Prospective, randomized, placebo-controlled, two-arm study to evaluate the efficacy of coadministration of garlic as a hydrogen sulfide donor and tadalafil in patients with erectile dysfunction not responding to tadalafil alone - A pilot study.

OBJECTIVE: The objective is to evaluate the efficacy of coadministration of garlic (as a hydrogen sulfide [H2S] donor) and tadalafil for patients with ED using a placebo-controlled, prospective, randomized, two-arm pilot study in patients responding poorly to tadalafil alone. MATERIALS AND METHODS: The patients with complaints of ED (with normal penile Doppler) who failed to maintain sustained improvement in erectile function with tadalafil were recruited after excluding those with comorbidities. The study sample was randomized into two groups. Group A received garlic 5 g twice a day orally and Group B received a placebo twice daily orally for 4 weeks. Both groups continued tadalafil 5 mg in the night for 4 weeks. Their erectile function was assessed at the beginning and at the end of 4 weeks using the International Index of Erectile Function (IIEF-EF), erectile function domain and compared. A value of P ≤ 0.05 was considered statistically significant. RESULTS: Nineteen patients in Group A (mean age 37.5 ± 10.6 years) and 16 patients in Group B (mean age 39.6 ± 9.6 years) participated in the pilot study conducted from May 2022 to August 2022. The participants treated with garlic (as an H2S donor) as a coadministrant had statistically significant improvement in IIEF-EF score (P ≤ 0.0001) at the end of 4 weeks compared to placebo. CONCLUSIONS: Garlic (as an H2S donor) as adjunctive therapy was beneficial in our study participants responding poorly to tadalafil alone.

Prospective randomized study to evaluate and compare the post-procedural sexual function in patients undergoing semi-rigid ureterorenoscopy for distal ureteric stones in three different operating room settings.

Objective: To evaluate and compare the effect of semi-rigid ureterorenoscopy on post-procedural sexual function with three different operating room settings. Methods: In this prospective randomized study, consecutive sexually active patients with normal pre-operative sexual function undergoing uncomplicated semi-rigid ureterorenoscopy for distal ureteric stones were randomized into three groups, with three different operating room settings. Procedure-related anxiety and sexual function were assessed pre-operatively using Amsterdam Preoperative Anxiety and Information Scale and Brief Sexual Function Inventory (in males) and Female Sexual Function Index-6 (in females), respectively. All the participants were stented following the procedure, and the stent was removed after 3 weeks. Post-procedural sexual function and general discomfort were assessed and compared between three groups at 1 week, 3 weeks, and 12 weeks. The effect of surgery-related anxiety, preoperative sexual function, age, and general discomfort (including stent-related discomfort) on post-procedural sexual function were analyzed using multiple regression analysis. A p-value of less than 0.05 was considered statistically significant. Results: Totally, 327 eligible patients were randomized into three groups. The group of patients who underwent the procedural with a screen separating the operating area from the patient vision, while the patient could watch the endoscopy through a separate monitor, had better post-procedural sexual function compared to those who had total vision of the operating area as well as to those whose eyes were blocked. This difference was statistically significant. This post-procedural reduction in sexual function could not be attributed to in situ stent alone. Conclusions: Our study showed that semi-rigid ureterorenoscopy can have significant negative effect on sexual function, which can be reduced with proper preoperative counseling and an ideal operating room settings.

Sexually Induced Orgasm to Improve Postpartum Pelvic Floor Muscle Strength and Sexual Function in Primiparous Women After Vaginal Delivery: A Prospective Randomized Two-Arm Study.

