Is bulbospongiosus muscle botox injection safe and effective in treating lifelong premature ejaculation? Randomized controlled study.

PURPOSE: To evaluate the safety and efficacy of botulinum-A toxin injections into the bulbospongiosus muscle for cases of lifelong drug-resistant premature ejaculation (PE). METHODS: Ninety-eight outpatients diagnosed with lifelong PE were randomly assigned to two groups: the botulinum-A toxin group comprising forty-nine patients and the placebo (saline) group also consisting of forty-nine patients. A 100 U botulinum-A toxin was diluted into 10 cc of saline, with 5 cc injected into one side of the muscle (botulinum-A toxin group) guided by ultrasound to distribute across most muscle fibers. The same technique was applied using the same volume of saline injected into the bulbospongiosus muscle. Intravaginal ejaculatory latency time (IELT), scores from the premature ejaculation profile (PEP), Premature Ejaculation Diagnostic Tool (PEDT), International Index of Erectile Function (IIEF), and recording of any complications were obtained. Follow-ups occurred at 1-, 3-, and 6-month post-procedure. RESULTS: Cases receiving injections of botulinum-A toxin into the bulbospongiosus muscle showed notably extended intravaginal ejaculatory latency times compared to their initial performance after treatment. In addition, there were enhancements in PEP scores, and notably, no significant complications were reported. Conversely, the bilateral injection of saline into the bulbospongiosus muscle did not demonstrate any impact on ejaculation latencies. CONCLUSION: Our study demonstrated that the injection of botulinum-A toxin into the bulbospongiosus muscle can serve as a safe and effective option for treating PE. Nonetheless, its clinical application warrants further studies involving larger sample sizes and longer follow-up periods.

The effect of piezoelectric shockwave lithotripsy with 2- and 8-mm focus sizes on stone disintegration and renal injury.

OBJECTIVES: To compare the efficacy and safety of shockwave lithotripsy (SWL) using a narrow focus or wide focus for renal stones. PATIENTS AND METHODS: A double-blind randomised trial included adult patients with a solitary radio-opaque renal pelvic stone of 1-2 cm. Patients were randomised into two groups: narrow-focus (2 mm) SWL and wide-focus (8 mm) SWL. The stone-free rate (SFR) and presence of complications such as haematuria, fever, pain, and peri-renal haematoma were evaluated. Pre- and postoperative urinary markers (neutrophil gelatinase-associated lipocalin [NGAL] and kidney injury molecule 1 [KIM-1]) concentrations were compared to assess renal injury. RESULTS: A total of 135 patients were recruited for this study. The SFR after the first SWL session was 79.2% and 69.1% in narrow- and wide-focus groups, respectively. There was a comparable rise in the median 2-h NGAL concentration in both groups (P = 0.62). However, the rise in the median (interquartile range [IQR]) 2-h KIM-1 concentration was significantly higher in the narrow-focus group at 4.9 (4.6, 5.8) ng/mL compared with the wide-focus group at 4.4 (3.2, 5.7) ng/mL (P = 0.02). Nevertheless, the 3-day NGAL and KIM-1 urinary marker concentrations were significantly improved (P = 0.263 and P = 0.963, respectively). The overall SFR after three sessions was 86.6% and 86.8% in the narrow- and wide-focus groups, respectively (P = 0.77). Both groups were comparable for complications, apart from the median pain score and the percentage of high-grade haematuria, which were significantly higher in the narrow-focus group (P < 0.001 and P = 0.03, respectively). CONCLUSION: Narrow- and wide-focus SWL were associated with comparable outcomes and re-treatment rates. However, narrow-focus SWL was associated with significantly higher morbidity in terms of pain and haematuria.

Optimum combined MET according to tolerability with efficacy, Silodosin Tadalafil versus Silodosin Vardenafil for distal ureteric stone: a prospective, double blinded, randomized clinical trial.

OBJECTIVES: To determine the optimum combination therapy of Silodosin-Tadalafil versus Silodosin-Vardenafil in terms of both tolerability and efficacy for the management of distal ureteric stones. METHODS: This prospective, double blinded, randomized clinical trial included 140 patients with distal ureteric stones, randomized into two groups: Group I (n = 67) received Silodosin 8 mg once daily combined with Tadalafil 5 mg once daily, and Group II (n = 68) received Silodosin 8 mg once daily combined with Vardenafil 10 mg once daily. The primary outcome was the tolerability of the combination therapies, assessed through the incidence of adverse events. Secondary outcomes included stone expulsion rate, expulsion time, and the need for analgesics. RESULTS: Both combination therapies demonstrated similar efficacy, with no significant differences in stone expulsion rate (70.1% vs. 67.6%, P = 0.754), expulsion time (19 ± 3 days for both groups, P = 0.793), and analgesic requirements (P > 0.05). However, the Silodosin-Tadalafil combination showed a significantly lower occurrence of adverse events, with notable differences in headache (23.9% vs. 57.4%, P < 0.001), dizziness (32.8% vs. 60.3%, P = 0.001), and gastrointestinal upset (9% vs. 66.2%, P < 0.001), and other adverse effects. The overall occurrence of any adverse event was significantly lower in the Silodosin-Tadalafil group (88.1% vs. 98.5%, P = 0.017). CONCLUSIONS: Both Silodosin-Tadalafil and Silodosin-Vardenafil therapies are effective in managing distal ureteric stones. However, the Silodosin-Tadalafil combination is associated with a significantly lower incidence of adverse events, making it a more tolerable option for patients.

Comparative study between retrograde intrarenal surgery and ultrasound- guided shock wave lithotripsy for treatment of 1 to 2 cm radiolucent lower calyceal stones.

