Inflatable penile prostheses (IPPs) were first described almost 50 years ago¹ and are common procedures worldwide. Medicare data from the United States show that from 2001–2010 over 53,000 American men aged ≥65 years old underwent penile implant surgery. Of these, 93% were IPPs.² Despite the prevalence of these surgeries, the data on patient satisfaction have been limited, with few high-quality data present in the literature. Chouhan et al evaluated the highest-cited articles on penile implant outcomes from 2009–2019.³ They concluded that there was no high-quality evidence on implant outcomes. The main limitations were that the method of assessing outcomes was either not disclosed or that there was no standardized method of evaluating outcomes.³ Similarly, Akakpo et al evaluated almost 50 articles on patient satisfaction with penile implants from 2006–2016.⁴ Of the articles evaluated 44% used questionnaires that were not intended for nor validated in IPP patients (such as the International Index of Erectile Function or the Erectile Dysfunction Inventory of Treatment Satisfaction). The remaining articles used proprietary, nonvalidated questionnaires.⁴

These earlier IPP outcome assessments are problematic. The use of different (and sometimes undisclosed) instruments makes it difficult to compare results between studies to get an accurate gauge of patient satisfaction. Given this lack of standardization, it is unsurprising that the results demonstrate variability. For example, one study found that 91% of IPP patients were “very satisfied”⁵ whereas another study showed only 69% of men were satisfied with their IPP.⁶ This demonstrates why there was a critical need for developing a standardized IPP satisfaction questionnaire.

The first validated instrument for IPP satisfaction was developed by Caraceni and Utizi but it is validated in Italian only.⁷ This lack of linguistic validation limits its usefulness for much of the world. This questionnaire focuses on quality of life with an IPP and includes questions pertaining to the 4 parameters of health as outlined by the World Health Organization: functional, social, relational and personal.⁷ While it was validated in IPP patients, this questionnaire does not contain questions specific to the IPP, such as pump location or ease of use. Data show high patient satisfaction with 85% of responses being positive (as defined by a score of ≥3/5) in the initial validation study.⁷ A followup study in a larger population of Italian men also showed high patient satisfaction with a median total score of 68/75.⁸ This questionnaire has been administered to English-speaking patients but without being linguistically validated in English. Results here were similar to prior studies, with 84% of men scoring ≥3/5 (which was the definition used for satisfaction).⁹ However, without prior English linguistic validation, the validity of these data is undermined. Thus, we identified a pressing need for an English-validated instrument on IPP satisfaction.

Therefore, we developed the Satisfaction Survey for Inflatable Penile Implant (SSIPI).¹⁰ This 16-item questionnaire assesses overall satisfaction, pain, function and appearance in English-speaking men with IPPs. SSIPI contains questions specific to IPPs such as pump location and function, as well as naturalness in the deflated and inflated states.¹⁰ SSIPI has undergone a rigorous validation process. The initial questionnaire contained 37 items and was the product of expert opinion from sexual medicine experts as well as feedback from patient cognitive interviews. Responses were on a 5-point Likert scale with a higher score denoting a more positive response. The verbiage of responses used PROMIS (Patient-Reported Outcomes Measurement Information System) approved answer choices. We then winnowed this down to the final 16-item version using Cronbach’s alpha and item-total correlation, removing any items that proved to be redundant or were not highly correlated with the overall score.¹⁰ This final version of SSIPI demonstrated high internal consistency with an overall Cronbach’s alpha coefficient of 0.97, with domains ranging from 0.85–0.89. Test-retest reliability was also favorable with intraclass correlation coefficients of 0.94 overall and 0.87–0.93 for the domains.¹⁰

Figure. Mean SSIPI results.

The questionnaire was administered to 118 men from 4 U.S. centers who were 6 months to 5 years status post initial IPP placement. Men were not excluded based on surgical complications, comorbidities, relationship status or sexual orientation.¹⁰ Preliminary SSIPI data show high patient satisfaction with a mean overall score of 4.15 out of 5 (see figure). With regards to subdomains, overall satisfaction had a mean score of 4.15, pain mean score was 4.56, appearance was 3.72 and function had a mean of 4.16 (all on a 5-point scale).¹⁰

We are in the process of external validation in English-speaking patients to assess patient satisfaction in a larger cohort of IPP patients. Our ultimate goal is to create a national registry, independent of industry involvement, to have a uniform method of collecting data on implant patient satisfaction. Ideally, we would track satisfaction outcomes in all of these men using SSIPI. We are also working with international collaborators to linguistically validate SSIPI in other languages, starting with Spanish and Portuguese. Another current SSIPI project entails evaluating IPP satisfaction based on race as well as health care literacy. By administering SSIPI to a large IPP population we hope to finally have accurate high-quality data on patient satisfaction after IPP.

