Test Devices Aim To Relieve Burden Of Urinary Incontinence
Three clinical trials might lead to new treatments for women, especially in low-resource and rural locations.
When it comes to urinary incontinence involuntary urine leakage many women just put up with it. They may be too embarrassed to mention it to their doctor, or feel too busy with day-to-day responsibilities to prioritize their health. Moreover, hardships created by COVID-19 have only increased reluctance to seek care.
Given that 43% of U.S. women over age 50 experience urinary incontinence, a lot of women likely are suffering needlessly, said Dr. Suzette Sutherland, UW Medicines director of female urology and a University of Washington School of Medicine associate professor of urology. Urinary incontinence can be caused by diet, stress, pregnancy or aging.
Lifes greatest adventure shouldnt be searching for the nearest bathroom, she said. We want women to know that there are such easy solutions available today, and new technological advances all the time.
Sutherland is involved in three clinical trials designed to make urinary incontinence more manageable.
Women experience the condition in different ways. The main two involve an overactive bladder and a feeling of urgency associated with a nagging or uncontrollable urge to void. One treatment for bladder-urgency is called neuromodulation, a therapy used for more than 20 years to treat bladder and pelvic disorders. All three of the clinical trials are evluating prospective advancements to this technology.
Data Collection And Analysis
Selection of studies
The title and abstract of all references identified by the search strategy were assessed by both update review authors. The reports of all possibly eligible studies were evaluated for appropriateness for inclusion by the review authors without prior consideration of the results. Any disagreements were resolved by discussion and, where this was not possible, a final decision was made by a third person. Studies were excluded from the review if they were not randomised or quasirandomised trials or if they made comparisons other than those specified. Excluded studies were listed with reasons for their exclusion.
Data extraction and management
Data extraction was undertaken independently by the two update review authors using a standard data extraction form. Where data were possibly collected but not reported, clarification was sought from the trialists. Included trial data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions . Trial data were considered according to the type of management against which the devices were being compared. Trials were also grouped by type of incontinence: either stress, urge or mixed incontinence based on symptom classification or urodynamic criteria. Any differences of opinion were resolved by discussion with a third party.
Assessment of risk of bias in included studies
Assessment of heterogeneity
Subgroup analysis and investigation of heterogeneity
What Causes Urinary Incontinence
Urinary incontinence is not an inevitable result of aging, but it is particularly common in older people. It is often caused by specific changes in body function that may result from diseases, use of medications and/or the onset of an illness. Sometimes it is the first and only symptom of a urinary tract infection. Women are most likely to develop urinary incontinence during pregnancy and after childbirth, or after the hormonal changes of menopause.
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Device And Procedure Description
The non-ablative radio frequency device Spectra G2 – Tonederm®, has been adjusted for use on the urethral meatus. The device consists of an electromagnetic wave generator – high frequency wave, 0.5MHz – which is connected to a monopolar active electrode with a diameter of 0.5cm, and a passive metal electrode, the return plate . Only equipment with the approval of the national organ can be used for this treatment method.
The undressed patient lays in lithotomy position, the return plate is placed under the sacrum and the active electrode is positioned on the external urethral meatus.
When starting the passage of electromagnetic waves, the active electrode is placed on the urethral meatus and moved in circles . The active electrode is removed regularly to perform the temperature check. The temperature is monitored with an infrared thermometer, and after reaching 39-41°C, this temperature and the motions are maintained for 2 minutes. We used the same principle of the monopolar radiofrequency that is used for tissue repair to genital regions . All patients had 5 sessions of treatment, with a weekly frequency, and did not undergo any other therapeutic treatment for urinary incontinence. Women currently taking medications such as hormones, diuretics, or other medications, remained on their usual dose of medicine throughout the study period.
How Is The Device Inserted
A surgeon will implant the device in an operating room under sedation, similar to sedation used during a colonoscopy. A 2- to 3-inch incision will be made in your lower back, and the small device will be placed below your skin and above the muscle. You will be able to go home the same day as the procedure.
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Lack Of Continuity Or Deformity
The most common cause of incontinence in this category is a fistula. In developed countries, vesicovaginal or ureterovaginal fistulas typically arise as complications of hysterectomy or other pelvic surgery.6 Patients with other abnormalities such as ectopic ureters and diverticulae can also present with incontinence.
New Artificial Urinary Sphincter Devices In The Treatment Of Male Iatrogenic Incontinence
Ioannis VakalopoulosAcademic Editor: Received
Severe persistent stress incontinence following radical prostatectomy for prostate cancer treatment, although not very common, remains the most annoying complication affecting patients quality of life, despite good surgical oncological results. When severe incontinence persists after the first postoperative year and conservative treatment has been failed, surgical treatment has to be considered. In these cases it is generally accepted that artificial urinary sphincter is the gold standard treatment. AUS 800 by American Medical Systems has been successfully used for more than 35 years. Recently three more sphincter devices, the Flow-Secure, the Periurethral Constrictor, and the ZSI 375, have been developed and presented in the market. A novel type of artificial urinary sphincter, the Tape Mechanical Occlusive Device, has been inserted in live canines as well as in human cadavers. These new sphincter devices are discussed in this paper focusing on safety and clinical results.
