Treatment of Stress Urinary Incontinence Via Smartphone

This study is currently recruiting participants.
Verified December 2013 by Umeå University
Sponsor:
Information provided by (Responsible Party):
Eva Samuelsson, Umeå University
ClinicalTrials.gov Identifier:
NCT01848938
First received: April 26, 2013
Last updated: December 23, 2013
Last verified: December 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848938

Contacts
Contact: Eva Samuelsson, MD, PhD +46(0)70 6966440 eva.samuelsson@jll.se
Contact: Göran Umefjord, MD PhD +46(0)70 3453793 goran.umefjord@lvn.se

Locations
Sweden
Umea University Recruiting
Umeå, Sweden, S-90185
Contact: Eva Samuelsson, MD PhD    +46(0)706966440    eva.samuelsson@jll.se   
Contact: Susanne Johansson, coordinator    +46(0)63142463    susanne.johansson@jll.se   
Principal Investigator: Eva Samuelsson, MD PhD         
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: December 23, 2013
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
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014