Rigi10™ Malleable Penile Prosthesis
Also Known As
Urethral sling, Mid-urethral sling, MUS, Tension-free vaginal tape, TVT, Transobturator tape, TOT, Pubovaginal sling, PVS, Bladder sling, Male sling, Suburethral sling, Fascial sling, Synthetic sling, Mesh sling
Definition
- Autologous tissue: Tissue taken from the patient’s own body¹.
- Allograft material: Tissue from a human donor.
- Xenograft material: Tissue from an animal source.
- Synthetic material: Man-made mesh, which is a common material for slings¹.
Clinical Context
Urethral sling procedures are clinically indicated for the treatment of stress urinary incontinence (SUI) in individuals, primarily women, who experience involuntary urine leakage during activities that increase intra-abdominal pressure, such as coughing, sneezing, laughing, exercising, or lifting heavy objects1,2. Surgery is typically considered when conservative treatments—including lifestyle modifications, pelvic floor muscle exercises (Kegel exercises), weight loss, or vaginal devices—have not provided adequate relief or are not suitable for the patient2.
Relevant Medical Conditions:
The primary medical condition addressed by urethral sling surgery is stress urinary incontinence (SUI)1,2. It may also be considered in cases of mixed urinary incontinence (a combination of stress and urge incontinence) if SUI is the predominant and most bothersome component2.
Patient Selection Criteria:
Ideal candidates for urethral sling surgery are typically individuals who:
- Have a confirmed diagnosis of SUI through appropriate clinical evaluation, which may include urodynamic studies1,2.
- Have experienced bothersome SUI that significantly impacts their quality of life2.
- Have failed or are not suitable candidates for conservative SUI therapies2.
- Understand the potential risks and benefits of the surgical procedure and have realistic expectations2.
- Are generally in good health to undergo surgery1.
- For women, it is often recommended to wait until they have completed childbearing, as pregnancy and childbirth can potentially compromise the long-term success of the sling procedure2.
Surgical Procedures:
Several types of urethral sling procedures exist, broadly categorized by the material used and the surgical approach:
- Materials: Slings can be made from synthetic mesh (e.g., polypropylene), the patient’s own tissue (autologous fascial sling), or, less commonly, donor tissue (allograft) or animal tissue (xenograft)1,2.
- Approaches:
- Mid-urethral slings (MUS): These are the most common type and involve placing a narrow strip of synthetic mesh under the mid-urethra. They can be inserted via different routes:
- Retropubic approach (e.g., Tension-free Vaginal Tape – TVT): The sling is passed from a small vaginal incision up behind the pubic bone, with small exit incisions above the pubic bone2.
- Transobturator approach (e.g., Transobturator Tape – TOT): The sling is passed from a vaginal incision out through the obturator foramen in the groin, with small exit incisions in the groin creases2.
- Single-incision mini-slings: These involve a smaller piece of mesh inserted through a single vaginal incision, with fixation into the pelvic tissues. Their efficacy compared to standard MUS is still under investigation2.
- Traditional slings (e.g., Pubovaginal sling – PVS): These often use autologous fascia (tissue from the patient’s abdomen or thigh) or other biologic materials. The sling is placed under the bladder neck or urethra and secured to the abdominal wall or pelvic structures. These are often reserved for more complex cases or when synthetic mesh is contraindicated2.
- Mid-urethral slings (MUS): These are the most common type and involve placing a narrow strip of synthetic mesh under the mid-urethra. They can be inserted via different routes:
The choice of procedure depends on various factors, including the surgeon’s experience, patient characteristics, and previous surgical history.
Expected Outcomes:
- Success Rates: Urethral sling procedures generally have high success rates in improving or curing SUI. Many studies report subjective cure rates (patient-reported improvement) and objective cure rates (based on clinical tests) in the range of 80-90% in the short to medium term. Long-term data also show good durability, though success can decrease over many years1.
- Recovery Timeline: Recovery varies depending on the specific procedure and individual patient factors. Most patients can expect:
- Hospital stay: Often same-day discharge or a 1-2 day stay, particularly for MUS procedures1,2.
- Return to normal daily activities: Typically within 2 to 6 weeks, with restrictions on heavy lifting, strenuous exercise, and sexual activity for a period advised by the surgeon (often 4-6 weeks or longer)1,2.
- Dissolvable stitches in the vagina are common1.
- Potential Complications: While generally safe, potential complications can include temporary difficulty urinating or emptying the bladder (urinary retention), development or worsening of urge incontinence or overactive bladder symptoms, urinary tract infection, wound infection, pain (groin, pelvic, or during intercourse), mesh erosion (where synthetic mesh protrudes into the vagina or other organs), and, rarely, injury to the bladder, urethra, or blood vessels1,2. The risk of mesh-related complications has been a subject of significant discussion and regulatory scrutiny, leading to careful patient selection and counseling.
It is crucial for patients to have a thorough discussion with their healthcare provider to understand the specific procedure, expected outcomes, and potential risks in their individual case1,2.