, we hypothesized that dilation of the retropubic space with a Foley catheter balloon before inserting the reservoir would decrease the rate of postoperative reservoir herniation. We believe that this technique provides an improved method of placing the reservoir by actively dilating the space before reservoir insertion, thus preventing malposition of the reservoir. By decreasing the rate of reservoir herniation, this technique could reduce the rate of revision operation, which carries a higher rate of infection. This technique is an easily reproducible and low-cost method for an atraumatic dilation of the retropubic space. We report our success with this novel technique and compare our results with other methods for IPP placement. 
Methods
A retrospective medical record review was performed of IPP implantations performed by 1 surgeon (G.V.M.) between 2011 and 2014. Institutional review board approval was granted through the St John Providence Health System. None of the patients had a history of pelvic surgery or prostatectomy. 
A penoscrotal incision was performed in all cases. For reservoir placement, the surgeon’s index finger was used to carefully penetrate the retropubic space. A 30-mL Foley catheter balloon was used because it can easily be overinflated to at least 100 mL, which is the usual size of an IPP reservoir. The tip of the 20-F, 30-mL balloon catheter was slid just under the index finger and held within the retropubic space while the balloon was inflated with 100 mL of water. The catheter was held in place for approximately 5 minutes to allow gentle dilation. Then the fluid was removed from the balloon and the Foley catheter discarded. The reservoir was placed into the dilated retropubic space, and the remainder of the procedure was completed per standard implantation technique.8 
Medical records from the 1- and 6-week postoperative visits were examined for reservoir herniation, infection, and other adverse effects. We also performed a literature search of IPP reservoir placement technique and complication rates of reservoir placement. We then compared our rates of herniation and infection with the national rates. 
Results
A total of 15 patient records were analyzed. Of note, 1 patient had a repeated procedure for explantation secondary to device infection detected 1 month after the initial IPP procedure. No patient had reservoir herniations, compared with the national average rate of 1% to 3%.9 Infection occurred in 1 of 15 patients (7%). This infection rate was comparable to the national infection rate of approximately 1% to 5% in patients undergoing a first IPP implantation.5,7 
Discussion
To our knowledge, this is the first report of a Foley catheter balloon being used to gently dilate the retropubic space for subsequent IPP reservoir placement. Our findings demonstrate that this method is safe, atraumatic, cost-effective, easily performed, and reproducible. 
The technique described by Hirsch et al10,11 involved dilating the retropubic space with a preperitoneal dilation balloon through a trocar placed lateral to the pubic bone to infiltrate the space of Retzius. That technique was found to be effective in a cohort study of 15 men with satisfactory outcomes. Our technique is similar in design, execution, and administration; however, it is less costly. 
The average cost of a 20-F Foley catheter with a 30-mL balloon is approximately $7. A preperitoneal dilation balloon inflated through a laparoscopic trocar as detailed in the studies by Hirsch et al10,11 costs anywhere between $200 and $250 per procedure, depending on the manufacturer. The technique described in the studies by Hirsch et al10,11 has been extensively published and is found to be a safe and atraumatic way of dilating the retropubic space before reservoir insertion and inflation. It is also easily reproduced and manipulated in an operative setting. However, our method of using a Foley catheter balloon can save about $193 to $243 per IPP procedure. 
Two studies detail the ability to continue finger dissection into the space of Retzius and use of a surgical instrument such as metzenbaum scissors or a nasal speculum to dissect the infrapubic space for blind reservoir placement despite patient history of pelvic surgery.12,13 
The rate of complications in the current study was comparable to the national rate for infection but lower than the national rate for herniation, as none of the patients studied had herniation. The 1 patient with infection underwent later washout and explantation of the device. Of note, the reservoir itself was found to be uninvolved with the infection during the explantation procedure. The patient was given the option of possible reimplantation in 6 months, but he declined. As stated previously, if herniation were to occur it would most likely be detected in the immediate perioperative or postoperative setting. At the 6-week postoperative visit, no signs of reservoir herniation were noted in the 15 patients. Our technique of dilating the retropubic space before reservoir placement is a likely explanation for the lack of herniated reservoirs in the patient sample. 
The most commonly reported outcome at the 1- and 6-week postoperative visits was pain (Table), and, for most, the pain subsided by 6 weeks postoperatively. Of note, as of January 2016, 10 patients remain in the continuing care of the surgeon and were all still satisfied with their IPPs. The most common complaint several months to years after the procedure remains difficulty with manual dexterity on inflation and deflation of the IPP. 
Table.
Patient Status After Penile Prosthesis Reservoir Placement Using a Foley Catheter Balloon for Retropubic Dilation (N=15)
Age, y Date of Operation 1-Week Follow-upa 6-Week Follow-upa
41 8/8/11 Pain
49 7/23/12
53 8/21/13 Pain Difficulty using pump
54 1/29/14 Pain Pain
58 4/16/12 Incision open with drainage Drainage resolved
59 5/23/11 Pain Drainage, infection; taken back to operating room for washout
8/17/11 Washout and removal of all parts of implant
62 10/8/14 Pain
63 1/4/12 Pain
64 1/30/12 Pain Pain
65 1/23/13 Pain
66 6/13/13 Pain
67 10/17/11
69 11/28/11 Pain
71 9/30/13 Difficulty deflating implant
79 6/29/11 Pain

