Frequently asked questions: urinary incontinence

Stress urinary incontinence, or SUI, is the involuntary loss of urine during physical activities, such as laughing, jumping, sneezing, or lifting heavy objects. It’s the most common form of urinary incontinence.

Stress urinary incontinence is the involuntary loss of urine during physical activity, which may include but is not limited to: coughing, laughing, or lifting. Incontinence occurs when the muscles that support the urethra (the tube that carries urine out of the body) are weakened or damaged. This can happen as a result of childbirth, trauma, obesity, family history, hormone changes, and many other reasons.

Yes, there are different types. One type is called hypermobility. “Hyper” means too much and “mobility” refers to movement, which can result from childbirth, previous pelvic surgery, or hormonal changes. Hypermobility occurs when the normal pelvic floor muscles can no longer provide the necessary support to the urethra. This may lead to the urethra dropping when any downward pressure is applied, resulting in involuntary leakage. Another type is called intrinsic sphincter deficiency, also sometimes referred to as ISD. This refers to the weakening of the urethral sphincter muscles or closing mechanism. As a result, the sphincter does not function normally regardless of the position of the bladder neck or urethra.

Many times, conservative treatment options for stress urinary incontinence are used initially. Some of those treatment options include behavioral modification — such as decreasing fluid intake, timed voiding, and eliminating caffeine, or pelvic floor muscle training such as Kegel exercises to strengthen the pelvic floor and sphincter muscles. These types of treatments may or may not improve symptoms. When symptoms are more severe, or conservative options aren’t working, bulking agent injections or surgery may be an option.

Stress urinary incontinence can be treated in several ways, depending on the exact nature of the incontinence and its severity. As disease state and anatomy differ for each patient, outcomes may vary. Consult a specialist for all available treatment options.

A mid-urethral sling system is designed to provide a hammock of support under the urethra to prevent it from dropping during physical activity.

Many sling options have been developed, the difference being how the mesh material is placed under the urethra. As disease state and anatomy differ for each patient, as well as the type of stress urinary incontinence, consult a specialist for all available treatment options.

This is a decision that should be made by you in consultation with a specialist. You should have the opportunity to discuss with your specialist all of your treatment options, and then decide which treatment plan is most appropriate for your specific medical situation.

A minimally invasive sling procedure is estimated to take between 30 and 45 minutes; this estimate can vary for many reasons. Your specialist will discuss the type of anesthesia with you, the specific procedure steps, and should answer all your questions. Mid-urethral sling procedures are frequently outpatient procedures, in which case, most patients return home the same day.

As with most surgical procedures, there are potential risks and complications associated with SUI mid-urethral sling surgery. Your specialist can further explain your specific risks based on your medical history and surgical approach used.

Please consult your physician to discuss the associated risk and complications for the specific surgical material you receive. Below is a list of potential adverse events for Boston Scientific’s mid-urethral sling surgical material. The following adverse events and known risks have been reported due to suburethral (beneath the urethra) mesh sling placement, any of which may be ongoing, but are not limited to:

• Abscess (swollen area within the body tissue, containing a buildup of pus)
• Allergic reaction to the implant
• Apareunia (inability to perform sexual intercourse)
• Bleeding from the vagina
• Complete failure of the procedure/failure to resolve a patient’s stress urinary incontinence
• Dehiscence of vaginal incision (opening of the incision after surgery)
• De novo detrusor instability (involuntary contraction of the bladder wall leading to an urge to urinate)
• Dyspareunia (pain during sexual intercourse)
• Edema and erythema at the surgical site (swelling and redness)
• Erosion into the following organs: urethra, bladder, or other surrounding tissues and exposure/extrusion into the vagina (when the mesh goes through the vagina into other organs or surrounding tissue)
• Fistula formation (a hole/passage that develops through the wall of the organs) that may be acute or chronic
• Foreign body reaction (body’s response to the implant) that may be acute or chronic
• Hematoma formation (bruising)
• Infection
• Inflammation that may be acute or chronic (redness, heat, pain or swelling at the surgical site as a result of the surgery)
• Irritation (redness or pain) at surgical site
• Leg weakness (muscle weakness)
• Mesh contracture (mesh shrinkage)
• Pain or discomfort to the patient’s partner during intercourse
• Pain/Ongoing Pain/Severe/Chronic Pain in the pelvis, vagina, groin/thigh, and suprapubic area that may be acute or chronic (pain or ongoing pain just above the pubic bone, pelvis, vagina, groin/thigh area that may be severe and could last for a long time)
• Pain with intercourse that may not resolve, Perforation or laceration of vessels, nerves, bladder, urethra, or bowel (a hole in or damage to these or other tissues that may happen during placement)
• Scarring, scar contracture (tightening of the scar)
• Stone formation (as a result of mesh erosion/exposure/extrusion in the urethra or bladder where the mesh is exposed to urine, mineral deposits may form along the mesh, also known as stones)
• Tissue contracture (tightening of the tissue)
• Voiding dysfunction: incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention (involuntary leakage of urine or reduced or complete inability to empty the bladder from the mesh being implanted too tightly beneath the urethra)

The following additional adverse events have been reported for the Solyx SIS System: Dysuria (painful/difficult urination), Hematuria (blood in the urine).

