Trial record 7 of 61 for:    Vulvar Cancer: Clinical Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01806350
First received: March 5, 2013
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Cervical Cancer
Endometrial Cancer
Ovarian Epithelial Cancer
Ovarian Germ Cell Tumor
Uterine Sarcoma
Vulvar Cancer
Other: questionnaire administration
Procedure: standard follow-up care
Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Improvement in the Patient Global Impression of Improvement (PGI-I) rating [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).


Secondary Outcome Measures:
  • Changes in the Incontinence Severity Index (ISI) score [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Urinary Distress Inventory (UDI) [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: November 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (PFMT)
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.
Other: questionnaire administration
Ancillary studies
Other: educational intervention
Undergo PFMT
Other Name: intervention, educational
Active Comparator: Arm II (usual care)
Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
Other: questionnaire administration
Ancillary studies
Procedure: standard follow-up care
Receive usual care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806350

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Teresa Rutledge, MD University of New Mexico Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01806350     History of Changes
Other Study ID Numbers: INST 0912, NCI-2012-01319
Study First Received: March 5, 2013
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Pelvic floor muscle training; incontinence; quality of life

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Cervical Neoplasms
Vulvar Neoplasms
Neoplasms, Germ Cell and Embryonal
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms, Connective and Soft Tissue
Urinary Incontinence
Germinoma
Sarcoma
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 14, 2014