BACKGROUND: Postpartum pelvic floor dysfunction is known to affect the quality of life of women and the methods to treat it are more complex with majority requiring training under supervision. AIM: To compare the efficacy of sexually induced orgasm along with Kegels exercises versus Kegels exercises alone as a treatment method to enhance postpartum pelvic floor muscle strength and sexual function in primiparous women undergoing uncomplicated vaginal deliveries. METHODS: The prospective randomized two-arm study was conducted on sexually active primiparous women who had undergone uncomplicated vaginal deliveries. Those with risk factors for female sexual dysfunction and pelvic floor muscle dysfunction were excluded. Participants in Group 1 were advised daily Kegel's exercises, whereas, those in Group 2 were advised to initiate self-initiated/partnered sexual activity-induced orgasms along with daily Kegel's exercises. Their pelvic floor muscle strength on voluntary contraction, ability to relax pelvic floor voluntarily, and sexual function (using FSFI-6) were assessed monthly for 6 months and the analysis was done using G* Power software (© 2021 Heinrich-Heine-Universität Düsseldorf, Germany). MAIN OUTCOME MEASURE: Postpartum pelvic floor strength and sexual function in 2 groups of women under study. RESULTS: The study period was from January 2020 to December 2020. The Group 1 had 26 participants (mean age 29.69 ± 2.2 years) and Group 2 had 29 participants (mean age 30.07 ± 2.57 years). The sexual function as well as ability to relax pelvic floor were significantly better in Group 2 compared to Group 1 at each monthly intervals whereas strength of pelvic floor muscles during voluntary contraction was significantly higher in Group 2 compared to Group 1 at the end of 6 months and it was statistically significant at a P value of .05. CLINICAL IMPLICATIONS: Novel method of using naturally occurring sexually induced orgasms for postpartum pelvic floor rehabilitation can revolutionize postpartum pelvic floor training in women, as it can be practiced at home with ease, along with easily performable Kegel's exercises. STRENGTHS AND LIMITATIONS: Use of prospective randomization and minimization of confounding factors is the strength of the study. The small sample size is the limitation of the study. CONCLUSIONS: Postpartum pelvic floor muscle strength and sexual function in primiparous women who have undergone uncomplicated vaginal deliveries can be significantly improved with the addition of sexually induced orgasm as a therapeutic tool along with physical exercises such as Kegels exercises in these women. Bhat GS, Shastry A. Sexually Induced Orgasm to Improve Postpartum Pelvic Floor Muscle Strength and Sexual Function in Primiparous Women After Vaginal Delivery: A Prospective Randomized Two-Arm Study. J Sex Med 2022;19:1634-1643.

Validation of holding time, a novel tool to assess control over ejaculation in males: A pilot study.

Premature ejaculation (PE) is considered as a disorder of perceived loss of ejaculatory control. However, we cannot objectively estimate ejaculatory control due to the absence of an objective tool to measure it. Hence, we designed a pilot study to validate holding time (HoT), a novel objective tool, hypothesized by us, to measure ejaculatory control in men. The construct validity of this tool to differentiate premature ejaculators from normal ejaculators was also assessed in our sample. The study sample had 10 healthy, sexually active normal ejaculators, and 10 premature ejaculators, who volunteered to participate in the study conducted from May 2020 to April 2021. The mean HoT in normal ejaculators was 120.2 ± 31.7 s and the same in premature ejaculators was 32.9 ± 12.9 s. Both the normal (r = 0.983) as well as premature ejaculators (r = 0.839) had good test-retest reliability. The construct validity of HoT to diagnose PE was good with 90% sensitivity, 91% specificity, 63.8% positive predictive value, and 98.1% negative predictive value to diagnose PE when compared with diagnosis by a standard tool. It could be concluded that HoT successfully measured ejaculatory control in men and differentiated normal ejaculators from the premature ejaculators in the sample studied.

Defining ejaculatory latencies in heterosexual males using novel tools in all types of sexual encounters in multinational population sample.