2. FlowSecure TM
|FlowSecure artificial urinary sphincter.|
Indications for implantation of the FlowSecure device in order of significance are postprostatectomy urinary incontinence, incontinence due to congenital abnormalities, neurogenic bladder with ISD, and women stress incontinence, where other surgical procedures have failed .
3. Periurethral Constrictor
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Overall Completeness And Applicability Of Evidence
Despite the addition of extra data from one trial and addition of a new trial, the review remains underpowered to assess the effectiveness of mechanical devices for female urinary incontinence.
Although there were several types of mechanical devices used in these studies, including different versions of each device, few are commercially available. Whilst it is not immediately obvious why so many devices seem to have been developed but never withstood the test of time, we can speculate that the lack of good quality supportive clinical trial data was a contributory factor. Another reason might be that women do not like using a mechanical device and would prefer to use the other available options such as PFMT or surgery.
What Should I Do After My Surgery To Treat Stress Urinary Incontinence
- Continue with annual check-ups and follow-up care, notifying your health care provider if complications develop, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain during sexual intercourse. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
- If you have complications or other symptoms:
- Discuss complications and treatment options with your health care provider. Only your health care provider can give you personalized medical advice.
- Consider getting a second opinion from a surgeon who specializes in female pelvic reconstruction if you are not satisfied with your discussion with your health care provider.
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Percutaneous Tibial Nerve Stimulation
Normal voiding depends not only on the normal function of organs and muscles, but also on nerves that deliver appropriate signals regarding urination. In urge incontinence, the nerves regulating the bladder can become hyper-reactive, sending strong signals to empty before the bladder is full. Nerve stimulation therapies “jam” the pathways that transmit these abnormal messages.
In PTNS, a small acupuncture needle is placed in the ankle along the tibial nerve. A handheld device connects to the needle to deliver mild electrical impulses to the nerve. These travel up the tibial nerve to the sacral nerve plexus, which regulates the bladder. PTNS sessions are painless, last 30 minutes and are repeated weekly for 12 weeks. All sessions take place in a medical office.
Guidance For Industry And Fda Staffclinical Investigations Of Devices Indicated For The Treatment Of Urinary Incontinence
This guidance represents the Food and Drug Administrations current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Millions Of Us Women Suffer From Urinary Incontinence
Renovia closed a $17m Series C funding round in April to support its future commercialisation. Backers included previous investors Perceptive Life Sciences, Longwood Fund, Ascension Ventures and OSF Ventures, as well as new investor Parian Global Management.
The company is now reaching out to OB-GYNs across the US to introduce them to the device and allow them to start prescribing it to their patients. Unlike some pelvic floor training devices available for direct purchase, Renovia intends for patients to be monitored by their doctor as they start using the leva device.
The money will also be used for additional clinical development of the device for the treatment of urinary incontinence and other pelvic floor disorders.
Maus says: About 20 million women in the US suffer from some type of urinary incontinence, and people are still told that this is a normal part of ageing. While its really common and so many women have it, having to just accept that this is your fate and maybe youre wearing diapers, to just suck it up and deal with it I just dont think thats appropriate.
Pads For Bladder Incontinence
Incontinence pads are probably the most common and well known type of product available. They are easily accessible either through your GP or from a retail store and are usually the first product tried by someone who has an issue with either bladder or bowel control.
There are many different combinations to try depending on your preference from thinner, more discreet pads through to disposable underwear. Incontinence pads are generally suitable for all. Some people can find them uncomfortable once they become soiled, it is important to change your pad as quick as possible after they become soiled to avoid sore, broken and irritated skin.
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Best For Leg: Wiesner Incontinence Clamp New Device For Female Urinary Incontinence
The Wiesner Incontinence Clamp New Device For Female Urinary Incontinence is capable of outshining several other devices featured in this list in overall features in its price range. The wiesner incontinence clamp new device forfemale urinary incontinence is easy to apply, It is very helpful and has a reasonable design. The Manufacturer says: Wiesner offers a 100% money-back guarantee on all our products, giving you the confidence you need. The clamp remains firmly secure for hours, so users can participate in any activity without concerns.
The device is ideal for daily use, it is very effective and has a great design. Moreover, it is the most convenient and best option for men suffering from urinary incontinence. Finally, the wiesner incontinence clamp newdevice for femaleurinary incontinence is made out of ab plastic and medical grade silicone rubber which is very light weight, easy to use and does not activate security screenings such as at airports or museums.
