Research Studies | The Canadian Continence Foundation

Treatments for Incontience

Table of Contents

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2. 1 NON-DRUG TREATMENTS

2.1.1 - Regular training by physiotherapist reduces urinary incontinence after radical prostatectomy

2.1.2 - Vaginal pessaries provide some relief from urinary and bowel symptoms with pelvic organ prolapse

2.1.3 - Behavioural training alongside medication improves urge incontinence

2.1.4 - How much do non-surgical treatments benefit incontinence

 


2.2. DRUG TREATMENTS

2.2.1 - Darifenacin improves symptoms of overactive bladder in women and men

2.2.2 - Solifenacin in urge and mixed urinary incontinence

2.2.3 - Drug therapy improves overactive bladder symptoms better than bladder and pelvic floor training alone

2.2.4 - DuloXetine (not available in Canada) improves stress incontinence in some women

2.2.5 - Incontinence due to spinal cord injury or multiple sclerosis may improve with Botox injections

2.2.6 - The effectiveness of drug treatment with duloxetine in men with stress incontinence after radical prostatectomy

 


2.3. SURGICAL TREATMENTS

2.3.1 - What complications can be expected from sling procedure for stress urinary incontinence

2.3.2 - What determines success of mid-urethral sling procedures in women with stress urinary incontinence

2.3.3 - Results with sling procedure for men with stress incontinence after prostate cancer surgery

 


2. 1 NON-DRUG TREATMENTS

2.1.1
Regular training by physiotherapist reduces urinary incontinence after radical prostatectomy

Overgård M, Angelsen A, Lydersen S, Mørkved S. Does physiotherapist-guided pelvic floor muscle training reduce urinary incontinence after radical prostatectomy? A randomised controlled trial. Eur Urol. 2008 Aug;54(2):438-48. Epub 2008 Apr 18.

Why they did the study
Urinary incontinence is a common problem after radical prostatectomy. It is worst in the first six months after the catheter is removed and improves somewhat between six months and two years. But many men continue to suffer from incontinence long after surgery. Pelvic floor training can improve continence and men are generally instructed in the technique while in hospital. The authors wondered whether better results could be obtained if men were provided regular follow-up pelvic floor training sessions with a physiotherapist in the first year after surgery. Studies of similar programs for women with stress urinary incontinence showed promising results.

How they did it
The authors invited all men treated with radical prostatectomy for prostate cancer at one hospital in Norway over the course of a year to participate in the study. The first 85 men to agree made up the study group. Half were provided standard instruction in pelvic floor exercises. The other half also attended weekly follow-up sessions with a physiotherapist to reinforce pelvic floor training techniques. All men reported on their continence status six weeks, three months, six months and one year after starting the study.

  • What they found
    After three months, there was no difference in continence between the two groups, though the group receiving physiotherapy follow-up reported milder problems than that group not receiving follow-up.
  • After six months, 79% of men in the follow-up group were continent, compared to 58% of men in the control group.
  • At one year, this difference was greater still, with 92% of men in follow-up reporting continence versus 72% of men in the control group.

Why it matters
Most hospitals provide one-time instruction in pelvic floor training to men who have undergone radical prostatectomy and then leave them to exercise on their own. This study makes it clear that follow-up instruction by a physiotherapist increases long-term adherence, improves exercise technique and results in significantly improved continence rates over time. It may be a good idea to make this sort of program commonplace. If you are scheduled for radical prostatectomy, you may want to find a physiotherapist to work with in the months after your surgery.

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2.1.2
Vaginal pessaries provide some relief from urinary and bowel symptoms with pelvic organ prolapse

Fernando RJ, Thakar R, Sultan AH, Shah SM, Jones PW. Effect of vaginal pessaries on symptoms associated with pelvic organ prolapse. Obstet Gynecol. 2006 Jul;108(1):93-9.

Why they did the study
Vaginal pessaries are an age-old mechanical means of controlling pelvic organ prolapse (a dropping down of the bladder into the vaginal vault, called a cystocele, or a bulging of the rectum into the vaginal vault), which often leads to problems with urinary and bowel incontinence. Pessaries can be used while waiting for surgery or as an alternative to surgery. Previous studies of their effectiveness failed to use standardized questionnaires. The authors wanted to improve the quality of evidence around how well pessaries work to control symptoms.

