Gynecologic CancerNCT03957434
Physiotherapy Treatment for Gynecological Cancer Survivors With Urinary Incontinence
A study testing Physiotherapy in people with Gynecologic Cancer and Urinary Incontinence, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The aims of this pilot study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence in preparation of a large randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Gynecologic Cancer, Urinary Incontinence
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 16 Oct 2018to 16 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
- Scheduled oncological treatments completed
- Stress or mixed urinary incontinence with a frequency of at least three urinary leakage per
Who cannot join
- Pelvic floor rehabilitation in the last year
- Other conditions interfering with assessment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors With Urinary Incontinence
The aims of this pilot study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence in preparation of a large randomized controlled study.
Read the detailed description
Epidemiological studies demonstrated a growing number of gynecological cancer survivors, and this population is at great risk of developing pelvic floor dysfunction after cancer and its treatment. Representing the most prevalent pelvic floor dysfunction, urinary incontinence affects up to 70% of gynecological cancer survivors. International practice guidelines, in line with available meta-analysis, recommend physiotherapy as a first-line treatment to reduce urinary incontinence. However, there is limited evidence on its effectiveness in gynecological cancer survivors. Considering the current knowledge and the negative impacts of urinary incontinence, there is an urgent need to examine whether this population can benefit from this intervention in a pilot study, to conduct eventually a larger randomized controlled trial. The objectives of the present study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence. A total of 44 participants will be randomized to receive either physiotherapy or standard usual care (wait-list for physiotherapy). Baseline and post-treatment evaluations will be realized by a physiotherapist.
- Conditions
- Gynecologic Cancer, Urinary Incontinence
- Being tested
- Physiotherapy
- Keywords
- Pilot study, Gynecological cancer survivors, Urinary Incontinence, Physiotherapy
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called Pelvic floor rehabilitation
Education, pelvic floor muscle exercises with biofeedback and home exercises.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Experimental | 12-weekly physiotherapy treatment sessions. Receives: Other: Physiotherapy |
| Standard usual care | No intervention | Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rates
To determine acceptability by assessing adherence to exercises.
Measured: Baseline to 2-week post-treatment evaluation
Retention rate
To determine feasibility by evaluating attrition.
Measured: Baseline to 2-week post-treatment evaluation
Secondary outcomes (8)
Change from baseline in number of urinary leaks
7-day voiding schedule will be used to evaluate the reduction of urinary leakage.
Measured: Baseline to 2-week post-treatment
Change from baseline in symptoms of pelvic floor dysfunction
To explore changes in pelvic floor symptoms (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form ranging from 0 to 21), a high score represents high pelvic floor symptoms.
Measured: Baseline to 2-week post-treatment evaluation
Change from baseline in pelvic floor muscle function
To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry).
Measured: Baseline to 2-week post-treatment evaluation
Change from baseline in pelvic floor muscle morphometry
To explore changes in pelvic floor muscle function at rest and during contraction (ultrasound).
Measured: Baseline to 2-week post-treatment evaluation
Change from baseline in sexual function
To explore changes in sexual function (Female Sexual Function Index ranging from 2 to 36), a low score represents a low sexual function.
Measured: Baseline to 2-week post-treatment evaluation
Change from baseline in quality of life
To explore changes in quality of life (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ranging from 0 to 100), a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life represents a high quality of life and a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: Baseline to 2-week post-treatment evaluation
Patient's global impression of change
To determine patient self-reported improvement (Patient's Global Impression of Change ranging from "very much worse" to "very much improved" on a 7-point scale.
Measured: Baseline to 2-week post-treatment evaluation
Rate of adverse events
To document any adverse events.
Measured: Baseline to 2-week post-treatment evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start16 Oct 2018
- Primary completion16 Oct 2025 (estimated)
- Study completion16 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Institut Universitaire de Gériatrie de Montréal, Jewish General Hospital, Centre hospitalier de l'Université de Montréal (CHUM)
- Responsible party
- Principal investigator, Mélanie Morin, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957434
- Sponsor's protocol ID
- MP-31-2017-1683
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2019
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Examining Feasibility and Effects of Physiotherapy Treatment Compared to Standard Usual Care in Gynecological Cancer Survivors With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03957434
- Acronym / sponsor ID
- MP-31-2017-1683
- Conditions
- Gynecologic Cancer, Urinary Incontinence
- Keywords
- Pilot study, Gynecological cancer survivors, Urinary Incontinence, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Institut Universitaire de Gériatrie de Montréal, Jewish General Hospital, Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 16 Oct 2025 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this pilot study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence in preparation of a large randomized controlled study.
Detailed description
Epidemiological studies demonstrated a growing number of gynecological cancer survivors, and this population is at great risk of developing pelvic floor dysfunction after cancer and its treatment. Representing the most prevalent pelvic floor dysfunction, urinary incontinence affects up to 70% of gynecological cancer survivors. International practice guidelines, in line with available meta-analysis, recommend physiotherapy as a first-line treatment to reduce urinary incontinence. However, there is limited evidence on its effectiveness in gynecological cancer survivors. Considering the current knowledge and the negative impacts of urinary incontinence, there is an urgent need to examine whether this population can benefit from this intervention in a pilot study, to conduct eventually a larger randomized controlled trial. The objectives of the present study are to examine the feasibility and to explore the effects of a physiotherapy treatment compared to standard usual care in gynecological cancer survivors with urinary incontinence. A total of 44 participants will be randomized to receive either physiotherapy or standard usual care (wait-list for physiotherapy). Baseline and post-treatment evaluations will be realized by a physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Baseline evaluation - Randomization to physiotherapy or standard usual care (12 weeks) - Post-treatment evaluation
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Experimental | Other: Physiotherapy12-weekly physiotherapy treatment sessions. |
| Standard usual care | No intervention | –Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus)
- Scheduled oncological treatments completed
- Stress or mixed urinary incontinence with a frequency of at least three urinary leakage per
Key exclusion criteria (2 listed)
- Pelvic floor rehabilitation in the last year
- Other conditions interfering with assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAlso: Pelvic floor rehabilitationEducation, pelvic floor muscle exercises with biofeedback and home exercises. | Other | Physiotherapy |
Primary outcome
Adherence rates
Time frame: Baseline to 2-week post-treatment evaluation
To determine acceptability by assessing adherence to exercises.
Retention rate
Time frame: Baseline to 2-week post-treatment evaluation
To determine feasibility by evaluating attrition.
8 secondary outcomes
Change from baseline in number of urinary leaks
Time frame: Baseline to 2-week post-treatment
Change from baseline in symptoms of pelvic floor dysfunction
Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in pelvic floor muscle function
Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in pelvic floor muscle morphometry
Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in sexual function
Time frame: Baseline to 2-week post-treatment evaluation
Change from baseline in quality of life
Time frame: Baseline to 2-week post-treatment evaluation
Patient's global impression of change
Time frame: Baseline to 2-week post-treatment evaluation
Rate of adverse events
Time frame: Baseline to 2-week post-treatment evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Gynecologic Cancer and Urinary Incontinence, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rates (time frame: Baseline to 2-week post-treatment evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.