motherfit

Recruiting

• Conditions: stress urinary incontinence, pelvic floor muscle training, peri-partum, pre-partum, post partum, grouptraining, randomizedclinical trial, pregnancy

• Registration Number: NL-OMON23435
• Lead Sponsor: Maastricht University Medical Centre, Maastricht, The Netherlands

Brief Summary

Moossdorff-Steinhauser HF, Albers-Heitner P, Weemhoff M, Spaanderman ME, Nieman FH, Berghmans B. Factors influencing postpartum women's willingness to participate in a preventive pelvic floor muscle training program: a web-based survey. Eur J Obstet Gynecol Reprod Biol. 2015 Oct 23;195:182-187 <br><br> Bary Berghmans, Fred Nieman, C. Leue, M. Weemhoff, S. Breukink, G. van Koeveringe. Prevalence and Triage of First-Contact Complaints on Pelvic Floor Dysfunctions in Female Patients at a Pelvic Care Centre. Neurourol. Urodynam. February 2015 <br><br> Berghmans LCM, Groot JAM, van Heeswijk-Faase I, Bols EMJ. Dutch evidence statement for pelvic physical therapy in patients with anal incontinence. Int Urogynecol J 2015 Apr;26(4):487-96, DOI: 10.1007/s00192-014-2555-y <br><br> Labrie J, Berghmans LCM, Fischer K, Milani AL, Roovers J-PWM, Ploeg van der M, Lagro-Janssen ALM, Vaart van der CH. Surgery or physiotherapy for stress incontinence: a randomized trial. N Engl J Med 2013;369:1124-33. DOI: 10.1056/ NEJM oa1210627 <br><br> Bernards, A, Berghmans B., et al. KNGF Guideline on Stress Urinary Incontinence. ISSN 1567-6137. April 2011 Issue. No. V-02/2011

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• primi gravid woman

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• UI prior to pregnancy, still existing during pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study I and II primary: 18 months post partum<br /><br>- ICIQ-UI-SF

Secondary Outcome Measures

Name	Time	Method
18 months post partum<br /><br>- Patient global impression of severity (PGI-S),<br /><br>- Incontinence Impact Questionnaire-7(IIQ-7); generic QoL (EQ-5D-5L)<br /><br>- Costs<br /><br>- Patient satisfaction