Research into ejaculatory dysfunction in sexual activities other than penovaginal intercourse is limited due to the absence of well-defined tools to measure ejaculatory latencies in these sexual activities. Our pilot study using Arousal to Ejaculation Time Interval (AETI) and Erection to Ejaculation Time Interval (EETI) as tools to measure ejaculatory latencies in different types of sexual encounters in medical professionals had yielded promising results. Hence, we conducted a similar study using AETI and EETI as tools, measured using stopwatch in healthy, sexually active heterosexual male population in a multinational sample from January 2018 to December 2020. Though mean AETI and EETI differed in different sexual activities, on analysing them across all sexual activities, mean AETI and EETI in normal ejaculators, premature ejaculators and delayed ejaculators were 10.3 ± 5.81 min and 6.8 ± 4.13 min, 4.31 ± 2.98 min and 3.35 ± 3.06 min and 20.9 ± 16.1 min and 16.3 ± 10.6 min respectively. Both AETI and EETI were significantly different from normal to premature as well as normal to delayed ejaculators (p-value < 0.05). It could be concluded that these novel tools can help to measure ejaculatory latencies in sexual activities in heterosexual males.

Time to Orgasm in Women in a Monogamous Stable Heterosexual Relationship.

BACKGROUND: Orgasm in women is a complex phenomenon, and the sparse data about time to orgasm (TitOr) in women are an impediment to the research on this complex phenomenon. AIM: To evaluate the stopwatch measured TitOr in women in a monogamous stable heterosexual relationship. METHODS: The study was conducted through web-based and personal interview using a questionnaire, which addressed the issues related to TitOr. Sexually active women older than 18 years and women in a monogamous stable heterosexual relationship were included in the study. Those with comorbidities such as diabetes, hypertension, asthma, psychiatric illness, sexual dysfunction and those with partners with sexual dysfunction were excluded. The participants reported stopwatch measured TitOr after adequate sexual arousal over an 8-week period. The data analysis was performed using GraphPad software (©2018 GraphPad Software, Inc, USA). OUTCOMES: The outcomes included stopwatch measured average TitOr in women. RESULTS: The study period was from October 2017 to September 2018 with a sample size of 645. The mean age of the participants was 30.56 ± 9.36 years. The sample was drawn from 20 countries, with most participants from India, the United Kingdom, the Netherlands, and the United States of America. The mean reported TitOr was 13.41 ± 7.67 minutes (95% confidence interval: 12.76 minutes-14.06 minutes). 17% of the participants had never experienced the orgasm. Penovaginal intercourse was insufficient to reach orgasm in the majority, in whom it was facilitated by certain positions and maneuvers. CLINICAL IMPLICATIONS: The knowledge of stopwatch measured TitOr in women in real-life setting helps to define, treat, and understand female sexual function/dysfunction better and it also helps to plan treatment of male ejaculatory dysfunction, as reported ejaculatory latency in healthy men is much less than the reported TitOr here. STRENGTHS & LIMITATIONS: Use of stopwatch to measure TitOr and a large multinational sample are the strength of the study. The absence of a crosscheck mechanism to check the accuracy of the stopwatch measurement is the limitation of the study. CONCLUSION: Stopwatch measured average TitOr in the sample of women in our study, who were in a monogamous stable heterosexual relationship, is 13.41 minutes (95% confidence interval: 12.76 minutes-14.06 minutes) and certain maneuvers as well as positions during penovaginal intercourse help achieving orgasm, more often than not. Bhat GS, Shastry A. Time to Orgasm in Women in a Monogamous Stable Heterosexual Relationship. J Sex Med 2020;17:749-760.

A prospective double-blind, randomized, placebo-controlled study to evaluate the efficacy of silodosin 8 mg as an on-demand, reversible, nonhormonal oral contraceptive for males: a pilot study.

PURPOSE: As silodosin 8 mg, used for treating BPH, is known to cause absence of sperms in the ejaculate, its potential as an on-demand, reversible, nonhormonal oral contraceptive for males was assessed in this pilot study. METHODS: In this randomized, double-blind, placebo-controlled pilot study, healthy, sexually active adult male volunteers in a stable sexual relationship with a female partner with proven fertility were recruited. Those using other contraceptive methods were excluded. During the first part of the study, silodosin 8 mg and placebo were crossed over among the randomly assigned two groups of participants and their post-masturbation semen and post-ejaculation urine were analyzed for spermatozoa. During the second part, both groups received silodosin 8 mg 3 h prior to heterosexual vaginal intercourse for 1 year. The primary outcome measure was the number of unintended pregnancies in their female partners. The secondary outcome measure was dropout rate due to adverse events. The clinical trial registry number was CTRI/2017/09/009872. RESULTS: The study period was January 2017 to December 2017 with sample size 63. Reversible azoospermia was noted following silodosin intake during the first part of the study. During the second part, no untended pregnancy was reported. None of the participants dropped out due to adverse events. Four patients were lost to follow-up. CONCLUSIONS: Silodosin 8 mg achieved total reversible azoospermia, hence prevented unintended pregnancies in the female partners of the males who used the drug as an on-demand oral contraceptive.

