Exercise for Urge Urinary Incontinence

(MOVEONUP Trial)

Overseen By Julia Vresilovic

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Cancer, Neurodegenerative, Stroke, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

375 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist older women with urge urinary incontinence—a sudden, strong need to urinate—by reducing their risk of falls. Participants in the exercise group will engage in physical therapy, pelvic floor exercises, Kegel exercises, and balance and strength training to improve balance, strength, bladder control, and home safety. The control group will receive booklets on fall prevention and bladder control tips. Women aged 70 or older, living independently, with moderate to severe urge urinary issues who aren't very active may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to valuable research that may enhance the quality of life for others facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not plan to start new treatments for urinary incontinence or overactive bladder during the study.

What prior data suggests that this exercise intervention is safe for older women with urinary urge incontinence?

Research has shown that exercises for the pelvic floor muscles are generally safe and manageable. These exercises can help manage symptoms like urinary leaking, often related to urinary urge incontinence. Studies have not reported any serious side effects, making these exercises a safe option for many people.

Pelvic floor exercises, such as Kegel exercises, are often recommended to improve bladder control. They are easy to perform and don't require medication or surgery, offering a low-risk way to strengthen the pelvic floor and reduce incontinence issues.

Overall, the exercise plan in this trial, which includes balance and strength training along with bladder training, should be safe with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise-based intervention for urge urinary incontinence because it offers a holistic approach compared to standard treatments like medications or pelvic floor physical therapy. This new method combines general balance and strength training with specific bladder training and urge suppression techniques, potentially enhancing both physical stability and bladder control. Additionally, the inclusion of home hazard assessments aims to create a safer living environment, which is a fresh angle not typically addressed by current treatments. This comprehensive approach could provide a more sustainable and accessible way to manage symptoms, reducing reliance on medication and its associated side effects.

What evidence suggests that this exercise intervention is effective for reducing falls in older women with urinary urge incontinence?

Research shows that exercises to strengthen the pelvic floor muscles can help manage urinary urge incontinence. By strengthening the muscles that support the urinary tract, these exercises help prevent leaks and control the sudden urge to urinate. Studies have found this training effective in about 29% to 59% of cases. Often, these exercises are the first recommended step for treating urinary incontinence in women. Participants in the trial's exercise group will focus on improving balance, building strength, and training the bladder to address these issues. ^{1 6 7 8 9}

Who Is on the Research Team?

Uduak Andy, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

The MoVEonUp trial is for women aged 70 or older who live independently, can consent and communicate in English, are not very physically active, and have moderate to severe urge-predominant urinary incontinence. They should be able to participate in an exercise program without harming their health as confirmed by a doctor.

Inclusion Criteria

I live on my own and manage my daily activities.

I am not planning to start new treatments for urinary issues during the study.

I can walk on my own or with help from a device.

Exclusion Criteria

You have a heart condition that is not stable according to your own report.

Not willing to sign Consent Form

I have a pelvic organ prolapse that extends beyond the vaginal opening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the exercise group will participate in home-based exercises including balance and strength training, bladder training, and home hazard assessments. The control group will receive informational booklets on fall prevention and behavioral treatment for urinary urge incontinence.

12 months

Follow-up

Participants are monitored for changes in urinary incontinence and number of falls over the course of the trial

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Group

Trial Overview This study tests if exercises that improve balance and strength combined with bladder training can reduce falls in older women with Urinary Urge Incontinence. Participants will either join the exercise group or receive educational booklets on fall prevention.

How Is the Trial Designed?

Group I: Exercise Group Active Control 1 Intervention

Participants in this group will participate in the home-based exercise group intervention that consists of general balance and strength training, bladder training and urge suppression, and home hazard assessments.

Group II: Control Group Active Control 1 Intervention

Participants in this group will receive informational booklets on fall prevention and behavioral treatment for Urgency Incontinence.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Pelvic floor muscle exercises are highly effective for treating urinary stress incontinence in women, with studies showing up to a 70% improvement in symptoms after proper training.

Supervised exercise programs led by physiotherapists or continence nurses are more effective than unsupervised methods, and a minimum of three months of training is recommended for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor exercise for urinary incontinence: a systematic literature review. Price, N., Dawood, R., Jackson, SR.[2022]

Female athletes experience a higher rate of urinary incontinence (61.1%) during high-intensity exercise compared to untrained women (12.5%), indicating that even well-trained athletes may be at risk for this issue.

Despite similar pelvic floor muscle strength between athletes and untrained women, the study suggests that specific pelvic floor exercises are necessary to strengthen these muscles, as general training does not appear to improve pelvic floor strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of pelvic floor muscle strength in competition-level athletes and untrained women]. Ludviksdottir, I., Hardardottir, H., Sigurdardottir, T., et al.[2019]

After two months of pelvic floor exercises, 21% of the 24 patients with grade II stress urinary incontinence showed improved urethral closure pressure, indicating a potential mechanism of reflex contraction of pelvic floor muscles during stress.

54% of patients reported subjective improvement in their condition, suggesting that pelvic floor exercises can be an effective primary treatment for stress urinary incontinence, especially for those with mild to moderate symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of pelvic floor exercises on urethral function in female stress urinary incontinence: an urodynamic study. Kujansuu, E.[2004]

A study involving 91 women with urinary incontinence found that both pelvic floor muscle training (PFMT) and assisted pelvic floor muscle training (APFMT) using the Kegelmaster device significantly improved urinary incontinence symptoms and quality of life after 12 weeks of training.