Objectives: The objective is to compare the safety and efficacy of retrograde intrarenal surgery (RIRS) and ultrasound-guided (US-guided) shock wave lithotripsy (SWL) for the treatment of radiolucent lower pole calculi of 1-2 cm. Materials and Methods: This prospective randomized study was performed at our tertiary care urology institute of Benha University Hospitals; cases were randomized either to undergo RIRS (Group A) or US-guided SWL with a triple focus system (Group B). The safety and effectiveness of both therapies were compared using new criteria for stone-free rate (SFR): Grade A (absolutely stone free), Grade B (≤2 mm fragments), and Grade C (>2 mm up to 4 mm fragments), fluoroscopy time, operative time, auxiliary procedures, retreatment, and complications. Results: Out of 100 patients, 92 were eligible for this study. RIRS had a higher SFR of 88.9% compared to SWL, 72.3% (P = 0.045). Furthermore, stone-free classification significantly differed between the studied groups (P < 0.001), with Grade A being significantly higher in Group A. Conversely, Grades B and C were lower in Group A. On the other hand, operative and fluoroscopy times were significantly reduced with SWL (P = 0.004 and < 0.001, respectively). While complications did not significantly differ between the two groups (P = 0.340), a significant distinction was observed in terms of the Clavien-Dindo classification. Conclusions: RIRS is an effective and safe option for treating radiolucent lower calyceal stones of ≤2 cm, with a greater SFR and lower need for auxiliary operations. However, Sono SWL is a cost-effective alternative that can achieve a comparable success rate after retreatment sessions.

Is Platelet Rich Plasma Safe and Effective in Treatment of Erectile Dysfunction? Randomized Controlled Study.

OBJECTIVE: To evaluate the safety and efficacy of platelet rich plasma (PRP) injections as a therapeutic modality for mild to moderate erectile dysfunction. METHODS: A placebo-controlled study of 100 cases with mild to moderate erectile dysfunction. Participants were allocated to 2 groups; the PRP group received 3 injections (3 mL each corpus) and the interval between injections was 15 days, while the Placebo (Saline) group received 6 mL saline injected intracavernous. Postinjection follow-up lasted 6 months. RESULTS: Compared to the placebo group, the PRP group demonstrated a significant improvement at the 1 and 3 months follow-up that slightly dropped at the 6 months follow-up (P <.001). The improvement was evident in the duplex parameters, International Index of Erectile Function Erectile Function (IIEF-EF), SEP Q2, and 3. At 1-month post-treatment follow-up (76%) patients in the PRP group had an improved IIEF-EF as they attained a minimal clinically important difference compared to (18%) in the saline group. At the 3-months post-treatment follow-up, (72%) patients achieved a minimal clinically important difference in the PRP group vs (16%) in saline group then dropped to (70%) in the PRP group vs (16%) in saline group at the 6-months post-treatment follow up. Patients' overall and intercourse satisfaction levels were higher in the PRP group than the placebo group as demonstrated with the higher IIEF score Q6, 7, 8, and IIEF score Q13, 14 respectively with the maximum improvement reported at the 3 months follow-up. No reports of plaque formation, subcutaneous bruising, or any other major side effects among participants. CONCLUSION: PRP is a safe and promising method for the improvement of mild to moderate erectile dysfunction.

Efficacy of pre-operative silodosin on flexible ureteroscopy procedure: A randomized controlled study.

Objectives: To evaluate the impact of silodosin on stages of flexible ureteroscopy (F-URS) procedures, complications, and stone-free rate (SFR). Patients and Methods: A prospective, randomized, controlled comparison research was conducted on 106 patients who were randomly allocated into two groups: the study group (52 patients) received F-URS with preoperative daily uptake of 8 mg silodosin for 10 days, and the control group (54 patients) received F- URS without silodosin uptake. Two patients were lost during the follow up in the study group and four patients were also lost in the controls. Results: Operative time, application access sheath time (AAST), entrance to ureteric orifice time (ETUOT), and entrance to bladder time (ETBT) were significantly lower in the study group compared to controls. Meanwhile, F-URS time & laser time was higher in the study group compared to controls but without statistically significant difference. Complications were insignificalty different between both studied goups with no impact on SFR. Conclusion: Before ureteroscopy, silodosin, an adjunctive alpha-blocker therapy, was successful in treating stones resulting in shortening the procedural time, with no impact on SFR or complication rate.

Gonadotoxic effect of tramadol administration: A prospective controlled study.

OBJECTIVE: To detect the possible gonadotoxic effects of tramadol dependence on seminal fluid parameters, and prolactin and testosterone hormone levels. PATIENTS SUBJECTS AND METHODS: There were 94 participants who were divided into a tramadol-dependent group (T-group; 56 patients) and a control group (C-group; 38 healthy volunteers). The following variables were evaluated: testosterone level, prolactin level, erectile function, libido, semen parameters, and effect of tramadol dose and dependence duration. RESULTS: There was a significant increase in erectile dysfunction (ED) and decreased libido in the T-group vs C-group. Also, the serum testosterone level was lower in the T-group vs the C-group, while the serum prolactin level was significantly higher in the T-group vs the C-group. All semen parameters were low in the T-group except for abnormal forms, which were high. As the dose of tramadol increased there was a more negative effect on the previous parameter, while ED, libido, semen volume and concentration showed no significant changes. When comparing tramadol doses of 400-1000 mg/day to >1000 mg/day, the tramadol blood level increased with high doses, while serum testosterone level decreased when the dose increased and the prolactin level increased when the dose increased. Progressive motility of the sperm decreased and abnormal forms increased. Also increased duration of tramadol administration was also accompanied by a more negative effect on these parameters. CONCLUSION: Tramadol administration has a negative effect on hormone levels, libido, erectile function, and semen characters.Abbreviations: ED: erectile dysfunction; EF: erectile function.