NCT01806350

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

March 5, 2013

Last Update Submit

March 6, 2013

Conditions

Cervical CancerEndometrial CancerOvarian Epithelial CancerOvarian Germ Cell TumorUterine SarcomaVulvar Cancer

Keywords

Pelvic floor muscle training; incontinence; quality of life

Outcome Measures

Primary Outcomes (1)

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

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

    12 weeks

Secondary Outcomes (3)

  • Changes in the Incontinence Severity Index (ISI) score

    Baseline to 3 months

  • Changes in Urinary Distress Inventory (UDI)

    Baseline to 3 months

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

    Baseline to 3 months

Study Arms (2)

Arm I (PFMT)

EXPERIMENTAL

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 administrationOther: educational intervention

Arm II (usual care)

ACTIVE COMPARATOR

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

Other: questionnaire administrationProcedure: standard follow-up care

Interventions

questionnaire administrationOTHER

Ancillary studies

Arm I (PFMT)Arm II (usual care)
standard follow-up carePROCEDURE

Receive usual care

Arm II (usual care)
educational interventionOTHER

Undergo PFMT

Also known as: intervention, educational
Arm I (PFMT)

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsCarcinoma, Ovarian EpithelialVulvar Neoplasms

Interventions

Early Intervention, EducationalMethods

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersVulvar Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Teresa Rutledge, MD

    University of New Mexico Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

November 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(1)