It is hypothesize that a non-degradable urethral bulking agent (UBA) is non-inferior in efficacy and superior in cost-effectiveness as compared to mid-urethral sling (MUS) surgery in the treatment of moderate to severe stress urinary incontinence…
ID
Bron
Verkorte titel
Aandoening
Stress urinary incontinence
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome of this study is subjective improvement assessed by the 1-item questionnaire ‘Patient Global Impression of Improvement’ (PGI-I) (Appendix A). The PGI-I has a 7-point Likert scale with a response range from ‘very much worse’ to ‘very much better’. Improvement is considered to be clinically significant when answers to the PGI-I are either “much better” or “very much better”. Subjective improvement will be assessed at 4-6 weeks, 6 months and 12 months.
Doel van het onderzoek
It is hypothesize that a non-degradable urethral bulking agent (UBA) is non-inferior in efficacy and superior in cost-effectiveness as compared to mid-urethral sling (MUS) surgery in the treatment of moderate to severe stress urinary incontinence SUI.
Onderzoeksopzet
Before treatment
T=0: informed consent, fill out first part of diary of discomfort and pain, fill out questionnaire (baseline, PGI-S, Sandvik severity scale, UDI-6, IIQ-7, PISQ-IR, EQ-5D-5L). Also the urinary flow + postresidual volume and 48-h voiding diary has to be completed if not already done (this is standard care).
Treatment
T=1: undergo treatment with UBA or MUS-surgery; as described in chapter 5.
After treatment
T=2: fill out diary of discomfort and pain at day: 0,1,2,3,7,14 and 28.
T=3: outpatient visit at 4-6 weeks: pelvic floor examination, standardized CST, questionnaire (PGI-I, PGI-S, Sandvik severity scale, UDI-6, IIQ-7, EQ-5D-5L)
T=4: telephonic consult at 6 months: evaluate extra outpatient visit, (S)AE, questionnaire (PGI-I, PGI-S, Sandvik severity scale, UDI-6, IIQ-7, PISQ-IR, EQ-5D-5L, patient satisfaction)
T=5: outpatient visit at 12 months: pelvic floor examination, standardized CST, questionnaire (PGI-I, PGI-S, Sandvik severity scale, UDI-6, IIQ-7, PISQ-IR, EQ-5D-5L, patient satisfaction)
Onderzoeksproduct en/of interventie
arm 1: Urethral bulkinjection therapy (urolastic)
arm 2: mid-urethral sling surgery
Publiek
Jan-Paul W.R. Roovers
Department of Obstetrics and Gynaecology
Academic Medical Center (AMC)
Meibergdreef 9, H4-140-1
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666429
j.p.roovers@amc.uva.nl
Wetenschappelijk
Jan-Paul W.R. Roovers
Department of Obstetrics and Gynaecology
Academic Medical Center (AMC)
Meibergdreef 9, H4-140-1
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666429
j.p.roovers@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Subject is female
2. at least 18 years of age
3. Subject has bothersome, moderate or severe SUI or stress predominant mixed urinary incontinence (Sandvik severity scale ¡Ý 3 (Appendix C)).
4. Subject has decided to undergo a MUS-operation or treatment with UBA ¡°Urolastic¡¯¡±
5. Subject has a positive result on the standardized cough stress test
6. Subject is willing and able to comply with the follow-up regime
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7382 |
| NTR-old | NTR7590 |
| CCMO | NL59107.018.16 |
| OMON | NL-OMON49210 |