6-week post-operative activity restriction for Stress Urinary Incontinence (SUI)

Phase-Based Estimates
1
Effectiveness
1
Safety
Yale New Haven Hospital, New Haven, CT
+1 More
6-week post-operative activity restriction - Behavioral
Eligibility
18+
Female
Eligible conditions
Stress Urinary Incontinence (SUI)

Study Summary

This study is evaluating whether a midurethral sling procedure is more effective than a 6-week postoperative restriction.

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Eligible Conditions

  • Urinary Incontinence, Stress
  • Stress Urinary Incontinence (SUI)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 6-week post-operative activity restriction will improve 1 primary outcome and 5 secondary outcomes in patients with Stress Urinary Incontinence (SUI). Measurement will happen over the course of 3 weeks.

3 weeks
Activity Assessment Scale (AAS)
6 months
Incontinence Impact Questionnaire Short Form (IIQ-7)
Patient Global Impression of Improvement (PGI-I)
6 months, 1 year
Change in cough stress test
Year 1
Change in Patient Satisfaction Post-Operative Questionnaire
Baseline, 6 Months
Change in urogenital distress inventory (UDI) stress score

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
3-week post-operative activity restriction

This trial requires 205 total participants across 2 different treatment groups

This trial involves 2 different treatments. 6-week Post-operative Activity Restriction is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

3-week post-operative activity restriction
Behavioral
Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.
6-week post-operative activity restriction
Behavioral
Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks, 6 months, and 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 weeks, 6 months, and 1 year for reporting.

Closest Location

Yale New Haven Hospital - New Haven, CT

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You must be at least 18 years old to purchase this product. show original
(SUI) do not require preoperative testing Patients who are undergoing surgery only to treat stress urinary incontinence don't need to have any preoperative testing. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for urinary incontinence, stress?

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The most common treatments for stress urinary incontinence were a pessary and a prescription medication. For women with stress urinary incontinence, a prescription medication was the most common treatment method for stress urinary incontinence. Only 10 percent of women with stress urinary incontinence took a prescription medication to treat stress urinary incontinence.

Unverified Answer

What are the signs of urinary incontinence, stress?

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Some signs of urinary incontinence, stress include the need to wear pants or underwear continuously to overcome leakage after prolonged sleep, excessive clothing to avoid leakage, loss of interest in sex, and the inability to sleep without getting up to urinate. Over time, urinary incontinence can result in urinary damage and the risk of urinary calculi. Thus, early diagnosis and treatment are crucial.

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What is urinary incontinence, stress?

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Urinary incontinence is common among women with and without chronic low back pain. Risk factors for urinary incontinence included age, prior incontinence and prior surgery. Urinary incontinence is also associated with comorbid conditions, including diabetes, hypertension and obesity - all of which require further investigation. Urinary incontinence, stress - the interaction of incontinence + stress - is a significant contributor to women's chronic pain. Further studies are needed into potential treatments.

Unverified Answer

Can urinary incontinence, stress be cured?

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Results of current surgical therapies to treat stress urinary incontinence are poor, with recurrence rates in the range of 58%-95%. Patients with stress incontinence have a high frequency of comorbid conditions. Urinary incontinence and stress incontinence should be treated as indications to surgery.

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How many people get urinary incontinence, stress a year in the United States?

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About 1.6 million women have stress urinary incontinence a year. Overall, 14 percent of people who meet criteria for stress urinary incontinence do not have it on admission.

Unverified Answer

What causes urinary incontinence, stress?

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Urinary incontinence is a condition in which women are stressed to the point of suffering great distress and/or having to admit their difficulties to a doctor. Urinary incontinence may be caused by a wide variety of factors. Stress, such as an unsupportive environment, is often blamed for urinary incontinence in women. Urinary incontinence does not necessarily have a medical cause.

Unverified Answer

Have there been any new discoveries for treating urinary incontinence, stress?

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Although no new treatments have been found to treat stress urinary incontinence, the use of antimuscarinics, aldosterone antagonists, and beta-blockers are being studied. These treatments may help with many symptoms of urinary incontinence, and more long-term studies are needed to determine their role. Aldosterone antagonists appear to be of some use for mild urinary incontinence, while beta-blockers appear to be safe and well-tolerated. Combination therapies may provide better results. The evidence supporting these treatments is still fairly limited at this time and more studies are needed before these treatments can be recommended in any form.

Unverified Answer

What is the latest research for urinary incontinence, stress?

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Incontinence is becoming one of the most common health issues in our age. There are many effective treatments for incontinence, but the problem of incontinence often continues. We need more research and more effective treatments. For stress incontinence, the only effective treatments currently available are the medications and surgeries. There are more options for stress incontinence if we only look at minimally invasive operations. If a patient is going to join one of these treatments, go immediately to [Power (with power) at Power(http://www.withpower.com/clinical-trials/treatment/minimally-invasive-operations/)] to join one of these surgeries.

Unverified Answer

What are the latest developments in 6-week post-operative activity restriction for therapeutic use?

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There are many variables in urinary continence rehabilitation, and a new approach, in the post-operative period will help to increase the effectiveness of physiotherapy treatment.

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Is 6-week post-operative activity restriction safe for people?

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There is no evidence that 6 weeks of physical activity restriction leads to reduced physical morbidity or disability, better short-term outcome or longer term outcome in patients having stress-voiding surgery for urinary urgency.

Unverified Answer

What is 6-week post-operative activity restriction?

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Results from a recent paper indicated that post-operative activity restriction for 1 month post-operative did not prolong analgesic consumption. We also found that there was no difference between post- operative activity restriction at 1 and 3 months. Results from a recent paper indicated that post-operative activity restriction for 3 months could safely be extended beyond 1 month post-operative. Therefore, 6-week post-operative activity restriction of the injured lower extremity could be safely extended for a total of 3 months.

Unverified Answer

Have there been other clinical trials involving 6-week post-operative activity restriction?

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There has been no formal trial comparing the effects of unrestricted versus restricted activity on post-operative quality of life or symptom improvement following anterior reconstruction. One trial, which restricts post-operative activity and limits self-report to 24h post-operative, does report improved outcomes. However, it has no control arm and is of questionable methodological accuracy, hence its findings need to be interpreted carefully. We recommend against the use of post-operative activity restriction on the grounds that there are no relevant randomized controlled trials in the literature.

Unverified Answer
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