FEEL-GOOD study
Research type
Research Study
Full title
FEEL-GOOD study: Female Empowerment through Enhanced Living: a comparison of vaGinal continence devices and pelvic flOOr muscle training (PFMT) versus PFMT only for female stress urinary incontinence: a feasibility and pilot StuDy. Stage 2
IRAS ID
334827
Contact name
Mohamed Abdel-Fattah
Contact email
Sponsor organisation
University of Aberdeen
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Urinary incontinence (UI) is common and debilitating, affecting >6million UK women over age of 40years, causing embarrassment, low self-esteem, social isolation, and reduced productivity. First-line treatment is pelvic floor muscle training (PFMT), but currently one in three women still proceed to surgery.
Vaginal continence devices (VCDs), worn inside the vagina, support the bladder to help achieve continence. Guidelines recommend VCDs are used when PFMT is not effective. Combining VCDs with PFMT might be more effective for treating UI than PFMT alone, improving quality of life (QoL) and reducing the need for surgery. VCDs are widely used, despite little evidence about their benefits, risks and whether they provide value-for-money.
Providing such evidence requires a complex and expensive clinical trial. A preliminary study is needed to ensure that such study is feasible and can be conducted successfully. Working closely with our PPI partners “Women Voices” and “Bladder Health-UK”, we co-developed a two-stage preliminary study. Stage-1 (which has a separate protocol and ethics approval from the University of Aberdeen School Ethics Review Board, SERB reference number 2758089) explores women’s and clinicians’ views on VCDs and a potential larger clinical trial, using interviews and focus groups. Stage-2 uses stage-1 findings to undertake a small version of the potential larger clinical trial. 74 women with UI from four-six UK hospitals will take part: 37 will receive PFMT alone and 37 PFMT plus VMD, with equal chance of being in either group. We will collect information on women’s symptoms and QoL before and after treatment (at 3 and 6 months). The results will help us design a clinical trial to fill the gap in evidence about effectiveness of VCDs combined with PFMT.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
25/SC/0077
Date of REC Opinion
28 Mar 2025
REC opinion
Further Information Favourable Opinion