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Bladder wall thickness in women with symptoms of overactive bladder and detrusor overactivity: Results from the randomised, placebo-controlled shrink study.
Neurourol Urodyn. 2016 09; 35(7):819-25.NU

Abstract

AIMS

Measurement of bladder wall thickness (BWT) by transvaginal ultrasound (TVUS) may be a less invasive method to diagnose overactive bladder (OAB) or detrusor overactivity (DO) and monitor response to therapy. This study assessed whether treatment with solifenacin affects BWT.

METHODS

This was a double-blind, randomised, placebo-controlled, phase 4 study. Adult women with OAB symptoms received solifenacin 5 or 10 mg or placebo once daily for 12 weeks. The co-primary endpoints were change from baseline to Week 12 in TVUS-measured BWT and urinary nerve growth factor. Only results for BWT are presented here.

RESULTS

Overall, 547 patients were randomised, 501 patients had a baseline BWT measurement, and change from baseline could be calculated for 478 patients. Mean BWT at baseline was 5.08 mm (range 2.2-11.1, SD = 1.14) and was normally distributed. A significant reduction in BWT from baseline to 12 weeks versus placebo was observed with solifenacin 5 mg (-0.42 vs. -0.16 mm, P = 0.03), but not with the 10 mg dose or with pooled solifenacin, considered the primary comparison. Both solifenacin doses were associated with improvements in efficacy and patient satisfaction endpoints versus placebo. Solifenacin was well tolerated, with dry mouth being the most common adverse event.

CONCLUSIONS

There was no consistent effect of solifenacin on BWT in women with OAB/DO, despite improvements in efficacy endpoints. This study suggests that routine clinical assessment of BWT with TVUS for monitoring the effects of OAB/DO treatment is not clinically useful. Neurourol. Urodynam. 35:819-825, 2016. © 2015 Wiley Periodicals, Inc.

Authors+Show Affiliations

King's College Hospital, London, United Kingdom.Hannover Medical School, Hannover, Germany.St Mary's Hospital, Imperial College, London, United Kingdom.Academic Medical Center University Hospital, Amsterdam and Eindhoven University of Technology, The Netherlands.Astellas Pharma Europe B.V., Leiden, The Netherlands.Astellas Pharma Europe, Chertsey, United Kingdom.Formerly of Astellas Pharma Europe, Chertsey, United Kingdom.La Sapienza University of Rome, Rome, Italy.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26199198

Citation

Robinson, Dudley, et al. "Bladder Wall Thickness in Women With Symptoms of Overactive Bladder and Detrusor Overactivity: Results From the Randomised, Placebo-controlled Shrink Study." Neurourology and Urodynamics, vol. 35, no. 7, 2016, pp. 819-25.
Robinson D, Oelke M, Khullar V, et al. Bladder wall thickness in women with symptoms of overactive bladder and detrusor overactivity: Results from the randomised, placebo-controlled shrink study. Neurourol Urodyn. 2016;35(7):819-25.
Robinson, D., Oelke, M., Khullar, V., Wijkstra, H., Tretter, R., Stow, B., Compion, G., & Tubaro, A. (2016). Bladder wall thickness in women with symptoms of overactive bladder and detrusor overactivity: Results from the randomised, placebo-controlled shrink study. Neurourology and Urodynamics, 35(7), 819-25. https://doi.org/10.1002/nau.22808
Robinson D, et al. Bladder Wall Thickness in Women With Symptoms of Overactive Bladder and Detrusor Overactivity: Results From the Randomised, Placebo-controlled Shrink Study. Neurourol Urodyn. 2016;35(7):819-25. PubMed PMID: 26199198.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bladder wall thickness in women with symptoms of overactive bladder and detrusor overactivity: Results from the randomised, placebo-controlled shrink study. AU - Robinson,Dudley, AU - Oelke,Matthias, AU - Khullar,Vik, AU - Wijkstra,Hessel, AU - Tretter,Reiner, AU - Stow,Bridget, AU - Compion,Gerhard, AU - Tubaro,Andrea, Y1 - 2015/07/21/ PY - 2014/12/23/received PY - 2015/05/18/accepted PY - 2015/7/23/entrez PY - 2015/7/23/pubmed PY - 2017/12/22/medline KW - antimuscarinics KW - bladder wall thickness KW - randomised controlled trial KW - solifenacin SP - 819 EP - 25 JF - Neurourology and urodynamics JO - Neurourol Urodyn VL - 35 IS - 7 N2 - AIMS: Measurement of bladder wall thickness (BWT) by transvaginal ultrasound (TVUS) may be a less invasive method to diagnose overactive bladder (OAB) or detrusor overactivity (DO) and monitor response to therapy. This study assessed whether treatment with solifenacin affects BWT. METHODS: This was a double-blind, randomised, placebo-controlled, phase 4 study. Adult women with OAB symptoms received solifenacin 5 or 10 mg or placebo once daily for 12 weeks. The co-primary endpoints were change from baseline to Week 12 in TVUS-measured BWT and urinary nerve growth factor. Only results for BWT are presented here. RESULTS: Overall, 547 patients were randomised, 501 patients had a baseline BWT measurement, and change from baseline could be calculated for 478 patients. Mean BWT at baseline was 5.08 mm (range 2.2-11.1, SD = 1.14) and was normally distributed. A significant reduction in BWT from baseline to 12 weeks versus placebo was observed with solifenacin 5 mg (-0.42 vs. -0.16 mm, P = 0.03), but not with the 10 mg dose or with pooled solifenacin, considered the primary comparison. Both solifenacin doses were associated with improvements in efficacy and patient satisfaction endpoints versus placebo. Solifenacin was well tolerated, with dry mouth being the most common adverse event. CONCLUSIONS: There was no consistent effect of solifenacin on BWT in women with OAB/DO, despite improvements in efficacy endpoints. This study suggests that routine clinical assessment of BWT with TVUS for monitoring the effects of OAB/DO treatment is not clinically useful. Neurourol. Urodynam. 35:819-825, 2016. © 2015 Wiley Periodicals, Inc. SN - 1520-6777 UR - https://www.unboundmedicine.com/medline/citation/26199198/Bladder_wall_thickness_in_women_with_symptoms_of_overactive_bladder_and_detrusor_overactivity:_Results_from_the_randomised_placebo_controlled_shrink_study_ L2 - https://doi.org/10.1002/nau.22808 DB - PRIME DP - Unbound Medicine ER -