Inflatable penile prostheses (IPPs) were first described almost 50 years ago¹ and are common procedures worldwide. Medicare data from the United States show that from 2001–2010 over 53,000 American men aged ≥65 years old underwent penile implant surgery. Of these, 93% were IPPs.² Despite the prevalence of these surgeries, the data on patient satisfaction have been limited, with few high-quality data present in the literature. Chouhan et al evaluated the highest-cited articles on penile implant outcomes from 2009–2019.³ They concluded that there was no high-quality evidence on implant outcomes. The main limitations were that the method of assessing outcomes was either not disclosed or that there was no standardized method of evaluating outcomes.³ Similarly, Akakpo et al evaluated almost 50 articles on patient satisfaction with penile implants from 2006–2016.⁴ Of the articles evaluated 44% used questionnaires that were not intended for nor validated in IPP patients (such as the International Index of Erectile Function or the Erectile Dysfunction Inventory of Treatment Satisfaction). The remaining articles used proprietary, nonvalidated questionnaires.⁴

These earlier IPP outcome assessments are problematic. The use of different (and sometimes undisclosed) instruments makes it difficult to compare results between studies to get an accurate gauge of patient satisfaction. Given this lack of standardization, it is unsurprising that the results demonstrate variability. For example, one study found that 91% of IPP patients were “very satisfied”⁵ whereas another study showed only 69% of men were satisfied with their IPP.⁶ This demonstrates why there was a critical need for developing a standardized IPP satisfaction questionnaire.

The first validated instrument for IPP satisfaction was developed by Caraceni and Utizi but it is validated in Italian only.⁷ This lack of linguistic validation limits its usefulness for much of the world. This questionnaire focuses on quality of life with an IPP and includes questions pertaining to the 4 parameters of health as outlined by the World Health Organization: functional, social, relational and personal.⁷ While it was validated in IPP patients, this questionnaire does not contain questions specific to the IPP, such as pump location or ease of use. Data show high patient satisfaction with 85% of responses being positive (as defined by a score of ≥3/5) in the initial validation study.⁷ A followup study in a larger population of Italian men also showed high patient satisfaction with a median total score of 68/75.⁸ This questionnaire has been administered to English-speaking patients but without being linguistically validated in English. Results here were similar to prior studies, with 84% of men scoring ≥3/5 (which was the definition used for satisfaction).⁹ However, without prior English linguistic validation, the validity of these data is undermined. Thus, we identified a pressing need for an English-validated instrument on IPP satisfaction.

Therefore, we developed the Satisfaction Survey for Inflatable Penile Implant (SSIPI).¹⁰ This 16-item questionnaire assesses overall satisfaction, pain, function and appearance in English-speaking men with IPPs. SSIPI contains questions specific to IPPs such as pump location and function, as well as naturalness in the deflated and inflated states.¹⁰ SSIPI has undergone a rigorous validation process. The initial questionnaire contained 37 items and was the product of expert opinion from sexual medicine experts as well as feedback from patient cognitive interviews. Responses were on a 5-point Likert scale with a higher score denoting a more positive response. The verbiage of responses used PROMIS (Patient-Reported Outcomes Measurement Information System) approved answer choices. We then winnowed this down to the final 16-item version using Cronbach’s alpha and item-total correlation, removing any items that proved to be redundant or were not highly correlated with the overall score.¹⁰ This final version of SSIPI demonstrated high internal consistency with an overall Cronbach’s alpha coefficient of 0.97, with domains ranging from 0.85–0.89. Test-retest reliability was also favorable with intraclass correlation coefficients of 0.94 overall and 0.87–0.93 for the domains.¹⁰

Figure. Mean SSIPI results.

The questionnaire was administered to 118 men from 4 U.S. centers who were 6 months to 5 years status post initial IPP placement. Men were not excluded based on surgical complications, comorbidities, relationship status or sexual orientation.¹⁰ Preliminary SSIPI data show high patient satisfaction with a mean overall score of 4.15 out of 5 (see figure). With regards to subdomains, overall satisfaction had a mean score of 4.15, pain mean score was 4.56, appearance was 3.72 and function had a mean of 4.16 (all on a 5-point scale).¹⁰

We are in the process of external validation in English-speaking patients to assess patient satisfaction in a larger cohort of IPP patients. Our ultimate goal is to create a national registry, independent of industry involvement, to have a uniform method of collecting data on implant patient satisfaction. Ideally, we would track satisfaction outcomes in all of these men using SSIPI. We are also working with international collaborators to linguistically validate SSIPI in other languages, starting with Spanish and Portuguese. Another current SSIPI project entails evaluating IPP satisfaction based on race as well as health care literacy. By administering SSIPI to a large IPP population we hope to finally have accurate high-quality data on patient satisfaction after IPP.