[Summary text]
Prospective randomised parallel-group trial.
N = 55. Withdrawal = 14. Stress urinary incontinence (SUI) assessed by clinical examination (stress test) or mixed incontinence with predominant SUI. Mean age = 58.7 (range 29-88). Inclusion: Aged 18 or more, SUI assessed by clinical examination (stress test) or mixed incontinence with predominant SUI (at least 4 incontinence episodes per week), postmenopausal/contraception, no vaginal delivery in the past 2 months, no bladder/vaginal disease, no acute or recurrent urinary infection, no pelvic organ prolapse >stage II according to POPQ classification, no surgical intervention for SUI in the past 6 months, no drug treatment for UI in the last month, no pelvic floor muscle training underway Exclusion: None. Multi-centre, France.
Use of intravaginal device (75NC007) for up to 24 hours a day for 14 days 1. 75NC007 (n = 29) 2. wearing no mechanical device (n = 26) 75NC007 is made of thermoplastic elastomer supplied in two sizes: medium and small. Inserted into the vagina with or without an applicator. It automatically locates beneath the urethra and bladder, removed by pulling string on cylindrical part of device. The device can be inserted by the woman and must be discarded and replaced with a new device after 24 hours
1. Incontinence Episode Frequency (IEF) according to bladder diaries.
2. Urinary Symptom Profile score
3. 24 hour pad weighing test
4. CONTILIFE questionnaire
Phase two data only analysed. Change from baseline scores were used for all measures
Description + Risk of Bias assessment is from review by Lipp et al 2014
Crossover RCT to examine the effects of Hodge pessary with support, a super tampon on urinary incontinence during exercise. Duration: three exercise sessions
N = 20. Withdrawal = 2. Stress incontinence by stress test. Age range = 33-73. Inclusion: History of exercise incontinence, physical ability to perform 40 minutes exercise and positive stress test. Exclusion: prolapse of uterus or vagina, stenotic vagina and pelvic mass. Single centre, Department of Obstetrics & Gynaecology, USA.
All participated in each of 3 separate standardised exercise sessions:
1. wearing a Hodge pessary with support (n= 18).
2. wearing a Tampax super tampon (n= 18).
3. wearing no mechanical device (n= 18)
The Hodge vaginal pessary is a ring, in this case with support, placed at the neck of the cervix and is plastic coated with wires that allow it to be shaped for different anatomies. The Tampax super tampon is placed in the vagina and is a commercially available tampon. The tampon string was ’hidden’ as participants were blinded to treatment. Both devices were placed by the investigator
1. Pad weighing test.
2. Patient self reported discomfort
4 patients were continent during the control exercise despite positive stress test initially
Description + Risk of Bias assessment is from review by Lipp et al 2014
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Computerised randomisation was centralised by the data coordinating centre
’Women were randomly allocated by blocked randomization in groups of four’
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Computerised randomisation was centralised by the data coordinating centre
’blocked randomization in groups of four’
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Not stated
Paticipants and outcome assessors were blinded to the intervention. It was unclear whether care providers were blinded
Detection bias due to knowledge of the allocated interventions by outcome assessors
Not stated
Paticipants and outcome assessors were blinded to the intervention. It was unclear whether care providers were blinded
Attrition bias due to amount, nature or handling of incomplete outcome data
14/55 dropouts (25%), ITT analysis performed.
2 withdrew before the start of the study.
Reporting bias due to selective outcome reporting
Prespecified outcomes reported on, but the trial protocol not assessed
Prespecified outcomes reported on, but the trial protocol not assessed
Bias due to problems not covered elsewhere in the table
Study funded by B. Braun Medical SAS. Consultancy honoraria from B. Braun by one of the authors (S Mouly)
Participants formed both intervention and control group.