Evidence map›Paper›PMID 28363809›Full record

ArticleSexual medicine2017

Vaginismus Treatment: Clinical Trials Follow Up 241 Patients.

Peter T Pacik, Simon Geletta

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Sexual medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% of its field
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.

NCT01352546 phase1completednot on this map

Open Label, Single Center, Pilot Study of the Use of BOTOX Injections, Sensorcaine Injections and Progressive Dilation Under Anesthesia for the Treatment of Primary Vaginismus

TypeinterventionalSponsorPlastic Surgery Professional AssociationRan2010 to 2012Enrolled31ConditionsVaginismusArmsBOTOX
NCT06755099 phase2 / phase3not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Experience of Vaginismus in Outpatient Attendants in Assiut University Women's Health Hospital: Prevalence, Impact on Quality of Life and Management

TypeinterventionalSponsorAssiut UniversityRan2025 to 2026Enrolled40ConditionsFemale Sexual DysfunctionArmsBotox, Radiofrequency
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 86 citations in OpenAlex.

  1. Pooled it
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  9. Botulinum toxin treatment of refractory vaginismus: a prospective study.International journal of women's dermatology · 2024
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  18. Botulinum injections for myofascial pelvic pain.International urogynecology journal · 2021
    Observational
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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

2 authors at 1 institution in 1 country.

Peter T PacikDunbarton, NH, USA. Electronic address: ptpacik@verizon.net.
Simon GelettaDepartment of Statistics, Des Moines University, Des Moines, IA, USA.
Des Moines University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVaginismus is mostly unknown among clinicians and women. Vaginismus causes women to have fear, anxiety, and pain with penetration attempts.

aimTo present a large cohort of patients based on prior published studies approved by an institutional review board and the Food and Drug Administration using a comprehensive multimodal vaginismus treatment program to treat the physical and psychologic manifestations of women with vaginismus and to record successes, failures, and untoward effects of this treatment approach.

methodsAssessment of vaginismus included a comprehensive pretreatment questionnaire, the Female Sexual Function Index (FSFI), and consultation. All patients signed a detailed informed consent. Treatment consisted of a multimodal approach including intravaginal injections of onabotulinumtoxinA (Botox) and bupivacaine, progressive dilation under conscious sedation, indwelling dilator, follow-up and support with office visits, phone calls, e-mails, dilation logs, and FSFI reports.

main outcome measuresLogs noting dilation progression, pain and anxiety scores, time to achieve intercourse, setbacks, and untoward effects. Post-treatment FSFI scores were compared with preprocedure scores.

resultsOne hundred seventy-one patients (71%) reported having pain-free intercourse at a mean of 5.1 weeks (median = 2.5). Six patients (2.5%) were unable to achieve intercourse within a 1-year period after treatment and 64 patients (26.6%) were lost to follow-up. The change in the overall FSFI score measured at baseline, 3 months, 6 months, and 1 year was statistically significant at the 0.05 level. Three patients developed mild temporary stress incontinence, two patients developed a short period of temporary blurred vision, and one patient developed temporary excessive vaginal dryness. All adverse events resolved by approximately 4 months. One patient required retreatment followed by successful coitus.

conclusionA multimodal program that treated the physical and psychologic aspects of vaginismus enabled women to achieve pain-free intercourse as noted by patient communications and serial female sexual function studies. Further studies are indicated to better understand the individual components of this multimodal treatment program. Pacik PT, Geletta S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med 2017;5:e114-e123.

Indexed as

DyspareuniaFemale Sexual PainGenito-Pelvic Pain/Penetration DisorderPenetration DisorderVaginismusVaginismus Treatment

Identifiers

PMID28363809
PMCPMC5440634
OpenAlexW2599418863

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.