Male stress urinary incontinence (SUI) is often comorbid with erectile dysfunction (ED) post prostatectomy. While the three piece inflatable penile prosthesis (IPP) is the gold standard surgical option for ED, there are many surgical options for male SUI as well as climacturia. We present our technique and outcomes for mini male sling (MMS) with IPP insertion for mild SUI and climacturia using a monofilament polyester mesh. A retrospective review of all IPPs performed by a single high-volume prosthetic urologist was conducted. A subset of men who underwent IPP insertion with concomitant MMS were identified and analyzed. The technique of MMS placement involves measurement of an approximately 5x3 cm two layered Parietex™ mesh (Covidien, MN); the mesh is overlayed ventrally on the bulbar urethra at the penoscrotal junction, just proximal to the corporotomy sites. The Parietex™ mesh includes a hydrophilic absorbable collagen film to minimize tissue reaction and risk of erosion. The lateral edges of the mesh are sutured to the 3 and 9 o’clock positions on the left and right corporal bodies, respectively, using a nonabsorbable, braided suture. Tightness of mesh is measured using the proximal end of a Debakey forceps, with ease of passage when the IPP is deflated, and inability to pass forceps when the IPP is inflated. A total of 63 men underwent IPP with MMS between January 2018 and October 2022. All patients had a diagnosis of concomitant ED and SUI after radical prostatectomy. Average IPP size was 21 cm with a 1 cm rear tip extender. A total of 59 men had SUI, with an average pad per day (PPD) of 1.5. Twenty-five men with SUI had comorbid climacturia, and 4 men had preoperative climacturia without SUI. Average PPD post IPP with MMS was 0.1. Of the 29 men with preoperative climacturia, only one did not have resolution of his symptoms post MMS. There was only one reported complication of acute urinary retention requiring sling removal. Two patients required subsequent AUS insertion, and two required IPP revision for malpositioned cylinders. There were no reported cases of infection or mesh erosion. The Parietex™ mesh is a safe, cost-effective, easy to use, and an effective material for mini male sling insertion at the time of IPP placement for men with ED and mild SUI or climacturia.
Article
Parietex™ Mini Male Sling for Stress Urinary Incontinence at the Time of Three Piece Penile Prosthesis: Technique and Outcomes
https://doi.org/10.21203/rs.3.rs-3664026/v1
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stress urinary incontinence
climacturia
erectile dysfunction
male sling
technique
Male stress urinary incontinence (SUI) is often comorbid with erectile dysfunction (ED) post radical prostatectomy (RP). Although most patients (68%) become completely continent within 2 months, persistent urinary incontinence after prostatectomy is common and affects 8% to 25% of patients.1-3 The Prostate Cancer Outcomes Study showed that regardless of nerve sparing status, long term ED is still a significant outcome after RP, with almost 60% of all men with persistent ED 18 months after surgery.2 Ultimately, many of these men with ED post RP require surgical treatment due to failure of medical therapy.4 A subset of men will also experience orgasmic dysfunction, such as climacturia, or urinary leakage at the time of climax. This has been estimated to occur in in 20-93% of patients after RP.5
While the three piece inflatable penile prosthesis (IPP) is the gold standard surgical option for ED, there are many surgical options for male SUI as well as climacturia including bulking agents, Virtue male sling, AdVance male sling, mini-Jupette with IPP, and artificial urinary sphincter (AUS).6, 7 These continence procedures can be performed alone or concomitantly with IPP insertion if comorbid ED exists. Slings and sphincters may also be placed in tandem with IPPs, either unilaterally controlling incontinence (AUS) or relying on partially tumescent phallus to maintain continence (slings).
Historical treatments for climacturia include pre-coital voiding, penile constriction band, IPP placement with partial cylinder inflation, and simultaneous or staged placement of male sling or AUS with IPP.8, 9
Indications for Procedure:
For men with comorbid erectile dysfunction and mild SUI or climacturia, the mini-Jupette and mini male sling have previously been described in the literature. We present our modified technique and outcomes for mini male sling (MMS) with IPP insertion for mild SUI and climacturia using a monofilament polyester mesh (Parietex™).
Preoperative Preparation:
A retrospective review of all IPPs performed by a single high-volume prosthetic urologist was conducted. A subset of men who underwent IPP insertion with concomitant MMS were identified and analyzed. Coloplast Titan three piece penile prostheses were used in all patients. Means and standard deviations were calculated. Hospital institutional review board (IRB) approval for chart review was obtained (IRB-20-01505).
