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Physiotherapy Treatment for Gynecological Cancer Survivors with Urinary Incontinence

U

Université de Sherbrooke

Status

Active, not recruiting

Conditions

Gynecologic Cancer
Urinary Incontinence

Treatments

Other: Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03957434
MP-31-2017-1683

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • Pelvic floor rehabilitation in the last year
  • Other conditions interfering with assessment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups

Physiotherapy
Experimental group
Description:
12-weekly physiotherapy treatment sessions.
Treatment:
Other: Physiotherapy
Standard usual care
No Intervention group
Description:
Participants will be asked to continue the usual care established during the regular follow-up with their medical doctor for 12 weeks.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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