The effect on quality of life of Contrelle Activgard
Research type
Research Study
Full title
A prospective observational study surveying the impact of utilising Contrelle Activgard in women with incontinence on quality of life.
IRAS ID
316674
Contact name
Alexandra Kermack
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This research is being conducted to assess whether utilising an intravaginal device (contrelle Activgard) for urinary incontinence significantly improves the patients' quality of life (QoL) in addition to relieving symptoms. Urinary incontinence can present significant problems to patients, affecting both their physical and mental wellbeing. This is therefore an important area to address. The aims of this study are:
• To determine if there is a reduction in urinary incontinence when utilising Contrelle Activgard at 4 weeks, 8 weeks and 12 weeks. There will be an option for additional questionnaires at six months and 12 months.
• To evaluate the frequency, severity and impact on quality of life (QoL) of urinary incontinence pre and post treatment with Contrelle Activgard (over a three month period).
• To understand which QoL domains are improved by the current treatment.Recruited women will be those aged between 18 and 65, who have been referred from primary care and are suffering from stress, mixed or urge incontinence and are willing to try an intravaginal device (Contrelle Activgard) for treatment.
Recruitment, consent and data collection will occur through the urogynaecology departments in recruiting hospitals and the study will last two years, to allow for follow up times. Participants will complete three questionnaires including demographic details and validated questions on urinary incontinence and quality of life (ICIQ-UI and ICIQ-LUTSqol).
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0055
Date of REC Opinion
29 Sep 2023
REC opinion
Further Information Favourable Opinion