Association Between Post-Ejaculatory Refractory Time (PERT) and Premature Ejaculation (PE).

INTRODUCTION: Patients with premature ejaculation (PE) often complain of difficulty in having second erection, which is not yet investigated using scientific methodology. AIM: Evaluation of the association between post-ejaculation refractory time (PERT) with PE by comparing PERT in premature ejaculators with their age-matched control subjects. METHODS: After ethical committee approval and written informed consent from the participants were obtained, men in a monogamous stable sexual relationship and reporting PE were recruited into the study. Sexually active, matched control subjects were recruited for comparison. Exclusion criteria were erectile dysfunction, diabetes mellitus, cardiovascular diseases, hypogonadism, psychiatric conditions, instrumentation of the genitourinary tract, genitourinary anomalies, and genitourinary infections. Both the premature ejaculators and their control subjects were evaluated with the PE diagnostic tool before initiation of the study. They were asked to record their IELT and PERT over 4 weeks. The statistical analysis was done to obtain descriptive statistics, namely, mean and SD, paired t-tests, and logistic regression analysis. P < .001 was considered significant. MAIN OUTCOME MEASURE: There was a statistically significant association between prolonged PERT and PE in patients with PE compared with their age-matched control subjects. RESULTS: 102 premature ejaculators and an equal number of matched control subjects were evaluated from January 2016-December 2017. The average PERT in premature ejaculators and control subjects was 330 ± 296.63 minutes and 105.64 ± 98.59 minutes, respectively (P < .0001). Increasing age was associated with increasing PERT. PE was more common in patients when PERT exceeded a threshold of 590 minutes. CLINICAL IMPLICATIONS: Until now, the association between PE and PERT with matched-pair analysis was not reported. Our study addresses this association, which can add a new paradigm in the evaluation and management of PE. STRENGTH & LIMITATIONS: The association between PE and prolonged PERT using a statistically appropriate, adequately powered methodology is the strength of the study. The inability to address the causal association between prolonged PERT and PE because of the paucity of evidence at present is the limitation of the study. We believe that the results of this study could trigger further research into such an association, so the mystery of such an association can be unraveled. CONCLUSIONS: The association between prolonged PERT and PE, as seen in our study, is a finding, that needs further research to establish a causal association. However, reporting such an association is necessary because it is contrary to the present understanding. Bhat GS, Shastry A. Association Between Post-Ejaculatory Refractory Time (PERT) and Premature Ejaculation (PE). J Sex Med 2019;16:1364-1370.

Acoustic-Perceptual Correlates of Voice in Indian Hindu Purohits.

OBJECTIVE: Purohit, in the Indian religious context (Hindu), means priest. Purohits are professional voice users who use their voice while performing regular worships and rituals in temples and homes. Any deviations in their voice can have an impact on their profession. Hence, there is a need to investigate the voice characteristics of purohits using perceptual and acoustic analyses. METHODS: A total of 44 men in the age range of 18-30 years were divided into two groups. Group 1 consisted of purohits who were trained since childhood (n = 22) in the traditional gurukul system. Group 2 (n = 22) consisted of normal controls. Phonation and spontaneous speech samples were obtained from all the participants at a comfortable pitch and loudness. The Praat software (Version 5.3.31) and the Speech tool were used to analyze the traditional acoustic and cepstral parameters, respectively, whereas GRBAS was used to perceptually evaluate the voice. RESULTS: Results of the independent t test revealed no significant differences across the groups for perceptual and traditional acoustic measures except for intensity, which was significantly higher in purohits' voices at P < 0.05. However, the cepstral values (cepstral peak prominence and smoothened cepstral peak prominence) were much higher in purohits than in controls at P < 0.05 CONCLUSIONS: Results revealed that purohits did not exhibit vocal deviations as analyzed through perceptual and acoustic parameters. In contrast, cepstral measures were higher in Indian Hindu purohits in comparison with normal controls, suggestive of a higher degree of harmonic organization in purohits. Further studies are required to analyze the physiological correlates of increased cepstral measures in purohits' voices.

