Treatment of Stress Urinary Incontinence Via Smartphone

Not Applicable

Completed

Conditions: Female Stress Urinary Incontinence

Interventions: Behavioral: Smartphone treatment with PFMT

Registration Number: NCT01848938

Lead Sponsor: Umeå University

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

Detailed Description: Female urinary incontinence (UI) is very common and affects up to one fourth of grownup women. It may reduce quality of life for those affected and costs for society are high. The most common type of urinary incontinence is SUI, i.e leakage when coughing, sneezing or jumping.

The recommended first line treatment is pelvic floor muscle training (PFMT)which leads to improvement or cure in two-thirds of patients. In addition, life style changes, such as weight loss when obese, smoking cessation and reduction of fluid intake if high is recommended.

There is a need for new , flexible and easily accessible treatment programmes for female urinary incontinence. In our previous study, we compared two treatment programmes for SUI without face-to-face contact: one internet based and one sent by post, both based on three months of PFMT. In this randomized controlled trial of 250 women aged 18-70 years, we found highly significant improvements (p\<0.001) with large effect sizes (\>0,8)concerning primary outcomes (symptoms and quality of life scores) but no significant differences between groups. Compared with the postal group, more participants in the internet group perceived they were much or very much improved (40.9% vs 26.5%, p\<0.01, reported reduced usage of incontinence aids (59.5% vs 41.4%, p=0.02) and were satisfied with the treatment programme (84.8% vs 62.9%, p\<0.001).

The selling of smartphones is increasing rapidly. About 75% of all cellphones sold in Sweden today are smartphones. Two million adults in Sweden have a smartphone. Many smartphone owners have at least one health app on their phone. Exercise, diet, and weight apps are the most popular types.

From our previous experience of an Internet-based programme, we have developed a treatment program designed for smartphone. The effect of the treatment programme will be evaluated after three months by comparing the effect in the "smartphone group" with the effect in the "waiting group".

Participants are consecutively recruited through our website. They answer an online screening survey with automated immediated response for initial screening of eligibility criteria. Informed consent and leakage diary (number of episodes of urinary leakage during 48 hours) are sent by post. After that, they answer a web questionnaire and finally they are interviewed by a researcher to confirm the diagnosis SUI and to ascertain that the patient is well informed of the study procedure.

Women are then randomized to either of the two groups. Women in the smartphone group get a smartphone application for iphone or android. Follow-up after three months with a web questionnaire and a leakage diary. After that the waiting group get their smartphone application.

We aim to recruit 120 women aged 18 and older via our website www.tät.nu. In the power calculation we assume that the improvement in the symptom score (ICIQ UI SF) and the QOL score (ICIQ luts QOL)in the smartphone group will be similar to the improvement we found in the postal group in our previous study. We also assume that the waiting group will improve in some extent.

To detect a difference between groups, power 80%, 2-side test and significance 0,05, group size as follow

ICIQ UI SF Smartphone group improves 2.9 (SD3,1) and waiting group 1,0 (SD2,0); 30 in each group

ICIQ luts QOL Smartphone group improves 4.6 (SD6,7) and waiting group 2.0(SD3.0), 35 in each group

PGI (patient´s global impression of improvement). 26,5% improves much or very much (smartphone) and 4% (waiting group):39 in each group

We expect a drop out rate of 33% and thus need approximately 120 persons, 60 in each group.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 123

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone treatment	Smartphone treatment with PFMT	Smartphone treatment with PFMT.

Primary Outcome Measures

Name	Time	Method
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)	baseline, three months	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.
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)	baseline, three months	Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity

Secondary Outcome Measures

Name	Time	Method
Patient's Global Impression of Improvement Scale (PGI-I)	three months	A self-rated question that asks about the change experienced after treatment with 7 response options, ranging from "very much better" to "very much worse".
Usage of Incontinence Aids	three months	Usage of incontinence aids during the last 4 weeks.
Patient Satisfaction	three months	A self-rated question about if the current treatment was sufficient, with three response options
Incontinence Episode Frequency (IEF)	baseline, three months	number of incontinence episodes per week