Vibration or Transcutaneous Tibial Nerve Stimulation as a Treatment for Sexual Dysfunction in Women with Spinal Cord Injury: Study Protocol for a Randomized Clinical Trial

Round 1

Reviewer 1 Report

Thank you for the opportunity to review the manuscript entitled: 

 

 Vibration or transcutaneous tibial nerve stimulation as a treat-2 ment for sexual dysfunction in women with spinal cord injury: 3 Study protocol for a randomized clinical trial. 

In this paper, the authors described a randomized clinical trial that will recruit 54 women who, one year after a spinal cord injury, suffer 19 from sexual dysfunction associated with the latter. The participants will be randomized to three 20 groups: a) intervention group 1 treated with transcutaneous tibial nerve electrostimulation (n=18), 21 b) intervention group 2 treated with genital vibration (n=18), and c) a control group (n= 18). 

The paper is clear, and explains accurately the aim and the flow of the investigations. 

The Introduction is concise, clear, and with an adequate number and quality of references.

The section of the material and methods is complete and clear.  Mesures and endpoints are well established and described. The statistical analysis is well described. The ethical statement is present. 

The discussion is pertinent and comprehensive of information. The references in the discussion section are updated and adequate. The conclusions and the perspective are clear.

 This protocol could be of interest for the small but relevant population of clinicians who treat patients with neurological alterations after the spinal cord injury. Even if the topic of this manuscript is very specific; this protocol of investigation could add in perspective some new knowledge in the field of interventions for sexual dysfunction in women after SCI.  

I think this manuscript could be accepted for publication after minor revision concerning the English language.

 

 

 

Author Response

Thank you for your comments. We are very pleased with your opinion, especially we agree with the importance of publishing new interventions for sexual dysfunction in women after spinal cord injury.

Regarding the English language, the manuscript has been revised and we have submitted the Language Proofreader Certificate of Accuracy.

Reviewer 2 Report

Dear Vivian He,
       the manuscript is well written, organized and have an exhaustive and correct explanation of the protocol, the inclusion and the exclusion criteria, the way of randomization, the questionnaires and the statistic analysis used.
The topic of this research (and the related article) has to be considered a pilot study, because of the subject treated.
Sexual problems are in fact really hard to analyse in this population because of the complexity of spinal cord injuries and, consequently, it's difficult to have a large sample to examine, with the purpose to obtain easily significant results.
I have just few notes and suggestions to give to the collegues:
- if it's possible, to extend the examination of the sample recruited at 12 months after the last session of the two therapies studied, in this way the probability to obtain significant results increases.
- this is a study characterized by a relatively small sample because of the reasons explained in the upper part of the review, but it is also a single blind study protocol; the valuability of the research project would increases if instead it could be changed in a double-blind one.
- in the "genital vibration" group, the results of the therapy appear less objectivable because the frequency of the sessions is entrusted to the single patients (cit.: "at least once a week") and the therapy it is to be done before or during the sexual encounter. In this way it could be hard to mantain a high compliance and, moreover, to compare different frequencies of use.
In the PTNS group infact, all the women recruited are requested to have a single session, under medical control, once a week. It could be done in the same way in the genital vibration group?

Author Response

Thank you for your comments. We are justify some considerations in the attached document and correct them in the manuscript.

Author Response File: Author Response.docx