How they did it
203 women who chose to try a pessary when referred to a uro-gynecologic specialist were included in the study. They completed a questionnaire asking about the impact of prolapse on urinary, bowel and sexual function and had a pelvic exam. Different types of pessary (ring, cube or doughnut) were inserted depending on factors such as whether the woman was sexually active. Women returned for a visit at two weeks and again after four months of using the pessary.

What they found

  • 75% of women were still using the pessary at two weeks. Women who did not keep it in were more likely to be of higher parity (having had many past pregnancies) or have had a hysterectomy.
  • Among women who kept the pessary in over the four-month follow-up, between 20% and 40% saw improvement in urinary symptoms, including difficulty emptying bladder, urgency and urge incontinence; about 20% of women reported improvements in fecal urgency and incontinence. There was no real improvement in stress urinary incontinence.

Why it matters
Surgery for pelvic organ prolapse is not possible for everyone and those who do undergo surgery often need to have it repeated. For some women, pessaries may provide relief from urinary and bowel symptoms either while waiting for surgery or instead of surgery.

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2.1.3
Behavioural training alongside medication improves urge incontinence

Burgio KL, Kraus SR, Menefee S, et al. Behavioural therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med. 2008 Aug 5;149(3):161-9.

Why they did the study
Training in continence skills and the drug tolterodine (an muscarinic-receptor antagonists drug that calm the overactive bladder muscle) are both first-line treatments for urge urinary incontinence. But many women do not achieve complete continence on either therapy alone and a good number stop taking antimuscarinic medications after a certain amount of time. The authors wondered whether ongoing behavioural training provided alongside medication would improve continence during treatment and provide continued improvements after medication was stopped.

How they did it
The authors recruited 237 women with urge incontinence in outpatient clinics at clinical centres of the Urinary Incontinence Treatment Network and randomly assigned them to receive either antimuscarinic therapy (tolterodine) alone or a combination of behavioural training and tolterodine for a period of 10 weeks.

All women were seen four times over the 10 weeks to assess whether they were taking the medication.

The women receiving behavioural training as well as drug therapy had an initial session with a nurse practitioner or physical therapist to instruct them on pelvic floor strengthening exercises and behavioural strategies to reduce urgency. At each of the four follow-up visits, pelvic floor strength was measured and further instruction provided.
After 10 weeks, medication and behavioural training were discontinued in all participants and women in the combined treatment group were instructed to continue their behavioural program. Women who requested a renewed drug prescription were provided with it free of charge.
Continence was assessed at the start of the study, at 10 weeks and finally at eight months.

What they found

  • After 10 weeks 69% of women in the combined drug and behavioural training group and 58% of women receiving drug treatment alone had achieved at least 70% improvement in continence. 21% of those in the combination therapy reported being completely dry, against 17% of those receiving only drug therapy.
  • At the eight-month assessment, fewer women from the group that had received combination therapy than women who had received drug therapy alone had resumed taking medication (29% vs 36%).
  • The number of women in each group achieving a 70% or greater reduction in incontinence at eight months was the same.

Why it matters
Behavioural training can improve results of medication therapy for urge incontinence but it provides no lasting benefit after medication is discontinued. Patient satisfaction and perceived improvement were better among women receiving combination therapy at each assessment.

Next question
Future studies should compare the long-term effectiveness of medications, surgeries and pessaries for stress urinary incontinence.

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2.1.4
How much do non-surgical treatments benefit incontinence

Shamliyan TA, Kane RL, Wyman J, Wilt TJ. Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med. 2008 Mar 18;148(6):459-73. Epub 2008 Feb 11.

Why they did the study
There are many studies of non-surgical treatments for urinary incontinence in women. The authors wanted to synthesize the results to provide guidance on what treatments work best.

How they did it
Research papers on all types of urinary incontinence treatments published between 1990 and 2007 were considered for inclusion in the analysis. Data from comparable studies was pooled together to assess the consistency of results with different incontinence treatments.

What they found

  • Pelvic floor training, alone or alongside bladder training, improves urinary incontinence. Individualized training produces better results than group training or training provided in a self-help booklet.
  • Electrical stimulation did not produce better results than pelvic floor muscle training.
  • Injected bulking agents produce mixed results that are similar for the different products used. Some studies of bulking agents for stress incontinence report cure rates of 15-60%, but statistically significant benefit was only shown in one clinical trial.
  • Stress and mixed urinary incontinence were resolved for some women by using intra-urethral or intra-vaginal devices to block urine, but results did not differ significantly among groups using vaginal cones, Hodge pessaries or disposable intravaginal devices.
  • There was strong evidence that oral hormone replacement therapy worsens urinary incontinence.
  • Vaginal and transdermal estrogen brings inconsistent improvement.
  • Adrenergic drugs (which liberate adrenaline) do not improve continence compared with placebo or pelvic floor training.
  • Anticholinergic drugs (oxybutynin or tolterodine) increase continence rates compared to placebo.