Sexuality in Surgically Treated Carcinoma Penis Patients and Their Partners.

Most common treatment offered to carcinoma penis patients is surgery. This results in not only mutilation of the genitals but also affects their sexuality. The treating physician fails to address the issue due to the paucity of the data in this regard. Hence, we decided to evaluate sexuality in these patients after surgical treatment for penile cancer. Most of the times, their partners also face problems of sex and sexuality, regarding which there is no literature. Hence, we decided to include their partners also in the study. We retrieved records of the patients who underwent surgical treatment for carcinoma penis at our institute. After obtaining ethical committee approval, they were invited along with their partners for personal interview. After obtaining written informed consent from each of them, they were administered sexual functioning questionnaire (SFQ). Sexuality was evaluated based on the scores obtained. Performance anxiety was reported by majority of these patients. Their sexual interest, arousal and desire remained almost intact with reduction in satisfaction more so in total penectomised patients. Though the partners had accepted the global reduction in sexuality as their fate, their interpersonal relationship remained little disturbed. The study reveals that sexuality is more than the sexual intercourse alone. Proper pre-operative counselling of these patients and their partners by the treating urologist helps better post-treatment adjustment with regards to sexuality in these patients as well as their partners.

New Tools to Measure Ejaculatory Latency-Arousal to Ejaculation Time Interval and Erection to Ejaculation Time Interval: A Pilot Study.

OBJECTIVE: The present study aimed to evaluate the proposed novel tools, namely, arousal to ejaculation time interval (AETI) and erection to ejaculation time interval (EETI), and to measure ejaculatory latency during different types of sexual encounters in a pilot study. MATERIALS AND METHODS: The study period was from September 2016 to December 2016. After obtaining informed consent and institutional review board approval, the medical practitioners without any comorbidity and who volunteered to participate were asked to report their self-assessed AETI and EETI during a sexual activity. They were also asked to opine as to whether they consider themselves as normal ejaculators, delayed ejaculators, or premature ejaculators. Statistical data including mean, standard deviation, and P value were obtained. RESULTS: The sample size was 60 with a mean age of 48.9 ± 10.8 years. A total of 48 participants reported themselves as normal. Their mean AETIs were 624.8 ± 83.6 seconds, 700 ± 79.1 seconds, and 420 ± 57.7 seconds, and their mean EETIs were 355 ± 82.6 seconds, 442.5 ± 46.6 seconds, and 240 ± 38.6 seconds during heterosexual vaginal intercourse, masturbation, and oral sex, respectively. Twelve participants reported premature ejaculation, and their mean AETIs were 122 ± 11.6 seconds, 73.33 ± 11.2 seconds, and 74 ± 12.3 seconds, and their mean EETIs were 106.7 ± 21.6 seconds, 70 ± 13.7 seconds, and 60 ± 11.8 seconds during heterosexual vaginal intercourse, masturbation, and oral sex, respectively. None of the participants reported themselves as delayed ejaculators. The differences between the means were statistically significant (P ≤.0001). CONCLUSION: AETI and EETI can be used to measure ejaculatory latency in different types of sexual encounters.

Use of a stopwatch to measure ejaculatory latency may not be accurate among Indian patients.