Patients are scrubbed and prepped using standard chlorhexidine wash and prep stick and a crural block with circumferential penile and cord block are given using 0.5% ropivacaine/1% lidocaine without epinephrine mixture. Subsequently, a mixture of 60mg papaverine in 3mL of ropivacaine is injected into one of the corporal bodies and massaged to ensure adequate spread. The cumulative effect of this anesthetic block is to augment blood flow, and therefore maximal dilation, of the corporal bodies. The patient is then draped as per standard protocol.
Intraoperative Considerations:
The procedure is begun as if a standard IPP insertion were being performed. At our institution, we routinely use a 16Fr Foley catheter for identification of the urethra, which is crucial when performing concurrent sling surgery. A midline scrotal approach is used, approximately 2 cm proximal to the penoscrotal junction. Layers of Dartos fascia are dissected away and, with the aid of a Wilson retractor, the corporal bodies and urethra are clearly defined using a combination of sharp and blunt dissection. Mobilization of the urethroscrotal septum is key to allow adequate visualization of the proximal urethra. This septum is taken down to the level of the ischiocavernosus. Minimal electrocautery is used in an effort to not distort natural tissue planes and avoid post-operative seroma formation. The scrotal compartment is packed away from the field using a 4x4 gauze.
Attention is then turned to sling placement. The technique of MMS placement involves measurement of an approximately 5x3 cm two layered Parietex™ mesh (Covidien, MN) and overlaying this ventrally on the bulbar urethra at the penoscrotal junction, just proximal to the eventual corporotomy sites. The Parietex™ mesh includes a hydrophilic absorbable collagen film to minimize tissue reaction and risk of erosion, which are very attractive characteristics given the close apposition to the urethra. Prior to introduction into the surgical field, the piece of mesh is soaked in a 0.05% chlorhexidine gluconate solution (Irrimax Corporation, Innovation Technologies, Inc., GA). The lateral edges of the mesh are then sutured to the 3 and 9 o’clock positions on the left and right corporal bodies, respectively, using a 2-0 nonabsorbable, braided suture (Ethibond, Ethicon, Raritan, NJ). Typically three interrupted sutures are used rather than running suture, as this prevents bunching of the mesh over the urethra. (Image 1).
At this point, stay sutures are placed just distal to the mesh for creation of corporotomies. After corporotomy creation, both erectile bodies are dilated using 9-inch Metzenbaum scissors in a corporal sparing approach, up to the level of the mid glans. Proximal and distal lengths are measured using Furlow dilator and appropriately sized cylinders are placed. Insertion of the prosthesis does not interfere with the MMS in any way. Corporotomies are closed and cylinders are cycled. Tightness of mesh is measured using the proximal end of a Debakey forceps. The proximal end should slide easily between the sling and the urethra with the cylinders in place and deflated. However, it should be unable pass when the IPP is inflated, thereby indicative of proper sizing. (Image 2). Visually, the urethra should maintain its color and consistency. If pallor is identified, this suggests vascular compromise, which could lead to a higher risk for erosion. If the sling is determined to be too tight, then serial removal of the anchoring sutures with replacement and re-tensioning is performed.
The remaining pump and reservoir are placed in a standard fashion, tubing connections are made, and a Jackson Pratt drain is placed through a separate stab incision in the groin ipsilateral to the reservoir. The Dartos fascia is closed in a running locking fashion using nonbraided monofilament suture. Next, the scrotal skin is closed with vertical mattress sutures. Cystoscopy is not routinely performed given possible increased risk of prosthetic infection with additional urinary tract manipulation. The prosthesis is left partially inflated for one hour, and a Kling wrap with covering mesh tube dressing is applied.
Postoperative Management and Follow-Up:
The dressing and drain are removed in the office two days later. Post-void residual urine volume is checked at postoperative day 2 and 30 to ensure adequate emptying. The IPP is left deflated for 4–6 weeks, at which time the patient returns for a wound check and device activation. If persistent SUI is noted with the device fully deflated, patients are instructed to add approximately 1–3 additional pumps to their cylinders after full deflation, even when not engaged in sexual activity. If tolerated, this can be maintained throughout the day or additional fluid pumps can be applied during activities associated with incontinence such as exercise. Routine clinic visits at 6 and 12 months after surgery, and yearly thereafter, are encouraged.
