Ahmed 1997.
Study characteristics | ||
Methods |
Study design: prospective, randomized parallel study. Study dates: study dates not available Setting: outpatient, single‐centre, national Country: United Kingdom |
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Participants |
Inclusion criteria: men with:
Exclusion criteria: men with:
Total number of participantsrandomized: 60 Group 1: n = 30 transurethral microwave thermotherapy (TUMT)
Group 2: n = 30 transurethral resection of the prostate (TURP)
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Interventions |
Group 1 (n = 30): TUMT Done by a single operator using the Prostatron treatment catheter using the Prostasoft software (TechnoMed, Lyon, France) in a single 60‐min session under topical anesthesia with Instillagel(r) (FarcoPharma GmBH, Cologne, Germany). Group 2 (n = 30): TURP Performed on the routine operating lists by a surgeon of Senior Registrar grade or above using a standard technique. No post‐operative irrigation was used and all the resected tissue was submitted for histological examination. The urethral catheter was removed 3 or 4 days after surgery. Co‐interventions: “Intramuscular gentamicin (80 mg) was given before the treatment and oral trimethoprim (200 mg twice daily) was continued for 5 days. The patients were followed up at 6 weeks, 3 and 6 months, with a detailed evaluation performed at the last assessment.” |
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Outcomes |
Urologic symptom scores How measured: AUA symptom score Time points measured: baseline, 6 weeks, 3 and 6 months Time points reported: not reported (probably 6 months) Subgroups: none Indwelling urinary catheter/acute urinary retention How measured: number of patients requiring an indwelling catheter after treatment due to acute urinary retention Time points measured: 6 weeks, 3 and 6 months Time points reported: not reported Subgroups: none Major adverse event How measured: number of patients requiring blood transfusions after treatment. Time points measured: not reported Time points reported: not reported Subgroups: none Minor adverse event / Erectile function / Ejaculatory function How measured: number of patients developing urinary tract infections or meatal narrowing that required dilatation. Furthermore, adverse events related to erectile function and ejaculation are described under adverse events. Time points measured: not reported Time points reported: not reported Subgroups: none Relevant outcomes not reported in this study:
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Funding sources | Not available | |
Declarations of interest | Not available | |
Notes | 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 to each treatment by selecting a sealed envelope. [...] Patients failing to complete treatment or return for follow‐up were substituted.” Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Allocation concealment (selection bias) | High risk | Quote: “[...] patients were randomized to each treatment by selecting a sealed envelope. [...] Patients failing to complete treatment or return for follow‐up were substituted.” Whereas envelopes might be sealed, substitution might indicate tampering of allocation. |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). The subjective outcomes were likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). The subjective outcomes were likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Whereas blinding was not mentioned, the interventions were visibly different (surgery versus outpatient procedure). The objective outcomes were unlikely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life | Unclear risk | Due to “substitution” noted above, the number of participants with missing outcome data was not provided. |
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events | Unclear risk | Due to “substitution” noted above, the number of participants with missing outcome data was not provided. |
Incomplete outcome data (attrition bias) Erectile function | Unclear risk | Due to “substitution” noted above, the number of participants with missing outcome data was not provided. |
Incomplete outcome data (attrition bias) Ejaculatory function | Unclear risk | Due to “substitution” noted above, the number of participants with missing outcome data was not provided. |
Incomplete outcome data (attrition bias) Acute urinary retention | Unclear risk | Due to “substitution” noted above, the number of participants with missing outcome data was not provided. |
Incomplete outcome data (attrition bias) Indwelling catheter | Unclear risk | Due to “substitution” noted above, the number of participants with missing outcome data was not provided. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Other bias | Low risk | No other sources of bias were detected. |