NCT07607990Recruiting
Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP
Effects of Rectal Indomethacin Suppository on Postoperative Catheter-Related Bladder Discomfort in Patients Undergoing Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
The postoperative incidence of catheter-related bladder discomfort (CRBD) ranges from 47% to 95%. It increases postoperative pain and agitation, thus requiring early intervention. Although a variety of drugs are used for the prevention or treatment of CRBD, the adverse reactions of most of these drugs have limited their clinical application. In long-term clinical practice, we found that indomethacin suppository has a good therapeutic effect on the discomfort of pelvic-related organs caused by nociceptive stimulation. However, its preventive effect on CRBD has not been reported yet. We hypothesized that indomethacin suppository has a preventive effect on postoperative CRBD. To verify this hypothesis, patients undergoing laparoscopic radical prostatectomy were enrolled in the study. Patients in the intervention group received 50 mg of indomethacin suppository via the rectal route immediately after surgery, while those in the control group received no treatment. The severity of CRBD, pain scores, consumption of analgesics, other perioperative adverse reactions, and patient satisfaction were observed and recorded at 0, 1, 2, and 6 hours after surgery.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 18 Jan 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Zhejiang University
- Diseases
- Prostate cancer
- NCT number
- NCT07607990
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 1 Jan 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other nonsteroidal anti-inflammatory drugs (NSAIDs) within one week;
Other illness
- Pre-existing bladder diseases, such as overactive bladder (frequency of micturition \> 3 times per night or \> 8 times within 24 hours), neurogenic bladder, and bladder outlet obstruction;
- Severe cardiac insufficiency (activity tolerance \< 4 METs) or clearly diagnosed coronary heart disease;
- Clearly diagnosed chronic obstructive pulmonary disease (COPD) or a history of asthma;
- Hepatic insufficiency with Child-Pugh Class C;
- Chronic kidney disease requiring dialysis;
- Active peptic ulcer/hemorrhagic disease;
- Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs);
- Mental or neurological disorders that prevent the completion of rating scales; or cognitive impairment resulting in the loss of capacity for civil conduct.
Other
- Postoperative status of pelvic organs or spine that affects bladder function;
- Postoperative status of total proctocolectomy;
- Body mass index (BMI) ≤ 18 kg/m² or ≥ 28 kg/m²;
- Chronic analgesic abuse;
Who the study is looking for
- Aged 18 to 80 years old (inclusive);
- American Society of Anesthesiologists (ASA) physical status classification Class I-III;
- Undergoing elective laparoscopic radical prostatectomy under general anesthesia;
- Having a clear understanding of the study, voluntarily participating, and providing informed consent signed by themselves or their family members.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.