METHODS: Men diagnosed with CPPS and ED (n = 50) were prescribed with LSWT. The LSWT was administered in 10 sessions over the course of 5 weeks at 3,000 pulses with .25 mJ/mm2 energy flow and 5 Hz frequency. Outcome parameters were measured before and after LSWT.
RESULTS: Clinical symptoms related to CPPS and ED were measured using four validated questionnaires namely National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Index of Erectile Function (IIEF), the International Prostate Symptom Score (IPSS), and Sexual Health Inventory for Men (SHIM). The effect of LSWT on each of the three domains of NIH-CPSI, namely Pain, Symptoms, and Quality of Life (QoL) were also analyzed. Uroflowmetry was measured to assess LSWT effect on urine voiding. The mean baseline CPPS symptoms on NIH-CPSI domains of pain, symptoms and QoL were 9.92 ± 5.72 (mean ± SD), 5.14 ± 14.5, and 8.02 ± 3.17, respectively. LSWT resulted in significant reduction of CPPS symptoms on all NIH-CPSI domains (Pain = .9 ± 1.37; Symptoms = .74 ± 1.03; QoL = 1.16 ± 1.78). The baseline means of CPPS symptoms on IIEF, IPSS, and SHIM were 45.42 ± 16.24, 24.68 ± 9.28, and 14.28 ± 6.02, respectively. LSWT significant improved CPPS symptoms on IIEF (49.48 ± 28.30) and IPSS (9.04 ± 7.01) but not on SHIM (16.02 ± 9.85). No statistically significant differences were observed with all uroflowmetry parameters.
CONCLUSION: The current study demonstrated for the first time the safety and efficacy of LSWT administered in 10 sessions over 5 weeks in improving symptoms of CPPS and ED without causing any significant adverse effect to the patient.
OBJECTIVES: To assess the benefits and harms of TENS for managing pain in people with SCD who experience pain crises or chronic pain (or both).
SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Register, comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries and the reference lists of relevant articles and reviews. Date of the last search: 26 Febraury 2020.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs, where TENS was evaluated for managing pain in people with SCD.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of the trials identified by the literature searches according to the inclusion criteria. Two review authors then independently extracted data, assessed for risk of bias using the Cochrane standard tool and rated the quality of evidence using the GRADE guidelines.
MAIN RESULTS: One double-blind cross-over RCT with 22 participants with SCD (aged 12 to 27 years) was eligible for inclusion. Following stratification into four pain crises severity grades, participants were then randomised to receive TENS or placebo (sham TENS). The trial was concluded after 60 treatment episodes (30 treatment episodes of each treatment group). There is a lack of clarity regarding the trial design and the analysis of the cross-over data. If a participant was allocated to TENS treatment for an episode of pain and subsequently returned with a further episode of a similar degree of pain, they would then receive the sham TENS treatment (cross-over design). For those experiencing a pain episode of a different severity, it is not clear whether they were re-randomised or given the alternate treatment. Reporting and analysis was based on the total number pain events and not on the number of participants. It is unclear how many participants were crossed over from the TENS group to the sham TENS group and vice versa. The trial had a high risk of bias regarding random sequence generation and allocation concealment; an unclear risk regarding the blinding of participants and personnel; and a low risk regarding the blinding of the outcome assessors and selective outcome reporting. The trial was small and of very low quality; furthermore, given the issue with trial design we were unable to quantitatively analyse the data. Therefore, we present only a narrative summary and caution is advised in interpreting the results. In relation to our pre-defined primary outcomes, the included trial did not report pain relief at two to four weeks post intervention. The trial authors reported that no difference was found in the changes in pain ratings (recorded at one hour and four hours post intervention) between the TENS and the placebo groups. In relation to our secondary outcomes, the analgesic usage during the trial also did not show any difference between groups. Given the quality of the evidence, we are uncertain whether TENS improves overall satisfaction as compared to sham TENS. The ability to cope with activities of daily living was not evaluated. Regarding adverse events, although one case of itching was reported in the TENS group, the site and nature of itching was not clearly stated; hence it cannot be clearly attributed to TENS. Also, two participants receiving 'sham' TENS reported a worsening of pain with the intervention.
AUTHORS' CONCLUSIONS: Since we have only included one small and very low-quality trial, with a high risk of bias across several domains, we are unable to conclude whether TENS is harmful or beneficial for managing pain in people with SCD. There is a need for a well-designed, adequately-powered, RCT to evaluate the role of TENS in managing pain in people with SCD.