Outcomes:
A total of 63 men underwent IPP with concomitant MMS between January 2018 and October 2022. This time frame allowed us to capture a mean of 1 year follow up data. All patients reported post radical prostatectomy erectile dysfunction refractory to medical management and mild stress urinary incontinence or climacturia. (Table 1). Four men had undergone adjuvant or salvage radiation for prostate cancer. Their outcomes are reported separately in Table 2. Twenty-five men with SUI had comorbid climacturia, and 4 men had preoperative climacturia without SUI. Average IPP size was 21 cm with a 1cm rear tip extender. A total of 59 men had SUI, with an average pad per day (PPD) of 1.5 (SD 0.69). At a mean follow up of 1 year (SD 6.4 months), average PPD post IPP with MMS was 0.1. As determined by physician follow up, of the 29 men with preoperative climacturia, only one (3.4%) did not have resolution of his symptoms post MMS. (Table 3).
Complications:
There were no intraoperative complications. There was only one reported postoperative complication of acute urinary retention requiring sling removal at 30 days postoperatively (Clavien-Dindo classification IIIb; complication rate 1.6%). This patient initially failed trial of void in the recovery room and had an indwelling catheter placed prior to discharge. He underwent a trial of void on postoperative day 1 but continued to experience recurrent bouts of urinary retention, which ultimately necessitated sling removal after one month. Two patients required subsequent uncomplicated AUS insertion due to persistent SUI requiring more than 2 pads per day. Two patients required distal IPP revision through a circumcision incision for malpositioned cylinders. This did not impact the integrity of the MMS. This resulted in a total surgical revision rate of 7.9%. There were no reported cases of wound or urinary tract infection or mesh erosion. (Table 3).
There are many options within the prosthetic surgeon’s arsenal to surgically treat urinary incontinence after prostatectomy with concomitant ED. The choice of sling versus sphincter procedure depends on the severity of incontinence. Slings are generally preferred in men with milder forms of SUI.6 There are many types of slings used alone for SUI. Historically, the mini-Jupette was the most commonly used sling when combined with IPP. The mini-Jupette was first described in the literature by Yafi et al. as a mechanism to manage climacturia and mild SUI (no greater than 2 pads per day [PPD]) after RP.10 It entailed placement of a mesh material as per surgeon preference between the medial aspects of the two corporotomies.10 This is in contradistinction to our MMS placement, which is placed on the lateral borders of the corpora to extend over the bulbar urethra. The mesh is secured prior to creating the corporotomies and is independent of the corporotomies. We make it a point to place the mesh as proximally as possible at the penoscrotal junction for a few reasons. First, it allows a much easier subsequent placement of the IPP cylinders without being involved in the corporotomy creation. Second, proximal placement of the mesh allows for urethral compression closer to the level of the crura, where the bulbospongiosus muscle overlying the urethra is thicker. This serves as another layer of protection of the urethra from mesh constriction.
In the initial study describing the mini-Jupette technique, the most frequently used grafting materials were human pericardium (52.6%), polypropylene mesh (18.4%), and Virtue mesh sling (10.5%). A total of 38 men underwent the procedure. 30 patients had post-RP climacturia and 32 patients had post-RP incontinence (mean = 1.3 ppd, SD = 0.8). Mean ppd improved from 1.6 (SD = 0.6) preoperatively to 0.3 (SD = 0.4) postoperatively (p < .001). Subjective improvement in climacturia was noted by 92.8% of patients.10 Complications occurred in 13.2% of patients and included intractable pain, epigastric vessel injury, urethra-corporal fistula, and urinary retention due to urethral erosion of mesh.10 While novel in approach and an excellent option for men with comorbid ED and mild SUI or climacturia, there were significant limitations to this initial study. First off, several different types of grafts were included in the analysis, thereby causing ambiguity as to the ideal graft material that optimizes outcomes and minimizes complications.10 Also, by incorporating the graft into the corporotomy, this limited how far proximally the graft could be placed, and possibly put the prosthesis at risk for injury during more complex corporotomy closures. Even more serious is the risk of urethral injury given that the graft is sutured on the medial aspects of both corporotomies.
Further studies to validate the mini-Jupette technique and evaluate long-term outcomes are limited. A literature search only revealed three unique studies in total describing the mini-Jupette. A recent systematic review and meta-analysis examining outcomes of combined surgery for ED and SUI showed that while combination IPP with AUS is the gold standard for more significant levels of urinary incontinence, more rigorous studies with controlled arms are needed for validation as well as long term outcomes.11 Ajay et al. performed a review of current methods of treating concomitant SUI with ED and also concluded that the decision to perform concurrent surgery for ED and incontinence should be left to the discretion of the surgeon, as there are many factors determining feasibility of the combined approach, including surgical skill, payor limitations, and patient preference.12
In our previous study, we presented our initial series of men who underwent MMS, predominantly using the Virtue sling, with mean follow up of 5 months.13 We have since transitioned to using Parietex™ mesh due to its ease of use and widespread availability in the operating room. This mesh material is commonly used in hernia repair, and more recently has been adopted for pelvic organ prolapse surgery.14, 15 In fact, polypropylene mesh is the only synthetic material FDA approved for use on female urethras and pelvic organs, attesting to its safety.16 While Parietex™, specifically, does not have FDA approval for use on the urethra, other commonly used male slings (eg. AdVance™) are polypropylene-based. Patients were thoroughly counseled on the off label use of and risks associated with the Parietex™ mesh during the informed consent process.