The occurrence of these events may require surgical intervention and possible removal of the entire mesh. In some instances, these events may be permanent after surgery or other treatments. Removal of mesh or correction of mesh-related complications may involve multiple surgeries. Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications.

There is no surgery for incontinence that has a 100% cure rate, but mid-urethral slings for bladder leakage have been studied since the mid-1990s and have shown to have high success rates of 80–95%.^1–5 As with any procedure, some patients will have success while others will not. It is difficult to estimate your specific results. Your physician will explain all of your options and determine with you which treatment plan is most appropriate for your specific medical situation. Your physician will consider a number of factors to determine the likelihood of recurrence in your situation. The most appropriate treatment plan for you will be determined by taking many of these factors into consideration.

Every patient’s recovery experience is unique, and you should consult your specialist as to what he or she expects in your individual case. As with any surgery, it is expected that you feel some soreness, but most patients return to normal activity after a short period of time. Please consult with your surgeon on specific activities to avoid during recovery to achieve optimal outcomes. Before you are discharged from the hospital, you may be given a prescription for an antibiotic and/or pain medication to relieve any discomfort you may experience. You will be instructed on how to care for your incision area. At the discretion of your physician, most patients resume moderate activities within 2 to 4 weeks, with no strenuous activity for up to 6 weeks. Talk with your specialist about post-procedure complications and when to notify him or her of a potential concern.

Most women see results right after the procedure. Talk with your specialist about what you should expect.

Injectable bulking agents are used to bulk or “fill out” the tissues surrounding the urethra to provide additional support during physical activity in order to prevent or minimize urine leakage caused by stress urinary incontinence.

This is a decision that should be made by you in consultation with your physician. You should have the opportunity to discuss with your physician all of your treatment options, and then which treatment plan is most appropriate for your specific medical situation.

The procedure will take place in a doctor’s office, an outpatient surgery center, or in an operating room. The procedure takes approximately 15 to 20 minutes. Your doctor will determine what type of anesthesia is best for you.

During the procedure, a needle is placed into the urethra using a cystoscope and the material is injected into the tissues surrounding your urethra providing a bulking effect. The doctor removes the needle and the procedure is completed. After the procedure, you will stay in the office or recovery room until you are able to pass urine on your own, usually within a few hours.

Your doctor will talk to you so you know what to expect from your treatment.

Studies show that effects of the treatment can last between one and three years.

Your physician will give you specific instructions regarding your activity level after your procedure. Most people return to normal activity within one to two days.

Please consult your physician to discuss the associated risks and complications from injectable urethral bulking. Some injectable urethral bulking products may have limitations on who should receive the product, such as patients who have inflammation of the bladder (cystitis) or the urethra (urethritis) or other infections. 

POTENTIAL ADVERSE EVENTS that may occur include: Urinary Tract Infection, Cystitis, Vulvovaginal Mycotic Infection, Urinary Retention, Urge Incontinence, Micturition Urgency, Pollakiuria, Hematuria, Nocturia, Urethritis non-infective, Hemorrhage Urinary Tract, dysuria, erosion, erythema, embolic phenomena, and vascular occlusion. 

• Narrowing of the bladder neck or urethra is called a urethral stricture. Your urethra could be blocked, and you may not be able to pass urine if you are treated when you have these strictures. Tell your doctor if you have to strain in order to start urinating. This may be a symptom of a stricture. Your doctor will be able to discuss the treatment options for urethral strictures. 
• If your doctor injects too much injectable urethral bulking, you may not be able to urinate. If this happens, the doctor may have to put a catheter in you until you can urinate normally. 
• Injectable urethral bulking may not stay in the place where it is injected, and this can lead to complications. 
• Injectable urethral bulking may erode through your tissue. If that happens, surgery may be needed to repair the damaged tissue. In a post-market clinical study for one type of injectable urethral bulking, two out of 158 patients developed this problem and had to have surgery to correct the problem. 
• Women with peripheral vascular disease and prior pelvic surgery, e.g., hysterectomy or surgery for urinary incontinence, may be at increased risk for tissue erosion. 
• Contact your doctor if you develop any procedure related problem especially if it lasts longer than 24 hours after your injectable urethral bulking procedure. If you do not contact your doctor, your problem may get worse and lead to a more severe problem. 

Safety and effectiveness of injectable urethral bulking in patients that are pregnant, or lactating has not been established. The effect of injectable urethral bulking on subsequent pregnancy and delivery, and the impact of subsequent pregnancy on the effect of injectable urethral bulking, is unknown. Therefore, the risks and benefits of the implant in women of childbearing potential should be carefully assessed. Patients should be counseled that one or more repeat injection procedures may be required to achieve dryness or a satisfactory level of improvement in urinary incontinence. 

Please refer to package insert provided with these products for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products.

Your physician will give you specific instructions regarding your activity level after your procedure. Most people return to normal activity within one to two days.

Most women see results right after the procedure. Talk with your physician about what you should expect.