Why it matters
It is difficult to combine studies in urinary incontinence because improvement is measured in different ways and over different time periods. The authors wanted to provide doctors and patients with an idea of the comparative effectiveness of different treatment options. From the analysis of studies accomplished to date, they can state that for every 1000 women treated:

  • pelvic floor muscle training would resolve 490 cases of SUI;
  • magnetic stimulation therapy would resolve 390 cases of urge incontinence;
  • tolterodine would resolve 202 cases of urge incontinence;
  • intensive llifestyle change would avoid 54 cases of stress urinary incontinence.

Next question
Future studies should use long-term continence as a common outcome to allow comparison of the benefits of different therapies.

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2.2. DRUG TREATMENTS

2.2.1
Darifenacin improves symptoms of overactive bladder in women and men

Chapple C, Steers W, Norton P, et al. A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder. BJU Int. 2005 May;95(7):993-1001.

Why they did the study
Overactive bladder, which is a combination of urgency (sometimes with urge incontinence), frequent urinating, and having to urinate at night, is common in the general population of both women and men.

Antimuscarinic drugs block the stimulation of muscarinic receptors in the detrusor muscle of the bladder, but existing drugs (such as oxybutinin and tolterodine) also cause dry mouth and constipation. Darifenacin is a new muscarinic M3 selective receptor antagonist, which appears to target the bladder without producing the side effects of less selective drugs.

Three Phase III studies (in which a new treatment, shown to be safe and efficacious in Phase I and II studies, is compared with results of standard treatment) were conducted to assess the effectiveness of darifenacin and see what dose worked best. The authors aimed to put the data from these three trials together to evaluate the efficacy, safety and tolerability of darifenacin.

How they did it
The authors took data from three studies of a total of 1059 adults (85% women) who had symptoms of overactive bladder lasting at least six months and took darifenacin for 12 weeks. All participants completed diaries to record the frequency and severity of incontinence episodes as well as the frequency of urination. The study compared those taking 7.5 mg of darifenacin once a day, 15 mg twice a day, and placebo.

Study visits were conducted two, six and 12 weeks after starting treatment, at which point investigators looked at participants' diaries, questioned them about improvement and inquired about adverse events. Blood pressure, heart rate and blood tests were taken at the beginning and end of the study.

Participants were not excluded if they took other medications for health conditions, but were required to be on a stable dose with no plans to change during the study.

What they found

  • The average decrease in weekly incontinence was -8.8 among participants taking 7.5 mg of darifenacin, and -10.6 for those taking 15 mg.
  • The proportion of people who achieved a 70% or greater reduction in number of incontinence episodes after 12 weeks was 48% in the group taking 7.5 mg of darifenacin and 57% for those taking 15 mg, compared with 33% to 39% in the placebo groups.
  • 34% of those taking 7.5 mg of darifenacin and 35% of those taking 15 mg attained normal urination frequency (eight or fewer times per day), compared to 27% of those on placebo.
  • 24% of patients on the 15 mg dose achieved seven or more consecutive dry days, compared with 16% of those taking the 7.5 mg dose.
  • 27% and 28% of those taking darifenacin saw a 90% or greater reduction in incontinence episodes, compared with 17% on placebo.
  • Treatment-related adverse events occurred in 37.1% and 52.1% of people given 7.5 mg or 15 mg compared to 20.9% of those taking placebo. The most common were dry mouth and constipation, which sometimes required laxative use. No other adverse events were more common in the treatment group than in the placebo group.

Why it matters
There is currently no cure for overactive bladder. However, darifenacin can reduce symptoms to almost normal for more than a quarter of those taking it. The poor tolerability of existing drugs makes it difficult for people to comply with therapy over the long term. Darifenacin did produce dry mouth and constipation in some people, but the need for laxatives and the withdrawal rate were not significantly different than in the placebo group. Increasing concerns about the cognitive effects of less selective muscarinic inhibitors make a new alternative even more welcome.