Top Customer Quotes:
- This would have no effect on whether the clamp works or not.
- This is good for control of leakage and has a durable design.
- This clamp is solidly designed and produced.
- This works well, but spongey material is harder to clean.
Most importantly, the kegelmaster newdevice forfemale urinary incontinence is pink and it is worth the money.
Top Customer Quotes:
Above all, the lady patch new devicefor femaleurinary incontinence is a perfect fit and it is private.
What Are The Symptoms Of Urinary Incontinence
The following are common symptoms of urinary incontinence. However, each individual may experience symptoms differently. Symptoms may include:
Needing to rush to the restroom and/or losing urine if you do not get to the restroom in time
Urine leakage with movements or exercise
Leakage of urine that prevents activities
Urine leakage with coughing, sneezing or laughing
Leakage of urine that began or continued after surgery
Leakage of urine that causes embarrassment
Constant feeling of wetness without sensation of urine leakage
Feeling of incomplete bladder emptying
The symptoms of urinary incontinence may resemble other conditions or medical problems. Always consult your doctor for a diagnosis.
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Search Methods For Identification Of Studies
We did not impose any language restriction or other limits on the searches.
This review has drawn on the search strategy developed for the Incontinence Group as a whole. Relevant trials have been primarily identified from the Cochrane Incontinence Group Specialised Register. The methods used to derive this, including the search strategy, are described under the Group’s module in The Cochrane Library. The register contains trials identified from the Cochrane Central Register of Controlled Trials , MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings. Most of the trials in the Incontinence Group Specialised Register are also contained in CENTRAL.
We searched the Incontinence Group Register using the Group’s own keyword system the search terms used are given in Appendix 1. The date of the most recent search of the Register for this review was 21 August 2014.
We also searched other electronic databases for this review:
- EMBASE on OvidSP . Search date: 26 August 2014.
- CINAHL on EBSCO . Search date: 26 Augsut 2014.
Details of the strategies used to search these databases can be found in Appendix 1.
Searching other resources
We also searched the reference lists of relevant articles for other possible relevant trials.
Control Your Urge To Urinate
You may be able to control, or suppress, the strong urge to urinate, which is called urge or urgency suppression. With this type of bladder training, you can worry less about finding a bathroom in a hurry. Some people distract themselves to take their minds off needing to urinate. Other people find that long, relaxing breaths or holding still can help. Doing pelvic floor exercises to strengthen your pelvic floor also can help control the urge to urinate. Quick, strong squeezes of the pelvic floor muscles can help suppress urgency when it occurs, which may help you get to the toilet before you leak.
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Best With Ball: Ultraflex Female Urinary Incontinence Device
We would, of course, be remiss if we didnt mention the Ultraflex Female Urinary Incontinence Device for daily purpose. The ultraflex female urinary incontinence device is great for the perfect size and it is post surgery. . In addition, the device is made for good luck and it is large. Above all, the ultraflex female urinaryincontinence device is temporary, is mixed and it is practical.
Almost all buyers quickly discovered that the device is great for those drunken nights. Also, they say that the device comes with a daytime and nighttime bag.
Top Customer Quotes:
- This is great for long car rides, or amazon employees.
- This is a sensitive part of the body.
- This is used for this reason by uber, taxi, and bus drivers.
- This does not leak and it is comfortable to wear.
Using Supports With Other Types Of Treatment
Although bladder supports work well on their own, they can also be a part of a more comprehensive treatment plan.
They can certainly be used with pelvic floor physical therapy to strengthen the pelvic floor muscles and supports around the urethra, says Dr. Ferrando. The supports must be removed during the therapy, but the two can work together, she says.
Dr. Vasavada says making lifestyle changes and taking medication for overactive bladder are also helpful in some cases.
Fda Medical Device For Stress Urinary Incontinence
I was thrilled when I learned that there was a comfortable, easy-to-use device that allows you o take control of this sensitive health issue in the comfort of your own home. This device doesnt require a prescription so you dont have to worry about an uncomfortable conversation with your doctor about urinary incontinence. Elitone is the first FDA-cleared medical device to relieve mild to moderate symptoms of urinary incontinence. Left untreated, urinary incontinence can become debilitating.
Elitone GelPads can be used 2 to 3 times if they are carefully placed back into the sealable pouch before they need to be replaced. Simply replace the gel pad if you notice that it isnt sticking to the skin properly or you no longer feel the same intensity of contractions during the previous session. About 50% of the women who have used Elitone reported that they had to shave for it to work properly.
Dont let urinary stress incontinence continue to keep you from doing the things you enjoy. Let ELITONE help you take a hold of and improve your symptoms. No sense in letting this treatable condition to become debilitating when this non-invasive treatment for several treatments for 4 to 5 weeks to help improve your pelvic floor muscles.