NCT01848938

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 9, 2016

Completed
Last Updated

April 5, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

April 26, 2013

Results QC Date

October 17, 2016

Last Update Submit

February 21, 2017

Conditions

Female Stress Urinary Incontinence

Keywords

femalestress urinary incontinencetreatmentpelvic floor muscle trainingsmartphoneinternetlife styleeHealth

Outcome Measures

Primary Outcomes (2)

  • International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)

    Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity

    baseline, three months

  • International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

    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.

    baseline, three months

Secondary Outcomes (4)

  • Usage of Incontinence Aids

    three months

  • Patient Satisfaction

    three months

  • Incontinence Episode Frequency (IEF)

    baseline, three months

  • Patient's Global Impression of Improvement Scale (PGI-I)

    three months

Study Arms (2)

Smartphone treatment

ACTIVE COMPARATOR

Smartphone treatment with PFMT.

Behavioral: Smartphone treatment with PFMT

Waiting list

NO INTERVENTION

Waiting list for three months. They receive the smartphone application after follow-up.

Interventions

Smartphone treatment with PFMTBEHAVIORAL

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

Smartphone treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 pelvic floor muscle training
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umea University

Umeå, Umeå, S-90185, Sweden

Location

Related Publications (1)

  • Asklund I, Samuelsson E, Hamberg K, Umefjord G, Sjostrom M. User Experience of an App-Based Treatment for Stress Urinary Incontinence: Qualitative Interview Study. J Med Internet Res. 2019 Mar 14;21(3):e11296. doi: 10.2196/11296.

    PMID: 30869644DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Eva Samuelsson
Organization
Umeå University, Umeå, Sweden
eva.samuelsson@umu.se
+46706966440

Study Officials

  • Eva Samuelsson, MD, PhD

    Department of Public Health and Clinical Medicine, Umeå University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, General Practitioner

Study Record Dates

First Submitted

April 26, 2013

First Posted

May 8, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 5, 2017

Results First Posted

December 9, 2016

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)