Next question

  • What is the additive effect of combining pelvic floor exercises and pharmacologic treatment in overactive bladder?

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2.2.2
Solifenacin in urge and mixed urinary incontinence

Kelleher C, Cardozo L, Kobashi K, et al. Solifenacin: as effective in mixed urinary incontinence as in urge urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):382-8. Epub 2005 Nov 8.

Why they did the study
Treatments for mixed and urge urinary incontinence are generally tested in much larger groups of people with any form of overactive bladder, many of whom do not experience incontinence. The authors wanted to see what results were achieved with the drug solifenacin for the subset of people in previous studies who had mixed and urge incontinence.

How they did it
The authors extracted data on the efficacy of solifenacin in mixed and urge incontinence from four international studies on people with overactive bladder to see results for this more specific population. Study methodology and patient selection criteria were close enough to permit combining data. Each study compared solifenacin to placebo. Participants were assessed at regular intervals through diaries that recorded incontinence episodes and other information over a period of at least 12 weeks. Over 1800 participants taking either 5 mg or 10 mg of solifenacin once a day were available for analysis, as were 1200 who took placebo.

What they found

  • Among people with mixed and urge urinary incontinence, decreases in the number of incontinence episodes per day were seen in 84% to 100% of the study subjects taking solifenacin, compared to 64% of those of placebo.
  • Decreases in the number of urgency episodes per day were seen in between 63-70% of those on solifenacin and 39% of those on placebo
  • Side effects of dry mouth occurred in 28% of patients on the 10 mg dose, but only 11% of those on the 5 mg dose.
  • Constipation was also more common at the higher dose (13% vs 5%)
  • 8% of people at the higher dose discontinued treatment because of side effects, compared to 4% of those on the 5 mg dose.

Why it matters
This analysis showed that solifenacin is an appropriate choice of antimuscarinic agent for the treatment of urge and mixed urinary incontinence.

Next question
We need to look at combination drug therapy alongside behavioural therapy with pelvic floor muscle training to see which is more effective.

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2.2.3
Drug therapy improves overactive bladder symptoms better than bladder and pelvic floor training alone

Alhasso AA, McKinlay J, Patrick K, Stewart L. Anticholinergic drugs versus non-drug active therapies for overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003193.

Why they did the study
Overactive bladder, which is defined as urinary urgency, with or without incontinence, is treated with either anticholinergic drugs or bladder and pelvic floor muscle training. The authors wanted to review existing trials of each type of therapy to see which had the best results.

How they did it
The authors included all randomized controlled clinical trials of treatment with anticholinergic drugs for overactive bladder in which one group of patients received a non-drug therapy. Data were extracted and reviewed all together.

What they found

  • Symptom improvement of overactive bladder, with or without incontinence, is more common among those taking anticholinergic drugs than those using non-drug treatment.
  • A combination of bladder and pelvic floor training with anticholinergic drugs may be better than drugs alone.
  • Adverse effects such as dry mouth were reported by about a third of people taking anticholinergic drugs.

Why it matters
Anticholinergic drugs produce the best symptom relief for people with overactive bladder. And there effectiveness improves in combination with pelvic floor muscle training.

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2.2.4
DuloXetine (not available in Canada) improves stress incontinence in some women

van Kerrebroeck P, Abrams P, Lange R, et al. Duloxetine versus placebo in the treatment of European and Canadian women with stress urinary incontinence. BJOG. 2004 Mar;111(3):249-57.

Why they did the study
Existing treatments for stress urinary incontinence are less than satisfactory. Continence surgery is undergone by only about 5% of American women with bothersome stress urinary incontinence. Pelvic floor exercises are used by an undetermined number of women but often not for long enough or regularly enough to significantly improve continence.

Animal studies have shown that serotonin and norepinephrine improve lower urinary tract function. They increase bladder storage by relaxing the bladder and increasing bladder outlet (the bladder neck area) resistance. Decreasing the uptake of serotonin and norepinephrine were therefore though to have potential in improving stress urinary incontinence. Animal studies using the uptake inhibitor duloxetine hydrochloride showed that it significantly increased bladder capacity and sphincter muscle activity. A phase II study in women with stress urinary incontinence showed improvement. Phase II studies include more people than Phase I studies and are intended to evaluate the efficacy of a treatment for the condition it is intended to treat as well as monitor for side effects.

