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Randomized clinical trials assessing third-line therapies to treat non-neurogenic overactive bladder syndrome: a review about methodology

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Abstract

Introduction and hypothesis

Using similar methodologies and outcome measures is crucial to allow pertinent literature reviews and meta-analyses. Therefore, this scoping review aims to compare methodologies of randomized clinical trials (RCTs) assessing the efficacy of third-line therapies to treat non-neurogenic OAB: intradetrusor onabotulinumtoxinA (BoNTA) injections, sacral neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS).

Methods

A literature search was conducted using the PubMed search database. Using filters, the search was limited to RCTs conducted on humans and written in English or French since 2000 which evaluated BoNTA injections, SNM and/or PTNS. RCTs focusing on pediatric or neurogenic OAB were excluded. For each included RCT, methodology was assessed using a standardized form investigating the study design, clinical outcomes and urodynamic outcomes. Inclusion criteria, sex ratio, blinding strategies, treatment arms, primary outcomes and delays for reevaluation were assessed. Availability of clinical and urodynamic outcomes was reported at baseline, 3 months and 6 months.

Results

Thirty-one RCTs were included in the final synthesis. The most frequent main outcome measure was change in the number of urinary incontinence episodes in 35.5% and in the number of voids per day in 25.8%. Bladder diaries were lacking in 12.9%, 32.3% and 80.1% at baseline, 3 and 6 months, respectively, while 26% of studies reported the results of urodynamic studies at any point.

Conclusion

Heterogeneity in study designs and data collection was pointed out between RCTs assessing the efficacy of third-line therapies to treat non-neurogenic OAB. We therefore advocate for the development of specific research guidelines focusing on OAB-related therapies.

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Abbreviations

OAB:

Overactive bladder syndrome

AUA:

American Urology Association

RCT:

Randomized controlled trial

BoNTA:

Onabotulinum toxin A

SNM:

Sacral nerve modulation

PTNS:

Posterior tibial nerve stimulation

UUI:

Urge urinary incontinence episodes

UI:

Urinary incontinence episodes

v/d:

Voids per day

/d:

Per day

/w:

Per week

AC:

Anticholinergic therapy

DO:

Detrusor overactivity

BD:

Bladder diary

VES:

Vaginal electric stimulation

IPN-SNS:

Intermittent percutaneous needle sacral nerve stimulation

SMT:

Standard medical therapy

GRA:

Global response assessment

PGI-I:

Patient’s Global Impression of Improvement

AQoL:

Assessment of quality of life

B3:

Urgent need to void

EQ5D:

EuroQoL 5 dimensions

HUI:

Health utility index

ICIQ:

International Consultation on Incontinence Questionnaire

IDC:

Volume at first involuntary detrusor contraction

IIQ7:

Incontinence Impact Questionnaire

IQOL:

Incontinence Quality of Life Questionnaire

KHQ:

King’s Health Questionnaire

MCC:

Mean cystometric capacity

OABq:

OAB quality of life

OABSatQ:

Overactive bladder satisfaction with treatment

PDetmax:

Maximum detrusor pressure during filling phase

PGSC:

Patient global symptoms control

PPBC:

Patient perception of bladder condition

PPIUS:

Patient perception of intensity of urgency scale

PVR:

Post-void residual

Qmax:

Maximum voiding flow

SB:

Symptom bother score

SRDS:

Self-reported depression scale

SRAS:

Self-reported anxiety scale

UDI:

Urogenital Distress Inventory

UIIQ:

Urinary Incontinence Impact Questionnaire

USI:

Urinary symptom interference

VAS:

Visual analog scale

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  1. Department of Urology, Claude Huriez Hospital, CHU LILLE, University of Lille, 1 rue Michel Polonovski, 59037, Lille cedex, France

    Pierre-Luc Dequirez & Xavier Biardeau

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X Biardeau is a consultant for Medtronic.

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Dequirez, PL., Biardeau, X. Randomized clinical trials assessing third-line therapies to treat non-neurogenic overactive bladder syndrome: a review about methodology. Int Urogynecol J 32, 2603–2618 (2021). https://doi.org/10.1007/s00192-021-04688-z

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