Treatment of Stress Urinary Incontinence Via Smartphone

Female Stress Urinary Incontinence Clinical Trial

Official title:

Treatment of Stress Urinary Incontinence Via Smartphone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848938
• Other study ID #: VisareNorr301811
• Secondary ID: JLL314561FAS2008
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: May 28, 2015
• Start date: March 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Female urinary incontinence 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 stress urinary incontinence (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 information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Sweden	Umea University	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the 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	three months	No
Primary	Change in the 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.	three months	No
Secondary	Change in usage of Incontinence Aids		Three months	No
Secondary	Patient Satisfaction		three months	No
Secondary	Change in Incontinence Episode Frequency (IEF)		three months	No
Secondary	Patient`s Global Impression of Improvement Scale (PGI-I)		three months	No