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N/A N=123 Randomized Treatment

Treatment of Stress Urinary Incontinence Via Smartphone

Female Stress Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT01848938 ↗
Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) — 11.1; 11.0; 7.0; 10.2 units on a scale — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Smartphone treatment with PFMT (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Umeå University
Primary completion
Nov 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)		 11.1; 11.0; 7.0; 10.2 <0.001 sig
PRIMARY
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)		 34.1; 34.8; 28.8; 34.1 0.005 sig
SECONDARY
Usage of Incontinence Aids		 23; 14; 13; 11; 10; 13 0.023 sig
SECONDARY
Patient Satisfaction		 5; 35; 20 —
SECONDARY
Incontinence Episode Frequency (IEF)		 21.0; 17.5; 7; 14 0.001 sig
SECONDARY
Patient's Global Impression of Improvement Scale (PGI-I)		 6; 0; 28; 3; 22; 9 <0.001 sig

Summary

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

Eligibility 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 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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01848938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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