Evidence map›Paper›PMID 39539076›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2025

The Efficacy of Botulinum Toxin A Injection in Pelvic Floor Muscles in Chronic Pelvic Pain Patients: A Double-Blinded Randomised Controlled Trial.

Melle A Spruijt, Wenche M Klerkx, Kim Notten, Hugo van Eijndhoven, Leonie Speksnijder, Manon H Kerkhof, Kirsten B Kluivers

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Melle A SpruijtDepartment of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0001-6509-8270
Wenche M KlerkxDepartment of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, The Netherlands.
Kim NottenDepartment of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.
Hugo van EijndhovenDepartment of Obstetrics and Gynaecology, Isala Hospital, Zwolle, The Netherlands.
Leonie SpeksnijderDepartment of Obstetrics and Gynaecology, Amphia Hospital, Breda, The Netherlands.
Manon H KerkhofDepartment of Obstetrics and Gynaecology, Amphia Hospital, Breda, The Netherlands.
Kirsten B KluiversDepartment of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.

Funding

AbbVieIsala ziekenhuis Hospital research funding programmeSt. Antonius Ziekenhuis Hospital research funding programme
6 · The paper itself

Abstract

objectiveTo evaluate and compare the efficacy and safety of Botulinum Toxin A (BTA) injections versus placebo injections, combined with pelvic floor muscle therapy (PFMT), in women with chronic pelvic pain (CPP).

designRandomised, double-blinded clinical trial (January 2020-April 2023).

settingThis multicentre study was conducted at four hospitals in the Netherlands. POPULATION AND SAMPLE: Ninety-four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled.

methodsParticipants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions. MAIN OUTCOMES AND MEASURES: Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain. Secondary outcomes covered quality of life and pelvic floor function. Follow-up visits were scheduled at 4, 8, 12, and 26 weeks post-treatment. Mixed models for repeated measurements were used for analysis.

resultsA 33% reduction or more in average pain score was reported by 15 participants (33%) after BTA treatment and 9 participants (20%) after placebo treatment (odd ratio placebo/BTA 1.88; 95% CI 0.72-4.90, p = 0.19). In both groups, 8 women (17%) reported their improvement as (very) much better (odd ratio placebo/BTA 0.947; 95% CI 0.32-2.80, p = 0.92). Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo (p = 0.001).

conclusionThe results from this study do not support the use of BTA injections in the management of CPP in women.

Indexed as

Botulinum Toxins, Type AChronic PainNeuromuscular AgentsPelvic FloorPelvic PainAdultDouble-Blind MethodFemaleHumansInjections, IntramuscularMiddle AgedNetherlandsPain MeasurementQuality of LifeTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsbotulinum toxin Achronic painpelvic floor musclepelvic painphysical therapy

Identifiers

PMID39539076
PMCPMC11704059

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.