|- candidate number||4356|
|- NTR Number||NTR1528|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-nov-2008|
|- Secondary IDs||05.0534 |
|- Public Title||A comparison of suprapubic and transurethral catheterization on postoperative urinary retention after vaginal prolapse repair.|
|- Scientific Title||A comparison of suprapubic and transurethral catheterization on postoperative urinary retention after vaginal prolapse repair.|
|- ACRONYM||CAD TRIAL |
|- hypothesis||We expected that the use of postoperative transurethral catheterization resulted in higher urinary retention rates in women after surgical correction of cystocele compared to suprapubic catheterization.|
|- Healt Condition(s) or Problem(s) studied||Urinary retention, Anterior prolapse surgery, Cystocele , Suprapubic catheterization, Transurethral catheterization|
|- Inclusion criteria||Women sceduled for surgical correction of cystocele (women undergoing prolapse surgery without the correction of cystocele did not meet the inclusion criteria; patients who were planned for a procedure combining prolapse surgery with any technique for correction of incontinence, e.g. tension-free vaginal tape, were also not eligible).|
|- Exclusion criteria||1. History of urinary retention. |
2. Urinary tract infection at the time of randomizaton.
3. History of urological disease or renal insufficiency.
4. Unability to speak and read the Dutch language.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2005|
|- planned closingdate||1-aug-2007|
|- Target number of participants||116|
|- Interventions||1. Suprapubic catheterization after cystocele correction.|
2. Transurethral catheterization after cystocele correction.
|- Primary outcome||Urinary residual volume, defined as the percentage of patients with a residual volume more than 150 ml after spontaneous voidance the morning of the fourth postoperative day, following clamping (SP) or removing (TU) the catheter the evening before.|
|- Secondary outcome||1. Need for prolonged catheterization; |
2. Length of hospital stay;
3. Number of patients with residual volumes exceeding 500 ml;
4. Need for recatheterization;
5. Rate of urinary tract infections;
6. Rate of complications.
|- Timepoints||1. Morning of the fourth postoperative day;|
2. In case of first residual volume exceeding 150 ml: monitoring of residual volumes every 4 hours (suprapubic) and every 24 hours (transurethral);
3. End of catheterization;
4. 6 weeks after surgery.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD PhD. Paul J.Q. Linden, van der|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD. Paul J.Q. Linden, van der|
|- Sponsor/Initiator ||Deventer Ziekenhuis|
(Source(s) of Monetary or Material Support)
|- Brief summary||Objective:|
To compare the effect of suprapubic catheterization with that of transurethral catheterization on residual urine volumes after vaginal prolapse surgery.
Patients who underwent operative cystocele repair were randomized between a suprapubic catheter and a transurethral catheter. At the third postoperative day, the catheter in the suprapubic group was clamped and the catheter in the transurethral group was removed. Residual volumes after voiding were measured. Where the residual volume exceeded 150 ml, a prolonged stay or recatheterisation was effectuated. Urinary samples were taken before clamping or removing the catheter to measure the number of urinary tract infection. Need for prolonged catheterization, recatheterization and number of complications were registered.
|- Main changes (audit trail)|
|- RECORD||8-nov-2008 - 9-dec-2009|