Evaluating discharge times after vaginal prolapse surgery with different voiding protocols
Post-operative Residual Voiding Volume Following Bulking and Vaginal Prolapse Surgery and Impact on In-hospital Stay
This study tests whether two different ways of managing bathroom use after vaginal prolapse surgery can help women go home sooner and reduce complications like infections and pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Odense C, Odense) |
| Trial ID | NCT06051916 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of two different postoperative voiding protocols on discharge times for women undergoing bulking and vaginal prolapse surgery. Patients will be randomized into two groups: one following a strict voiding regime and the other a minimalistic voiding regime. The study aims to determine which protocol allows for earlier discharge and assesses the incidence of complications such as urinary tract infections and pain. The trial will be conducted at Odense University Hospital, with patients receiving thorough preoperative information and consent.
Who should consider this trial
Good fit: Ideal candidates are women over 18 undergoing anterior, posterior, or vaginal vault prolapse surgery or bulking surgery.
Not a fit: Patients with malignancies, previous pelvic surgeries, or certain medical conditions like multiple sclerosis or type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved discharge times and reduced complications for women undergoing urogynecological surgeries.
How similar studies have performed: While similar studies have explored postoperative protocols, this specific approach comparing strict versus minimalistic voiding regimes is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • 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. Exclusion Criteria: * 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
Where this trial is running
Odense C, Odense
- martin Rudnicki — Odense C, Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Martin Rudnicki — Odense Universitetshospital
- Study coordinator: martin Rudnicki, professor
- Email: martin.rudnicki@rsyd.dk
- Phone: 22325313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.