De Wildt 1996.
| Study characteristics | ||
| Methods |
Study design: parallel group randomized trial Study dates: Start date June 1991 – End date December 1992 Setting: outpatient, multicenter, international Country: Netherlands and the United Kingdom |
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| Participants |
Inclusion criteria: men aged > 45 years complaining of symptoms of bladder outlet obstruction for > 3 months, with a Madsen symptom score of > 8 and urinary free‐flow rate estimates of < 15 mL/s during two voids of >150 mL. Prostatic enlargement was confirmed by transrectal ultrasonography, PSA or prostatic biopsy if necessary. Exclusion criteria: prostate cancer, prostatitis, urethral stricture, intravesical pathology (stones, neoplasm), neurogenic bladder dysfunction, urinary tract infection, isolated enlargement of the middle lobe, a residual urine volume of >300 mL, use of drugs influencing bladder or prostate function, previous transurethral resection of the prostate or transurethral incision, a metallic pelvic implant, disorders of blood flow or coagulation, diabetes mellitus and mental incapacity or inability to give informed consent. Total number of participantsrandomized: 93 men recruited but 90 were randomized (there is no further detail on the report) Group 1: n = 46 TUMT
Group 2: n = 47 Sham
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| Interventions |
Group 1 (n = 46): TUMT A single session of Prostatron treatment unit which consisted of a microwave generator, urethral applicator/cooler, fiber optic temperature‐monitor, and couch. This study used the lower energy thermotherapy protocol (Prostasoft 2.0). Group 2 (n = 47): Sham Same procedure as in TUMT with a simulated program. Co‐interventions: Not described |
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| Outcomes |
Urologic symptoms score How measured: Madsen symptom score Time points measured: baseline, 6, 12, 26, 52 weeks Time points reported: baseline, 6, 12, 26, 52 weeks Subgroups: none Quality of life How measured: ad‐hoc questionnaire (not validated) Time points measured: baseline, 12 and 26 weeks Time points reported: baseline, 12 and 26 weeks (this questionnaire includes questions of sexual function) Major and minor adverse event How measured: major and minor adverse events Time points measured: not reported Time points reported: at 3 months Indwelling urinary catheter/acute urinary retention How measured: number of participants that required a catheter after the procedure due to urinary retention Time points measured: not reported Time points reported: at 3 months Relevant outcomes not reported in this study
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| Funding sources | Not available | |
| Declarations of interest | Not available | |
| Notes | This study reports the trial by location and globally. The quality of life results are only available for the Netherlands report. After three months patients were offered TUMT. 27 participants in the Sham group and 4 participants in the TUMT group received a verum procedure, thus the results of this trial beyond three months are not included in this review. No contact information available. Protocol: not available Language of publication: English |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Patients were randomized after informed consent was obtained.” Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
| Allocation concealment (selection bias) | Unclear risk | Quote: “Patients were randomized after informed consent was obtained.” Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
| Blinding of participants and personnel (performance bias) Subjective outcomes | Low risk | Quote: “As far as possible, the patient and the investigator were kept unaware as to the treatment administered.” (first three months) Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Quote: “As far as possible, the patient and the investigator were kept unaware as to the treatment administered.” (first three months) Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken. |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: “As far as possible, the patient and the investigator were kept unaware as to the treatment administered.” (first three months) Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken. |
| Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life | Low risk | Data was not available at three months for 3 participants in the Sham group (2 losses at follow‐up and 1 technical failure) and 2 participants in the TUMT group (underwent TURP). |
| Incomplete outcome data (attrition bias) Major adverse events/minor adverse events | Low risk | Data was not available at three months for 3 participants in the Sham group (2 losses at follow‐up and 1 technical failure) and 2 participants in the TUMT group (underwent TURP). |
| Incomplete outcome data (attrition bias) Acute urinary retention | Low risk | Data was not available at three months for 3 participants in the Sham group (2 losses at follow‐up and 1 technical failure) and 2 participants in the TUMT group (underwent TURP). |
| Incomplete outcome data (attrition bias) Indwelling catheter | Unclear risk | Data was not available at three months for 3 participants in the Sham group (2 losses at follow‐up and 1 technical failure) and 2 participants in the TUMT group (underwent TURP). Not fully measured (narrative statement). |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
| Other bias | Low risk | No other sources of bias were identified. |