There was no significant difference in effectiveness between PFMT and APFMT, indicating that both methods are equally beneficial for strengthening pelvic floor muscles and reducing involuntary urine passage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effect of pelvic floor muscle training (PFMT or Kegel exercise) and assisted pelvic floor muscle training (APFMT) by a resistance device (Kegelmaster device) on the urinary incontinence in women: a randomized trial. Kashanian, M., Ali, SS., Nazemi, M., et al.[2022]

Intensive group physical therapy significantly reduced daytime urinary frequency by 22% after 4 weeks and 19% after 3 months, while biofeedback training showed minimal improvement in daytime frequency, indicating that physical therapy may be more effective for this aspect of urinary stress incontinence.

Both therapies improved nocturnal urinary frequency, but biofeedback training resulted in a higher percentage of patients reporting complete resolution of incontinence episodes (62% vs. 28% in the physical therapy group), suggesting that while physical therapy is effective, biofeedback may offer better subjective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women. Pages, IH., Jahr, S., Schaufele, MK., et al.[2019]

A systematic review of seven randomized controlled trials found no convincing evidence that alternative exercises, such as abdominal training, the Paula method, or Pilates, effectively reduce urinary leakage in women with stress urinary incontinence.

Due to the lack of strong evidence, alternative exercise regimens should not be recommended for clinical practice in treating stress urinary incontinence, as they remain in the Testing Phase of evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There is not yet strong evidence that exercise regimens other than pelvic floor muscle training can reduce stress urinary incontinence in women: a systematic review. Bø, K., Herbert, RD.[2018]

In a review of 21 trials involving 1490 women, pelvic floor muscle training with regular supervision (weekly or bi-weekly group sessions) significantly improved outcomes for women with stress urinary incontinence, with only 10% reporting no improvement compared to 43% in the individual supervision group.

Despite the positive findings, the evidence is not strong enough to recommend a specific training approach, highlighting the need for more consistent and well-defined training protocols in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Hay-Smith, EJ., Herderschee, R., Dumoulin, C., et al.[2022]

A short-term physical therapy intervention, including transvaginal electrical stimulation and pelvic floor kinesiotherapy, significantly improved muscle function in pelvic floor muscles among 82 women with urinary incontinence, with a satisfaction rate of 88.9%.

Despite no significant change in perineometry measurements, the intervention effectively addressed mixed, stress, and urge urinary incontinence, leading to increased patient satisfaction and reported continence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of outpatient physical therapy intervention on pelvic floor muscles in women with urinary incontinence. Knorst, MR., Resende, TL., Santos, TG., et al.[2013]

Kegel exercises significantly enhance the effectiveness of resistance training in reducing stress urinary incontinence (SUI) among incontinent women, as shown by a comparative study with pre and post intervention assessments.

Women who performed Kegel exercises before resistance training experienced greater improvements in pelvic floor muscle strength and body composition, including increased muscle mass and decreased fat mass, highlighting the importance of Kegel exercises in managing SUI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a Kegel Exercise Program Prior to Resistance Training Reduce the Risk of Stress Urinary Incontinence? Cross, D., Kirshbaum, MN., Wikander, L., et al.[2023]

Pelvic floor muscle training (PFMT) is effective for women with urinary incontinence, showing that those who participated in PFMT were more likely to report improvement or cure compared to those who did not, based on a review of 13 trials involving 714 women.

While PFMT generally resulted in about one fewer incontinence episode per day, the studies showed significant variability in methods and outcomes, suggesting that younger women with stress urinary incontinence may benefit the most from longer, supervised training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Hay-Smith, EJ., Dumoulin, C.[2022]

Pelvic muscle exercises have been used for 50 years to manage pelvic floor dysfunction, particularly after childbirth, and their applications have expanded over time.

The article reviews various techniques for these exercises, including biofeedback and electrical stimulation, and highlights their effectiveness in treating stress and urge urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsurgical management of pelvic floor dysfunction. Visco, AG., Figuers, C.[2019]

Citations

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Pelvic floor muscle exercise and training for coping with ... PFME strengthens the pelvic floor muscles to provide urethral support to prevent urine leakage and suppress urgency. This exercise has been recommended for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10301414/

Effectiveness of Pelvic Floor Muscle Training on Quality ... Several studies have reported that training regimens that strengthen the pelvic floor muscles have effectiveness rates from 29% to 59%. These ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1836955325001092

Supervised exercise and pelvic floor muscle training eases ... Research. Supervised exercise and pelvic floor muscle training eases current pelvic and genital pain but not worst pelvic and genital pain in women with ...

4. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-022-01742-w

Mechanisms of pelvic floor muscle training for managing ... Pelvic floor muscle training is recommended as first line treatment for urinary incontinence in women based on three proposed theorized mechanisms.

5. gastrojournal.org gastrojournal.org/article/S0016-5085(03)01613-5/fulltext

Behavioral treatment options for urinary incontinence Most studies have focused on demonstrating the effectiveness of pelvic floor muscle training and exercise; little research has focused on the mechanisms of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07048145

Effects of Kegel Ball and Pelvic Floor Exercises on Sexual ... The use of vaginal Kegel balls may enhance the effects of these exercises by promoting increased muscle activation and pelvic awareness.

7. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009508.pub2/abstract

Comparisons of approaches to pelvic floor muscle training ... ‐ Pelvic floor muscle training combined with indirect training may make little to no difference compared to pelvic floor muscle training alone.

8. mayoclinic.org mayoclinic.org/healthy-lifestyle/womens-health/in-depth/kegel-exercises/art-20045283

Kegel exercises: A how-to guide for women Kegel exercises can help prevent or control urinary leaking and other pelvic floor symptoms. Here's a step-by-step guide to doing Kegel ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211524003889

Comparison of the effects of pelvic floor muscle training ... The aim of this study was to compare the effects of pelvic floor muscle training (PFMT) and modified pilates exercises (MPE) in elderly women with stress ...