Neha G Gaddam, Joanna Marantidis, Noha T Ahmed, Rachael D Sussman, Elizabeth T Brown, Alexis A Dieter, Andrew I Sokol, Robert E Gutman, Lee A Richter
{"title":"聚丙烯酰胺水凝胶注射最佳麻醉：一项随机试验。","authors":"Neha G Gaddam, Joanna Marantidis, Noha T Ahmed, Rachael D Sussman, Elizabeth T Brown, Alexis A Dieter, Andrew I Sokol, Robert E Gutman, Lee A Richter","doi":"10.1097/SPV.0000000000001757","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>Despite the popularity of urethral bulking with polyacrylamide hydrogel (PAHG) for stress urinary incontinence (SUI)/intrinsic sphincter deficiency (ISD), no studies have assessed optimal anesthetic protocols.</p><p><strong>Objectives: </strong>To compare pain scores between 2 anesthetic protocols in women undergoing in-office PAHG injection: (1) combined anesthetic [external lidocaine-plus-prilocaine (EMLA) cream, intraurethral lidocaine gel, and lidocaine periurethral block] or (2) topical-only (external EMLA cream and intraurethral lidocaine gel).</p><p><strong>Study design: </strong>This single-blinded trial randomized women to 1 of 2 anesthetic protocols. The primary outcome was pain reported via a 10-point visual analog scale (VAS). Secondary outcomes included International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) and Patient Global Impression of Improvement (PGI-I) scores. A safety endpoint of 3 subjects in the topical-only arm requiring unplanned periurethral block to complete the PAHG procedure, and an a priori sample size of 52 subjects was set.</p><p><strong>Results: </strong>Recruitment stopped at 23 subjects (N=11 combined anesthetic vs. N=12 topical-only) upon meeting the safety endpoint. Mean procedural VAS pain scores were lower with concomitant periurethral block (4.5±2.7 combined anesthetic vs. 7.4±2.3 topical-only; P<0.01). For 3 subjects in the topical-only arm requiring additional anesthesia, VAS pain scores were reduced following periurethral block (10.0±0.0 preblock to 4.0±2.6 postblock; P=0.04). There was no difference between arms in procedure duration, reinjection, or questionnaire scores. Subjects in the combined anesthetic arm were less likely to require post-procedure straight catheterization (0% vs. 33% topical-only; P=0.04).</p><p><strong>Conclusions: </strong>Use of a periurethral block with topical anesthetics reduced pain scores and improved postprocedure voiding. These findings support using a combined anesthetic protocol for women undergoing in-office PAHG injection.</p>","PeriodicalId":75288,"journal":{"name":"Urogynecology (Hagerstown, Md.)","volume":" ","pages":""},"PeriodicalIF":1.2000,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Optimal Anesthesia for Polyacrylamide Hydrogel Injection: A Randomized Trial.\",\"authors\":\"Neha G Gaddam, Joanna Marantidis, Noha T Ahmed, Rachael D Sussman, Elizabeth T Brown, Alexis A Dieter, Andrew I Sokol, Robert E Gutman, Lee A Richter\",\"doi\":\"10.1097/SPV.0000000000001757\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>Despite the popularity of urethral bulking with polyacrylamide hydrogel (PAHG) for stress urinary incontinence (SUI)/intrinsic sphincter deficiency (ISD), no studies have assessed optimal anesthetic protocols.</p><p><strong>Objectives: </strong>To compare pain scores between 2 anesthetic protocols in women undergoing in-office PAHG injection: (1) combined anesthetic [external lidocaine-plus-prilocaine (EMLA) cream, intraurethral lidocaine gel, and lidocaine periurethral block] or (2) topical-only (external EMLA cream and intraurethral lidocaine gel).</p><p><strong>Study design: </strong>This single-blinded trial randomized women to 1 of 2 anesthetic protocols. The primary outcome was pain reported via a 10-point visual analog scale (VAS). Secondary outcomes included International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) and Patient Global Impression of Improvement (PGI-I) scores. A safety endpoint of 3 subjects in the topical-only arm requiring unplanned periurethral block to complete the PAHG procedure, and an a priori sample size of 52 subjects was set.</p><p><strong>Results: </strong>Recruitment stopped at 23 subjects (N=11 combined anesthetic vs. N=12 topical-only) upon meeting the safety endpoint. Mean procedural VAS pain scores were lower with concomitant periurethral block (4.5±2.7 combined anesthetic vs. 7.4±2.3 topical-only; P<0.01). For 3 subjects in the topical-only arm requiring additional anesthesia, VAS pain scores were reduced following periurethral block (10.0±0.0 preblock to 4.0±2.6 postblock; P=0.04). There was no difference between arms in procedure duration, reinjection, or questionnaire scores. Subjects in the combined anesthetic arm were less likely to require post-procedure straight catheterization (0% vs. 33% topical-only; P=0.04).</p><p><strong>Conclusions: </strong>Use of a periurethral block with topical anesthetics reduced pain scores and improved postprocedure voiding. 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Optimal Anesthesia for Polyacrylamide Hydrogel Injection: A Randomized Trial.
Importance: Despite the popularity of urethral bulking with polyacrylamide hydrogel (PAHG) for stress urinary incontinence (SUI)/intrinsic sphincter deficiency (ISD), no studies have assessed optimal anesthetic protocols.
Objectives: To compare pain scores between 2 anesthetic protocols in women undergoing in-office PAHG injection: (1) combined anesthetic [external lidocaine-plus-prilocaine (EMLA) cream, intraurethral lidocaine gel, and lidocaine periurethral block] or (2) topical-only (external EMLA cream and intraurethral lidocaine gel).
Study design: This single-blinded trial randomized women to 1 of 2 anesthetic protocols. The primary outcome was pain reported via a 10-point visual analog scale (VAS). Secondary outcomes included International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) and Patient Global Impression of Improvement (PGI-I) scores. A safety endpoint of 3 subjects in the topical-only arm requiring unplanned periurethral block to complete the PAHG procedure, and an a priori sample size of 52 subjects was set.
Results: Recruitment stopped at 23 subjects (N=11 combined anesthetic vs. N=12 topical-only) upon meeting the safety endpoint. Mean procedural VAS pain scores were lower with concomitant periurethral block (4.5±2.7 combined anesthetic vs. 7.4±2.3 topical-only; P<0.01). For 3 subjects in the topical-only arm requiring additional anesthesia, VAS pain scores were reduced following periurethral block (10.0±0.0 preblock to 4.0±2.6 postblock; P=0.04). There was no difference between arms in procedure duration, reinjection, or questionnaire scores. Subjects in the combined anesthetic arm were less likely to require post-procedure straight catheterization (0% vs. 33% topical-only; P=0.04).
Conclusions: Use of a periurethral block with topical anesthetics reduced pain scores and improved postprocedure voiding. These findings support using a combined anesthetic protocol for women undergoing in-office PAHG injection.
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