Urinary Incontinence Clinical Trial
Official title:
Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial
Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital
prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of
women with prenatal pelvic floor exercises and a control group.
Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.
Justification:
Pelvic floor disorders lead to handicap and medical care consumption. Pregnancy and delivery
are the main etiologies. Pelvic floor exercises are proposed for prevention and may reduce
immediate postpartum incontinence but we do not know if this preventive effect persists at 1
year.
Principal criteria:
- Urinary incontinence score at 12 months post-partum (ICIQ-SF)
Secondary criteria:
- Urinary incontinence prevalence at pregnancy end, 2 and 12 months post-partum
- Other pelvic floor disorders at pregnancy end, 2 and 12 months post-partum: symptoms
questionnaires, QOL questionnaire, Pad-test, POP-Q.
- Mode of delivery, length of active second phase, perineal tears, Apgar score.
- Number of postpartum pelvic floor session, number of medical consultations, Kegel
exercises.
Progress:
- Inclusion between 20 and 28 weeks, initial assessment, randomization.
- 8 sessions of pelvic floor exercises with a physiotherapist between 24 and 36 weeks
versus written information only.
- Assessment at pregnancy end, 2 and 12 (+/-1) month post-partum
Study length:
- For each women 18 months.
- For each center 30 months.
Number of subjects:
- To show a 1 point difference on ICIQ-SF score, we need 182 subjects (sd=2,4, a=0,05,
β=0,20 bilateral test).
- Taking in account lost of follow-up (estimated 1/3) we are going to include 280 women.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05534412 -
A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence
|
N/A | |
Recruiting |
NCT05515198 -
Improving Care for Women With Urinary Incontinence (EMPOWER)
|
N/A | |
Completed |
NCT04071301 -
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
|
N/A | |
Completed |
NCT03623880 -
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
|
N/A | |
Recruiting |
NCT05880862 -
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
|
Early Phase 1 | |
Recruiting |
NCT04159467 -
Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet
|
N/A | |
Completed |
NCT05485922 -
Performance of a Single-use Intermittent Micro-hole Zone Catheter
|
N/A | |
Completed |
NCT06268782 -
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
|
N/A | |
Not yet recruiting |
NCT03027986 -
Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
|
N/A | |
Recruiting |
NCT02490917 -
ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence
|
N/A | |
Enrolling by invitation |
NCT02530372 -
Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
|
N/A | |
Enrolling by invitation |
NCT02529371 -
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
|
N/A | |
Completed |
NCT02600676 -
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
|
N/A | |
Completed |
NCT02338726 -
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
|
N/A | |
Completed |
NCT02549729 -
Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy
|
N/A | |
Completed |
NCT02368262 -
Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT02239796 -
Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence
|
N/A | |
Completed |
NCT01942681 -
Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride
|
N/A | |
Recruiting |
NCT01804153 -
Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)
|
Phase 1/Phase 2 | |
Completed |
NCT01520948 -
Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
|
Phase 3 |