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N/A N=250 Randomized Treatment

Web-based Management of Female Stress Urinary Incontinence

Female Stress Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT01032265 ↗
Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) — 10.3; 10.4; 7.3; 6.9 units on a scale — p=0.27

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Web-based treatment with PFMT and elements of CBT (Behavioral); Pamphlet treatment (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Umeå University
Primary completion
Apr 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)		 10.3; 10.4; 7.3; 6.9 0.27
PRIMARY
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)		 33.6; 33.6; 28.8; 27.8 0.52
SECONDARY
EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)		 79.2; 79.1; 81.8; 83.3 0.30
SECONDARY
Usage of Incontinence Aids		 11; 17; 23; 30; 46; 32 0.02 sig
SECONDARY
Patient Satisfaction		 15; 46; 56; 43; 31; 13 <0.001 sig
SECONDARY
Incontinence Episode Frequency (IEF)		 9.4; 12.7; 4.4; 4.8 0.23
SECONDARY
Patient's Global Impression of Improvement Scale (PGI-I)		 4; 12; 26; 31; 60; 48 0.01 sig

Summary

The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.

Eligibility Criteria

Inclusion Criteria

  • stress urinary incontinence
  • leakage once a week or more often
  • ability to read and write Swedish
  • asset to computer with Internet connection

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01032265). 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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