Post-operative Residual Voiding Volume Following Bulking and Vaginal Prolapse Surgery and Impact on In-hospital Stay

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Post operative urinary retention is a commonly observed complication following women undergoing urogynecology surgery. The trial includes patients undergoing bulking and vaginal prolapse surgery, who are randomized in two postoperative groups prior to surgery in order to test two void regimes. One group includes a strict voiding regime, where patients are discharged when voiding volume is minimum 150 ml and residual volume is maximum 200 ml. Comparatively, the minimalistic voiding group discharge patients after one spontaneous voiding, independent of voiding volume and residual volume. The primary aim of this study is to evaluate time to discharge in two different voiding trials techniques (strict vs minimalistic) after anterior, posterior or vaginal vault prolapse surgery as well as bulking surgery. Secondly, to register the development of postoperative urinary tract infection, urine retention, gynecological pain and patients' calls to the gynecological ward after discharge.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• • Women who undergo anterior, posterior or vaginal vault prolapse surgery or bulking surgery at the departments of obstetric and gynecology, OUH.

‣ Women who have the catheter removed at the operating room.

⁃ Women \>18 years old.

Locations
Other Locations
Denmark
martin Rudnicki
RECRUITING
Odense C
Contact Information
Primary
martin Rudnicki, professor
martin.rudnicki@rsyd.dk
22325313
Backup
Ulla Darling, Professor
Ulla.Darling.Hansen@rsyd.dk
66113333
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 84
Treatments
Active_comparator: group B
Group B is the intervention group with minimalistic voiding trial. The patients in this group need to have one spontaneous voiding before discharge with the sensation of normal voiding, meaning there is no measurement of the voiding volume or residual volume.
No_intervention: Group A
Group A is the control group and presents the current procedures with strict voiding trial. The bladder is scanned before voiding to determine the bladder volume, and the voiding volume is measured. If the voiding volume is \>150 ml and the residual volume is \<200 ml, the patient can be discharged. If no acceptable residual volume is reached, the patient will be instructed in intermittent catheterization
Sponsors
Leads: Odense University Hospital
Collaborators: University of Southern Denmark

This content was sourced from clinicaltrials.gov