A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence.
Int Urogynecol J
; 33(4): 861-868, 2022 04.
Article
en En
| MEDLINE
| ID: mdl-34505171
ABSTRACT
INTRODUCTION AND HYPOTHESIS:
To conduct a multi-centered randomized trial evaluating stress urinary incontinence (SUI) treatment based on the Patient Global Impression of Improvement score after 4 weeks using a continence pessary (CP) or a disposable intravaginal continence device (DICD). The null hypothesis is no difference in treatment success between cohorts.METHODS:
This parallel group, active treatment comparative effectiveness trial randomized women with SUI to either CP or DICD for 4 weeks in a 11 allocation ratio. Exclusion criteria included pregnancy, UTI, postmenopausal bleeding, neurogenic bladder, urinary retention, prolapse, contraindication to or prior treatment with CP/DICD, and prior SUI surgery. Assuming an 80% power, an alpha of 5% and 20% dropout, we needed 138 participants to detect 50% success with CP versus 25% with DICD. Due to slow enrollment, the study was stopped after 16 months with 50 participants enrolled.RESULTS:
Of the 50 women enrolled, 25 (50%) were randomized to CP and 25 (50%) to DICD. Thirty-five of 50 (70%) completed a fitting, and 22/50 (44%) completed 4-week and 17/50 (34%) completed 6-month follow-up. Baseline characteristics were similar, and there was high treatment success in each cohort [80% (8/10) CP vs. 75% (9/12) DICD; p = 1.0]. DICD patients showed improvement on all questionnaires but had higher use of other therapies over 6 months. CP patients showed improvements except for lower sexual function scores at 4 weeks. No serious adverse events occurred.CONCLUSIONS:
Most women fitted with a CP/DICD experienced treatment success after 4 weeks without serious adverse events.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Incontinencia Urinaria de Esfuerzo
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
Int Urogynecol J
Asunto de la revista:
GINECOLOGIA
/
UROLOGIA
Año:
2022
Tipo del documento:
Article
País de afiliación:
Estados Unidos