To compare which treatment (indwelling catheter versus intermittend catheterisation) has the best clinical effect in women with symptomatic PUR.
ID
Source
Brief title
Condition
- Postpartum and puerperal disorders
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main point of this trial is bladder related quality of life at 3 months
after randomisation.
Secondary outcome
Secondary outcomes are prevalence of overt PUR, risk factors,
cost-effectiveness and patient preference.
Background summary
Postpartum urinary retention (PUR) is a common complication with a varying
prevalence, from 0.5 - 18%. This great variety is mainly due to the use of
different and non-standardized definitions.
Therefore, it seams plausible that there is a large discrepancy between the
registered patients with PUR and the unknown and untreated. Postpartum urinary
retention is most often selflimiting; patients are able to void spontaneous and
empty their bladders completely within a few days. More than 50% of women with
overt PUR recover within 24-48 hours, but a small part has to learn self
catheterization for the duration of weeks to months.
Untreated and unrecognized postpartum urinary retention can lead to serious
complications like urinary tract infections, pyelonefritis, urinary
incontinence, renal failure and bladder rupture. This could have detrimental
effects on the patient*s general health and quality of life. Accordance about
definition and management of symptomatic urinary retention postpartum is
missing worldwide; treatment is therefor in hands of the treating physician.
Study objective
To compare which treatment (indwelling catheter versus intermittend
catheterisation) has the best clinical effect in women with symptomatic PUR.
Study design
A randomized controlled trial within a multi-centre prospective cohort study.
Intervention
Women who are diagnosed with overt postpartum urinary retention will be
randomized between an indwelling catheter or intermittent bladder
catheterization.
Study burden and risks
Women in both treatment arms in this RCT will receive a non-experimental
treatment. Current management is most often continuous catheterization, but
also intermittent catheterization is part of standard care. This means there is
no special burden associated with participation in this trial; sometimes it
will mean that women can go home even sooner than now a days.
This trial do not involve specific risks for the participants.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Women, 18 years and above, who are unable to void within six hours after vaginal or surgical delivery (symptomatic urinary retention)
Exclusion criteria
1. Age < 18 years
2. Insufficient knowledge or understanding of the Dutch language
3. Congenital urinary tract abnormalities
4. Pre-existent and treated urinary tract infection < 1 week before the delivery
5. Patients with an indwelling catheter before delivery for parturition related reasons.
6. History of chronic neurological disease, including diabetic neuropathy
7. Maternal fever (i.e. temperature >= 38.0 °C) due to a urinary tract infection, confirmed by a urine culture.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33094.018.10 |