Physiotherapy for Urinary Incontinence in Gynecologic Cancer Survivors

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Pelvic floor rehab, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of physiotherapy (also known as Pelvic Floor Physical Therapy or Pelvic Health Physiotherapy) for women who have had gynecological cancer and experience urinary incontinence. It compares a 12-week physiotherapy program to the usual care provided by doctors. The trial targets women who have completed cancer treatments and experience stress or mixed urinary incontinence at least three times a week. The goal is to determine if physiotherapy can reduce these leaks and improve quality of life. As an unphased trial, this study offers a unique opportunity to explore new methods to enhance recovery and quality of life after cancer treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that physiotherapy is safe for gynecologic cancer survivors with urinary incontinence?

Research has shown that physiotherapy is generally safe for people with urinary incontinence. It often includes exercises like pelvic floor muscle training, which addresses pelvic floor issues. These exercises are typically easy to perform and don't cause problems for most individuals.

Studies have found that pelvic floor muscle training benefits women who have had gynecological cancer, helping them manage urinary incontinence after treatment. Importantly, no major negative side effects have been reported from these exercises.

This type of physiotherapy can also be conducted through telehealth (remote healthcare), with patients managing well without serious issues. Overall, physiotherapy remains a safe option for those dealing with urinary incontinence after gynecological cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about physiotherapy for urinary incontinence in gynecologic cancer survivors because it offers a non-invasive, drug-free alternative to traditional treatments like medication or surgery. Unlike other treatments that often focus on managing symptoms, physiotherapy aims to improve pelvic floor strength and function, potentially addressing the root cause of incontinence. This approach not only enhances physical health but also empowers survivors with self-management techniques, promoting long-term well-being.

What evidence suggests that physiotherapy is effective for urinary incontinence in gynecologic cancer survivors?

Research has shown that physiotherapy can help manage urinary incontinence in women who have survived gynecologic cancer. In this trial, participants will join either a physiotherapy group or a standard usual care group. One effective method under study is pelvic floor muscle training, a type of physiotherapy that helps control symptoms and improve quality of life. Studies have found that these exercises effectively treat pelvic floor problems, which are common after cancer treatment. Additionally, delivering physiotherapy via telehealth has proven effective for treating incontinence after surgery. Overall, these findings suggest that physiotherapy offers a promising way to manage urinary incontinence in this group. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women who have survived gynecological cancers like endometrial or cervical cancer and are now experiencing urinary incontinence at least three times a week. They should be done with their scheduled cancer treatments but haven't had pelvic floor rehab in the past year, and don't have other conditions that could affect the study.

Inclusion Criteria

I have finished all my planned cancer treatments.

I experience urinary leakage at least three times a week.

I have had cancer in my reproductive organs.

Exclusion Criteria

Other health issues that might make it hard to evaluate the study results.

I have undergone pelvic floor rehabilitation in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 12-weekly physiotherapy treatment sessions or continue standard usual care for 12 weeks

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Physiotherapy

Trial Overview The study is testing physiotherapy as a treatment for urinary incontinence against standard care given to survivors of gynecological cancers. It's a pilot study meant to set up for a larger future trial by checking how feasible this approach is.

How Is the Trial Designed?

Group I: Physiotherapy Experimental Treatment 1 Intervention

12-weekly physiotherapy treatment sessions.

Group II: Standard usual care Active Control 1 Intervention

Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks.

Physiotherapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Pelvic Floor Physical Therapy for:

• Urinary incontinence in gynecological cancer survivors
• Pelvic pain
• Sexual dysfunction

Approved in United States as Pelvic Floor Physical Therapy for:

• Urinary incontinence in gynecological cancer survivors
• Pelvic pain
• Sexual dysfunction

Approved in Canada as Pelvic Floor Physical Therapy for:

• Urinary incontinence in gynecological cancer survivors
• Pelvic pain
• Sexual dysfunction

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

Institut Universitaire de Gériatrie de Montréal

Collaborator

Trials

3

Recruited

130+

Jewish General Hospital

Collaborator

Trials

144

Recruited

283,000+

Published Research Related to This Trial

Pelvic floor muscle training (PFMT) significantly improves symptoms of stress urinary incontinence (SUI), with women in PFMT groups being eight times more likely to report a cure compared to those receiving no treatment, based on a systematic review of 31 trials involving 1817 women.

PFMT not only reduces the number of leakage episodes but also enhances quality of life and treatment satisfaction, with rare minor adverse events, suggesting it should be considered a first-line treatment for urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Dumoulin, C., Cacciari, LP., Hay-Smith, EJC.[2023]

In a review of 24 trials involving 1583 women, it was found that adding biofeedback to pelvic floor muscle training (PFMT) significantly improved the likelihood of women reporting their urinary incontinence as cured or improved, with a risk ratio of 0.75.

Despite the positive findings, many trials had a moderate to high risk of bias, and it remains unclear whether the benefits were due to the feedback itself or increased contact with healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Herderschee, R., Hay-Smith, EJ., Herbison, GP., et al.[2022]

In a study of 49 women undergoing vaginal reconstruction, pelvic floor physical therapy (PFPT) showed initial improvements in muscle function at 12 weeks, but these benefits did not persist by the 24-week follow-up.