The authors felt that earlier phase studies were promising enough to warrant a Phase III trial of duloxetine in women with stress urinary incontinence. A Phase III trial is meant to prove effectiveness of a drug compared to placebo or standard treatment.

How they did it
The authors recruited 494 women aged 24 to 83 in seven European countries and Canada who had bothersome stress urinary incontinence lasting at least three months. The severity of incontinence ranged from two or three pads per day to 10 pads per day, meaning that these women would be considered candidates for incontinence surgery.
All women were given a placebo (sugar pill) for two weeks, after which half the group was given duloxetine and the other half continued on placebo. Neither the women, nor the researchers performing the assessments knew who was taking the active drug and who was taking placebo.

Women were seen at four-week intervals throughout the 12-week study and completed surveys about the frequency of incontinence episodes based on diaries they kept every day. Women also completed incontinence-related quality of life surveys at each visit. Drug safety was assessed through questions about adverse events and investigations of discontinuations.

What they found

  • Fewer women in the duloxetine group (73%) completed the 12-week study than women in the placebo group (92%). The difference was due to more frequent side effects. The discontinuations occurred in the first four weeks of taking the drug, after which none of the women taking duloxetine discontinued for adverse events.
  • 51.9% of women in the duloxetine group had a 50% to 100% decrease in incontinence episode frequency compared with 33.5% of those in the placebo group. The improvements were apparent four weeks after starting the drug and continued throughout the 12-week study period. Improvements were greater in women with severe incontinence.
  • Differences in health-related quality of life were not significant, though at the 12-week assessment 64.8% of women on duloxetine considered their urinary tract condition to be very much, much or a little better, compared with 48.2% of women on placebo.
  • The most common adverse effects of duloxetine were nausea, dry mouth, constipation, fatigue, insomnia, dizziness, headache and sweating. Each of these either occurred in more than 5% of women taking duloxetine or occurred significantly more often with duloxetine than with placebo.
  • There was an increase in average heart rate in women taking duloxetine, but it generally stayed within normal range, and there were no significant changes in blood pressure.

Why it matters
The study supports the beneficial effect of duloxetine found in other studies. Duloxetine appears as a pharmacologic option for the treatment of stress urinary incontinence. Side effects are a consideration, but these do not appear to include cardiovascular changes other than slight increase in heart rate.

Next question
Do side effects bother some women and not others, or do they diminish with time?

Does effectiveness persist beyond 12 weeks?

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2.2.5
Incontinence due to spinal cord injury or multiple sclerosis may improve with Botox injections

Schurch B, Denys P, Kozma CM, et al. Botulinum toxin A improves the quality of life of patients with neurogenic urinary incontinence. Eur Urol. 2007 Sep;52(3):850-8. Epub 2007 Apr 19.

Why they did the study
Urinary incontinence has a negative impact on quality of life for people with spinal cord injury and multiple sclerosis. It can restrict activities and impede rehabilitation exercises. The authors wanted to see whether Botox injections could improve quality of life related to urinary incontinence.

How they did it
The authors recruited 59 patients with urinary incontinence caused by neurogenic detrusor overactivity (when the bladder muscle becomes overactive) secondary to spinal cord injury (53 patients) or multiple sclerosis (6 patients). All patients were performing regular catheterizations but had urinary incontinence between catheterizations for more than six weeks and inadequate improvement with anticholinergic drugs.

Half the group were given Botox injections (Botulinum Toxin A). Two different dosages, 200U and 300U were tried. The other half was given placebo.

Incontinence-related quality of life scores were calculated based on a 22 item questionnaire

What they found

  • After two weeks of treatment, the Botox groups had quality of life scores of 65 and 68, compared to 35 in those who received placebo.
  • By 12 weeks, the Botox groups reached quality of life scores of 71 and 89, compared to 30 in the placebo group.
  • After week 12, scores levelled off and even dropped a little in the Botox groups, reaching 76 and 68 at 24 weeks, but were still much higher than the score of 40 among patients who received placebo.

Why it matters
The study showed that Botox injections could produce a significant improvement in health-related quality of life for patients with neurogenic incontinence compared to placebo. Patients were less worried about rushing to the toilet, sneezing or drinking too much, and were also less likely to feel depressed, frustrated, helpless or embarrassed.

Previous studies of Botox in patients with non-neurogenic urge incontinence have shown improvements in continence over placebo and good tolerability. This study shows that these improvements increase health-related quality of life in patients with incontinence related to spinal cord injury and multiple sclerosis.