INTRODUCTION: Although the use of a stopwatch is recommended to record intravaginal ejaculatory latency time (IELT) for premature ejaculation, there is no Indian literature which assesses the reliability of this method among our patients. Hence, we assessed the accuracy of stopwatch-measured IELT and compared it with other methods such as number of thrusts and self-assessed IELT in an Indian context. METHODS: Between January 2015 and December 2015, couples with premature ejaculation (PE) confirmed with the Premature Ejaculation Diagnostic Tool were enrolled in this study. They were asked to report self-assessed IELT for the first 2 weeks, number of thrusts before ejaculation following vaginal penetration for the next 2 weeks, and stopwatch-clocked IELT for the last 2 weeks. At each 2-week interval, the couples answered erectile/ejaculatory performance anxiety index questionnaire (EPAI). The data were analyzed at the end of 6 weeks. RESULTS: A total of 42 couples with an average married life of 5.53 years were included in the study. Average stopwatch-clocked IELT was almost 1 min more than the self-reported IELT, which was statistically significant. The average number of thrusts reported was 6.31. Anxiety on the EPAI scale was maximum while using stopwatch to measure IELT. CONCLUSION: Use of stopwatch to clock the IELT does not appear to represent true IELT in Indian patients. Self-assessed IELT correlated more accurately with symptoms of PE.

Effectiveness of 'on demand' silodosin in the treatment of premature ejaculation in patients dissatisfied with dapoxetine: a randomized control study.

INTRODUCTION: Premature ejaculation is a common sexual disorder, which is usually underreported. Multiple treatment methodologies are in use due to the absence of an effective, universally acceptable treatment modality. The most common drug used is dapoxetine, which has adverse effects limiting its long-term use. Hence, we decided to evaluate the effectiveness of 'on demand' silidosin 4 mg in patients with premature ejaculation, who were dissatisfied with dapoxetine 30 mg. MATERIAL AND METHODS: The study included 64 patients who reported premature ejaculation who were unhappy with the treatment with 'on demand' dapoxetine 30 mg, either due to its adverse effects or because of its overall inefficacy. They were divided into two groups of 33 and 31 respectively by simple randomization, with Group A treated with 'on demand' silodosin 4 mg three hours prior to intercourse, whereas Group B was treated with placebo. Pre- and post-treatment intravaginal ejaculatory latency time (IELT), premature ejaculation profile (PEP) and clinical global impression of change (CGIC) for premature ejaculation were evaluated. RESULTS: Patients in Group A (silodosin 4 mg) reported statistically significant improvement (p <0.005) in intravaginal ejaculatory latency time (IELT), premature ejaculation profile (PEP) and clinical global impression of change (CGIC) for premature ejaculation, with four patients reporting uncomfortably-delayed ejaculation. CONCLUSIONS: 'On demand' silodosin 4 mg is an effective treatment option with very few adverse events in those patients suffering from premature ejaculation, who are dissatisfied with dapoxetine 30 mg due to its adverse effects or inefficacy.

Cepstral Characteristics of Voice in Indian Female Classical Carnatic Singers.

BACKGROUND: The cepstral measures are gaining attention in the voice analysis as it is reported to be strong predictor of voice impairments. As singer's voice is reported to be present with more harmonics, it can be hypothesized that there would be an increase in the value of cepstral parameters. Also, little is known about the cepstral characteristics of voices in Indian classical Carnatic singers; and hence, the present study was undertaken with an aim to characterize the singer's voice using cepstral measures. METHODS: Thirty Indian female classical Carnatic singers and 30 nonsingers participated in the study. Phonation of vowel /a/ was recorded at their habitual pitch and loudness. The cepstral peak prominence and smoothened cepstral peak prominence were analyzed using the Hillenbrand algorithm available in Speech Tool software. Mean and standard deviation was calculated for each group. Obtained scores were analyzed using independent t test. RESULTS: Mean raw scores were found to be increased in classical Carnatic singers in comparison with nonsingers. Results of independent t test revealed significant difference between the means of singers and nonsingers for both the cepstral measures at P < 0.05. CONCLUSIONS: The present study investigated the cepstral characteristic of voice in singers and nonsingers. Results revealed that there was a significant difference between the means of singers and nonsingers indicating that cepstral parameters were higher among the singers in comparison with nonsingers. The obtained results were attributed to the harmonic organization in the voices of singers.