Postoperative Catheterization After Anterior Colporrhaphy

Atrium Medical Center

Status: Unknown

Conditions: Cystocele; Cystitis

Treatments: Procedure: postoperative catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT00622076

05-P-47

Details and patient eligibility

About

Randomised controled multicenter trial about the appropriate length of postoperative catheterization after anterior colporrhaphy. Patients are included at the moment that they are planned for surgery and are allocated to one of the study arms after the operation in the recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and half of the patients will have a catheter during five days postoperatively and the other half will be catheterized only during two days. Main outcome measurements regards replacement of a catheter because of bladder retention and the occurence of cystitis.

Enrollment: 230 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients planned for a cystocele repair

Exclusion criteria

• patients who already have voiding problems before the operation not related to the cystocele
• patients that are not capable of understanding our patient information form because of mental status or language

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

1

Active Comparator group

Description:

postoperative catheterization after anterior colporrhaphy during five days.

Treatment:

Procedure: postoperative catheterization

2.

Active Comparator group

Description:

postoperative catheterization after anterior colporrhaphy during two days

Treatment:

Procedure: postoperative catheterization