We hypothesize that TVT-O and TVT-S are equally effective in the management of stress-incontinence. We hypothesize that there are differences in morbidity and post-operative recovery between both procedures as TVT-S it is a less invasive technique.
ID
Bron
Verkorte titel
Aandoening
1. Urinary incontinence (NLD: urine incontinentie);
2. stress incontinence;
3. prosthesis;
4. implants;
5. TVT;
6. TVT-o;
7. TOT;
8. TVT-s.
Ondersteuning
Piet Hinoul, MD, Ziekenhuis Oost Limburg, Genk, Belgium
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Morbidity:<br>
1. A questionnaire to assess activities of daily life;<br>
2. A visual analogue scale (VAS score) to assess the experienced pain.
Achtergrond van het onderzoek
The purpose of the proposed study is:
1. To compare the effectivity of TVT-O and TVT-S as surgical correction of stress-incontinence;
2. To compare the complications of TVT-O and TVT-S;
3. To compare the morbidity and post-operative recovery of TVT-O and TVT-S;
4. To compare the need for repeated stress-incontinence surgery or specialized physiotherapy following both techniques;
5. To compare pelvic floor function following both techniques.
Doel van het onderzoek
We hypothesize that TVT-O and TVT-S are equally effective in the management of stress-incontinence. We hypothesize that there are differences in morbidity and post-operative recovery between both procedures as TVT-S it is a less invasive technique.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients are randomised to undergo a TVT-obturator (TVT-O©) or a TVT-Secure (TVT-S©) procedure.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Urodynamically proven urinary stress incontinence.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Stage 2 or more genital prolapse (ICS classification);
2. Recurrent stress-incontinence;
3. Concomitant surgical procedures.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1106 |
| NTR-old | NTR1141 |
| Ander register | : incomplete |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |