Gynecological Pelvic Floor Muscle Training

University of British Columbia

Status: Unknown

Conditions: Urinary Incontinence

Treatments: Other: Training; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01811602

H12-02473

F12-00262 (Other Grant/Funding Number)

Details and patient eligibility

About

A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training intervention led by a physiotherapist on urinary incontinence, quality of life and sexual health in women who report urinary urgency and incontinence following surgery and radiation treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).

Enrollment: 40 estimated patients

Sex: Female

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years

Exclusion criteria

• stage IV cancer or stage III and IV cervical cancer
• radiation not part of treatment
• known spinal or long bone metastases diagnosis with a neuromuscular disorder that may impact pelvic floor muscle function
• urinary incontinence issues prior to cancer diagnosis
• scheduled or previous surgical treatment of incontinence
• fecal incontinence
• body mass index (BMI) > 35
• use of medications to improve bladder function
• unable to complete questionnaires in English or unable to actively participate in physiotherapy treatment provided in English.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Training

Other group

Description:

Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction

Treatment:

Other: Training

Usual Care Control

Other group

Description:

Participants randomized to this arm will receive a 1-page educational pamphlet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.

Treatment:

Other: Usual Care