a Ellipses indicate that no notable symptoms existed or events occurred at follow-up.

Table.
Patient Status After Penile Prosthesis Reservoir Placement Using a Foley Catheter Balloon for Retropubic Dilation (N=15)
Age, y Date of Operation 1-Week Follow-upa 6-Week Follow-upa
41 8/8/11 Pain
49 7/23/12
53 8/21/13 Pain Difficulty using pump
54 1/29/14 Pain Pain
58 4/16/12 Incision open with drainage Drainage resolved
59 5/23/11 Pain Drainage, infection; taken back to operating room for washout
8/17/11 Washout and removal of all parts of implant
62 10/8/14 Pain
63 1/4/12 Pain
64 1/30/12 Pain Pain
65 1/23/13 Pain
66 6/13/13 Pain
67 10/17/11
69 11/28/11 Pain
71 9/30/13 Difficulty deflating implant
79 6/29/11 Pain

a Ellipses indicate that no notable symptoms existed or events occurred at follow-up.

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Mechanical failure of an IPP necessitates complete reimplantation of all components and, often, a washout with several antibacterial solutions. Previous studies have documented that it is possible to leave the failed reservoir in place while reimplanting a new reservoir on the contralateral side.14,15 The technique used in the current study allows a failed reservoir to remain in place during removal of the other failed components, which saves time. 
Our study is limited by the small number of patients included. It is also limited to men without a history of pelvic surgery or prostatectomy. Retropubic dissection is difficult in these cases, owing to lack of space and scarring from previous dissection. The current recommendations for reservoir insertion in patients with a history of pelvic surgery involve an additional incision to the transversalis fascia with dissection of the retropubic space under direct visualization and placement of the reservoir separately from the other components. 
Conclusion
The use of a Foley catheter balloon is a safe, atraumatic, cost-effective, and easily performed method of dilating the retropubic space for subsequent inflatable penile prosthesis reservoir placement. With the increasing number of robotic prostate procedures being performed, our technique has the potential to be developed for use after robotic surgery. Specifically, in the future it may be used in men who have undergone previous pelvic procedures (most commonly, robotic-assisted laparoscopic prostatectomy), as these patients oftentimes have unfavorable anatomy after these major operations. This study is ongoing and will benefit from a larger number of patients. 
References
Scott FB, Bradley WE, Timm GW. Management of erectile impotence: use of implantable inflatable prosthesis. Urology. 1973;(2):80-82. [CrossRef] [PubMed]
Bernal RM, Henry GD. Contemporary patient satisfaction rates for three-piece inflatable penile prostheses. Adv Urol. 2012;2012:707321. doi:10.1155/2012/707321. [CrossRef] [PubMed]
Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function in patients treated with sildenafil, intracavernous prostaglandin e1 and penile implant surgery for erectile dysfunction in urology practice. J Urol. 2003;170(1):159-163. doi:10.1097/01.ju.0000072524.82345.6d. [CrossRef] [PubMed]
Sadeghi-Nejad H, Sharma A, Irwin RJ, Wilson SK, Delk JR. Reservoir herniation as a complication of three-piece penile prosthesis insertion. Urology. 2001;57(1):142-145. [CrossRef] [PubMed]
Bennett NE, Mulhall JP. Complications of surgery for erectile dysfunction and Peyronie’s disease. In: Taneja SS, ed. Complications of Urologic Surgery. 4th ed. Philadelphia, PA: Saunders; 2010:617-626.
