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Completed

NCT Number: NCT01806350

Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors

This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.

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Key information

About this study

PRIMARY OBJECTIVES:

I. To assess whether pelvic floor muscle training and behavioral therapy in gynecologic cancer survivors results in improvement in incontinence symptoms as measured by a validated questionnaire (Patient Global Impression of Improvement) at three month follow-up when compared to women who do not undergo pelvic floor muscle training.

II. To evaluate whether women who undergo pelvic floor muscle training and behavioral therapy report greater improvement in validated urinary incontinence symptom severity, pelvic floor distress and quality of life measures than women who do not undergo pelvic floor muscle training.

III. To evaluate the acceptability of pelvic floor muscle training (PFMT) among gynecological cancer survivors and to provide preliminary data to inform a power analysis for a larger randomized trial.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.

ARM II: Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.

After completion of study treatment, patients are followed up at 3 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of uterine, cervical, ovarian or vulvar malignancy
  • Treatment free interval of >= one year and currently have no evidence of cancer
  • Reports urinary incontinence based on screening questionnaire
  • Must have a stable address for the three month period

Exclusion criteria

  • Current clinical evidence of urinary tract infection
  • Within three months of failed surgery for urinary incontinence
  • Planned surgery for urinary incontinence in the next three months
  • Presence of neurologic condition that may impact bladder symptoms such as multiple sclerosis, stroke
  • Pregnancy

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies

standard follow-up care

Procedure

Receive usual care

Educational Intervention

Other

Undergo PFMT

Other names: intervention, educational

Primary outcomes

  1. Improvement in the Patient Global Impression of Improvement (PGI-I) rating

    Time frame: 12 weeks

    Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).

Secondary outcomes

  1. Changes in the Incontinence Severity Index (ISI) score

    Time frame: Baseline to 3 months

    The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.

  2. Changes in Urinary Distress Inventory (UDI)

    Time frame: Baseline to 3 months

    The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.

  3. Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life

    Time frame: Baseline to 3 months

    The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner. A two sample t-test on the within individual differences will be used. A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.

Sponsors and collaborators

Lead sponsor

New Mexico Cancer Research Alliance

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2013
Registry last updated
Mar 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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