N/A
Completed N=100
Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms
Prostatic Hyperplasia · lower urinary tract symptoms · Transurethral Resection of Prostate
Source: ClinicalTrials.gov NCT03936244 ↗
Enrolled (actual)
100
Serious AEs
3.6%
Results posted
Oct 2020
Primary outcomePrimary: International Prostate Symptom Score (IPSS) — 14.6; 12.7; 12.2; 11.3 points
Summary
Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Prostate Symptom Score (IPSS) |
14.6; 12.7; 12.2; 11.3; 9.7; 9.4 | — |
| PRIMARY Maximum Urinary Flow Rate (Qmax |
17.5; 18.9; 18.2; 16.8; 21; 18.7 | — |
| PRIMARY Postvoid Residual Urine (PVRU) Volume |
14.2; 13; 22.8; 18.2; 15.3; 14.7 | — |
| SECONDARY Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire |
3.7; 2.9; 2.9; 2.6; 2.3; 1.6 | — |
| SECONDARY Number of Participants Reporting Sexual Activity in the Last Month |
23; 22; 33; 28; 30; 29 | — |
| SECONDARY International Index of Erectile Function (IIEF-5) |
8.5; 9.5; 9.9; 10.7; 10.7; 12.4 | — |
| SECONDARY Prostate Volume (PV) |
22.3; 22.5 | — |
| SECONDARY Operative Time |
39.7; 47.7 | — |
| SECONDARY Irrigation Volume |
16; 20.2 | — |
| SECONDARY Change in Plasmatic Sodium in 24 Hours Post-operation |
3.3; 2.2 | — |
| SECONDARY Change in Haemoglobin in 24 Hours Post-operation |
0.9; 1 | — |
| SECONDARY Transfusion Rate |
0; 0 | — |
| SECONDARY Catheter Duration |
3.6; 3.5 | — |
| SECONDARY Hospital Stay |
1.1; 1.1 | — |
| SECONDARY Resected Tissue Weigh |
12.7; 12.4 | — |
| SECONDARY Resected Tissue Percentage |
33.5; 28.8 | — |
| SECONDARY Speed Resection |
0.9; 0.9 | — |
| SECONDARY Early Reoperation Rate |
2; 1 | — |
| SECONDARY Late Reoperation Rate |
2; 1 | — |
| SECONDARY Post-TURP Syndrome Rate |
1; 0 | — |
| SECONDARY Clavien Dindo System |
2; 2; 2; 2; 2; 1 | — |
| SECONDARY Bleeding Complications Rate |
8; 7 | — |
| SECONDARY Urinary Tract Infections Rate |
5; 1; 0; 0; 0; 0 | — |
| SECONDARY Stenotic Complications Rate: Meatal Stenosis |
2; 2; 5; 2; 2; 0 | — |
| SECONDARY Stenotic Complications Rate: Urethral Stricture |
0; 0; 2; 1; 2; 2 | — |
| SECONDARY Stenotic Complications Rate: Bladder Neck Contracture |
0; 0; 1; 0; 2; 0 | — |
| SECONDARY Stress Urinary Incontinence Rate |
18; 12; 12; 9; 7; 3 | — |
| SECONDARY Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate |
9; 3; 3; 3; 3; 2 | — |
| SECONDARY Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate |
8; 4; 6; 3; 6; 4 | — |
| SECONDARY Sequelae Rate: Retrograde Ejaculation |
17; 13; 24; 18; 21; 17 | — |
| SECONDARY Sequelae Rate: Dysuria |
5; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Sign the informed consent voluntarily and will be willing to follow-up
- Prostate volume <80 g
- Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention)
- The use of antiplatelet agents or anticoagulant drugs is allowed.
Exclusion Criteria
- Previous history of pelvic surgery
- Previous history of pelvic radiotherapy
- Previous history of neurogenic bladder dysfunction
- Documented or suspected prostate carcinoma
- Patients with severe cardiopulmonary disease or severe mental disorders
- Poor compliance, and can not be followed up.
Data sourced from ClinicalTrials.gov (NCT03936244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.