The Parietex™ mesh has the added benefit of being hydrophilic, allowing it to be soaked in any antimicrobial solution of choice prior to utilization. It is also double layered and porous, with one side covered in a collagen fleece, ensuring minimal constriction upon the urethra and thereby decreasing the risk for erosion. It is packaged in rectangular pieces, allowing for ease of trimming by the surgeon. The elastic properties of the Parietex™ mesh allow for adequate stretch to prevent excessive tension on the underlying urethra, while still providing excellent support when the IPP is inflated. Another benefit of the Parietex™ mesh is the cost savings for patient and hospital. An average Coloplast Virtue™ male sling costs $5000, whereas the competitor Boston Scientific AdVance™ male sling is valued at $8531. In contradistinction, the Parietex™ mesh costs the hospital $200. (Table 4).
Strengths of our study include the use of a consistent operative technique with a single graft material, which may have contributed to our low overall complication rate of 1.6%, which is significantly lower than the described complication rate from mini-Jupette (13.2%). Limitations include the retrospective study design, use of subjective preoperative evaluation and postoperative outcomes, lack of comparison group, and relatively moderate follow-up duration. Given the single-surgeon and single-institution from which our results are derived from, our findings may also not be generalizable to all types of practices. Additionally, some of our outcome measures were marred by recall bias. For example, climacturia is an inherently subjective symptom, and patients may have reported less climacturia post MMS simply due to treatment of their comorbid ED. Future studies will examine long term functional outcomes.
The Parietex™ mesh is a safe, cost-effective, easy to use, and effective material for mini male sling insertion at the time of IPP placement for men with ED and mild SUI or climacturia.
Disclosures: The authors have no sources of funding or conflicts of interest to report.
The authors have no acknowledgements.
Acknowledgments: The authors have no acknowledgements.
Author Contribution Statement:
Shirin Razdan, MD: conceptualization, data curation, formal analysis, original draft writing, review and editing
Alexandra R. Siegal MD: conceptualization, data curation, formal analysis, review and editing
Robert J. Valenzuela MD: conceptualization, review and editing, supervision
Ethical Approval: Not applicable.
Competing Interests: The authors have no sources of funding or conflicts of interest to report.
Data Availability Statement:
All data generated or analyzed during this study are included in this published article and are available upon request as well.
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Table 1: Patient Demographics and Preoperative Parameters
|
Patient Characteristics |
|
|
Total Patients |
63 |
|
Age |
63 (6.80) |
|
Hypertension |
57 |
|
Diabetes Mellitus |
48 |
|
Post Prostatectomy Incontinence |
63 |
|
Adjuvant or Salvage Radiation |
4 |
|
Preoperative SUI |
59 |
|
Preoperative Climacturia |
29 |
|
Both SUI and Climacturia |
25 |
|
Preoperative PPD Use |
1.5 (0.69) |
Values reported as total count or mean with standard deviation.
Table 2: Outcomes in Radiated Patients
|
Adjuvant and Salvage Radiation |
|
|
Total Patients |
4 |
|
Age |
66 (6.96) |
|
Preoperative SUI |
4 |
|
Preoperative Climacturia |
3 |
|
Both SUI and Climacturia |
3 |
|
Preoperative PPD Use |
1 (0.00) |
|
Postoperative PPD Use |
1 (2.00) |
|
Complications |
0 |
|
Second Continence Procedure |
1 (AUS) |
|
Revision Surgery |
0 |
Values reported as total count or mean with standard deviation.
Table 3: Postoperative Outcomes of Entire Cohort
|
Postoperative Outcome |
|
|
Average IPP Size |
21cm with 1cm RTE |
|
Postoperative PPD Use |
0.1 (0.56) |
|
Resolution of Climacturia |
28 patients (97%) |
|
Complications |
1 (urinary retention requiring sling removal) |
|
Second Continence Procedure |
2 (sling removal with AUS insertion) |
|
Revision Surgery |
2 (malpositioned cylinders) |
|
Wound or Urinary Tract Infection |
0 |
Table 4: Cost Comparison of Commonly Used Male Urethral Slings
There is NO conflict of interest to disclose.