Next question
Longer term studies with larger patient numbers for recruitment need to be conducted.

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2.2.6
The effectiveness of drug treatment with duloxetine in men with stress incontinence after radical prostatectomy

Filocamo MT, Li Marzi V, Del Popolo G, Pharmacologic treatment in postprostatectomy stress urinary incontinence. Eur Urol. 2007 Jun;51(6):1559-64. Epub 2006 Aug 15.

Why they did the study
Even with the improvements in surgical technique seen in recent years, many men who undergo radical prostatectomy (an operation to remove the prostate gland for the purpose of treating prostate cancer) suffer from stress urinary incontinence after their surgery. Pelvic floor muscle training is the primary treatment recommended to improve continence after surgery. As well, many men will gradually recover continence as the urinary sphincter heals naturally in the year after surgery. The authors wondered whether duloxetine, a relatively new drug treatment approved for use in women with stress incontinence in many countries (though not Canada) could help men recover continence earlier in the post-operative period when used alongside pelvic muscle training.

How they did it
After undergoing radical prostatectomy, 112 men who had symptoms of stress incontinence after their catheter was removed were randomly assigned to receive either pelvic muscle training alone or training along with duloxetine (40 mg twice daily). Men were examined and questioned at four, 10, 16, 20 and 24 weeks for improvements in continence and medication side effects. At 16 weeks, duloxetine was stopped.

What they found

  • Nine men stopped duloxetine early because of adverse events (mainly nausea).
  • After four weeks, 30% of men receiving medication and training were completely dry, compared to 11.5% of men on training alone. After 10 weeks, these numbers climbed to 57.6% and 26.9%, respectively. By 16 weeks, 78% of men on medication and training were dry, compared to 51.9% on training alone.
  • At 20 weeks, four weeks after medication was stopped (while training continued for everyone), results switched: only 46% of men who started out on medication and training were dry, compared to 73% of men who started out on training alone. After 24 weeks, the first group improved to the point that 62% were dry, as were 78% of the training alone group.

Why it matters
Pelvic muscle training produces slow and steady improvements in continence in the six months after surgery. But even this duration of incontinence can have very negative psychosocial effects on men after prostate cancer surgery. The authors found that it was possible to improve continence earlier by using duloxetine alongside muscle training but that once the medication was stopped, these men had worse continence than men who had only received training. This could be due to the fact that men on muscle training alone had more incentive to work hard at the exercises. Eight weeks after the stop of drug therapy, continence improved to levels similar to, though still lower than, men who had been on training alone.

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SURGICAL TREATMENTS

2.3.1
What complications can be expected from sling procedure for stress urinary incontinence

Novara G, Galfano A, Boscolo-Berto R, Secco S, Cavalleri S, Ficarra V, Artibani W. Complication rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol. 2008 Feb;53(2):288-308. Epub 2007 Nov 8.

Why they did the study
Options for surgical treatment of stress urinary have expanded from the traditional Burch colosuspension surgery since about 1995. Mid-urethral tension-free vaginal tape (TVT) gained popularity for its ease of use and effectiveness (continence rates of 70-80%), and more than 1 million surgeries have been performed worldwide to date. Further efforts were made to make the mid-urethral sling procedure less invasive and reduce complication rates, bringing another set of slings and techniques into the mix.

Complications with surgical treatments can include bladder perforation, nerve injuries and bleeding during surgery, as well as urinary tract infections, voiding dysfunction and vaginal or bladder erosion following surgery. Further, the need for re-operation several years after the initial surgery is not uncommon.

The authors wanted to review the studies available on complication rates with TVT and other surgical procedures for stress urinary incontinence to provide better guidance in physician and patient choice.

How they did it
The authors reviewed all studies of surgical treatment of stress urinary incontinence and found 169 of high enough quality to include in their metanalysis, including 33 randomized controlled trials with data on complication rates.

What they found

  • Complication rates were similar after TVT and Burch colosuspension, except for bladder perforation, which was more common after TVT, and reoperation, which was more common after Burch colosuspension.
  • TVT and pubovaginal sling had similar post-operative complication rates
  • Suprapubic arc sling (SPARC) led to more voiding lower urinary tract symptoms and reoperations than TVT.
  • Transobdurator tape procedures had less bladder perforation, pelvic bruising and urinary storage complications than retropubic tape procedures.

