Effectiveness and durability of solifenacin versus percutaneous tibial nerve stimulation versus their combination for the treatment of women with overactive bladder syndrome: a randomized controlled study with a follow-up of ten months

Vecchioli-Scaldazza, Carlo; Morosetti, Carolina

doi:10.1590/S1677-5538.IBJU.2016.0611

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Sumário

Original Article • IBJUInt. braz j urol 44 (1) • Jan-Feb 2018 • https://doi.org/10.1590/S1677-5538.IBJU.2016.0611 copy

Effectiveness and durability of solifenacin versus percutaneous tibial nerve stimulation versus their combination for the treatment of women with overactive bladder syndrome: a randomized controlled study with a follow-up of ten months

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Purpose

To assess effectiveness and durability of Solifenacin (SS) versus tibial nerve stimulation (PTNS) versus combination therapy (PTNS + SS) in women with overactive bladder syndrome (OAB).

Materials and Methods

105 women with OAB were divided randomly into three groups of 35 patients each. In group A women received SS, in group B women underwent PTNS, in group C women underwent combination of PTNS + SS. Improvements in OAB symptoms were assessed with OABSS questionnaire; patients’ quality of life was assessed with OAB-q SF questionnaire. Evaluation of effectiveness of treatments was performed with PGI-I questionnaire. OABSS and PGI-I were also assessed monthly for ten months.

Results

All treatments were effective on symptoms. PTNS showed a greater effectiveness than SS, but PTNS + SS was more effective than SS and PTNS. Furthermore, PTNS + SS showed a greater duration of effectiveness than PTNS and SS.

Conclusions

Combination of PTNS with SS showed more effectiveness and more durability than PTNS and SS alone.

Keywords
Urinary Bladder; Overactive; Combined Modality Therapy; Solifenacin Succinate

Patients N°	SS			PTNS			SS + PTNS
Patients N°	27			34			33
Age	62(41-70)			60 (45-73)			63 (43-72)
Age	before	after	p value	before	after	p value	before	after	p value
OABSS	1.19±0.39	0.71±0.45	0.0020^* * Wilcoxon test (paired samples);	1.24±0.42	0.47±0.50	<0.0001^ Paired samples t-test;	1.22±0.42	0.33±0.47	<0.0001^* * Wilcoxon test (paired samples);
Day-time	SS after		vs	PTNS after		0.1334^* ***** Independent samples t-test;
frequency	SS after		vs	SS + PTNS after		0.0167^* ***** Independent samples t-test;
	PTNS after		vs	SS + PTNS after		0.4224^* ***** Independent samples t-test;
Night-time frequency (score 0-3)	2.62±0.79	1.76±1.31	0.0078^* * Wilcoxon test (paired samples);	2.71±0.67	1.41±1.19	0.0010^* * Wilcoxon test (paired samples);	2.89±0.31	0.89±0.87	<0.0001^* * Wilcoxon test (paired samples);
	SS after		vs	PTNS after		0.4110^* ***** Independent samples t-test;
	SS after		vs	SS + PTNS after		0.0243^* ***** Independent samples t-test;
	PTNS after		vs	SS + PTNS after		0.1585^* ***** Independent samples t-test;
Urgency (score 0-5)	4.29±0.63	3.43±1.09	0.0002^* * Wilcoxon test (paired samples);	4.35±0.59	3.00±1.14	<0.0001^ Paired samples t-test;	4.44±0.68	2.11±0.99	<0.0001^ Paired samples t-test;
	SS after		vs	PTNS after		0.2586^* ***** Independent samples t-test;
	SS after		vs	SS + PTNS after		0.0005^* ***** Independent samples t-test;
	PTNS after		vs	SS + PTNS after		0.0225^* ***** Independent samples t-test;
Urge incontinence (score 0-5)	3.71±1.12	2.67±1.49	0.0005^* * Wilcoxon test (paired samples);	4.00±0.69	2.24±1.35	0.0001^* * Wilcoxon test (paired samples);	3.44±1.5	0.56±1.26	<0.0001^* * Wilcoxon test (paired samples);
	SS after		vs	PTNS after		0.3742^* ***** Independent samples t-test;
	SS after		vs	SS + PTNS after		0.0003^** ****** Mann-Whitney test (independent samples)
	PTNS after		vs	SS + PTNS after		0.0015^** ****** Mann-Whitney test (independent samples)

	SS			PTNS			SS + PTNS
	before	after	p value	before	after	p value	before	after	p value
OAB-q SF 6	3.85±0.59	3.08±0.95	0.0001^* * Paired samples t-test	4.08±0.32	2.98±0.79	<0.0001^* * Paired samples t-test	4.21±0.24	2.32±0.87	<0.0001^* * Paired samples t-test
	SS after		vs	PTNS after		0.7525^ Independent samples t-test
	SS after		vs	SS + PTNS after		0.0168^ Independent samples t-test
	PTNS after		vs	SS + PTNS after		0.0287^ Independent samples t-test
OAB-q SF 13	3.92±0.62	3.16±0.95	0.0001^* * Paired samples t-test	4.22±0.32	2.96±0.97	<0.0001^* * Paired samples t-test	4.04±0.24	2.27±0.84	<0.0001^* * Paired samples t-test
	SS after		vs	PTNS after		0.5318^ Independent samples t-test
	SS after		vs	SS + PTNS after		0.0049^ Independent samples t-test
	PTNS after		vs	SS + PTNS after		0.0361^ Independent samples t-test
PGI-I		2.81±0.96			2.41±0.84			1.83±0.76
	SS		vs	PTNS		0.1997^ Independent samples t-test
	SS		vs	SS + PTNS		0.0017^ Independent samples t-test
	PTNS		vs	SS + PTNS		0.0468^ Independent samples t-test

	SS		PTNS		SS + PTNS
OAB-SS	0.93±1.44		2.50±2.38		5.88±2.20
	Solifenacin	vs	PTNS	p	0.0039^* * Mann-Whitney test (independent samples)
	Solifenacin	vs	Solifenacin + PTNS	p	<0.0001^* * Mann-Whitney test (independent samples)
	PTNS	vs	Solifenacin + PTNS	p	0.0009^* * Mann-Whitney test (independent samples)
PGI-I	0.71±1.13		2.10±1.92		5.63±2.00
	Solifenacin	vs	PTNS	p	0.0017^* * Mann-Whitney test (independent samples)
	Solifenacin	vs	Solifenacin + PTNS	p	<0.0001^* * Mann-Whitney test (independent samples)
	PTNS	vs	Solifenacin + PTNS	p	0.0002^* * Mann-Whitney test (independent samples)

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[1] Correspondence address: Carlo Vecchioli-Scaldazza, MD, Division of Urogynecology, ASUR, Corso Cavour 66, 62100, Macerata, Italy. E-Mail: cascave@alice.it