Pelvic organ prolapse in general practice: effects of pelvic floor physiotherapy and of pessary treatment

• Conditions: cystocele and rectocele; pelvic relaxation; 10018188; 10046828

• Registration Number: NL-OMON33065
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 274

Inclusion Criteria

Symptomatic prolapse, able to fill in a Dutch questionnaire, mobile enough to visit a pelvic floor physiotherapist, informed consent

Exclusion Criteria

Severe cognitive decline, serious or teminal disease (according to the general practitioner), urogynaecological malignancies, being currently treated for urogynaecological disorders, conservative prolapse therapies in the preceding year, severe (stage 4) prolapse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is the score on the Pelvic Floor Distress<br /><br>Inventory (which measures prolapse-related symptoms) and the satisfaction with<br /><br>the results of the treatment (the global perception of improvement).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are the quality of life (condition specific and<br /><br>general) and the degree of prolapse and the function of bladder and bowel.<br /><br>Also, the number of women in which a succesful fitting of a pessary is possible<br /><br>will be recorded and the number of referrals to secondary care. The acceptance<br /><br>of the treatments and the side effects will be assessed, just as the costs of<br /><br>the treatments under study. </p><br>