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

NCT06051916 | Recruiting DMC

• 1 other identifier: Odense University Hospital SDU
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery-Complications

Keywords

surgery; complication

Outcome Measures

Primary Outcomes (1)

• Residual urine

  Residual urine after surgery

  12 hours postoperatively

Study Arms (2)

group B

ACTIVE COMPARATOR

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.

Other: residual urine

Group A

NO INTERVENTION

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

Interventions

residual urine OTHER

The study includes two group, A and B. Se previously

group B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any surgery performed by due to malignancy
• Previous cancer in the pelvic area
• Previous radiation therapy in the pelvic area
• Previous surgery in the pelvic area
• Patients not understanding Danish
• Patients with mental or similar illness
• Patients with multiple sclerosis or diabetes type 1
• Patients with late KAD removal based on per operative assessment

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

martin Rudnicki

Odense C, Odense, 4300, Denmark

RECRUITING

Study Officials

• Martin Rudnicki

  Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

martin Rudnicki, professor

CONTACT

22325313; martin.rudnicki@rsyd.dk

Ulla Darling, Professor

CONTACT

66113333; Ulla.Darling.Hansen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Group A receives a strict voiding trial and group B receives a minimalistic voiding trial. In both groups the patient's catheter is removed at the operation room before returning to the gynecological ward.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)