Treatment of Stress Urinary Incontinence Via Smartphone

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eva Samuelsson, Umeå University
ClinicalTrials.gov Identifier:
NCT01848938
First received: April 26, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine whether treatment of stress urinary incontinence via smartphone is effective.


Condition Intervention
Female Stress Urinary Incontinence
Behavioral: Smartphone treatment with PFMT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Stress Urinary Incontinence Via Smartphone

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Change in the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) [ Time Frame: three months ] [ Designated as safety issue: No ]
    Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity

  • Change in the International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) [ Time Frame: three months ] [ Designated as safety issue: No ]
    The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.


Secondary Outcome Measures:
  • Change in usage of Incontinence Aids [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Change in Incontinence Episode Frequency (IEF) [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Patient`s Global Impression of Improvement Scale (PGI-I) [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Smartphone treatment
Smartphone treatment with PFMT.
Behavioral: Smartphone treatment with PFMT
A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. The treatment period is three months
No Intervention: Waiting list
Waiting list for three months. They receive the smartphone application after follow-up.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stress urinary incontinence
  • leakage once a week or more often
  • duration of symptoms for at least 6 months
  • motivation and time to perform a 12 week long treatment with PMFT
  • ability to read and write Swedish
  • asset to smartphone
  • possibility to send and receive email and asset to printer
  • accept to be randomized to one of two groups; a treatment group or a waiting list group

Exclusion Criteria:

  • participation in our previous internet study
  • pregnancy
  • former incontinence surgery
  • known malignancy in lower abdomen
  • difficulties with passing urine
  • visual blood in urine
  • intermenstrual bleeding
  • severe psychiatric diagnosis
  • neurological disease with affection on sensibility in legs or lower abdomen
  • urge incontinence
  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: NCT01848938

Locations
Sweden
Umea University
Umeå, Sweden, S-90185
Sponsors and Collaborators
Umeå University
Investigators
Study Chair: Eva Samuelsson, MD, PhD Department of Public Health and Clinical Medicine, Umeå University
  More Information

Additional Information:
No publications provided

Responsible Party: Eva Samuelsson, Associate professor, General Practitioner, Umeå University
ClinicalTrials.gov Identifier: NCT01848938     History of Changes
Other Study ID Numbers: VisareNorr301811, JLL314561, FAS2008-0952, ALFVLL222081
Study First Received: April 26, 2013
Last Updated: June 17, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
female
stress urinary incontinence
treatment
pelvic floor muscle training
smartphone
internet
life style
eHealth

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014