Mulcahy JJ, Austoni E, Barada JH, et al. The penile implant for erectile dysfunction. J Sex Med. 2004;1(1):98-109. [CrossRef] [PubMed]
Eid JF, Wilson SK, Cleves M, Salem EA. Coated implants and “no touch” surgical technique decreases risk of infection in inflatable penile prosthesis implantation to 0.46%. Urology. 2012;79(6):1310-1315. doi:10.1016/j.urology.2011.11.076. [CrossRef] [PubMed]
Anderson PC, Jain S, Summerton DJ, Terry TR. Surgical atlas: insertion of an inflatable penile prosthesis. Br J U Int. 2007;99(2):467-482. doi:10.1111/j.1464-410X.2007.06732.x. [CrossRef]
Levine LA, Hoeh MP. Review of penile prosthetic reservoir: complications and presentation of a modified reservoir placement technique. J Sex Med. 2012;9(11):2759-2769. doi:10.1111/j.1743-6109.2012.02807.x. [CrossRef] [PubMed]
Hirsch IH, Moreno J, Gomella LG. Facilitated implantation of the inguinal reservoir of the multicomponent inflatable penile prosthesis. J Urol. 1994;152(1):142-143. [PubMed]
Hirsch IH, Shenot P, Gomella LG. Radial dilatation in the insertion of the multi-component inflatable penile prosthesis. Br J Urol. 1995;75(6):792. [CrossRef] [PubMed]
Wilson SK, Henry GD, Delk JRJr, Cleves MA. The mentor alpha 1 penile prosthesis with reservoir lock-out valve: effective prevention of auto-inflation with improved capability for ectopic reservoir placement. J Urol. 2002;168(4 pt 1):1475-1478. doi:10.1097/01.ju.0000030603.29170.c2. [CrossRef] [PubMed]
Perito PE, Wilson SK. Traditional (retroperitoneal) and abdominal wall (ectopic) reservoir placement. J Sex Med. 2011;8(3):656-659. doi:10.1111/j.1743-6109.2011.02202.x. [CrossRef] [PubMed]
Rajpurkar A, Bianco FFJr, Al-Omar O, Terlecki R, Dhabuwala C. Fate of the retained reservoir after replacement of 3-piece penile prosthesis. J Urol. 2004;172(2):664-666. [CrossRef] [PubMed]
Bartley J, Zimmerman WB, Dhabuwala C. Inflatable penile prosthesis and salvage protocol for mechanical failure: is it really necessary? J Sex Med. 2012;9(8):2175-2181. [CrossRef] [PubMed]
Table.
Patient Status After Penile Prosthesis Reservoir Placement Using a Foley Catheter Balloon for Retropubic Dilation (N=15)
Age, y Date of Operation 1-Week Follow-upa 6-Week Follow-upa
41 8/8/11 Pain
49 7/23/12
53 8/21/13 Pain Difficulty using pump
54 1/29/14 Pain Pain
58 4/16/12 Incision open with drainage Drainage resolved
59 5/23/11 Pain Drainage, infection; taken back to operating room for washout
8/17/11 Washout and removal of all parts of implant
62 10/8/14 Pain
63 1/4/12 Pain
64 1/30/12 Pain Pain
65 1/23/13 Pain
66 6/13/13 Pain
67 10/17/11
69 11/28/11 Pain
71 9/30/13 Difficulty deflating implant
79 6/29/11 Pain

a Ellipses indicate that no notable symptoms existed or events occurred at follow-up.

Table.
Patient Status After Penile Prosthesis Reservoir Placement Using a Foley Catheter Balloon for Retropubic Dilation (N=15)
Age, y Date of Operation 1-Week Follow-upa 6-Week Follow-upa
41 8/8/11 Pain
49 7/23/12
53 8/21/13 Pain Difficulty using pump
54 1/29/14 Pain Pain
58 4/16/12 Incision open with drainage Drainage resolved
59 5/23/11 Pain Drainage, infection; taken back to operating room for washout
8/17/11 Washout and removal of all parts of implant
62 10/8/14 Pain
63 1/4/12 Pain
64 1/30/12 Pain Pain
65 1/23/13 Pain
66 6/13/13 Pain
67 10/17/11
69 11/28/11 Pain
71 9/30/13 Difficulty deflating implant
79 6/29/11 Pain

a Ellipses indicate that no notable symptoms existed or events occurred at follow-up.

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