Why it matters
With a greater number of surgical procedures for stress urinary incontinence available, awareness of the complication rates associated with each may help women and their doctors make informed choices. The authors caution that many studies were of limited quality and that long-term follow-up data was seldom available.

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2.3.2
What determines success of mid-urethral sling procedures in women with stress urinary incontinence

Novara G, Ficarra V, Boscolo-Berto R, et al. Tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials of effectiveness. Eur Urol. 2007 Sep;52(3):663-78.

Why they did the study
Tension free vaginal tape (TVT) surgery was introduced in 1995 and has now replaced most other forms of urinary incontinence surgery. And results are good: after seven years, 81% of patients are completely continent and a further 16% experience improvement. But complications do occur and the authors wanted to find out whether certain specific factors influenced the efficacy and safety of the TVT procedure in a teaching hospital.

How they did it
The authors reviewed the medical records of women who underwent TVT surgery over a three-year period for stress or mixed incontinence and combined this with information on continence status collected in a follow-up questionnaire sent to these women. Characteristics of the women and of the surgery were entered into the analysis to see if any particular ones affected complication rates.

What they found

  • Complications occurred in 19% of all TVT procedures, including prolonged catheterisation in 9.6% and bladder perforation in 4%.
  • The only significant risk factor for complications (mainly prolonged catheterization) was having prolapse surgery at the same time as the TVT surgery.

Why it matters
The authors recommend separating the two surgeries. A woman with both pelvic organ prolapse and stress urinary incontinence should have the prolapse surgery first. If urinary continence is not much improved afterwards, physiotherapy to improve pelvic floor strength should be provided and only if this fails to produce improvement should TVT surgery be proposed.

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2.3.3
Results with sling procedure for men with stress incontinence after prostate cancer surgery

Guimarães M, Oliveira R, Pinto R. Intermediate-term results, up to 4 years, of a bone-anchored male perineal sling for treating male stress urinary incontinence after prostate surgery. BJU Int. 2008 Sep 8.

Why they did the study
Stress urinary incontinence is a frequent complication after prostatectomy. The bone-anchored InVance sling was developed as a more widely acceptable option than artificial urinary sphincter and bulking agents, and more effective than other sling models. The authors wanted to see how much the sling improved stress urinary incontinence four years following prostate surgery.

How they did it
The authors followed 62 men who had the InVance sling inserted between 2003 and 2007. All men had stress urinary incontinence; 58 after undergoing radical prostatectomy and four after surgery for benign prostatic hyperplasia (BPH, which is a common enlargement of the prostate that usually happens after age 50). Follow-up assessments were conducted at one, three, six and 12 months, and then every year until year four. Treatment was considered successful if the patient stopped wearing continence pads altogether or the number of pads used decreased by at least half. Men were also asked about any complications resulting from the sling procedure.

What they found

  • At one month, urinary incontinence was cured in 67% of men and improved in 25%. Cure rates were higher (88%) in men who had used less than five pads per day before the sling procedure and in men who did not have adjuvant radiation therapy (combined surgery and radiation treatment) for their prostate cancer.
  • The procedure failed to improve continence in 8% of men.
  • Failures were generally apparent immediately after the catheter was removed.
  • Cure and improvement rates remained about the same out to three years after the procedure was performed.
  • Too few men were available for four-year follow-up to obtain meaningful results.
  • The most frequent complication associated with the InVance sling was localized occasional pain in the scrotum, perineum or thighs, which was relieved with non-opioid analgesics such as Tylenol etc. Infections occurred in two men.

Why it matters
This study showed improvements in urinary incontinence similar to previous studies of the InVance sling, but further indicated that these results could be maintained up to three or four years after the procedure. The InVance sling therefore appears superior to the earlier Kauffman sling, which produced cure rates of 56% at four years with an additional 8% of men showing improvement. In 27% of men with the Kauffman sling, strings needed to be re-tightened after a time. The authors believe the InVance sling's better performance has to do with the durable anchorage provided by the six screws inserted into the public bone.

The InVance sling also produces better results than alternative urinary incontinence treatments such as bulking agents, which produce good initial improvements but have one-year success rates below 20%. The sling offers comparable advantages to artificial urinary sphincter and liberates men from having to fiddle with the artifical sphincter.

The authors feel that the InVance sling should be considered a first choice in men with less severe stress urinary incontinence who have not undergone radiation therapy.

Next question
Longer-term studies need to be conducted.

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