INTRODUCTION: Initial psychometric evaluation of the Female Sexual Well-Being Scale(TM) (FSWB Scale(TM)) demonstrated its validity for assessing sexual well-being in sexually functional US women. AIM: To evaluate the responsiveness of the FSWB Scale to interventional products in sexually functional women and to confirm its psychometric validity. METHODS: In a 5-week, randomized, multicenter study, the responsiveness of FSWB Scale scores to interventional products was evaluated in 326 sexually functional, heterosexual women randomized to: (i) no intervention; (ii) couple lubricants (1 lubricant for female and second lubricant for male partner); (iii) female arousal gel; or (iv) female lubricant. At baseline, participants were instructed to have >or=3 occurrences of vaginal intercourse over the next 4 weeks. Participants assigned to an intervention were instructed to use the product immediately before intercourse. Women completed the self-administered FSWB Scale at week 1 (screening), week 2 (baseline), and week 5 (study end). MAIN OUTCOME MEASURES: Changes from baseline in the FSWB Scale overall score and four domain scores were analyzed using analysis of covariance. Additional analyses were conducted to confirm psychometric validity. RESULTS: The mean change from baseline in the FSWB Scale overall score improved significantly among the four arms (treatment-effect P = 0.03). The within-treatment mean increase from baseline in the overall score was significant for each product arm (all P <or= 0.002), whereas no significant change was observed for the no intervention arm (P = 0.13). Changes from baseline in the four domain scores improved differentially according to the expected effects of each product. Factor structure, reliability, and construct validity results confirmed those reported previously. CONCLUSIONS: The FSWB Scale demonstrated excellent responsiveness to interventional products, with scores remaining relatively stable with no intervention and changing differentially and by domain with different product types. The results strongly support the usefulness of the FSWB Scale for assessing sexual well-being in future studies.
RCT Entities:
INTRODUCTION: Initial psychometric evaluation of the Female Sexual Well-Being Scale(TM) (FSWB Scale(TM)) demonstrated its validity for assessing sexual well-being in sexually functional US women. AIM: To evaluate the responsiveness of the FSWB Scale to interventional products in sexually functional women and to confirm its psychometric validity. METHODS: In a 5-week, randomized, multicenter study, the responsiveness of FSWB Scale scores to interventional products was evaluated in 326 sexually functional, heterosexual women randomized to: (i) no intervention; (ii) couple lubricants (1 lubricant for female and second lubricant for male partner); (iii) female arousal gel; or (iv) female lubricant. At baseline, participants were instructed to have >or=3 occurrences of vaginal intercourse over the next 4 weeks. Participants assigned to an intervention were instructed to use the product immediately before intercourse. Women completed the self-administered FSWB Scale at week 1 (screening), week 2 (baseline), and week 5 (study end). MAIN OUTCOME MEASURES: Changes from baseline in the FSWB Scale overall score and four domain scores were analyzed using analysis of covariance. Additional analyses were conducted to confirm psychometric validity. RESULTS: The mean change from baseline in the FSWB Scale overall score improved significantly among the four arms (treatment-effect P = 0.03). The within-treatment mean increase from baseline in the overall score was significant for each product arm (all P <or= 0.002), whereas no significant change was observed for the no intervention arm (P = 0.13). Changes from baseline in the four domain scores improved differentially according to the expected effects of each product. Factor structure, reliability, and construct validity results confirmed those reported previously. CONCLUSIONS: The FSWB Scale demonstrated excellent responsiveness to interventional products, with scores remaining relatively stable with no intervention and changing differentially and by domain with different product types. The results strongly support the usefulness of the FSWB Scale for assessing sexual well-being in future studies.
Authors: Benjamin G Cooper; Stacy L Chin; Ruiqing Xiao; Karen Buch; Ducksoo Kim; Mark W Grinstaff Journal: R Soc Open Sci Date: 2018-10-17 Impact factor: 2.963