Overall quality of life and bladder symptoms improved for all participants by 24 weeks post-surgery, indicating that while PFPT did not provide additional long-term benefits, patients experienced ongoing improvements in their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy: impact on quality of life 6 months after vaginal reconstructive surgery. Pauls, RN., Crisp, CC., Novicki, K., et al.[2022]

In a study involving 25 young continent women over 8 weeks, both groups performing different frequencies of pelvic floor muscle (PFM) training showed significant improvements in PFM strength and activation, indicating that PFM training is effective for enhancing muscle function.

However, increasing the frequency of training sessions from one to three per day did not result in any additional benefits, suggesting that the total number of sessions may not be crucial for improving PFM function in women without dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of different regimens for pelvic floor muscle training in young continent women: Randomized controlled clinical trial. Pereira-Baldon, VS., Avila, MA., Dalarmi, CB., et al.[2019]

A qualitative study involving 28 gynecological cancer survivors found that multimodal pelvic floor physical therapy (PFPT) is acceptable and beneficial for treating dyspareunia, with participants reporting significant improvements in their condition.

Despite some participants finding the treatment intensity demanding, overall satisfaction was high, and all participants recommended the therapy, highlighting its effectiveness and relevance in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of multimodal pelvic floor physical therapy to treat dyspareunia after gynecological malignancies: a qualitative study of women's views and experiences. Cyr, MP., Dostie, R., Camden, C., et al.[2023]

Pelvic floor muscle training (PFMT) is highly effective for women with stress urinary incontinence (UI), showing a significant cure rate with a relative risk (RR) of 8.38 based on high-quality evidence from 21 trials involving 1281 women.

For women with any type of urinary incontinence, PFMT also demonstrates moderate quality evidence of being associated with a cure (RR 5.5) or improvement, reinforcing its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Dumoulin, C., Hay-Smith, J., Habée-Séguin, GM., et al.[2022]

Postpartum pelvic floor muscle training (PFMT) significantly reduces bothersome symptoms of pelvic organ prolapse (POP) and urinary incontinence (UI), particularly stress urinary incontinence, based on a meta-analysis of 15 randomized controlled trials involving 3845 women.

While PFMT may improve sexual function and could benefit women with anal sphincter injuries regarding anal incontinence, its effect on the actual staging of POP remains uncertain, indicating a need for more high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic Floor Muscle Training Versus Watchful Waiting and Pelvic Floor Disorders in Postpartum Women: A Systematic Review and Meta-analysis. Wu, YM., McInnes, N., Leong, Y.[2019]

Pelvic physical therapy is an effective first-line treatment for various types of urinary incontinence, offering non-invasive symptom relief with low risk of side effects and moderate costs, making it suitable for a wide range of patients including women, men, children, and the elderly.

Specific interventions like pelvic floor muscle (PFM) training and electrical stimulation have been shown to improve outcomes, particularly after radical prostatectomy in men, by reducing incontinence duration and enhancing quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of the pelvic physical therapist]. Berghmans, B.[2019]

Pelvic floor physiotherapy (PFPT) is an essential part of conservative treatment for women experiencing urogenital issues like urinary incontinence and pelvic organ prolapse, helping to improve their quality of life.

PFPT employs various techniques such as behavioral therapy, exercise, manual therapy, biofeedback, and electrical stimulation, making it a versatile approach to managing pelvic and sexual pain disorders linked to bladder symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physiotherapy for women with urogenital dysfunction: indications and methods. Rosenbaum, TY.[2017]

A pelvic floor muscle training (PFMT) program was developed and found to be acceptable among pregnant women in Nepal, with 57% attending the recommended four or more supervised visits.

The program showed promise in motivating women to perform daily PFMT at home, although no significant differences in urinary incontinence or pelvic organ prolapse symptoms were observed between those who attended the visits and those who did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training programme in pregnant Nepalese women-a feasibility study. Shijagurumayum Acharya, R., Tveter, AT., Grotle, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11579103/

Effectiveness of Pelvic Floor Muscle and Education-Based ... A recent systematic review examined the effectiveness of pelvic floor muscle (PFM) therapies in gynecological cancer survivors [9]. At the time of the review, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2468784723001551

Physiotherapy interventions in the treatment of pelvic floor ... Overall, pelvic floor training appears to be an effective technique in the treatment of pelvic floor dysfunction after the treatment of gynaecological ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10517895/

Pelvic floor muscle training delivered via telehealth to treat ... Telehealth-delivered PFMT may be feasible to treat incontinence after gynaecological cancer surgery.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01806350

Pelvic Floor Muscle Training in Treating Urinary ... Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211523002920

Pelvic floor dysfunction in gynecologic cancer survivors Pelvic floor dysfunction (PFD) is a common complication in gynecologic cancer survivors (GCS) and is now a worldwide medical and public health problem.

6. ejog.org ejog.org/article/S0301-2115(23)00292-0/abstract

Pelvic floor dysfunction in gynecologic cancer survivors Gynecologic cancer survivors often develop pelvic floor dysfunction after treatment. •. Treatments for early prevention of pelvic floor dysfunction is ...

7. link.springer.com link.springer.com/article/10.1007/s00520-024-09041-w

Female pelvic cancer survivors' experiences of pelvic floor ... The women who live with the experience of pelvic cancer experienced PFMT as a meaningful intervention for managing urinary and/or fecal incontinence after ...