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Clinical study of Tamsulosin on the recovery of voluntary urinary function after total mesorectal excision(TME) for rectal cancer

Clinical study of Tamsulosin on the recovery of voluntary urinary function after total mesorectal excision(TME) for rectal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123186
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-04-22
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Tamsulosin Group:For patients scheduled to undergo TME surgery, tamsulosin 0.4 mg once daily is administered 4 hours before surgery until the second day after surgery. The catheter is removed on the s
Control Group:For patients scheduled to undergo TME surgery, give a placebo QD starting 4 hours before surgery until the second day after surgery. Remove the urinary catheter on the second day after s

Sponsors

The Sixth Affiliated hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male patients aged >=60 years; 2. Colonoscopy pathological biopsy confirmed adenocarcinoma (including tubular adenocarcinoma, papillary adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma); 3. According to the 8th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, preoperative evaluation shows clinical tumor stage T1-T3 N0 M0, requiring TME radical resection; 4. ASA score I-III; 5. Performance status on the ECOG (Eastern Cooperative Oncology Group) scale of 0 or 1; 6. The patient or family members can understand the study protocol and are willing to participate in this study, providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to or contraindicated for tamsulosin; 2. Patients who have recently taken a-receptor agonists or a-receptor inhibitors, or who take related medications outside the study during the intervention phase; 3. Patients with pre-existing indwelling catheters, suprapubic catheters, or urinary stomas before intervention; 4. Patients with orthostatic hypotension (defined as a decrease in systolic blood pressure of 20 mmHg upon standing from a sitting position, or a decrease in diastolic blood pressure of 10 mmHg after 2-3 minutes of standing from a sitting position); 5. Patients who received preoperative neoadjuvant radiotherapy; 6. Patients with a preoperative IPSS score >=20; 7. Tumors invading the external sphincter and levator ani muscle or involving adjacent organs requiring combined organ resection; 8. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery; 9. Patients with uncontrolled preoperative infection or severe cardiovascular or endocrine system diseases, poorly controlled and unable to tolerate surgery; 10. Patients deemed by the investigator as unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Voluntary Urination Rate;

Secondary

MeasureTime frame
Postoperative Urinary Function;Postoperative Urinary Tract Infection Rate;Postoperative Recovery Outcomes;Perioperative Outcomes;Quality of Life;

Countries

China

Contacts

Public ContactKang Liang

The Sixth Affiliated hospital of Sun Yat-sen University

kangl@mail.sysu.edu.cn+86 136 0288 6833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026