Cost-effectiveness of a Non-degradable Urethral Bulking Agent as compared to Mid-urethral Sling surgery in women with Stress Urinary Incontinence

Phase 4

Completed

• Conditions: urinary incontinence; 10018188

• Registration Number: NL-OMON49210
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-10-13
• Results First Posted: 2022-08-05
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 216

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Subject is at least 18 years of age
2. Subject has bothersome, moderate or severe SUI or stress predominant mixed
urinary incontinence (Sandvik severity scale of 3 and higher).
3. Subject has decided to undergo a MUS-operation or treatment with UBA
*Urolastic**
4. Subject has a positive result on the standardized cough stress test
5. Subject is willing and able to comply with the follow-up regime

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Subject has predominating urge incontinence
2. Subject has a genital prolapse with a POP-Q score of point Aa or Ba >/=0
3. Subject has had previous treatment with UBA.
4. Subject is pregnant or intends to become pregnant during the study.
5. Subject has a untreated urinary tract infection
6. Subject has a bladder capacity of <250ml
7. Subject has a post-voiding residu of >150ml
8. Subject has a flow of <15ml/sec
9. Subject is not capable of giving informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study is subjective improvement assessed by the<br /><br>1-item questionnaire *Patient Global Impression of Improvement* (PGI-I). The<br /><br>PGI-I has a 7-point Likert scale with a response range from *very much worse*<br /><br>to *very much better*. Improvement is considered to be clinically significant<br /><br>when answers to the PGI-I are either *much better* or *very much better*.<br /><br>Subjective improvement will be assessed at 4-6 weeks, 6 months and 12 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Economic evaluation<br /><br>- Subjective cure<br /><br>- Objective cure<br /><br>- Morbidity and complications<br /><br>- Disease specific quality of life<br /><br>- Seksual function<br /><br>- Re-interventions<br /><br>- Patient preference</p><br>