NCT03883178 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Beco J, Climov D, Bex M
Pudendal nerve decompression in perineology: a case series. BMC Surg. 2004 Oct 30;4:15.
Erdogru T, Avci E, Akand M
Laparoscopic pudendal nerve decompression and transposition combined with omental flap protection of the nerve (Istanbul technique): technical description and feasibility analysis. Surg Endosc. 2014 Mar;28(3):925-32. doi: 10.1007/s00464-013-3248-1. Epub 2013 Oct 23.
Konschake M, Brenner E, Moriggl B, Hörmann R, Bauer S, Foditsch E, Janetschek G, Künzel KH, Sievert KD, Zimmermann R
New laparoscopic approach to the pudendal nerve for neuromodulation based on an anatomic study. Neurourol Urodyn. 2017 Apr;36(4):1069-1075. doi: 10.1002/nau.23090. Epub 2016 Aug 4.
Labat JJ, Riant T, Robert R, Amarenco G, Lefaucheur JP, Rigaud J
Diagnostic criteria for pudendal neuralgia by pudendal nerve entrapment (Nantes criteria). Neurourol Urodyn. 2008;27(4):306-10.
Ploteau S, Salaud C, Hamel A, Robert R
Entrapment of the posterior femoral cutaneous nerve and its inferior cluneal branches: anatomical basis of surgery for inferior cluneal neuralgia. Surg Radiol Anat. 2017 Aug;39(8):859-863. doi: 10.1007/s00276-017-1825-z. Epub 2017 Feb 24.
Robert R, Labat JJ, Bensignor M, Glemain P, Deschamps C, Raoul S, Hamel O
Decompression and transposition of the pudendal nerve in pudendal neuralgia: a randomized controlled trial and long-term evaluation. Eur Urol. 2005 Mar;47(3):403-8.

New Endoscopic Minimal Invasive Approach for Pudendal Nerve and Inferior Cluneal Nerve Neurolysis: a Clinical Study

Clinical trial NCT03883178 - References